Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2490 | Placebo Wiki | 0.39 |
| drug1507 | Hydroxychloroquine Wiki | 0.21 |
| drug2557 | Placebo oral tablet Wiki | 0.16 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1740 | Ivermectin Wiki | 0.14 |
| drug3191 | Standard of Care Wiki | 0.13 |
| drug2827 | Remdesivir Wiki | 0.13 |
| drug2215 | No intervention Wiki | 0.11 |
| drug2192 | Nitazoxanide Wiki | 0.11 |
| drug2730 | Questionnaire Wiki | 0.10 |
| drug1861 | Losartan Wiki | 0.09 |
| drug884 | Convalescent Plasma Wiki | 0.09 |
| drug3628 | Vitamin C Wiki | 0.09 |
| drug3199 | Standard of care Wiki | 0.09 |
| drug2879 | Rivaroxaban Wiki | 0.09 |
| drug341 | Azithromycin Wiki | 0.08 |
| drug1292 | Favipiravir Wiki | 0.08 |
| drug1366 | Gam-COVID-Vac Wiki | 0.08 |
| drug2805 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.08 |
| drug2892 | Ruxolitinib Wiki | 0.08 |
| drug2985 | Saline Wiki | 0.08 |
| drug2575 | Placebos Wiki | 0.08 |
| drug4004 | placebo Wiki | 0.07 |
| drug899 | Convalescent plasma Wiki | 0.07 |
| drug3697 | Zinc Wiki | 0.07 |
| drug1527 | Hydroxychloroquine Sulfate Wiki | 0.07 |
| drug1672 | Interferon Beta-1A Wiki | 0.07 |
| drug2903 | SARS-CoV-2 Wiki | 0.07 |
| drug2916 | SARS-CoV-2 convalescent plasma Wiki | 0.07 |
| drug2152 | Nasopharyngeal swab Wiki | 0.07 |
| drug3430 | Tocilizumab Wiki | 0.06 |
| drug1842 | Lopinavir / Ritonavir Wiki | 0.06 |
| drug623 | COVID-19 convalescent plasma Wiki | 0.06 |
| drug2135 | Nafamostat Mesilate Wiki | 0.06 |
| drug1508 | Hydroxychloroquine (HCQ) Wiki | 0.06 |
| drug3173 | Standard Medical Treatment Wiki | 0.06 |
| drug1859 | Lopinavir/ritonavir Wiki | 0.06 |
| drug1673 | Interferon Beta-1B Wiki | 0.06 |
| drug2579 | Plasma Wiki | 0.06 |
| drug761 | Chloroquine or Hydroxychloroquine Wiki | 0.06 |
| drug2210 | No Intervention Wiki | 0.06 |
| drug1675 | Interferon beta-1a Wiki | 0.06 |
| drug1592 | INO-4800 Wiki | 0.06 |
| drug2180 | Niclosamide Wiki | 0.06 |
| drug1808 | Leronlimab (700mg) Wiki | 0.06 |
| drug2958 | SCTA01 Wiki | 0.06 |
| drug2870 | Ribavirin Wiki | 0.06 |
| drug3185 | Standard care Wiki | 0.06 |
| drug2998 | Saliva collection Wiki | 0.06 |
| drug1786 | LY3819253 Wiki | 0.06 |
| drug1906 | Lung ultrasound Wiki | 0.05 |
| drug3630 | Vitamin D Wiki | 0.05 |
| drug2665 | Prone positioning Wiki | 0.05 |
| drug2763 | REGN10933+REGN10987 combination therapy Wiki | 0.05 |
| drug3168 | Standard Care Wiki | 0.05 |
| drug1995 | Melatonin Wiki | 0.05 |
| drug557 | CELLECTRA® 2000 Wiki | 0.05 |
| drug2607 | Povidone-Iodine Wiki | 0.05 |
| drug2253 | Normal saline Wiki | 0.05 |
| drug2198 | Nitric Oxide Wiki | 0.05 |
| drug2249 | Normal Saline Wiki | 0.05 |
| drug4084 | standard care Wiki | 0.05 |
| drug1023 | Dexamethasone Wiki | 0.05 |
| drug731 | ChAdOx1 nCoV-19 Wiki | 0.05 |
| drug3869 | human monoclonal antibody DZIF-10c (Group 1A-2D) Wiki | 0.05 |
| drug1939 | MW33 injection Wiki | 0.05 |
| drug1455 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.05 |
| drug170 | Aeonose Wiki | 0.05 |
| drug1409 | HB-adMSCs Wiki | 0.05 |
| drug1587 | IMU-838 Wiki | 0.05 |
| drug2700 | Pulmozyme Wiki | 0.05 |
| drug3029 | Self Supportive Care (SSC) Alone Wiki | 0.05 |
| drug2186 | Nigella Sativa / Black Cumin Wiki | 0.05 |
| drug4053 | retrospective analysis Wiki | 0.05 |
| drug3461 | Tranexamic acid Wiki | 0.05 |
| drug1848 | Lopinavir-Ritonavir Wiki | 0.05 |
| drug2426 | Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki | 0.05 |
| drug3007 | Sample collection Wiki | 0.05 |
| drug2930 | SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki | 0.05 |
| drug1315 | Fisetin Wiki | 0.05 |
| drug2384 | PLX-PAD Wiki | 0.05 |
| drug1539 | Hydroxychloroquine Sulfate Tablets Wiki | 0.05 |
| drug1710 | Intramuscular injection Wiki | 0.05 |
| drug4142 | vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki | 0.05 |
| drug1728 | Ion Mobility Spectrometry (IMS) Wiki | 0.05 |
| drug2829 | Remdesivir placebo Wiki | 0.05 |
| drug4143 | vv-ECMO only (no cytokine adsorption) Wiki | 0.05 |
| drug3095 | Silmitasertib Wiki | 0.05 |
| drug2449 | Peripheral blood draw Wiki | 0.05 |
| drug678 | CVnCoV Vaccine Wiki | 0.05 |
| drug714 | Carrimycin Wiki | 0.05 |
| drug2435 | Peginterferon Lambda-1A Wiki | 0.05 |
| drug519 | Brequinar Wiki | 0.05 |
| drug1323 | Flow cytometric analysis Wiki | 0.05 |
| drug2780 | Radiation therapy Wiki | 0.05 |
| drug1866 | Low Dose Radiation Therapy Wiki | 0.05 |
| drug2897 | SAB-185 Wiki | 0.05 |
| drug2103 | N-Acetyl cysteine Wiki | 0.05 |
| drug1228 | Exercise Wiki | 0.05 |
| drug1762 | KB109 + Self Supportive Care (SSC) Wiki | 0.05 |
| drug3180 | Standard Therapy Wiki | 0.05 |
| drug3154 | Spirometry Wiki | 0.05 |
| drug1520 | Hydroxychloroquine - Weekly Dosing Wiki | 0.05 |
| drug2076 | Molnupiravir Wiki | 0.05 |
| drug2618 | Practice details Wiki | 0.05 |
| drug2301 | Olokizumab 64 mg Wiki | 0.05 |
| drug1769 | Ketogenic diet Wiki | 0.05 |
| drug1008 | Deferoxamine Wiki | 0.05 |
| drug2553 | Placebo on a 0- and 28-day schedule Wiki | 0.05 |
| drug1940 | MW33 injection placebo Wiki | 0.05 |
| drug1068 | Disulfiram Wiki | 0.05 |
| drug2494 | Placebo (NaCl 0.9%) (Group 2D) Wiki | 0.05 |
| drug2023 | Metformin Wiki | 0.05 |
| drug3207 | Standard of care treatment Wiki | 0.05 |
| drug2918 | SARS-CoV-2 diagnostic rapid test Wiki | 0.05 |
| drug2908 | SARS-CoV-2 PCR Wiki | 0.05 |
| drug1343 | Fostamatinib Wiki | 0.05 |
| drug2894 | Ruxolitinib Oral Tablet Wiki | 0.05 |
| drug2972 | SOC Wiki | 0.05 |
| drug1141 | Ebselen Wiki | 0.05 |
| drug1990 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.05 |
| drug1330 | Fluvoxamine Wiki | 0.05 |
| drug1755 | Ivermectin and Doxycycline Wiki | 0.05 |
| drug1037 | Diagnostic test Wiki | 0.05 |
| drug2181 | Niclosamide Oral Tablet Wiki | 0.05 |
| drug890 | Convalescent Plasma Transfusion Wiki | 0.05 |
| drug1104 | Duvelisib Wiki | 0.05 |
| drug885 | Convalescent Plasma (CP) Wiki | 0.05 |
| drug1969 | Matching Placebo Wiki | 0.05 |
| drug1874 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.05 |
| drug2776 | RTB101 Wiki | 0.05 |
| drug1513 | Hydroxychloroquine + azithromycin Wiki | 0.05 |
| drug1496 | Human biological samples Wiki | 0.05 |
| drug1751 | Ivermectin Oral Product Wiki | 0.05 |
| drug1256 | Expressive writing Wiki | 0.05 |
| drug3104 | Single Dose of Hydroxychloroquine Wiki | 0.05 |
| drug3871 | hydroxychloroquine Wiki | 0.05 |
| drug1084 | Doxycycline Wiki | 0.05 |
| drug2322 | Online questionnaire Wiki | 0.05 |
| drug289 | Aspirin Wiki | 0.05 |
| drug2317 | Online Survey Wiki | 0.05 |
| drug808 | Colchicine Wiki | 0.05 |
| drug686 | Camostat Mesilate Wiki | 0.04 |
| drug1193 | Enoxaparin Wiki | 0.04 |
| drug3015 | Sarilumab Wiki | 0.04 |
| drug756 | Chloroquine Wiki | 0.04 |
| drug2663 | Prone position Wiki | 0.04 |
| drug210 | Anakinra Wiki | 0.04 |
| drug3065 | Serological test Wiki | 0.04 |
| drug976 | DWRX2003 Wiki | 0.04 |
| drug1642 | Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki | 0.04 |
| drug119 | AV-COVID-19 Wiki | 0.04 |
| drug1787 | LY3832479 Wiki | 0.04 |
| drug3923 | mRNA-1273 Wiki | 0.04 |
| drug1676 | Interferon beta-1b Wiki | 0.04 |
| drug3880 | hzVSF-v13 Wiki | 0.04 |
| drug3637 | Vitamin Super B-Complex Wiki | 0.04 |
| drug2495 | Placebo (Normal saline solution) Wiki | 0.04 |
| drug4070 | serology Wiki | 0.04 |
| drug2676 | Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki | 0.04 |
| drug2137 | Naltrexone Wiki | 0.04 |
| drug3043 | Selinexor Wiki | 0.04 |
| drug656 | COViage Wiki | 0.04 |
| drug3319 | TY027 Wiki | 0.04 |
| drug3196 | Standard of Care (SoC) Wiki | 0.04 |
| drug1807 | Lenzilumab Wiki | 0.04 |
| drug2200 | Nitric Oxide Gas Wiki | 0.04 |
| drug2555 | Placebo oral capsule Wiki | 0.04 |
| drug2771 | RT-PCR Wiki | 0.04 |
| drug1288 | Famotidine Wiki | 0.04 |
| drug16 | 0.9% saline Wiki | 0.04 |
| drug1116 | EIDD-2801 Wiki | 0.04 |
| drug2272 | Nuvastatic Wiki | 0.03 |
| drug1412 | HCQ & AZ Wiki | 0.03 |
| drug2459 | Personalized ambulatory training Wiki | 0.03 |
| drug2939 | SARS-CoV-2 vaccine formulation 2 with adjuvant 1 Wiki | 0.03 |
| drug2766 | RIA-device (Remote Investigation and Assessment) Wiki | 0.03 |
| drug2907 | SARS-CoV-2 IgG Antibody Testing Kit Wiki | 0.03 |
| drug1404 | Guided online support program Wiki | 0.03 |
| drug121 | AVIGAN Wiki | 0.03 |
| drug887 | Convalescent Plasma 1 Unit Wiki | 0.03 |
| drug3298 | T89 Wiki | 0.03 |
| drug1470 | High-dose placebo (18-59 years) & Two dose regimen Wiki | 0.03 |
| drug1678 | Interferon-Beta Wiki | 0.03 |
| drug1598 | IV Dexamethasone Wiki | 0.03 |
| drug2113 | NETosis markers Wiki | 0.03 |
| drug332 | Aviptadil 67μg Wiki | 0.03 |
| drug2125 | NO-Immunosuppressive Wiki | 0.03 |
| drug1682 | Interleukin 6 (IL6) Antagonist Wiki | 0.03 |
| drug3052 | SensiumVitals wearable sensor Wiki | 0.03 |
| drug741 | Change in knowledge, motivation, skills, resources Wiki | 0.03 |
| drug936 | Covid-19 swab PCR test Wiki | 0.03 |
| drug3106 | Single high dose vitamin D Wiki | 0.03 |
| drug4128 | urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic Wiki | 0.03 |
| drug188 | Airwave Oscillometry Wiki | 0.03 |
| drug2257 | Normal saline solution (NSS), Placebo, Day 189 - Phase 2 Wiki | 0.03 |
| drug279 | ArtemiC Wiki | 0.03 |
| drug2039 | Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension Wiki | 0.03 |
| drug2207 | Nitroglycerin Wiki | 0.03 |
| drug2334 | Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East Wiki | 0.03 |
| drug2943 | SARS-CoV-2-test Wiki | 0.03 |
| drug1813 | Levamisole and Isoprinosine Wiki | 0.03 |
| drug2989 | Saline containing 1% Human serum albumin（solution without UC-MSCs） Wiki | 0.03 |
| drug3639 | Vitamins and Minerals Wiki | 0.03 |
| drug3850 | glenzocimab Wiki | 0.03 |
| drug3206 | Standard of care therapy Wiki | 0.03 |
| drug2008 | Merimepodib Wiki | 0.03 |
| drug1097 | Drugs and supportive care Wiki | 0.03 |
| drug2108 | NA-831 Wiki | 0.03 |
| drug2762 | REGN10933+REGN10987 Wiki | 0.03 |
| drug2364 | P2Et (Caesalpinia spinosa extract) Wiki | 0.03 |
| drug1895 | Low-dose placebo (60-85 years) & Two dose regimen Wiki | 0.03 |
| drug1401 | Growth Hormone Wiki | 0.03 |
| drug2830 | Remdesivir-HU Wiki | 0.03 |
| drug2940 | SARS-CoV-2 vaccine formulation 2 with adjuvant 2 Wiki | 0.03 |
| drug4028 | pulmonary rehabilitation Wiki | 0.03 |
| drug2714 | Quality of Life Wiki | 0.03 |
| drug1606 | Icosapent ethyl (IPE) Wiki | 0.03 |
| drug1938 | MVC-COV1901 Wiki | 0.03 |
| drug774 | Clarithromycin Wiki | 0.03 |
| drug1593 | INOpulse Wiki | 0.03 |
| drug1266 | F-652 Wiki | 0.03 |
| drug676 | CVnCoV 12μg Wiki | 0.03 |
| drug2341 | Oral supplement enriched in antioxidants Wiki | 0.03 |
| drug642 | COVID-19 testing Wiki | 0.03 |
| drug2758 | RDV Wiki | 0.03 |
| drug1396 | Group B Control Wiki | 0.03 |
| drug1099 | Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki | 0.03 |
| drug1117 | EIT-Group Wiki | 0.03 |
| drug1780 | LAU-7b Wiki | 0.03 |
| drug1386 | Grocery store gift cards Wiki | 0.03 |
| drug1443 | Hepatitis A vaccine Wiki | 0.03 |
| drug2482 | Piclidenoson Wiki | 0.03 |
| drug1631 | Immunoglubulins Wiki | 0.03 |
| drug3428 | To assess for development of IgG antibodies against SARS-CoV2 Wiki | 0.03 |
| drug1473 | High-flow nasal cannula treatment Wiki | 0.03 |
| drug2857 | Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki | 0.03 |
| drug1468 | High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki | 0.03 |
| drug1746 | Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets Wiki | 0.03 |
| drug1578 | ID NOW vs. Accula Wiki | 0.03 |
| drug2078 | Monitoring Visit - Baseline Wiki | 0.03 |
| drug2372 | PEP flute Wiki | 0.03 |
| drug3246 | Study D Wiki | 0.03 |
| drug2282 | Observation of patients with known, suspected, or at risk for COVID-19 infection Wiki | 0.03 |
| drug1314 | Fingolimod 0.5 mg Wiki | 0.03 |
| drug2318 | Online Survey about Dietary and Lifestyle Habits Wiki | 0.03 |
| drug1512 | Hydroxychloroquine + Sorbitol Wiki | 0.03 |
| drug2869 | Rhea Health Tone® Wiki | 0.03 |
| drug1828 | Linagliptin Wiki | 0.03 |
| drug3589 | Vehicle + Heparin along with best supportive care Wiki | 0.03 |
| drug3202 | Standard of care (SOC) plus placebo Wiki | 0.03 |
| drug2402 | Pacritinib Wiki | 0.03 |
| drug2536 | Placebo for "Deficiency of Qi and Yang" Wiki | 0.03 |
| drug3365 | Test: Favipiravir 200 mg (LOQULAR) Wiki | 0.03 |
| drug1476 | Home Pulse Oximetry Monitoring Wiki | 0.03 |
| drug1384 | Glycine Wiki | 0.03 |
| drug2337 | Oral Wiki | 0.03 |
| drug3465 | Transcutaneous Auricular Vagus Nerve Stimulation Wiki | 0.03 |
| drug3584 | Validation of the POCT Antigen tests Wiki | 0.03 |
| drug1157 | Electrical Impedance tomography Wiki | 0.03 |
| drug3495 | Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki | 0.03 |
| drug2412 | Particle measurement Wiki | 0.03 |
| drug1192 | Enisamium Iodide Wiki | 0.03 |
| drug3525 | UCMSCs Wiki | 0.03 |
| drug2552 | Placebo on a 0- and 14-day schedule Wiki | 0.03 |
| drug3623 | Viruxal Oral and Nasal Spray Wiki | 0.03 |
| drug1493 | Human Biological samples Wiki | 0.03 |
| drug3780 | cellulose-containing placebo capsules Wiki | 0.03 |
| drug2454 | Personal behaviours Wiki | 0.03 |
| drug2933 | SARS-CoV-2 serological assessment (IgG) Wiki | 0.03 |
| drug178 | Aerosolized 13 cis retinoic acid plus Inhalation Inhaled testosterone Wiki | 0.03 |
| drug2223 | No intervention, this is an observational study that uses validated questionnaires and qualitative interviews.. Wiki | 0.03 |
| drug2262 | Novel laser inferometry test for CORONA virus Wiki | 0.03 |
| drug3245 | Study C Wiki | 0.03 |
| drug2862 | Retrospective case-control analysis Wiki | 0.03 |
| drug322 | Auricular neuromodulation Wiki | 0.03 |
| drug2787 | Randomized booster Wiki | 0.03 |
| drug1352 | GAMUNEX-C Wiki | 0.03 |
| drug2924 | SARS-CoV-2 rS/Matrix M1-Adjuvant Wiki | 0.03 |
| drug2538 | Placebo for ABBV-47D11 Wiki | 0.03 |
| drug3164 | Standard (specific) therapy for COVID-19 Wiki | 0.03 |
| drug3238 | Stool collection or fecal swab Wiki | 0.03 |
| drug3423 | Tigerase® and best available care Wiki | 0.03 |
| drug2129 | NP-120 (Ifenprodil) Wiki | 0.03 |
| drug2659 | Prone Position (PP) Wiki | 0.03 |
| drug1820 | Lidocaine 2% Wiki | 0.03 |
| drug2612 | Povidone-Iodine 0.6% NI Wiki | 0.03 |
| drug2914 | SARS-CoV-2 antibody test Wiki | 0.03 |
| drug2022 | MetaNeb® System Wiki | 0.03 |
| drug2096 | Muscle ultrasound Wiki | 0.03 |
| drug4145 | web based survey Wiki | 0.03 |
| drug2082 | Monitoring physiological data with the Hexoskin smart shirt Wiki | 0.03 |
| drug3553 | Use of mobile application Wiki | 0.03 |
| drug1923 | MR or M-M-R II ® vaccine Wiki | 0.03 |
| drug2997 | Saliva based assay: crude RNA extraction Wiki | 0.03 |
| drug1070 | Doctella telehealth monitoring Wiki | 0.03 |
| drug2097 | MuscleSound Ultrasound Wiki | 0.03 |
| drug3386 | The usual treatment Wiki | 0.03 |
| drug4147 | zinc acetate Wiki | 0.03 |
| drug2138 | Nanocovax Wiki | 0.03 |
| drug2037 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.03 |
| drug2496 | Placebo (PB0) Wiki | 0.03 |
| drug1362 | GPs reports of potential patient safety incidents, non-COVID-19 related Wiki | 0.03 |
| drug734 | ChAdOx1 nCoV-19 (qPCR) Wiki | 0.03 |
| drug2687 | Psychological stress and adaptation at work score (PSAS) Wiki | 0.03 |
| drug2028 | MethylPREDNISolone 80 Mg/mL Injectable Suspension Wiki | 0.03 |
| drug3011 | Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol Wiki | 0.03 |
| drug3994 | pathogen reduced SARS-CoV-2 convalescent plasma Wiki | 0.03 |
| drug1150 | Education sessions Wiki | 0.03 |
| drug744 | Chat-based support Wiki | 0.03 |
| drug2452 | Personal Exercise Intervention Wiki | 0.03 |
| drug1680 | Interferon-β 1a Wiki | 0.03 |
| drug1826 | Lift Wiki | 0.03 |
| drug2719 | Quantitative analysis of SARS-CoV-2 antibodies Wiki | 0.03 |
| drug1743 | Ivermectin + Doxycycline + Placebo Wiki | 0.03 |
| drug2590 | Plitidepsin 1.5 mg/day Wiki | 0.03 |
| drug661 | CSL324 Wiki | 0.03 |
| drug1887 | Low-dose Chest CT Wiki | 0.03 |
| drug1444 | Hesperidin and Diosmin mixture Wiki | 0.03 |
| drug2092 | Multicapillary column coupled ion mobility spectrometry Wiki | 0.03 |
| drug1693 | Internet-based self-help Wiki | 0.03 |
| drug1894 | Low-dose placebo (60-85 years) & Three dose regimen Wiki | 0.03 |
| drug1761 | Janus Kinase Inhibitor (ruxolitinib) Wiki | 0.03 |
| drug913 | Core Warming Wiki | 0.03 |
| drug1522 | Hydroxychloroquine Only Product in Oral Dose Form Wiki | 0.03 |
| drug3174 | Standard Of Care (SOC) Wiki | 0.03 |
| drug1054 | Digital oximeter monitoring Wiki | 0.03 |
| drug1908 | LungFit™ Wiki | 0.03 |
| drug1837 | Liver, lung, heart and kidney biopsy Wiki | 0.03 |
| drug2133 | NaCl 0.9% Wiki | 0.03 |
| drug2945 | SARS-CoV2 Infection Wiki | 0.03 |
| drug3496 | Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Wiki | 0.03 |
| drug970 | DECT Wiki | 0.03 |
| drug60 | 80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki | 0.03 |
| drug817 | Colgate periogard mouthwash Wiki | 0.03 |
| drug2401 | Pacebo: Calcium citrate Wiki | 0.03 |
| drug2959 | SCTA01 Placebo Wiki | 0.03 |
| drug1846 | Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki | 0.03 |
| drug3680 | XC7 200 mg single Wiki | 0.03 |
| drug1745 | Ivermectin 3mg Tab Wiki | 0.03 |
| drug3012 | Sampling of tissue Wiki | 0.03 |
| drug2024 | Metformin Glycinate Wiki | 0.03 |
| drug406 | Base therapy Wiki | 0.03 |
| drug1999 | MenACWY Wiki | 0.03 |
| drug2347 | Other Wiki | 0.03 |
| drug2450 | Peripheral blood sampling Wiki | 0.03 |
| drug2944 | SARS-CoV2 Autoantibody detection Wiki | 0.03 |
| drug1392 | Group A HCQ Wiki | 0.03 |
| drug2366 | PCR Wiki | 0.03 |
| drug1819 | Licorice extract Wiki | 0.03 |
| drug1615 | IgM and IgG antibodies assay Wiki | 0.03 |
| drug2803 | Recombinant Human Interferon α2b Spray Wiki | 0.03 |
| drug3872 | hydroxychloroquine + azithromycin Wiki | 0.03 |
| drug3144 | Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group Wiki | 0.03 |
| drug1408 | HB-adMSC Wiki | 0.03 |
| drug1187 | Endoscopic procedure Wiki | 0.03 |
| drug3656 | Web Based Questionnaire Wiki | 0.03 |
| drug2994 | Saline-sodium citrate (SSC) buffer Wiki | 0.03 |
| drug1594 | IP-10 in CDS protocol Wiki | 0.03 |
| drug2380 | PHR160 Spray Wiki | 0.03 |
| drug3677 | XC221 Wiki | 0.03 |
| drug1926 | MRI Wiki | 0.03 |
| drug2030 | Methylene Blue 5 MG/ML Wiki | 0.03 |
| drug2872 | Ringer's lactate Wiki | 0.03 |
| drug237 | Anti-COVID-19 human immunoglobulin Wiki | 0.03 |
| drug3070 | Serology Wiki | 0.03 |
| drug1597 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.03 |
| drug1540 | Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki | 0.03 |
| drug592 | COVID positive via testing Wiki | 0.03 |
| drug357 | BAT2020 Wiki | 0.03 |
| drug1490 | Hospitalized Patients for COVID-19 Infection Wiki | 0.03 |
| drug2465 | Phlebotomy Wiki | 0.03 |
| drug1105 | Dysphagia Handicap Index (DHI) Wiki | 0.03 |
| drug2682 | Psycho-Social Questionnaire Wiki | 0.03 |
| drug2136 | Nafamostat Mesylate Wiki | 0.03 |
| drug1565 | Hyperbaric oxygen therapy Wiki | 0.03 |
| drug1759 | Ivermectin plus Nitazoxanide Wiki | 0.03 |
| drug2484 | Pioglitazone Wiki | 0.03 |
| drug1389 | Group 2: control group with enoxaparin 40mg/d Wiki | 0.03 |
| drug2292 | Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples Wiki | 0.03 |
| drug110 | ASC09/ritonavir group Wiki | 0.03 |
| drug334 | Awake Prone Positioning Wiki | 0.03 |
| drug2395 | PT-Pal Wiki | 0.03 |
| drug2281 | Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings Wiki | 0.03 |
| drug2388 | PRO-SERO-COV Wiki | 0.03 |
| drug1423 | Health Care Worker Survey Wiki | 0.03 |
| drug3803 | convalescent plasma application to SARS-CoV-2 infected patients Wiki | 0.03 |
| drug353 | Açaí palm berry extract - natural product Wiki | 0.03 |
| drug2598 | Polyoxidonium Wiki | 0.03 |
| drug3700 | Zinc (zinc gluconate) & Vitamin D (cholecalciferol) Wiki | 0.03 |
| drug1501 | Humoral and cellular immunity Wiki | 0.03 |
| drug737 | ChAdOx1 nCoV-19 full boost Wiki | 0.03 |
| drug725 | Centricyte 1000 Wiki | 0.03 |
| drug1482 | Home-based exercise training Wiki | 0.03 |
| drug2286 | Observational Study Wiki | 0.03 |
| drug2837 | Remote consultation Wiki | 0.03 |
| drug3608 | Videofluoroscopy Wiki | 0.03 |
| drug4055 | revised HOME-CoV score Wiki | 0.03 |
| drug2127 | NOWDx COVID-19 Test Wiki | 0.03 |
| drug2457 | Personal protective equipment (PPE) Wiki | 0.03 |
| drug604 | COVID-19 IgG / IgM rapid test (whole blood, serum, plasma) Wiki | 0.03 |
| drug4137 | virgin coconut oil (VCO) Wiki | 0.03 |
| drug2504 | Placebo (two doses), priming Wiki | 0.03 |
| drug983 | Dalcetrapib Wiki | 0.03 |
| drug2397 | PTC299 Wiki | 0.03 |
| drug281 | Artemisinin / Artesunate Wiki | 0.03 |
| drug2729 | Questionaire Wiki | 0.03 |
| drug4120 | thymosin alpha 1 Wiki | 0.03 |
| drug846 | Complete thrombophilic profile testing by multiplex PCR Wiki | 0.03 |
| drug3538 | Umbilical Cord Lining Stem Cells (ULSC) Wiki | 0.03 |
| drug1855 | Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet Wiki | 0.03 |
| drug3115 | Six-minute walk test (6MWT) Wiki | 0.03 |
| drug2833 | Remote Automated Monitoring System Wiki | 0.03 |
| drug1332 | FoTv Wiki | 0.03 |
| drug376 | BIO101 Wiki | 0.03 |
| drug1098 | Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki | 0.03 |
| drug1129 | EQ001 Placebo Wiki | 0.03 |
| drug2367 | PCR Value Wiki | 0.03 |
| drug1354 | GC5131 Wiki | 0.03 |
| drug1596 | ISIS 721744 Wiki | 0.03 |
| drug1666 | Innova Lateral Flow Device Wiki | 0.03 |
| drug1867 | Low Dose Radiation Therapy (LD-RT) Wiki | 0.03 |
| drug1567 | Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) Wiki | 0.03 |
| drug3005 | Sample Collection/Performance Evaluation (A) Wiki | 0.03 |
| drug2638 | Primary care professionals reports of potential patient safety incidents, non-COVID-19 related Wiki | 0.03 |
| drug1918 | MFS Wiki | 0.03 |
| drug2335 | Optional blood completion Wiki | 0.03 |
| drug2445 | Performance of the test antigenic and test RT-PCR Wiki | 0.03 |
| drug2629 | Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 Wiki | 0.03 |
| drug2726 | Quercetin Prophylaxis Wiki | 0.03 |
| drug824 | Collection of samples Wiki | 0.03 |
| drug356 | BAT + Calcifediol Wiki | 0.03 |
| drug2312 | One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki | 0.03 |
| drug1948 | Maintenance or reduction of immunosuppression Wiki | 0.03 |
| drug699 | Capillary and salivary sampling Wiki | 0.03 |
| drug3445 | Toremifene Wiki | 0.03 |
| drug453 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki | 0.03 |
| drug2415 | Patch, Nicotine Wiki | 0.03 |
| drug2589 | Plethysmography & DLCO Wiki | 0.03 |
| drug2503 | Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki | 0.03 |
| drug3449 | Tracheotomy Wiki | 0.03 |
| drug2248 | Noninvasive ventilation treatment Wiki | 0.03 |
| drug4139 | vitamin D Wiki | 0.03 |
| drug2204 | Nitric Oxide-Releasing Drug Wiki | 0.03 |
| drug3397 | There is no intervention Wiki | 0.03 |
| drug2708 | Q16 testing Wiki | 0.03 |
| drug3294 | T memory cells and NK cells Wiki | 0.03 |
| drug3491 | Trimodulin Wiki | 0.03 |
| drug1852 | Lopinavir/ Ritonavir Placebo Wiki | 0.03 |
| drug1127 | EPIC risk score display Wiki | 0.03 |
| drug2603 | Post-intensive Care unit syndrome Wiki | 0.03 |
| drug1318 | Fixed site standard of care testing Wiki | 0.03 |
| drug1148 | Edoxaban Tablets Wiki | 0.03 |
| drug1276 | FSD201 Wiki | 0.03 |
| drug2193 | Nitazoxanide 500 MG Wiki | 0.03 |
| drug2718 | Quantitative IgG Test Wiki | 0.03 |
| drug2551 | Placebo of excipient(s) will be administered Wiki | 0.03 |
| drug3613 | Virtual Assistant first, then Human Coach Wiki | 0.03 |
| drug2634 | Prevalence of COVID-19 Wiki | 0.03 |
| drug4100 | survey work Wiki | 0.03 |
| drug1989 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.03 |
| drug2424 | Patient sampling Wiki | 0.03 |
| drug2195 | Nitazoxanide Tablets Wiki | 0.03 |
| drug2165 | Negative COVID Test Result - Hypothetical Scenario Wiki | 0.03 |
| drug2431 | Patients with the treatment agains COVID19 Wiki | 0.03 |
| drug3635 | Vitamin D3 or Placebo Wiki | 0.03 |
| drug2937 | SARS-CoV-2 vaccine formulation 1 with adjuvant 1 Wiki | 0.03 |
| drug2224 | No interventions Wiki | 0.03 |
| drug1154 | Elective Cancer Surgery Wiki | 0.03 |
| drug3618 | Virtual Group Intervention Wiki | 0.03 |
| drug2645 | Probiotics Wiki | 0.03 |
| drug841 | Comparative Observational Cohort Study Wiki | 0.03 |
| drug2519 | Placebo Hydroxychloroquine Wiki | 0.03 |
| drug2236 | Non-contact ECG Wiki | 0.03 |
| drug4009 | plasma from convalescent patients with COVID-19 Wiki | 0.03 |
| drug1087 | Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki | 0.03 |
| drug2470 | Phsyiotherapy Wiki | 0.03 |
| drug3417 | Thromboprophylaxis Wiki | 0.03 |
| drug1542 | Hydroxychloroquine and azithromycin treatment Wiki | 0.03 |
| drug3498 | Two dose MenACWY vaccine Wiki | 0.03 |
| drug3642 | Voice Symptom Scale (VoiSS) Wiki | 0.03 |
| drug1783 | LMWH Wiki | 0.03 |
| drug850 | Complex diagnostic panel Wiki | 0.03 |
| drug2437 | Peginterferon beta-1a Wiki | 0.03 |
| drug1120 | ELISPOT Wiki | 0.03 |
| drug1603 | Ibuprofen Wiki | 0.03 |
| drug540 | Burnout Wiki | 0.03 |
| drug1875 | Low dose Interferon-beta 1a Wiki | 0.03 |
| drug302 | Assessment of ventilator-associated pneumonia criteria Wiki | 0.03 |
| drug3485 | Treatment group Wiki | 0.03 |
| drug1812 | Levamisole Pill + Budesonide+Formoterol inhaler Wiki | 0.03 |
| drug3634 | Vitamin D3 (cholecalciferol) Wiki | 0.03 |
| drug2351 | Ovotransferrin Wiki | 0.03 |
| drug2572 | Placebo: Emtricitabine/tenofovir disoproxil Placebo Wiki | 0.03 |
| drug114 | AT-527 Wiki | 0.03 |
| drug1802 | Late-Dexamethasone Wiki | 0.03 |
| drug3833 | exercise brochure Wiki | 0.03 |
| drug2021 | Messaging Wiki | 0.03 |
| drug3899 | intradermal injection of BCG Vaccine Wiki | 0.03 |
| drug1518 | Hydroxychloroquine - Daily Dosing Wiki | 0.03 |
| drug3053 | Sequencing Wiki | 0.03 |
| drug964 | D-dimer,CBC.ESR,CRP, Wiki | 0.03 |
| drug3023 | Savicell's ImmunoBiopsy™ Wiki | 0.03 |
| drug3042 | Self-questionnary Wiki | 0.03 |
| drug1456 | High dose Interferon-beta 1a Wiki | 0.03 |
| drug733 | ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki | 0.03 |
| drug1890 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen Wiki | 0.03 |
| drug3483 | Treatment as usual vitamin D Wiki | 0.03 |
| drug2258 | Normal saline solution (NSS), Placebo, Day 21 - Phase 1 Wiki | 0.03 |
| drug1550 | Hydroxychloroquine sulfate &Azithromycin Wiki | 0.03 |
| drug2965 | SIR1-365 Wiki | 0.03 |
| drug1207 | Environmental exposure and clinical features Wiki | 0.03 |
| drug2546 | Placebo nebuliser solution Wiki | 0.03 |
| drug1447 | High Dose of KBP-COVID-19 Wiki | 0.03 |
| drug2621 | Prazosin Wiki | 0.03 |
| drug399 | Bardoxolone methyl Wiki | 0.03 |
| drug2757 | RD-X19 Wiki | 0.03 |
| drug2287 | Observational cohort study on the natural history of hospitalized SARS-COV-2 patients. Wiki | 0.03 |
| drug3831 | evaluation of skin microvascular flow and reactivity Wiki | 0.03 |
| drug3856 | high flow nasal cannula device Wiki | 0.03 |
| drug3110 | Sirukumab Wiki | 0.03 |
| drug1474 | High-titer Convalescent COVID-19 Plasma (CCP1) Wiki | 0.03 |
| drug1629 | Immunoglobulin Wiki | 0.03 |
| drug2964 | SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) Wiki | 0.03 |
| drug912 | Cordio App Wiki | 0.03 |
| drug2144 | Nasal Spray Wiki | 0.03 |
| drug1661 | Inhaled budesonide Wiki | 0.03 |
| drug2139 | Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) Wiki | 0.03 |
| drug1548 | Hydroxychloroquine plus standard preventive measures Wiki | 0.03 |
| drug3302 | TAK-919 Wiki | 0.03 |
| drug2080 | Monitoring Visit - Week 8 Wiki | 0.03 |
| drug1511 | Hydroxychloroquine + Metabolic cofactor supplementation Wiki | 0.03 |
| drug1633 | Immunosuppressive Wiki | 0.03 |
| drug1019 | Desidustat Wiki | 0.03 |
| drug2686 | Psychological and Behaviour Change Support Wiki | 0.03 |
| drug2456 | Personal protective equipment Wiki | 0.03 |
| drug3693 | Zavegepant (BHV-3500) Wiki | 0.03 |
| drug2664 | Prone position ventilation Wiki | 0.03 |
| drug312 | Atazanavir and Dexamethasone Wiki | 0.03 |
| drug7 | 0.12% Chlorhexidine Gluconate Wiki | 0.03 |
| drug3531 | UV Light Treatment Wiki | 0.03 |
| drug2359 | Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki | 0.03 |
| drug2115 | NG test Wiki | 0.03 |
| drug254 | Antibody-Rich Plasma from COVID-19 recovered patients Wiki | 0.03 |
| drug3248 | Study of immune-mediated mechanisms in patients tested positive for SARS-CoV-2 Wiki | 0.03 |
| drug1486 | Hospital admission Wiki | 0.03 |
| drug790 | Cliniporator Wiki | 0.03 |
| drug2633 | Preservative-free saline Wiki | 0.03 |
| drug1640 | In-person postoperative visit Wiki | 0.03 |
| drug248 | Antibiotic Wiki | 0.03 |
| drug1841 | Lopinavir Wiki | 0.03 |
| drug2905 | SARS-CoV-2 Antibody Analysis Wiki | 0.03 |
| drug840 | Comparable Placebo of drug Wiki | 0.03 |
| drug1132 | EUROIMMUN assay Wiki | 0.03 |
| drug1048 | Differential Leucocyte Count (CLDC) device and algorithm Wiki | 0.03 |
| drug4132 | vadadustat Wiki | 0.03 |
| drug454 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki | 0.03 |
| drug2874 | Risankizumab Wiki | 0.03 |
| drug1748 | Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets Wiki | 0.03 |
| drug3927 | measurement of circulating sFlt1 concentration Wiki | 0.03 |
| drug4127 | unfractionated heparin Wiki | 0.03 |
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| drug174 | Aerolized Hydroxychloroquine Sulfate Wiki | 0.03 |
| drug1891 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki | 0.03 |
| drug679 | CYNK-001 Wiki | 0.03 |
| drug3652 | Walk Test Wiki | 0.03 |
| drug1914 | MCN (Methylene blue, vitamin C, N-acetyl cysteine) Wiki | 0.03 |
| drug1336 | Follow up calls Wiki | 0.03 |
| drug2623 | Predictive factors for clinical response in patients with COVID-19. Wiki | 0.03 |
| drug2868 | RhACE2 APN01 Wiki | 0.03 |
| drug3913 | lopinavir/ritonavir Wiki | 0.03 |
| drug3254 | Sulodexide Wiki | 0.03 |
| drug1744 | Ivermectin + Placebo Wiki | 0.03 |
| drug900 | Convalescent plasma (CP) Wiki | 0.03 |
| drug2069 | Model Building Wiki | 0.03 |
| drug1832 | Listerine Mouthwash Product Wiki | 0.03 |
| drug2854 | Respiratory physiotherapy Wiki | 0.03 |
| drug2537 | Placebo for "Deficiency of Qi and Yin" Wiki | 0.03 |
| drug2727 | Quercetin Treatment Wiki | 0.03 |
| drug1784 | LSALT peptide Wiki | 0.03 |
| drug2920 | SARS-CoV-2 non-immune Plasma Wiki | 0.03 |
| drug3678 | XC7 100 mg single Wiki | 0.03 |
| drug1574 | IC14 Wiki | 0.03 |
| drug1609 | IgG Wiki | 0.03 |
| drug2214 | No active intervention (observational only) Wiki | 0.03 |
| drug1546 | Hydroxychloroquine in combination of Azithromycin Wiki | 0.03 |
| drug2695 | Pulmonary and Motor Rehabilitation Wiki | 0.03 |
| drug3021 | Sars-Cov2 serology Wiki | 0.03 |
| drug2460 | Personalized health education Wiki | 0.03 |
| drug2739 | Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index Wiki | 0.03 |
| drug1893 | Low-dose placebo (18-59 years) & Two dose regimen Wiki | 0.03 |
| drug2808 | Recombinant human interferon α1β Wiki | 0.03 |
| drug1774 | Kukaa Salama: mHealth intervention Wiki | 0.03 |
| drug3383 | The standard therapy Wiki | 0.03 |
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| drug1754 | Ivermectin Tablets Wiki | 0.03 |
| drug861 | Continuation of ARB/ACEI Wiki | 0.03 |
| drug1020 | Detection of anti-COVID-19 antibody level Wiki | 0.03 |
| drug2002 | MenACWY single dose + paracetamol Wiki | 0.03 |
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| drug1361 | GO2 PEEP MOUTHPIECE Wiki | 0.03 |
| drug1655 | Infrared Energy and Dietary Supplement Wiki | 0.03 |
| drug931 | Covid-19 Antibody testing (IgG and IgM) Wiki | 0.03 |
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| drug2527 | Placebo Subcutaneous Solution Wiki | 0.03 |
| drug2593 | Pneumococcal vaccine Wiki | 0.03 |
| drug1481 | Home-based exercise Wiki | 0.03 |
| drug2646 | Probiotics (2 strains 10x10^9 UFC) Wiki | 0.03 |
| drug1858 | Lopinavir/Ritonavir 400 mg/100 mg Wiki | 0.03 |
| drug2297 | Odd/Even birth year intervention groups Wiki | 0.03 |
| drug116 | ATI-450 Wiki | 0.03 |
| drug3318 | TXA127 Wiki | 0.03 |
| drug287 | Ascorbic Acid and Zinc Gluconate Wiki | 0.03 |
| drug531 | Bromhexine Hydrochloride Tablets Wiki | 0.03 |
| drug2814 | Reference: Favipiravir 200 mg (Avigan) Wiki | 0.03 |
| drug18 | 0.9%NaCl Wiki | 0.03 |
| drug3243 | Study Arm Wiki | 0.03 |
| drug3497 | Two dose ChAdOx1 nCoV-19/Covishield 0.5mL Wiki | 0.03 |
| drug919 | Coronavirus Disease 2019 Wiki | 0.03 |
| drug2491 | Placebo (0.9% normal saline) Wiki | 0.03 |
| drug2938 | SARS-CoV-2 vaccine formulation 1 with adjuvant 2 Wiki | 0.03 |
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| drug1322 | Flow controlled ventilation (Evone-ventilator) Wiki | 0.03 |
| drug3709 | Zofin Wiki | 0.03 |
| drug3565 | V590 Wiki | 0.03 |
| drug2680 | Proxalutamide Wiki | 0.03 |
| drug3702 | Zinc Gluconate Wiki | 0.03 |
| drug637 | COVID-19 standard care Wiki | 0.03 |
| drug1753 | Ivermectin Powder Wiki | 0.03 |
| drug2403 | Pamrevlumab Wiki | 0.03 |
| drug2183 | Nicotinamide riboside Wiki | 0.03 |
| drug1211 | Equipment with smartwatch throughout hospital stay on the general ward Wiki | 0.03 |
| drug1765 | Kaletra and beta interferon Wiki | 0.03 |
| drug1041 | Dialectical Behavioral Therapy (DBT) Skills Wiki | 0.03 |
| drug829 | Combination of oral polio vaccine and NA-831 Wiki | 0.03 |
| drug1590 | INC424 / Ruxolitinib Wiki | 0.03 |
| drug2413 | Passed infection of SARS-CoV-2 Wiki | 0.03 |
| drug1641 | Inactivated SARS CoV 2 vaccine (Vero cell). Wuhan Wiki | 0.03 |
| drug2436 | Peginterferon Lambda-1a Wiki | 0.03 |
| drug2711 | QazCovid-in®-vaccine against COVID-19 Wiki | 0.03 |
| drug1255 | Expression of receptors and activating proteases Wiki | 0.03 |
| drug2414 | Passive Microwave Radiometry Wiki | 0.03 |
| drug1022 | Device used to record voice for screening Wiki | 0.03 |
| drug2174 | Neutral writing control Wiki | 0.03 |
| drug2741 | Questionnaire, phone call Wiki | 0.03 |
| drug2962 | SF12, EQ-5D-5L and work status standardized quantitative assessments Wiki | 0.03 |
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| drug2507 | Placebo 0.10 mg + 1.00 mg/kg Wiki | 0.03 |
| drug1479 | Home exercise program Wiki | 0.03 |
| drug2348 | Others(No intervention) Wiki | 0.03 |
| drug1902 | Lung Function tests Wiki | 0.03 |
| drug1583 | IIBR-100, low dose (prime) Wiki | 0.03 |
| drug3013 | Sampling salivary Wiki | 0.03 |
| drug1809 | Let It Out (LIO)-C Wiki | 0.03 |
| drug2392 | PSQI Wiki | 0.03 |
| drug2736 | Questionnaire completion Wiki | 0.03 |
| drug2915 | SARS-CoV-2 antibody testing Wiki | 0.03 |
| drug2120 | NK Cells Wiki | 0.03 |
| drug2578 | Plaquenil 200Mg Tablet Wiki | 0.03 |
| drug1420 | HLX71 Wiki | 0.03 |
| drug2252 | Normal Saline intranasal Wiki | 0.03 |
| drug614 | COVID-19 Specific T Cell derived exosomes (CSTC-Exo) Wiki | 0.03 |
| drug1979 | Medical Mask Wiki | 0.03 |
| drug2910 | SARS-CoV-2 Specific T Cells Wiki | 0.03 |
| drug2109 | NA-831 and Atazanavir Wiki | 0.03 |
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| drug1390 | Group A (AG0302-COVID19) Wiki | 0.03 |
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| drug2971 | SNO Wiki | 0.03 |
| drug1869 | Low Dose of KBP-COVID-19 Wiki | 0.03 |
| drug2197 | Nitazoxanide with ivermectin Wiki | 0.03 |
| drug2212 | No Personal protective equipment (PPE) Wiki | 0.03 |
| drug1445 | Heterologous stimuli Wiki | 0.03 |
| drug600 | COVID-19 Convalescent Plasma (CCP) Wiki | 0.03 |
| drug1691 | Internet-based Cognitive Behavioral Therapy Wiki | 0.03 |
| drug2419 | Patient Education Wiki | 0.03 |
| drug3295 | T-Detect™ SARS-CoV-2 Assay Wiki | 0.03 |
| drug2323 | Online questionnaire and interviews Wiki | 0.03 |
| drug2520 | Placebo Nitazoxanide Wiki | 0.03 |
| drug2222 | No intervention, observational Wiki | 0.03 |
| drug3157 | St. George's Respiratory Questionnaire (SGRQ) Wiki | 0.03 |
| drug3419 | Thymosin+standard treatment Wiki | 0.03 |
| drug3805 | conventional management of patients Wiki | 0.03 |
| drug106 | ARDSNet Wiki | 0.03 |
| drug2986 | Saline Control Wiki | 0.03 |
| drug624 | COVID-19 convalescent plasma (CCP) plus standard of care (SOC) Wiki | 0.03 |
| drug3427 | Titanium blood test Wiki | 0.03 |
| drug669 | CT-imaging Wiki | 0.03 |
| drug2387 | PRAYER Wiki | 0.03 |
| drug2196 | Nitazoxanide and atazanavir/ritonavir Wiki | 0.03 |
| drug3489 | Triazavirin (Riamilovir) Wiki | 0.03 |
| drug1721 | Intubation Box Wiki | 0.03 |
| drug3999 | personal protective Measures Wiki | 0.03 |
| drug6 | 0.075% Cetylpyridinium Chloride Wiki | 0.03 |
| drug3371 | Testing procedure for Binding antibodies Wiki | 0.03 |
| drug2053 | Mindfulness training Wiki | 0.03 |
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| drug582 | COVICU Wiki | 0.03 |
| drug1093 | Drug: NA-831 Wiki | 0.03 |
| drug712 | Carotid Artery Reactivity Testing Wiki | 0.03 |
| drug3992 | oxygen treatment Wiki | 0.03 |
| drug436 | Bicalutamide 150 mg Wiki | 0.03 |
| drug3604 | Video based exercise Wiki | 0.03 |
| drug3882 | iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System Wiki | 0.03 |
| drug2807 | Recombinant human angiotensin-converting enzyme 2 (rhACE2) Wiki | 0.03 |
| drug2101 | N-803 Wiki | 0.03 |
| drug2941 | SARS-CoV-2 vaccine formulation 2 without adjuvant Wiki | 0.03 |
| drug2923 | SARS-CoV-2 rS - Phase 1 Wiki | 0.03 |
| drug2483 | Pilot a rapid SARS-CoV-2 testing strategy Wiki | 0.03 |
| drug1534 | Hydroxychloroquine Sulfate 400 mg twice a day Wiki | 0.03 |
| drug2285 | Observational (registry) Wiki | 0.03 |
| drug1421 | HOME-CoV rule implementation Wiki | 0.03 |
| drug1612 | IgG antibodies immunoassay Wiki | 0.03 |
| drug732 | ChAdOx1 nCoV-19 (Abs 260) Wiki | 0.03 |
| drug327 | Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) Wiki | 0.03 |
| drug2374 | PF-06650833 Wiki | 0.03 |
| drug2330 | Opt-in Recruitment Email Wiki | 0.03 |
| drug3282 | Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors Wiki | 0.03 |
| drug2580 | Plasma Donation Wiki | 0.03 |
| drug2640 | PrimePro Wiki | 0.03 |
| drug1040 | Diagnostic test for detection of SARS-CoV-2 Wiki | 0.03 |
| drug1544 | Hydroxychloroquine as post exposure prophylaxis Wiki | 0.03 |
| drug999 | Data monitoring for 48h within the first 12 hours of admission for COVID-19 Wiki | 0.03 |
| drug1549 | Hydroxychloroquine sulfate Wiki | 0.03 |
| drug2229 | Non Intervention Wiki | 0.03 |
| drug1560 | Hyperbaric Chamber Wiki | 0.03 |
| drug2033 | Methylprednisolone Injectable Product Wiki | 0.03 |
| drug2218 | No intervention - quality of life measure Wiki | 0.03 |
| drug2929 | SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 Wiki | 0.03 |
| drug543 | C-reactive protein Wiki | 0.03 |
| drug2428 | Patients admitted in Intensive Care Units Wiki | 0.03 |
| drug3213 | Standard therapy Wiki | 0.03 |
| drug930 | Covid-19 + patients Wiki | 0.03 |
| drug932 | Covid-19 PCR , IGM Wiki | 0.03 |
| drug2977 | SOC plus Placebo IV Wiki | 0.03 |
| drug3351 | Telerehabilitation Wiki | 0.03 |
| drug1897 | Lower-dose prophylactic anticoagulation Wiki | 0.03 |
| drug2845 | Resilience Program Wiki | 0.03 |
| drug2390 | PSC-04 Wiki | 0.03 |
| drug2560 | Placebo plus standard preventive measures Wiki | 0.03 |
| drug3731 | alpha one antitrypsin inhalation Wiki | 0.03 |
| drug2969 | SNDX-6352 Wiki | 0.03 |
| drug3003 | Saliva-based testing Wiki | 0.03 |
| drug2530 | Placebo booster Wiki | 0.03 |
| drug1738 | Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki | 0.03 |
| drug1626 | Immunfluorescence Wiki | 0.03 |
| drug1427 | Health warning leaflet Wiki | 0.03 |
| drug1648 | Indomethacin Wiki | 0.03 |
| drug1517 | Hydroxychloroquine , Sofosbuvir, daclatasvir Wiki | 0.03 |
| drug747 | Chest MRI Wiki | 0.03 |
| drug4047 | recombinant human interferon Alpha-1b Wiki | 0.03 |
| drug2269 | Nutrition support Wiki | 0.03 |
| drug3150 | Specimen Collection Wiki | 0.03 |
| drug4017 | pre_lunch Yoga-based breathing support Wiki | 0.03 |
| drug1184 | Emtricitabine/tenofovir disoproxil Wiki | 0.03 |
| drug2501 | Placebo (potato starch and magnesium stearate) Wiki | 0.03 |
| drug865 | Continuous positive airway pressure (CPAP) treatment Wiki | 0.03 |
| drug1088 | Drug: GS-5734 - 1.00 mg/kg Wiki | 0.03 |
| drug377 | BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki | 0.03 |
| drug381 | BM-MSCs Wiki | 0.03 |
| drug366 | BCG Vaccine Wiki | 0.03 |
| drug1569 | Hyperpolarized Xe129 Wiki | 0.03 |
| drug1795 | Lactobaciltus rhamnosus GG Placebo Wiki | 0.03 |
| drug2091 | MultiStem Wiki | 0.03 |
| drug1910 | MAGEC Spine Rod Wiki | 0.03 |
| drug293 | Assembled mask Wiki | 0.03 |
| drug2027 | Methotrexate-LDE phase 2 Wiki | 0.03 |
| drug2658 | Prone Wiki | 0.03 |
| drug3708 | Zithromax Oral Product Wiki | 0.03 |
| drug1327 | Fluorescein Wiki | 0.03 |
| drug1519 | Hydroxychloroquine - Daily dosing Wiki | 0.03 |
| drug3887 | impliminting Online Distance Learning Wiki | 0.03 |
| drug2234 | Non-Interventional Wiki | 0.03 |
| drug709 | Cardiorespiratory Exercise Wiki | 0.03 |
| drug3579 | Vaccine Therapy Wiki | 0.03 |
| drug272 | Apremilast placebo Wiki | 0.03 |
| drug1815 | Levilimab Wiki | 0.03 |
| drug1997 | Melatonin intravenous Wiki | 0.03 |
| drug3300 | TAK-671 Wiki | 0.03 |
| drug4007 | placebo for clazakizumab Wiki | 0.03 |
| drug1498 | Human milk donors Wiki | 0.03 |
| drug2123 | NO intervention planned due to the observational study design - only a diagnostic testing Wiki | 0.03 |
| drug2891 | Ruconest Wiki | 0.03 |
| drug2906 | SARS-CoV-2 IgG Wiki | 0.03 |
| drug1095 | Drug: NA-831 - 0.20 mg/kg Wiki | 0.03 |
| drug1725 | Investigation of the prevalence of test positivity Wiki | 0.03 |
| drug1137 | Early rehabilitation Wiki | 0.03 |
| drug1299 | Favipiravir Combined With Tocilizumab Wiki | 0.03 |
| drug2163 | Nebulized Sterile Saline Wiki | 0.03 |
| drug2606 | Povidine iodine nasal swabs Wiki | 0.03 |
| drug2106 | N95 respirator Wiki | 0.03 |
| drug3321 | Tafenoquine Oral Tablet Wiki | 0.03 |
| drug891 | Convalescent Plasma as Therapy for Covid-19 patients Wiki | 0.03 |
| drug791 | CloSYS mouthwash Wiki | 0.03 |
| drug1356 | GLS-1027 Wiki | 0.03 |
| drug1245 | Experimental: Questionnaire without precaution information Wiki | 0.03 |
| drug2339 | Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions Wiki | 0.03 |
| drug96 | ARBs and/or ACE inhibitors Wiki | 0.03 |
| drug954 | Customized questionnaire Wiki | 0.03 |
| drug1625 | Immune response study Wiki | 0.03 |
| drug2493 | Placebo (Methylcellulose) capsule Wiki | 0.03 |
| drug35 | 2019-nCoV IgG/IgM Rapid Test Cassette Wiki | 0.03 |
| drug3149 | Specific anti-SARS-CoV-2 antibodies Wiki | 0.03 |
| drug635 | COVID-19 positive via testing Wiki | 0.03 |
| drug2577 | Plant Polyphenol Wiki | 0.03 |
| drug2440 | Pegylated interferon lambda Wiki | 0.03 |
| drug1484 | Honey Wiki | 0.03 |
| drug3267 | Surgery Wiki | 0.03 |
| drug1090 | Drug: Isotretinoin plus Tamoxifen Wiki | 0.03 |
| drug1741 | Ivermectin (IVM) Wiki | 0.03 |
| drug2562 | Placebo solution Wiki | 0.03 |
| drug2876 | Ritonavir Wiki | 0.03 |
| drug112 | AT-001 Wiki | 0.03 |
| drug851 | Comprehensive treatment Wiki | 0.03 |
| drug1850 | Lopinavir/ Ritonavir Wiki | 0.03 |
| drug1271 | FFP2 Wiki | 0.03 |
| drug2842 | Repeat SARS-CoV-2 IgG antibodies at 45-65 days Wiki | 0.03 |
| drug3128 | Sodium bicarbonate Wiki | 0.03 |
| drug2398 | PTSD Wiki | 0.03 |
| drug2856 | Respiratory rehabilitation program (RR). Wiki | 0.03 |
| drug760 | Chloroquine diphosphate Wiki | 0.03 |
| drug497 | Bloodwork Wiki | 0.03 |
| drug1843 | Lopinavir / ritonavir tablets combined with Xiyanping injection Wiki | 0.03 |
| drug1650 | Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration Wiki | 0.03 |
| drug1726 | Investigational Product - ViraCide Wiki | 0.03 |
| drug2613 | Povidone-Iodine 0.6% NS Wiki | 0.03 |
| drug815 | Colgate Peroxyl mouthwash Wiki | 0.03 |
| drug2256 | Normal saline solution (NSS), Placebo - Phase 2 Wiki | 0.03 |
| drug3933 | metformin glycinate Wiki | 0.03 |
| drug2203 | Nitric Oxide-Continuous and Sessions Wiki | 0.03 |
| drug2826 | Remain COVID Free SSI Wiki | 0.03 |
| drug1888 | Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen Wiki | 0.03 |
| drug2745 | Questionnaires for specific phobia Wiki | 0.03 |
| drug3089 | Sham irradiation Wiki | 0.03 |
| drug2000 | MenACWY boost Wiki | 0.03 |
| drug422 | Best Available Therapy Wiki | 0.03 |
| drug1844 | Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride Wiki | 0.03 |
| drug2841 | Renin-angiotensin system inhibitors Wiki | 0.03 |
| drug2167 | Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection Wiki | 0.03 |
| drug2532 | Placebo comparator: DW-NI Wiki | 0.03 |
| drug3848 | gammaCore® Sapphire (non-invasive vagus nerve stimulator) Wiki | 0.03 |
| drug1461 | High volume evacuation (HVE) Wiki | 0.03 |
| drug3303 | TAK-981 Wiki | 0.03 |
| drug2932 | SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics Wiki | 0.03 |
| drug2360 | Oxytocin Wiki | 0.03 |
| drug990 | Data Collection: Clinical Care Assessments Wiki | 0.03 |
| drug21 | 1% w/v Povidone-iodide Wiki | 0.03 |
| drug1729 | Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops) Wiki | 0.03 |
| drug2176 | New QIAstat-Dx fully automatic multiple PCR detection platform Wiki | 0.03 |
| drug3582 | Validation of the LAMP assays Wiki | 0.03 |
| drug2786 | Random Donor Plasma Wiki | 0.03 |
| drug2921 | SARS-CoV-2 plasma Wiki | 0.03 |
| drug3132 | Sofosbuvir and Ledipasvir Wiki | 0.03 |
| drug3788 | cholecalciferol 50,000 IU Wiki | 0.03 |
| drug2601 | Post COVID-19 Functional Satus Scale Wiki | 0.03 |
| drug2617 | Povidone-iodine Wiki | 0.03 |
| drug1851 | Lopinavir/ Ritonavir Oral Tablet Wiki | 0.03 |
| drug286 | Ascorbic Acid Wiki | 0.03 |
| drug3873 | hydroxychloroquine in combination with camostat mesylate Wiki | 0.03 |
| drug2696 | Pulmonary function testing Wiki | 0.03 |
| drug2709 | QUANTIFERON Wiki | 0.03 |
| drug2597 | Polymorphism of the HSD3B1 Wiki | 0.03 |
| drug2294 | Occupational health workers Wiki | 0.03 |
| drug1770 | Ketogenic diet with phytoextracts Wiki | 0.03 |
| drug2875 | Risk factors Wiki | 0.03 |
| drug1723 | Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours Wiki | 0.03 |
| drug4000 | phone call Wiki | 0.03 |
| drug2175 | Neutralizing antibodies Wiki | 0.03 |
| drug3532 | Ulinastatin Wiki | 0.03 |
| drug3662 | Weck-cel Swab Collection Wiki | 0.03 |
| drug2955 | SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant Wiki | 0.03 |
| drug814 | Coldamaris pro, nasal spray Wiki | 0.03 |
| drug2609 | Povidone-Iodine 0.5% Wiki | 0.03 |
| drug2243 | Non-interventional study Wiki | 0.03 |
| drug3083 | Severe Acute Respiratory Syndrome CoronaVirus 2 detection Wiki | 0.03 |
| drug3948 | muscle ultrasound Wiki | 0.03 |
| drug1791 | Laboratory Analyses Wiki | 0.03 |
| drug3796 | congenital malformation Wiki | 0.03 |
| drug1268 | FAVIR 200 MG FT Wiki | 0.03 |
| drug902 | Convalesscent Plasma Wiki | 0.03 |
| drug2157 | Natural Killer Cells infusion Wiki | 0.03 |
| drug2543 | Placebo intravenous Wiki | 0.03 |
| drug3987 | oral polio vaccine + information Wiki | 0.03 |
| drug816 | Colgate Total mouthwash Wiki | 0.03 |
| drug1056 | Diphenhydramine Wiki | 0.03 |
| drug2611 | Povidone-Iodine 0.5% NS Wiki | 0.03 |
| drug697 | Cannabis, Medical Wiki | 0.03 |
| drug186 | AirFLO2 Wiki | 0.03 |
| drug1816 | Lianhua Qingwen Wiki | 0.03 |
| drug3361 | Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE) Wiki | 0.03 |
| drug963 | D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester Wiki | 0.03 |
| drug1946 | Magnetic Resonance Imaging Wiki | 0.03 |
| drug751 | Chinese Herbal Medicine Wiki | 0.03 |
| drug1058 | Dipyridamole 100 Milligram(mg) Wiki | 0.03 |
| drug2333 | Optical coherence tomography angiography Wiki | 0.03 |
| drug3062 | Serological Assay or IgG for SARS-CoV-2 Wiki | 0.03 |
| drug666 | CT-P59/Placebo Wiki | 0.03 |
| drug3182 | Standard Treatment Wiki | 0.03 |
| drug2464 | Philips Lumify Ultrasound System Wiki | 0.03 |
| drug1505 | Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 Wiki | 0.03 |
| drug1210 | EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki | 0.03 |
| drug992 | Data collection and clinical testing of subjects Wiki | 0.03 |
| drug3204 | Standard of care management Wiki | 0.03 |
| drug2790 | Rapid Diagnostic Test vs PCR Wiki | 0.03 |
| drug1533 | Hydroxychloroquine Sulfate 200 milligram (mg) Tab Wiki | 0.03 |
| drug1471 | High-dose placebo (60-85 years) & Three dose regimen Wiki | 0.03 |
| drug3563 | V/Q SPECT-CT Wiki | 0.03 |
| drug1996 | Melatonin 2mg Wiki | 0.03 |
| drug2587 | Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 Wiki | 0.03 |
| drug668 | CT-V Wiki | 0.03 |
| drug2474 | Physical and Cognitive Activity Wiki | 0.03 |
| drug2995 | Saliva Assay Wiki | 0.03 |
| drug3301 | TAK-671 Placebo Wiki | 0.03 |
| drug1749 | Ivermectin 6 MG Oral Tablet (2 tablets) Wiki | 0.03 |
| drug4043 | rNAPc2 Wiki | 0.03 |
| drug2075 | Molgramostim nebuliser solution Wiki | 0.03 |
| drug3162 | Standar medical treatmen Wiki | 0.03 |
| drug3738 | anti-SARS-CoV-2 plasma Wiki | 0.03 |
| drug3499 | Two dose MenACWY vaccine min. 4 weeks apart Wiki | 0.03 |
| drug1469 | High-dose placebo (18-59 years) & Three dose regimen Wiki | 0.03 |
| drug2591 | Plitidepsin 2.0 mg/day Wiki | 0.03 |
| drug1153 | Ejaculated semen sample Wiki | 0.03 |
| drug1927 | MRI (heart, brain, lungs, liver) Wiki | 0.03 |
| drug1432 | Helmet Continuous Positive Airway Pressure (CPAP) Wiki | 0.03 |
| drug2353 | Oxidative Stress ELISA Kit Wiki | 0.03 |
| drug2799 | Razuprotafib Subcutaneous Solution Wiki | 0.03 |
| drug95 | ARBOX Wiki | 0.03 |
| drug684 | Cambridge Validated Viral Detection Method Wiki | 0.03 |
| drug1400 | Group1 Wiki | 0.03 |
| drug460 | Biomarkers expression Wiki | 0.03 |
| drug245 | Anti-Sars-CoV-2 Convalescent Plasma Wiki | 0.03 |
| drug1873 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.03 |
| drug832 | Communication Wiki | 0.03 |
| drug2205 | Nitric Oxide-Sessions Wiki | 0.03 |
| drug1523 | Hydroxychloroquine Oral Product Wiki | 0.03 |
| drug1454 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.03 |
| drug2156 | Natural Honey Wiki | 0.03 |
| drug1367 | Gam-COVID-Vac Lyo Wiki | 0.03 |
| drug1663 | Inhaled nitric oxide gas Wiki | 0.03 |
| drug916 | CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test Wiki | 0.03 |
| drug1632 | Immunological profiling Wiki | 0.03 |
| drug2365 | PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) Wiki | 0.03 |
| drug1045 | Dietary counselling on Food Groups according to IYC Feeding practices, WHO Wiki | 0.03 |
| drug4058 | risk factors Wiki | 0.03 |
| drug3347 | Telephonic medical visit Wiki | 0.03 |
| drug2690 | Public space exposure Wiki | 0.03 |
| drug1794 | Lactobaciltus rhamnosus GG Wiki | 0.03 |
| drug805 | Cognitive testing Wiki | 0.03 |
| drug3309 | TD139 Wiki | 0.03 |
| drug2725 | Quercetin Phytosome Wiki | 0.03 |
| drug1929 | MRx-4DP0004 Wiki | 0.03 |
| drug1442 | Heparin sodium Wiki | 0.03 |
| drug3942 | monthly serologic IgM/G test Wiki | 0.03 |
| drug573 | CONTROL GROUP Wiki | 0.03 |
| drug2911 | SARS-CoV-2 and/or MIS-C Exposure Wiki | 0.03 |
| drug3710 | ZofinTM (OrganicellTM Flow) Wiki | 0.03 |
| drug3996 | patients receiving nasal high flow Wiki | 0.03 |
| drug2276 | OP-101 Wiki | 0.03 |
| drug1101 | Duplex ultrasound and Computed Tomography Angiography Wiki | 0.03 |
| drug1613 | IgG test Wiki | 0.03 |
| drug2031 | Methylene-Blue Photodisinfection Wiki | 0.03 |
| drug3463 | Trans Sodium Crocetinate Wiki | 0.03 |
| drug837 | Community-driven messages to promote COVID-19 testing Wiki | 0.03 |
| drug2896 | Ruxolitinib plus simvastatin Wiki | 0.03 |
| drug584 | COVID 19 Diagnostic Test Wiki | 0.03 |
| drug1263 | Extraoral vacuum aspirator (EVA) Wiki | 0.03 |
| drug2500 | Placebo (human albumin 1%) Wiki | 0.03 |
| drug3897 | interleuken 6 level measurment Wiki | 0.03 |
| drug1635 | Impact Event Score Wiki | 0.03 |
| drug957 | CytoSorb Wiki | 0.03 |
| drug2142 | Nasal Dexamethasone Wiki | 0.03 |
| drug1916 | MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg Wiki | 0.03 |
| drug1591 | INM005 Wiki | 0.03 |
| drug3569 | VESTA respirator Wiki | 0.03 |
| drug2295 | Octagam Wiki | 0.03 |
| drug3889 | indirect calorimetry Wiki | 0.03 |
| drug1835 | Liver function tests ,serum ferritin and PCR for COVID-19 . Wiki | 0.03 |
| drug2674 | Prospective observation Wiki | 0.03 |
| drug1118 | ELISA Wiki | 0.03 |
| drug2386 | POOL RT-PCR Wiki | 0.03 |
| drug2653 | Project ECHO Wiki | 0.03 |
| drug175 | Aerosol Box Wiki | 0.03 |
| drug901 | Convalescent plasma transfusion Wiki | 0.03 |
| drug1185 | Endoscopic intervention Wiki | 0.03 |
| drug157 | Ad26.COV2.S Wiki | 0.03 |
| drug1012 | Degarelix Wiki | 0.03 |
| drug2846 | Respiratory Exercise Training Wiki | 0.03 |
| drug2928 | SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 Wiki | 0.03 |
| drug2661 | Prone Positioning (PP) Wiki | 0.03 |
| drug2614 | Povidone-Iodine 2% Wiki | 0.03 |
| drug2976 | SOC plus 15mg/kg EB05 IV Wiki | 0.03 |
| drug2327 | Opaganib Wiki | 0.03 |
| drug3130 | Sofosbuvir Wiki | 0.03 |
| drug1658 | Inhaled Hypertonic ibuprofen Wiki | 0.03 |
| drug1966 | Matched Placebo Wiki | 0.03 |
| drug1067 | Distilled water Wiki | 0.03 |
| drug452 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki | 0.03 |
| drug2128 | NOX66 Wiki | 0.03 |
| drug896 | Convalescent anti-SARS-CoV-2 MBT Plasma Wiki | 0.03 |
| drug355 | BAT Wiki | 0.03 |
| drug2338 | Oral 25-Hydroxyvitamin D3 Wiki | 0.03 |
| drug749 | Chest physiotherapy post-covid19 Wiki | 0.03 |
| drug446 | Biological sample and clinical data collection Wiki | 0.03 |
| drug1607 | Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki | 0.03 |
| drug2308 | Omegaven® Wiki | 0.03 |
| drug1934 | MSCs-derived exosomes Wiki | 0.03 |
| drug602 | COVID-19 Diagnostic and Assessment Tests Wiki | 0.03 |
| drug3109 | Sirolimus 1 MG/ML Wiki | 0.03 |
| drug127 | AWARD plus COVID-specific advice Wiki | 0.03 |
| drug2471 | Physical Exercises Wiki | 0.03 |
| drug2772 | RT-PCR Covid-19 Wiki | 0.03 |
| drug1695 | Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic Wiki | 0.03 |
| drug1654 | Informed consent Wiki | 0.03 |
| drug367 | BCG vaccine Wiki | 0.03 |
| drug2740 | Questionnaire with precaution information Wiki | 0.03 |
| drug233 | Anluohuaxian Wiki | 0.03 |
| drug2216 | No intervention (survey study for medical doctors). Wiki | 0.03 |
| drug2724 | Quercetin Wiki | 0.03 |
| drug2510 | Placebo 250 cc 24 hours continuous infusion for 15 days Wiki | 0.03 |
| drug1925 | MRG-001 Wiki | 0.03 |
| drug2681 | Psychiatric counseling Wiki | 0.03 |
| drug2947 | SARS-CoV2 nasal swab Wiki | 0.03 |
| drug2742 | Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Wiki | 0.03 |
| drug1529 | Hydroxychloroquine Sulfate + Azithromycin Wiki | 0.03 |
| drug490 | Blood samples collection Wiki | 0.03 |
| drug2093 | Multifrequency Bioimpedance Spectroscopy Wiki | 0.03 |
| drug3747 | azoximer bromide Wiki | 0.03 |
| drug2151 | Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR Wiki | 0.03 |
| drug2122 | NK-1R antagonist Wiki | 0.03 |
| drug3279 | Surveys Wiki | 0.03 |
| drug1337 | Follow-up at 14 days Wiki | 0.03 |
| drug1585 | IL-12 plasmid Wiki | 0.03 |
| drug2194 | Nitazoxanide 500Mg Oral Tablet Wiki | 0.03 |
| drug2720 | Quantitative analysis of anti-SARS-CoV-2-antibodies Wiki | 0.03 |
| drug3398 | There is no intervention in this study Wiki | 0.03 |
| drug1644 | Inactivated convalescent plasma Wiki | 0.03 |
| drug3143 | Soterix taVNS model 0125-LTE Stimulator - Active-Active Group Wiki | 0.03 |
| drug37 | 21% Ethanol plus essential oils Wiki | 0.03 |
| drug1559 | Hydroxycloroquine and Azythromycine Wiki | 0.03 |
| drug2090 | Mucodentol Wiki | 0.03 |
| drug1038 | Diagnostic test Covid-19 Wiki | 0.03 |
| drug3400 | Thiazide or Thiazide-like diuretics Wiki | 0.03 |
| drug2922 | SARS-CoV-2 questionnaire survey Wiki | 0.03 |
| drug2806 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki | 0.03 |
| drug2385 | POOL LAMP Wiki | 0.03 |
| drug2561 | Placebo single Wiki | 0.03 |
| drug2781 | Radiological Detection Wiki | 0.03 |
| drug1863 | Losmapimod oral tablet Wiki | 0.03 |
| drug3544 | Unavailable COVID Test Result - Hypothetical Scenario Wiki | 0.03 |
| drug3227 | Standards of Care Wiki | 0.03 |
| drug1907 | Lung ultrasound use in patients hospitalized with COVID Wiki | 0.03 |
| drug2251 | Normal Saline Infusion + standard of care Wiki | 0.03 |
| drug1217 | Estrogen Therapy Wiki | 0.03 |
| drug1371 | Gargle/Mouthwash Wiki | 0.03 |
| drug3231 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 0.03 |
| drug4011 | plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Wiki | 0.03 |
| drug104 | ARCT-021 two higher dose priming Wiki | 0.03 |
| drug839 | Comparable Placebo of Oral Polio Vaccine and Placebo of drug Wiki | 0.03 |
| drug3751 | bidirectional oxygenation mouthpiece Wiki | 0.03 |
| drug933 | Covid-19 Rapid Test Kit (RAPG-COV-019) Wiki | 0.03 |
| drug960 | Cytokine Adsorption Wiki | 0.03 |
| drug2987 | Saline Nasal Irrigation Wiki | 0.03 |
| drug1716 | Intravenous Infusions of Stem Cells Wiki | 0.03 |
| drug3663 | Weekly Assessment Wiki | 0.03 |
| drug1021 | Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus. Wiki | 0.03 |
| drug3904 | laboratory biomarkers Wiki | 0.03 |
| drug1188 | Endothelial damage and angiogenic biomarkers Wiki | 0.03 |
| drug148 | Acetylsalicylic acid Wiki | 0.03 |
| drug1647 | Individualized-Chinese herbal medicine Wiki | 0.03 |
| drug1937 | MVA-SARS-2-S vaccinations (days 0 & 28) Wiki | 0.03 |
| drug2259 | Normal saline solution (NSS), Placebo, Day 21 - Phase 2 Wiki | 0.03 |
| drug236 | Anti- SARS-CoV-2 Plasma Wiki | 0.03 |
| drug3694 | Zilucoplan Wiki | 0.03 |
| drug2274 | OCTAPLAS Wiki | 0.03 |
| drug2217 | No intervention - exposure is to COVID-19 Wiki | 0.03 |
| drug2567 | Placebo- 1.00 mg/kg Wiki | 0.03 |
| drug2592 | Plitidepsin 2.5 mg/day Wiki | 0.03 |
| drug928 | Covax-19™ Wiki | 0.03 |
| drug2117 | NHANES smell and taste tests Wiki | 0.03 |
| drug3597 | Veru-111 Wiki | 0.03 |
| drug1285 | Facial mask Wiki | 0.03 |
| drug3285 | Symptom Survey Wiki | 0.03 |
| drug3699 | Zinc (zinc gluconate) Wiki | 0.03 |
| drug836 | Community-based, mobile van testing Wiki | 0.03 |
| drug123 | AVIGAN 200 mg FT Wiki | 0.03 |
| drug2246 | Non-invasive ventilatory support Wiki | 0.03 |
| drug1915 | MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg Wiki | 0.03 |
| drug2079 | Monitoring Visit - Week 4 Wiki | 0.03 |
| drug3167 | Standard COVID-19 therapies Wiki | 0.03 |
| drug221 | Anatolian Propolis Wiki | 0.03 |
| drug1306 | Fibreoptic Endoscopic Evaluation of Swallowing (FEES) Wiki | 0.03 |
| drug3135 | Sofosbuvir/Daclatasvir Wiki | 0.03 |
| drug1829 | Linagliptin 5 MG Wiki | 0.03 |
| drug888 | Convalescent Plasma 2 Units Wiki | 0.03 |
| drug1413 | HCQ & AZ vs HCQ+SIR Wiki | 0.03 |
| drug2446 | Performing of lung ultrasound Wiki | 0.03 |
| drug2220 | No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests Wiki | 0.03 |
| drug3242 | Study A Wiki | 0.03 |
| drug1422 | HOPE intervention Wiki | 0.03 |
| drug2624 | Predictors adverse evolution Wiki | 0.03 |
| drug2737 | Questionnaire for evaluation of confinement on deviant sexual fantasies Wiki | 0.03 |
| drug36 | 2019-nCoV PCR Wiki | 0.03 |
| drug3326 | Tear Collection Wiki | 0.03 |
| drug3906 | lactoferrin, green tea extract Wiki | 0.03 |
| drug2545 | Placebo multiple Wiki | 0.03 |
| drug1757 | Ivermectin nasal Wiki | 0.03 |
| drug3641 | VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki | 0.03 |
| drug2311 | On-Line Survey Wiki | 0.03 |
| drug3450 | Tradipitant Wiki | 0.03 |
| drug2533 | Placebo comparator: DW-NS Wiki | 0.03 |
| drug3001 | Saliva specimen Wiki | 0.03 |
| drug3035 | Self-collected, home-based testing Wiki | 0.03 |
| drug3578 | Vaccinated with polio vaccine (IPV) Wiki | 0.03 |
| drug1510 | Hydroxychloroquine + Azithromycin Wiki | 0.03 |
| drug3541 | Umbilical cord Wharton's jelly-derived human Wiki | 0.03 |
| drug2731 | Questionnaire : Preparedness for Caregiving Scale Wiki | 0.03 |
| drug3706 | Zinc Sulfate 220 MG Wiki | 0.03 |
| drug2861 | Resveratrol Placebo Wiki | 0.03 |
| drug247 | Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients Wiki | 0.03 |
| drug2769 | RPH-104 80 mg Wiki | 0.03 |
| drug2050 | Mindfulness intervention Wiki | 0.03 |
| drug3973 | not applicable (observational study) Wiki | 0.03 |
| drug677 | CVnCoV 6 μg Wiki | 0.03 |
| drug220 | Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. Wiki | 0.03 |
| drug2594 | Point-of-Care Ultrasonography (POCUS) Wiki | 0.03 |
| drug3444 | Toraymyxin PMX-20R (PMX Cartridge) Wiki | 0.03 |
| drug3943 | morning Yoga-based breathing support Wiki | 0.03 |
| drug1994 | MejoraCare Wiki | 0.03 |
| drug2565 | Placebo- 0.10 mg/kg Wiki | 0.03 |
| drug2492 | Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) Wiki | 0.03 |
| drug1589 | INB03 Wiki | 0.03 |
| drug1864 | Lovenox 40 MG in 0.4 mL Prefilled Syringe Wiki | 0.03 |
| drug739 | ChAdOx1 nCoV-19 single dose + paracetamol Wiki | 0.03 |
| drug3158 | Stabilized hypochlorous acid Wiki | 0.03 |
| drug2230 | Non applicable Wiki | 0.03 |
| drug569 | CNM-ZnAg Wiki | 0.03 |
| drug1387 | Group 1 Wiki | 0.03 |
| drug2336 | Optional questionnaire completion Wiki | 0.03 |
| drug1313 | Fingerstick Wiki | 0.03 |
| drug4088 | standard operating procedures Wiki | 0.03 |
| drug1152 | Eicosapentaenoic acid gastro-resistant capsules Wiki | 0.03 |
| drug1811 | Levamisole Wiki | 0.03 |
| drug3975 | nutritional intervention Wiki | 0.03 |
| drug1363 | GRAd-COV2 Wiki | 0.03 |
| drug179 | Aerosolized 13 cis retinoic acid plus Inhalation administration by nebulization captopril 25mg Wiki | 0.03 |
| drug2559 | Placebo patch Wiki | 0.03 |
| drug898 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.03 |
| drug1599 | IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki | 0.03 |
| drug2630 | Premier Biotech COVID-19 IgG/IgM Rapid test Cassette Wiki | 0.03 |
| drug3342 | Telemedicine visit Wiki | 0.03 |
| drug3556 | Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki | 0.03 |
| drug1931 | MSC Treatment Wiki | 0.03 |
| drug2026 | Methotrexate-LDE phase 1 Wiki | 0.03 |
| drug3006 | Sample Collection/Performance Evaluation (B) Wiki | 0.03 |
| drug1737 | Isotretinoin Only Product in Oral Dose Form Wiki | 0.03 |
| drug1395 | Group B (Placebo) Wiki | 0.03 |
| drug1394 | Group B (AG0302-COVID19) Wiki | 0.03 |
| drug1428 | Health-related quality of life Wiki | 0.03 |
| drug1714 | Intravenous Immune Globulin Wiki | 0.03 |
| drug1391 | Group A (Placebo) Wiki | 0.03 |
| drug1096 | Drug: Standard treatment Standard treatment Wiki | 0.03 |
| drug925 | Cospherunate/Phytomedicine/Azythromycien Wiki | 0.03 |
| drug2689 | Public Health England Gold Standard Wiki | 0.03 |
| drug3014 | Sargramostim Wiki | 0.03 |
| drug487 | Blood sample for whole genome sequencing Wiki | 0.03 |
| drug2946 | SARS-CoV2 infection Wiki | 0.03 |
| drug2255 | Normal saline solution (NSS), Placebo - Phase 1 Wiki | 0.03 |
| drug2429 | Patients admitted to Intensive Care Unit with SARS-CoV2 Wiki | 0.03 |
| drug2100 | N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I Wiki | 0.03 |
| drug2863 | Retrospective data collection Wiki | 0.03 |
| drug3494 | Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki | 0.03 |
| drug2523 | Placebo Ribavirin Wiki | 0.03 |
| drug2508 | Placebo 0.20 mg + 2.00 mg/kg Wiki | 0.03 |
| drug26 | 150 ppm Nitric Oxide delivered through LungFit Delivery System Wiki | 0.03 |
| drug1736 | Isotonic saline 0.9% Wiki | 0.03 |
| drug611 | COVID-19 Pneumonia Wiki | 0.03 |
| drug1411 | HCQ Wiki | 0.03 |
| drug2793 | Rapid detection test Wiki | 0.03 |
| drug3446 | Tracheal intubation and cardiopulmonary resuscitation Wiki | 0.03 |
| drug1645 | Increasing Willingness and Uptake of COVID-19 Testing and Vaccination Wiki | 0.03 |
| drug2506 | Placebo - Starch Powder Soft gels Wiki | 0.03 |
| drug1483 | Home-use Test and Follow-up Questionnaire Wiki | 0.03 |
| drug2153 | Nasopharyngeal swab and main laboratory Wiki | 0.03 |
| drug3355 | Telmisartan 40Mg Oral Tablet Wiki | 0.03 |
| drug239 | Anti-SARS-CoV-2 IgT seropositivity Wiki | 0.03 |
| drug2416 | Patch, Placebo Wiki | 0.03 |
| drug942 | Crest Pro-Health Multi-Protection mouthwash Wiki | 0.03 |
| drug2934 | SARS-CoV-2 serology Wiki | 0.03 |
| drug232 | Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) Wiki | 0.03 |
| drug1683 | Interleukin 6 (IL6) Antagonist and corticosteroids Wiki | 0.03 |
| drug1581 | IIBR-100 low-dose (prime-boost) Wiki | 0.03 |
| drug1905 | Lung impedance technique Wiki | 0.03 |
| drug2712 | QuadraMune(TM) Wiki | 0.03 |
| drug4093 | standard treatment Wiki | 0.03 |
| drug3425 | Tirofiban Injection Wiki | 0.03 |
| drug2232 | Non invasive visual acuity testing Wiki | 0.03 |
| drug1779 | LAMP Wiki | 0.03 |
| drug3968 | none - observational Wiki | 0.03 |
| drug1504 | Hydrogen Peroxide Wiki | 0.03 |
| drug539 | Budesonide dry powder inhaler Wiki | 0.03 |
| drug2509 | Placebo 0.9% NaCl solution Wiki | 0.03 |
| drug1370 | Garadacimab, Factor XIIa Antagonist Monoclonal Antibody Wiki | 0.03 |
| drug3010 | Sampling (EDTA blood, pharyngeal and nose swabs, bronchoalveolar lavage ,urine) Wiki | 0.03 |
| drug2716 | Quality of life promotion Wiki | 0.03 |
| drug2187 | Nigella sativa Wiki | 0.03 |
| drug1694 | Internet-based self-help after 3 weeks Wiki | 0.03 |
| drug451 | Biological/Vaccine: Angiotensin peptide (1-7) derived plasma Wiki | 0.03 |
| drug1487 | Hospital anxiety and depression scale Wiki | 0.03 |
| drug105 | ARCT-021 two lower dose priming Wiki | 0.03 |
| drug2004 | MenCare+/Bandebereho fathers'/couples' group education Wiki | 0.03 |
| drug785 | Clinical diagnosis of COVID-19 by a health care professional Wiki | 0.03 |
| drug3881 | iAMP test Wiki | 0.03 |
| drug3019 | Sarilumab SAR153191 Wiki | 0.03 |
| drug109 | AS03-adjuvanted SCB-2019 vaccine Wiki | 0.03 |
| drug1563 | Hyperbaric Oxygen Therapy (HBOT) Wiki | 0.03 |
| drug1917 | MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg Wiki | 0.03 |
| drug3729 | allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) Wiki | 0.03 |
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| drug238 | Anti-SARS-CoV-2 Human Convalescent Plasma Wiki | 0.03 |
| drug2185 | Nicotine patch Wiki | 0.03 |
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| drug838 | Comparable Placebo Wiki | 0.03 |
| drug3073 | Serology for Covid-19 Wiki | 0.03 |
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| drug1414 | HCQ+AZT Wiki | 0.03 |
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| drug1580 | IIBR-100 high-dose (prime) Wiki | 0.03 |
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| drug3737 | anti-SARS-CoV-2 human convalescent plasma Wiki | 0.03 |
| drug1535 | Hydroxychloroquine Sulfate 600 mg once a day Wiki | 0.03 |
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| drug1767 | Kaplan Meier analysis Wiki | 0.03 |
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| drug2368 | PCR for COVID-19 Wiki | 0.03 |
| drug3224 | Standard-titer Convalescent COVID-19 plasma (CCP2) Wiki | 0.03 |
| drug1419 | HLX70 Wiki | 0.03 |
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| drug2072 | Modified Bai He Gu Jin Tang Wiki | 0.03 |
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| drug2968 | SMS-based support Wiki | 0.03 |
| drug3840 | favipiravir Wiki | 0.03 |
| drug3129 | Sodium chloride Wiki | 0.03 |
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| drug1525 | Hydroxychloroquine Pre-Exposure Prophylaxis Wiki | 0.03 |
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| drug854 | Conestat alfa Wiki | 0.03 |
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| drug2764 | RESP301, a Nitric Oxide generating solution Wiki | 0.03 |
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| drug3797 | conjunctival RT PCR Wiki | 0.03 |
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| drug23 | 1.5-2% w/v Hydrogen Peroxide Wiki | 0.03 |
| drug975 | DWJ1248 Wiki | 0.03 |
| drug2574 | Placebo; 0.9% saline Wiki | 0.03 |
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| drug1732 | Isoprinosine Wiki | 0.03 |
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| drug3367 | Tested for SARS-CoV-2 (regardless of the result) Wiki | 0.03 |
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| drug729 | Cereset Research Wiki | 0.03 |
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| drug3682 | Xiang-Sha-Liu-Jun formula Wiki | 0.03 |
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| drug230 | Angiotensin receptor blocker Wiki | 0.03 |
| drug1818 | Licensed seasonal influenza vaccine Wiki | 0.03 |
| drug2003 | MenACWY vaccine Wiki | 0.03 |
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| drug3412 | Throat swab Wiki | 0.02 |
| drug2206 | Nitrogen gas Wiki | 0.02 |
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| drug3389 | Therapeutic Plasma Exchange Wiki | 0.02 |
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| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.83 |
| D003141 | Communicable Diseases NIH | 0.30 |
| D007239 | Infection NIH | 0.29 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011014 | Pneumonia NIH | 0.16 |
| D013577 | Syndrome NIH | 0.15 |
| D014777 | Virus Diseases NIH | 0.15 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.11 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.11 |
| D011024 | Pneumonia, Viral NIH | 0.11 |
| D055371 | Acute Lung Injury NIH | 0.10 |
| D003333 | Coronaviridae Infections NIH | 0.08 |
| D012141 | Respiratory Tract Infections NIH | 0.08 |
| D012327 | RNA Virus Infections NIH | 0.07 |
| D012140 | Respiratory Tract Diseases NIH | 0.07 |
| D016638 | Critical Illness NIH | 0.06 |
| D030341 | Nidovirales Infections NIH | 0.05 |
| D009220 | Myositis NIH | 0.05 |
| D003139 | Common Cold NIH | 0.05 |
| D044882 | Glucose Metabolism Disorders NIH | 0.05 |
| D012120 | Respiration Disorders NIH | 0.05 |
| D003428 | Cross Infection NIH | 0.05 |
| D008659 | Metabolic Diseases NIH | 0.04 |
| D004408 | Dysgeusia NIH | 0.04 |
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.04 |
| D003289 | Convalescence NIH | 0.04 |
| D007249 | Inflammation NIH | 0.04 |
| D000860 | Hypoxia NIH | 0.04 |
| D008173 | Lung Diseases, Obstructive NIH | 0.04 |
| D008171 | Lung Diseases, NIH | 0.04 |
| D006685 | Hoarseness NIH | 0.03 |
| D019965 | Neurocognitive Disorders NIH | 0.03 |
| D012507 | Sarcoidosis NIH | 0.03 |
| D000070627 | Chronic Traumatic Encephalopathy NIH | 0.03 |
| D059246 | Tachypnea NIH | 0.03 |
| D009080 | Mucocutaneous Lymph Node Syndrome NIH | 0.03 |
| D051346 | Mobility Limitation NIH | 0.03 |
| D001997 | Bronchopulmonary Dysplasia NIH | 0.03 |
| D008595 | Menorrhagia NIH | 0.03 |
| D007319 | Sleep Initiation and Maintenance Disorders NIH | 0.03 |
| D013166 | Spondylitis NIH | 0.03 |
| D013167 | Spondylitis, Ankylosing NIH | 0.03 |
| D006929 | Hyperaldosteronism NIH | 0.03 |
| D014552 | Urinary Tract Infections NIH | 0.03 |
| D058070 | Asymptomatic Diseases NIH | 0.03 |
| D011470 | Prostatic Hyperplasia NIH | 0.03 |
| D054559 | Hyperphosphatemia NIH | 0.03 |
| D019446 | Endotoxemia NIH | 0.03 |
| D055154 | Dysphonia NIH | 0.03 |
| D006965 | Hyperplasia NIH | 0.03 |
| D004314 | Down Syndrome NIH | 0.03 |
| D000073436 | Microvascular Rarefaction NIH | 0.03 |
| D024821 | Metabolic Syndrome NIH | 0.03 |
| D015163 | Superinfection NIH | 0.03 |
| D001424 | Bacterial Infections NIH | 0.03 |
| D011649 | Pulmonary Alveolar Proteinosis NIH | 0.03 |
| D018376 | Cardiovascular Abnormalities NIH | 0.03 |
| D063806 | Myalgia NIH | 0.03 |
| D005879 | Tourette Syndrome NIH | 0.03 |
| D014832 | Voice Disorders NIH | 0.03 |
| D020767 | Intracranial Thrombosis NIH | 0.03 |
| D018410 | Pneumonia, Bacterial NIH | 0.03 |
| D003424 | Crohn Disease NIH | 0.03 |
| D000309 | Adrenal Insufficiency NIH | 0.03 |
| D007008 | Hypokalemia NIH | 0.03 |
| D007010 | Hyponatremia NIH | 0.03 |
| D010608 | Pharyngeal Diseases NIH | 0.03 |
| D006562 | Herpes Zoster NIH | 0.03 |
| D016769 | Embolism and Thrombosis NIH | 0.03 |
| D055501 | Macrophage Activation Syndrome NIH | 0.03 |
| D003920 | Diabetes Mellitus, NIH | 0.03 |
| D014808 | Vitamin D Deficiency NIH | 0.03 |
| D055370 | Lung Injury NIH | 0.03 |
| D000073397 | Occupational Stress NIH | 0.03 |
| D000857 | Olfaction Disorders NIH | 0.03 |
| D019851 | Thrombophilia NIH | 0.03 |
| D004194 | Disease NIH | 0.03 |
| D013927 | Thrombosis NIH | 0.03 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.03 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.03 |
| D015212 | Inflammatory Bowel Diseases NIH | 0.03 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.03 |
| D000505 | Alopecia NIH | 0.02 |
| D000070642 | Brain Injuries, Traumatic NIH | 0.02 |
| D000690 | Amyotrophic Lateral Sclerosis NIH | 0.02 |
| D012640 | Seizures NIH | 0.02 |
| D000075902 | Clinical Deterioration NIH | 0.02 |
| D012772 | Shock, Septic NIH | 0.02 |
| D009101 | Multiple Myeloma NIH | 0.02 |
| D007410 | Intestinal Diseases NIH | 0.02 |
| D009205 | Myocarditis NIH | 0.02 |
| D011618 | Psychotic Disorders NIH | 0.02 |
| D016472 | Motor Neuron Disease NIH | 0.02 |
| D058345 | Asymptomatic Infections NIH | 0.02 |
| D014786 | Vision Disorders NIH | 0.02 |
| D009410 | Nerve Degeneration NIH | 0.02 |
| D006330 | Heart Defects, Congenital NIH | 0.02 |
| D000208 | Acute Disease NIH | 0.02 |
| D001528 | Behcet Syndrome NIH | 0.02 |
| D006402 | Hematologic Diseases NIH | 0.02 |
| D015354 | Vision, Low NIH | 0.02 |
| D004700 | Endocrine System Diseases NIH | 0.02 |
| D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.02 |
| D006526 | Hepatitis C NIH | 0.02 |
| D054219 | Neoplasms, Plasma Cell NIH | 0.02 |
| D013923 | Thromboembolism NIH | 0.02 |
| D000066553 | Problem Behavior NIH | 0.02 |
| D054556 | Venous Thromboembolism NIH | 0.02 |
| D053717 | Pneumonia, Ventilator-Associated NIH | 0.02 |
| D058186 | Acute Kidney Injury NIH | 0.02 |
| D018450 | Disease Progression NIH | 0.02 |
| D020246 | Venous Thrombosis NIH | 0.02 |
| D040921 | Stress Disorders, Traumatic NIH | 0.02 |
| D003680 | Deglutition Disorders NIH | 0.02 |
| D025241 | Spondylarthritis NIH | 0.02 |
| D001289 | Attention Deficit Disorder with Hyperactivity NIH | 0.02 |
| D004417 | Dyspnea NIH | 0.02 |
| D011565 | Psoriasis NIH | 0.02 |
| D012859 | Sjogren's Syndrome NIH | 0.02 |
| D006470 | Hemorrhage NIH | 0.02 |
| D000370 | Ageusia NIH | 0.02 |
| D013651 | Taste Disorders NIH | 0.02 |
| D001714 | Bipolar Disorder NIH | 0.02 |
| D053120 | Respiratory Aspiration NIH | 0.02 |
| D014947 | Wounds and Injuries NIH | 0.02 |
| D020141 | Hemostatic Disorders NIH | 0.02 |
| D001778 | Blood Coagulation Disorders NIH | 0.02 |
| D005356 | Fibromyalgia NIH | 0.02 |
| D000755 | Anemia, Sickle Cell NIH | 0.02 |
| D012818 | Signs and Symptoms, Respiratory NIH | 0.02 |
| D000163 | Acquired Immunodeficiency Syndrome NIH | 0.02 |
| D003327 | Coronary Disease NIH | 0.02 |
| D004617 | Embolism NIH | 0.02 |
| D015535 | Arthritis, Psoriatic NIH | 0.02 |
| D060085 | Coinfection NIH | 0.02 |
| D006973 | Hypertension NIH | 0.02 |
| D015658 | HIV Infections NIH | 0.02 |
| D007154 | Immune System Diseases NIH | 0.02 |
| D001930 | Brain Injuries, NIH | 0.02 |
| D001927 | Brain Diseases NIH | 0.02 |
| D009102 | Multiple Organ Failure NIH | 0.02 |
| D001523 | Mental Disorders NIH | 0.02 |
| D009765 | Obesity NIH | 0.01 |
| D007153 | Immunologic Deficiency Syndromes NIH | 0.01 |
| D000073496 | Frailty NIH | 0.01 |
| D010300 | Parkinsonian NIH | 0.01 |
| D008175 | Lung Neoplasms NIH | 0.01 |
| D008180 | Lupus Erythematosus, Systemic NIH | 0.01 |
| D009461 | Neurologic Manifestations NIH | 0.01 |
| D019337 | Hematologic Neoplasms NIH | 0.01 |
| D012769 | Shock, NIH | 0.01 |
| D001327 | Autoimmune Diseases NIH | 0.01 |
| D006331 | Heart Diseases NIH | 0.01 |
| D008231 | Lymphopenia NIH | 0.01 |
| D012598 | Scoliosi NIH | 0.01 |
| D018805 | Sepsis NIH | 0.01 |
| D009103 | Multiple Sclerosis NIH | 0.01 |
| D002318 | Cardiovascular Diseases NIH | 0.01 |
| D011248 | Pregnancy Complications NIH | 0.01 |
| D059350 | Chronic Pain NIH | 0.01 |
| D003095 | Collagen Diseases NIH | 0.01 |
| D006333 | Heart Failure NIH | 0.01 |
| D002055 | Burnout, Professional NIH | 0.01 |
| D001008 | Anxiety Disorders NIH | 0.01 |
| D001172 | Arthritis, Rheumatoid NIH | 0.01 |
| D012216 | Rheumatic Diseases NIH | 0.01 |
| D007251 | Influenza, Human NIH | 0.01 |
| D017563 | Lung Diseases, Interstitial NIH | 0.01 |
| D020521 | Stroke NIH | 0.01 |
| D001168 | Arthritis NIH | 0.01 |
| D011655 | Pulmonary Embolism NIH | 0.01 |
| D011658 | Pulmonary Fibrosis NIH | 0.01 |
| D003863 | Depression, NIH | 0.01 |
| D000077062 | Burnout, Psychological NIH | 0.01 |
| D009369 | Neoplasms, NIH | 0.01 |
| D013315 | Stress, Psychological NIH | 0.01 |
| D004630 | Emergencies NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002090 | Pneumonia HPO | 0.15 |
| HP:0011947 | Respiratory tract infection HPO | 0.08 |
| HP:0100614 | Myositis HPO | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005978 | Type II diabetes mellitus HPO | 0.04 |
| HP:0012418 | Hypoxemia HPO | 0.04 |
| HP:0006536 | Pulmonary obstruction HPO | 0.04 |
| HP:0002088 | Abnormal lung morphology HPO | 0.04 |
| HP:0002905 | Hyperphosphatemia HPO | 0.03 |
| HP:0002900 | Hypokalemia HPO | 0.03 |
| HP:0000819 | Diabetes mellitus HPO | 0.03 |
| HP:0000846 | Adrenal insufficiency HPO | 0.03 |
| HP:0001618 | Dysphonia HPO | 0.03 |
| HP:0001621 | Weak voice HPO | 0.03 |
| HP:0100724 | Hypercoagulability HPO | 0.03 |
| HP:0002355 | Difficulty walking HPO | 0.03 |
| HP:0008711 | Benign prostatic hyperplasia HPO | 0.03 |
| HP:0002789 | Tachypnea HPO | 0.03 |
| HP:0000132 | Menorrhagia HPO | 0.03 |
| HP:0003326 | Myalgia HPO | 0.03 |
| HP:0002902 | Hyponatremia HPO | 0.03 |
| HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.03 |
| HP:0000859 | Hyperaldosteronism HPO | 0.03 |
| HP:0100280 | Crohn's disease HPO | 0.03 |
| HP:0001609 | Hoarse voice HPO | 0.03 |
| HP:0100512 | Low levels of vitamin D HPO | 0.03 |
| HP:0000458 | Anosmia HPO | 0.03 |
| HP:0001907 | Thromboembolism HPO | 0.03 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.03 |
| HP:0002037 | Inflammation of the large intestine HPO | 0.03 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.03 |
| HP:0006802 | Abnormal anterior horn cell morphology HPO | 0.02 |
| HP:0001871 | Abnormality of blood and blood-forming tissues HPO | 0.02 |
| HP:0000709 | Psychosis HPO | 0.02 |
| HP:0000505 | Visual impairment HPO | 0.02 |
| HP:0001627 | Abnormal heart morphology HPO | 0.02 |
| HP:0012819 | Myocarditis HPO | 0.02 |
| HP:0000224 | Hypogeusia HPO | 0.02 |
| HP:0100754 | Mania HPO | 0.02 |
| HP:0000818 | Abnormality of the endocrine system HPO | 0.02 |
| HP:0002293 | Alopecia of scalp HPO | 0.02 |
| HP:0007354 | Amyotrophic lateral sclerosis HPO | 0.02 |
| HP:0002242 | Abnormal intestine morphology HPO | 0.02 |
| HP:0012047 | Hemeralopia HPO | 0.02 |
| HP:0002180 | Neurodegeneration HPO | 0.02 |
| HP:0006775 | Multiple myeloma HPO | 0.02 |
| HP:0000708 | Behavioral abnormality HPO | 0.02 |
| HP:0001919 | Acute kidney injury HPO | 0.02 |
| HP:0002098 | Respiratory distress HPO | 0.02 |
| HP:0002625 | Deep venous thrombosis HPO | 0.02 |
| HP:0003765 | Psoriasiform dermatitis HPO | 0.02 |
| HP:0002015 | Dysphagia HPO | 0.02 |
| HP:0001250 | Seizure HPO | 0.02 |
| HP:0007018 | Attention deficit hyperactivity disorder HPO | 0.02 |
| HP:0100785 | Insomnia HPO | 0.02 |
| HP:0001928 | Abnormality of coagulation HPO | 0.02 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.02 |
| HP:0000822 | Hypertension HPO | 0.02 |
| HP:0001513 | Obesity HPO | 0.02 |
| HP:0001298 | Encephalopathy HPO | 0.02 |
| HP:0002721 | Immunodeficiency HPO | 0.01 |
| HP:0002725 | Systemic lupus erythematosus HPO | 0.01 |
| HP:0100526 | Neoplasm of the lung HPO | 0.01 |
| HP:0001888 | Lymphopenia HPO | 0.01 |
| HP:0100806 | Sepsis HPO | 0.01 |
| HP:0001635 | Congestive heart failure HPO | 0.01 |
| HP:0012532 | Chronic pain HPO | 0.01 |
| HP:0001370 | Rheumatoid arthritis HPO | 0.01 |
| HP:0001909 | Leukemia HPO | 0.01 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.01 |
| HP:0001297 | Stroke HPO | 0.01 |
| HP:0001369 | Arthritis HPO | 0.01 |
| HP:0002206 | Pulmonary fibrosis HPO | 0.01 |
| HP:0002204 | Pulmonary embolism HPO | 0.01 |
| HP:0002664 | Neoplasm HPO | 0.01 |
Navigate: Correlations HPO
There are 820 clinical trials
A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.
Description: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination
Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety) Time: Up to 12 months post enrollmentDescription: Virologically-confirmed COVID-19 clinical disease will be defined as an acute respiratory illness that is clinically consistent with COVID-19 disease, AND SARS-CoV-2 RT-PCR positivity.
Measure: Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy) Time: Up to 12 months post enrollmentDescription: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination
Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety) Time: Up to 12 months post enrollmentDescription: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination
Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity) Time: Up to 12 months post enrollmentDescription: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV Time: Up to 12 months post enrollmentDescription: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus
Measure: Assess humoral Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity) Time: Up to 12 months post enrollmentDescription: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination
Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity) Time: Up to 12 months post enrollmentDescription: Cellular Fc effector functionality assays to measure the ability of vaccine elicited antibodies to mediate cellular cytotoxicity, complement deposition, and phagocytosis.
Measure: Assess Fc effector functionality in participants who receive ChAdOx1 nCoV-19 vaccine or placebo Time: Up to 12 months post enrollmentDescription: Flow cytometric sorting of plasmablasts and memory B cells to using spike and receptor binding domain "baits" to isolate SARS-CoV-2 specific B cells, sequence their immunoglobulin genes and define their epitope specificity.
Measure: Assess B cell responses to SARS-CoV-2 spike trimer and/or the receptor binding domain in participants who receive ChAdOx1 nCoV-19 vaccine or placebo Time: Up to 12 months post enrollmentNon tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.
Description: Measure the number of unanticipated adverse events over the duration of the study protocol
Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects Time: 26 DaysDescription: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy
Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects Time: Day 5,12,19 and 26Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy
Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum Time: Day 19 and 26Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)
Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score Time: Day 19 and 26Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.
Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions Time: Day 26Description: Measured by death from all causes
Measure: Efficacy in reduction of mortality Time: Day 26Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract
Measure: Antiviral effect Time: Day 26Description: Time to clinical recovery as measured by resolution of clinical signs
Measure: Efficacy on clinical improvement Time: Day 26Description: Measured by change in the Modified Jackson Cold Score
Measure: Efficacy on the respiratory symptoms Time: Day 26The primary objective of this study is to determine the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in Phase 1, to evaluate preliminary efficacy of TAK-981 in participants with select solid tumors or relapsed/refractory CD20-positive (CD20+) non-hodgkin lymphoma (NHL) indications in Phase 2, and to assess change in severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID-19 Expansion.
Description: Severity grade will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which will be assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Measure: Phase 1: Number of Participants Based on Severity of TEAEs Time: Up to 48 monthsDescription: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Overall Response Rate (ORR) Time: From the first dose until best response is achieved (up to 4 years)Description: Severity grade will be evaluated as per the NCI CTCAE Version 5.0, except for CRS, which will be assessed by ASTCT consensus grading criteria.
Measure: Phase 2: Number of Participants Based on Severity of TEAEs Time: Up to 48 monthsDescription: ORR is defined as percentage of participants who achieve CR and PR through the study (approximately 4 years), as determined by the investigator according to the RECIST V1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: ORR Time: From the first dose until best response is achieved (up to 4 years)Description: DOR is the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease for responders (PR or better) and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Duration of Response (DOR) Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to 4 years)Description: DCR is defined as the percentage of participants who achieve stable disease (SD) or better (determined by the investigator according to RECIST v1.1 criteria for solid tumors or Lugano classification for lymphoma) greater than (>) 6 weeks during the study in the response-evaluable population.
Measure: Phase 2: Disease Control Rate (DCR) Time: From the first dose until best response is achieved (up to 4 years)Description: TTR is defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Time to Response (TTR) Time: From the date of first study drug administration to the date of first documented PR or better (up to 4 years)Description: TTP is defined as the time from the date of the first dose administration to the date of first documented progressive disease and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Time to Progression (TTP) Time: From the date of first study drug administration to the date of first documented PD (up to 4 years)Description: PFS is defined as the time from the date of the first dose administration to the date of first documentation of progressive disease or death due to any cause, whichever occurs first and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.
Measure: Phase 2: Progression-free Survival (PFS) Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to 4 years)Description: OS is defined as the time from the date of the first dose administration to the date of death.
Measure: Phase 2: Overall Survival (OS) Time: From the date of first study drug administration to the date of death (up to 4 years)Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.
Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs Time: Up to 9 monthsDescription: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.
Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS) Time: Up to 9 monthsDescription: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).
Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating Time: Up to 9 monthsDescription: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.
Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 monthsDescription: Time from the first dose of TAK-981 to viral load negativity (below level of detection).
Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples Time: Up to 9 monthsDescription: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.
Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours Time: Up to 9 monthsLOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.
Description: Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors
Measure: Number of deceased participants or with persistent organ dysfunction Time: Both assessed at 28 daysDescription: Persistent organ dysfunction-free days in intensive care unit
Measure: Number of participants with persistent organ dysfunction-free days in intensive care unit Time: Up to day 28Description: Mortality at 6 months
Measure: Number of participants deceased at 6 months Time: 6 monthsDescription: Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measure: Score of health related quality of life in 6-month survivors Time: 6 monthsDescription: Assessed by serum lactate concentration
Measure: Global tissue dysoxia Time: Days 1, 3, 7Description: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Measure: Organ function (including renal function) Time: Days 1, 2, 3, 4, 7, 10, 14, 28Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Measure: Rate of inflammation Time: Days 1, 3, 7Description: Assessed by procalcitonin (PCT)
Measure: Rate of infection Time: Days 1, 3, 7Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Measure: Rate of endothelial injury Time: Days 1, 3, 7Description: Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Measure: Occurrence of stage 3 acute kidney injury Time: Up to day 28Description: clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Measure: Acute hemolysis Time: Up to day 28Description: Core lab-validated glucose level of less than 3.8 mmol/L
Measure: Hypoglycemia Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last doseDescription: Assessed by chromatography-tandem mass spectrometry
Measure: Vitamin C volume of distribution Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)Description: Assessed by chromatography-tandem mass spectrometry
Measure: Vitamin C clearance Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)Description: Assessed by chromatography-tandem mass spectrometry
Measure: Vitamin C plasma concentration Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).
Measure: Prevention of COVID-19 Time: Five yearsDescription: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).
Measure: Treatment of COVID-19 Time: Five yearsDescription: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.
Measure: Treatment of Symptoms Time: Five yearsDescription: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.
Measure: Cannabis Impact on Quality of Life Time: Five yearsDescription: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.
Measure: Cannabis Route and Dosing Time: Five yearsDescription: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.
Measure: Monitoring Adverse Events Time: Five yearsIn late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China. It is now confirmed that the etiology of this outbreak is a novel coronavirus, namely, 2019-nCoV. Of critical importance is rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of 2019-nCoV. Recombinase aided amplification (RAA) assay is a novel isothermal nucleic acid amplification technique in recent years, which has a variety of the advantages including high specificity and sensitivity, rapid detection (30 min), low cost, low equipment requirements and simple operation. The has successfully detected a variety of pathogens using this technique. To develop a RAA assay for 2019-nCoV with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. The investigators established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, The investigators also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference.
Description: Detection sensitivity is greater than 95%
Measure: Detection sensitivity is greater than 95% Time: at baselineDescription: Detection specificity is greater than 95%
Measure: Detection specificity is greater than 95% Time: at baselineDescription: Consistent with existing universal reagent detection rates greater than 95%
Measure: Consistent with existing universal reagent detection rates greater than 95% Time: at baselineIn December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.
Description: PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
Measure: Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case. Time: 12 days (+/-2)Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)
Measure: Time to apparition of any symptom suggestive of SARS-CoV-2 from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case. Time: 12 days (+/-2)Description: nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
Measure: Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion Time: 12 days (+/-2)Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)
Measure: Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection Time: 12 days (+/-2)Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)
Measure: Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection Time: 12 days (+/-2)Description: ELISA, microneutralisation essay
Measure: Proportion of contact subjects with positive serology defined as the presence of SARS-CoV-2 IgM or IgG at day 30 (+/-7) following last contact Time: 30 days (+/-7)Description: Whole exome sequencing
Measure: Host genetic variants Time: 1 dayDescription: ELISA, microneutralisation essay
Measure: The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology. Time: 365 days (+/-30)Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.
Description: Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.
Measure: The incidence of composite adverse outcome Time: 14 daysDescription: Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.
Measure: Time to recovery Time: 14 daysInfectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.
Description: Describe the clinical features of the illness or syndrome (cardio-respiratory signs or symptoms, and laboratory results) and complications, and determinants of severity. Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
Measure: Clinical features Time: 6 monthsDescription: Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments. Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
Measure: Response to treatment Time: 6 monthsDescription: high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples. Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Measure: Pathogen replication, excretion and evolution, within the host Time: 6 monthsDescription: Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood. Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
Measure: Immune host responses to infection and therapy Time: 6 monthsDescription: Identify host genetic variants associated with disease progression or severity
Measure: Host genetic variants Time: Day 1The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.
Description: Evaluation of Pneumonia Improvement
Measure: Pneumonia severity index Time: From Baseline (0W) to 12 week after treatmentDescription: Evaluation of Pneumonia Improvement
Measure: Oxygenation index (PaO2/FiO2) Time: From Baseline (0W) to 12 week after treatmentDescription: Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.
Measure: Side effects in the UC-MSCs treatment group Time: From Baseline (0W) to 96 week after treatmentDescription: Marker for efficacy of treatment
Measure: 28-days survival Time: Day 28Description: Markers of organ function（Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.）
Measure: Sequential organ failure assessment Time: Day 28Description: Markers of Infection
Measure: C-reactive protein Time: From Baseline (0W) to 12 week after treatmentDescription: Markers of Infection
Measure: Procalcitonin Time: From Baseline (0W) to 12 week after treatmentDescription: Marker of Immunological function
Measure: Lymphocyte count Time: From Baseline (0W) to 12 week after treatmentDescription: Marker of Immunological function
Measure: CD3+, CD4+ and CD8+ T celll count Time: From Baseline (0W) to 12 week after treatmentDescription: Marker of Immunological function
Measure: CD4+/CD8+ratio Time: From Baseline (0W) to 12 week after treatmentCompare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19). Random, open, group sequential design.
Description: Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Measure: Time to clinical recovery after treatment Time: within 14 days from the start of medicationDescription: Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg
Measure: Rate of aggravation Time: within 14 days from the start of medicationDescription: Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.
Measure: Clinical remission rate Time: within 14 days from the start of medicationDescription: oxygenation index
Measure: Dynamic changes of oxygenation index Time: within 14 days from the start of medicationDescription: time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
Measure: Time to cure Time: within 14 days from the start of medicationDescription: proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Measure: rate to cure Time: within 14 days from the start of medicationDescription: defervescence is defined as below 37 Celcius degrees（ear temperature）
Measure: Time to defervescence Time: within 14 days from the start of medicationThere was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.
the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.
Description: From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours
Measure: Clinical recovery time Time: Up to Day 14Description: From the beginning of research drug use to body temperature <37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more
Measure: Complete fever time Time: Up to Day 14Description: Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above
Measure: Cough relief time Time: Up to Day 14Description: From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Measure: Virus negative time Time: Up to Day 14Description: Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia
Measure: Incidence of severe or critical neocoronavirus pneumonia Time: Up to Day 14The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental symptoms and usually presents in severe and critical coronavirus disease (COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is considered as the most potent vascular permeability inducers. Numerous studies have revealed that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab, an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary edema.
Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Time: 24 hoursDescription: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio Time: 7 daysDescription: The oxygen-support status includes 6 levels: mechanical ventilation, non-invasive ventilation, a transition status of alternate use of non-invasive ventilation and high-flow oxygen, high-flow oxygen, low-flow oxygen and ambient air. The improvement of oxygen-support status is defined as switch from a higher level of oxygen-support to a lower level.
Measure: Rate of improvement of oxygen-support status Time: 28 daysDescription: The areas of pulmonary lesions are analysised by a professional imaging software.
Measure: The change of areas of pulmonary lesions shown on chest radiological imaging (chest CT or X-ray) Time: 7 daysDescription: Blood lymphocyte counts
Measure: Blood lymphocyte counts Time: 7 daysDescription: Level of CRP
Measure: Level of CRP Time: 7 daysDescription: Level of hs-CRP
Measure: Level of hs-CRP Time: 7 daysDescription: All-cause mortality
Measure: All-cause mortality Time: 28 daysDescription: Discharge rate
Measure: Discharge rate Time: 28 daysA combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir
Description: Time to negative NPS 2019-n-CoV RT-PCR
Measure: Time to negative NPS Time: Up to 1 monthDescription: Time to negative saliva 2019-n-CoV RT-PCR
Measure: Time to negative saliva Time: Up to 1 monthDescription: Time to NEWS of 0
Measure: Time to clinical improvement Time: Up to 1 monthDescription: Length of hospitalisation
Measure: Hospitalisation Time: Up to 1 monthDescription: 30-day mortality
Measure: Mortality Time: Up to 1 monthDescription: Cytokine/ chemokine changes
Measure: Immune reaction Time: up to 1 monthDescription: Adverse events during treatment
Measure: Adverse events Time: up to 1 monthDescription: Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR
Measure: Time to negative all clinical specimens Time: up to 1 monthIn December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).
Description: Safety evaluation within 28 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
Measure: Adverse reaction (AE) and severe adverse reaction (SAE) Time: Up to 28 daysDescription: Efficiency evaluation within 28 days, including time to clinical improvement (TTIC)
Measure: Time to clinical improvement (TTIC) Time: Up to 28 daysDescription: Number of patients weaning from mechanical ventilation within 28 days
Measure: Number of patients weaning from mechanical ventilation Time: Up to 28 daysDescription: Duration (days) of ICU monitoring within 28 days
Measure: Duration (days) of ICU monitoring Time: Up to 28 daysDescription: Duration (days) of vasoactive agents using within 28 days
Measure: Duration (days) of vasoactive agents usage Time: Up to 28 daysDescription: Duration (days) of mechanical ventilation supply among survivors
Measure: Duration (days) of mechanical ventilation supply Time: Up to 28 daysDescription: Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs
Measure: Number of patients with improved organ failure Time: Up to 28 daysDescription: Rate of mortality within 28 days
Measure: Rate of mortality Time: Up to 28 daysDescription: Records of daily sequential organ failure assessment (SOFA) score (From 0 to 24 points, higher scores mean a worse outcome)
Measure: Sequential organ failure assessment (SOFA) score Time: Every day for 28 daysDescription: Records of Blood routine test
Measure: Lymphocyte Count (10E9/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Coagulation function
Measure: D-dimer (mg/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Records of heart failure
Measure: pro-type B natriuretic peptide (pro-BNP) (pg/ml) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-1β (pg/ml) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-2R (ng/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-6 (ng/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Record of serum cytokine
Measure: IL-8 (ng/L) Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Computed tomography or X-ray
Measure: Chest imaging Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if availableDescription: Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimens
Measure: Time to SARS-CoV-2 RT-PCR negativity Time: Up to 28 daysThe study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Outbreak of 2019 Novel Coronavirus infection started in Wuhan and quickly spread to the world. Suspected patients were isolated and treated in our department. Clinical data was recorded to investigate the clinical features of patients confirmed and excluded diagnosed of 2019 Novel Coronavirus infection.
Description: If the patient will survive after comprehensive treatment
Measure: Survival rate Time: 28 daysDescription: Images of chest computed tomography are obtained to find out the changes in the course of treatment
Measure: Chest computed tomography Time: 28 daysDescription: Time for recovery from admission to discharged
Measure: Recovery Time Time: 28 daysDescription: A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition.
Measure: Depression evaluation Time: 28 daysOutbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.
Description: rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples
Measure: Positive rate of 2019 Novel Coronavirus RNA Time: 28 daysDescription: If the patient will survive after comprehensive treatment
Measure: Survival rate Time: 28 daysSince december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
Description: Evaluation of pneumonia improvement
Measure: Improvement of clinical symptoms including duration of fever Time: Measured from day 0 through day 28Description: Evaluation of pneumonia improvement
Measure: Improvement of clinical symptoms including respiratory frequency Time: Measured from day 0 through day 28Description: Safety evaluation
Measure: Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0 Time: Measured from day 0 through day 28Description: Marker for 2019-nCoV
Measure: Time of virus nucleic acid test negative Time: Measured from day 0 through day 28Description: Marker of immunological function
Measure: CD4+ and CD8+ T cell count Time: Measured from day 0 through day 28Description: Marker for efficacy of treatment
Measure: Rate of mortality within 28-days Time: Day 28Description: Recovery of lung injury
Measure: Size of lesion area by thoracic imaging Time: Measured from day 0 through day 28Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).
Description: The lesion change on X-ray images from day 5 to baseline
Measure: The change of pneumonia severity on X-ray images Time: 5 day after fingolimod treatmentAs of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.
Description: The primary outcome is the time to negative conversion of coronavirus
Measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2 Time: 1 monthDescription: The time of hospitalization.
Measure: Length of stay in hospital Time: 1 monthDescription: The rate of survival within hospitalization of these patients will be tracked.
Measure: Survival Time: 1 monthDescription: The rate of intubation within hospitalization of these patients will be tracked.
Measure: Intubation Time: 1 monthSince Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.
Description: The screening accuracy of the two screening strategies were calculated and compared.
Measure: Screening accuracy Time: 1 monthDescription: The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.
Measure: Cost-effectiveness analysis Time: 1 monthThis is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
Description: From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.
Measure: The time to oxygen saturation recovery to normal level (≥97%) Time: Day -1 to 10Description: The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.
Measure: The proportion of patients with normal level of oxygen saturation(≥97%) Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the symptoms will be assessed 2 times daily, and the time to achievement of remission for each symptom will be calculated finally based on the record and compared between two groups.
Measure: The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc. Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.
Measure: The time to the myocardial enzyme spectrum recovery to normal after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with normal myocardial enzyme spectrum after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
Measure: The time to the electrocardiogram recovery to normal level after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with normal electrocardiogram after treatment Time: Day -1, 3, 7 and 10Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
Measure: The time to the hemodynamics recovery to normal after treatment Time: Day -1 and 10Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with normal hemodynamics after treatment Time: Day -1 and 10Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
Measure: The time to exacerbation or remission of the disease after treatment; Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
Measure: The proportion of the patients with exacerbation or remission of disease after treatment Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
Measure: The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders Time: Day -1 to 10Description: For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
Measure: The all-cause mortality rate Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
Measure: The proportion of patients with acidosis Time: Day -1 and 10Description: For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
Measure: The total duration of the patients in-hospital Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measure: The total duration of oxygen inhalation during treatment Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measure: The oxygen flow rate during treatment Time: Day -1 to 10Description: From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measure: The oxygen concentration during treatment Time: Day -1 to 10The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.
Description: Fever to normal time (day)
Measure: Fever to normal time (day) Time: 30 daysDescription: Pulmonary inflammation resolution time (HRCT) (day)
Measure: Pulmonary inflammation resolution time (HRCT) (day) Time: 30 daysDescription: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
Measure: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment Time: 30 daysCOVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.
Description: Evaluation of Pneumonia Improvement
Measure: Change in lesion proportion (%) of full lung volume from baseline to day 28. Time: Day 28Description: Evaluation of Pneumonia Improvement
Measure: Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90 Time: Day 10, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90. Time: Day 10, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90. Time: Day 10, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening Time: Day 90Description: Evaluation of Pneumonia Improvement
Measure: Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel) Time: Day 10, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90. Time: Day 10, Day 28, Day 90Description: Clinical improvement defined as a one-point deduction from baseline in a 6 ordinal scale: Not hospitalized; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Time to clinical improvement in 28 days. Time: Day 28Description: Evaluation of Pneumonia Improvement
Measure: Oxygenation index( PaO2/FiO2) Time: Day 6, Day 10, Day 28Description: Evaluation of Pneumonia Improvement
Measure: Duration of oxygen therapy(days) Time: Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Blood oxygen saturation Time: Day 6, Day 10, Day 28Description: Evaluation of Pneumonia Improvement
Measure: 6-minute walk test Time: Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Maximum vital capacity (VCmax) Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Diffusing Capacity (DLCO) Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.
Measure: mMRC (Modified Medical Research Council) dyspnea scale Time: Day 28, Day 90Description: Marker of Immunological function
Measure: Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90. Time: Day 6, Day 10, Day 28, Day 90Description: Marker of Immunological function
Measure: Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90. Time: Day 6, Day 10, Day 28, Day 90Description: Safety endpoints
Measure: Adverse events Time: Day 0 through Day 90Description: Safety endpoints
Measure: Serious adverse events Time: Day 0 through Day 90Description: Safety endpoints
Measure: All-cause mortality Time: Day 0 through Day 90Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.
The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
Description: The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.
Measure: Reduction in the incidence of intubation and mechanical ventilation Time: 28 daysDescription: Mortality from all causes
Measure: Mortality Time: 28 daysDescription: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab
Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract Time: 7 daysDescription: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).
Measure: Time to clinical recovery Time: 28 daysThe investigators will enroll 102 patients with a confirmed diagnosis of COVID-19. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or placebo. ICU Standards of care will be the institution's own protocols (such as ventilation strategies and use and dose of antivirals and antimicrobials, steroids, inotropic and vasopressor agents).
Description: Percentage of patients that have a PaO2/FiO2 ratio steadily > 300 in ambient air
Measure: SARS-free patients at 14 days Time: 14 days since beginning of treatmentDescription: Composite outcome in which: Death=0, Days of treatment =1
Measure: SARS-free days at 28 days Time: 28 daysDescription: Composite outcome in which: Death=0, Days of treatment =1
Measure: SARS -free days at 90 days Time: 90 daysDescription: Incidence
Measure: Renal Replacement Therapy Time: 28 daysDescription: Incidence
Measure: Liver Failure Time: 28 daysDescription: Incidence of patients requiring VA-ECMO, LVAD, IABP
Measure: Mechanical Support of Circulation Time: 28 daysDescription: In ambient air if possible
Measure: PaO2/FiO2 ratio in ambient air Time: daily for 28 daysObjects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types. Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.
Description: The mortality of COVID-19 in 28 days
Measure: Mortality Time: 28 dayDescription: The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.
Measure: The time interval of Nucleic acid detection become negative Time: 28 dayThere is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.
Description: The SARS-CoV-2 nuclei acid was quantified using RT-PCR
Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1 Time: 1 day after receiving plasma transmissionDescription: Clinical outcomes include death, critical illness, recovery
Measure: Numbers of participants with different Clinical outcomes Time: From receiving plasma transmission to 4 weeksNew coronavirus infection is an important cause of public health emergencies at home and abroad, which seriously affects people's health and social stability. The outbreak of SRAR-COV in China in 2003 caused serious social impact. From January 2002 to August 7, 2003, there were a total of 8,422 cases worldwide, involving 32 countries and regions, of which 919 cases were fatal, with a fatality rate of nearly 11%. The fatality rate of elderly patients and patients with underlying diseases was even more high.There is no precise and effective treatment for coronavirus infection. In vitro, IFN-α2β has inhibitory effects on MERS-CoV and closely related coronavirus severe acute respiratory syndrome (SARS) -CoV. A study showed the effects of interferon-α2β and ribavirin on the replication of nCoV isolates hCoV-EMC / 2012 in Vero and LLC-MK2 cells. The combined application may be useful for the management of patients with nCoV infection in the future. At present, the combination therapy of interferon α2β and ribavirin has been successfully applied in the initial treatment and prevention of SARS and MERS.The purpose of this study was to evaluate the efficacy and safety of recombinant human interferon α1β in treating patients with new coronavirus infection in Wuhan.
Description: dyspnea
Measure: The incidence of side effects Time: Within 14 days after enrollmentDescription: SPO2≤94%
Measure: The incidence of side effects Time: Within 14 days after enrollmentDescription: respiratory rate ≥24 breaths/min in oxygen state)
Measure: The incidence of side effects Time: Within 14 days after enrollmentDescription: the patient had a normal body temperature of > for 24 hours (without taking antipyretic drugs or hormones) without self-consciousness Dyspnea or reduced dyspnea;
Measure: Time from patient enrollment to clinical remission Time: Within 14 days after enrollmentDescription: Proportion of patients with normal body
Measure: Proportion of patients with normal body Time: Within 14 days after enrollmentDescription: Proportion of patients without dyspnea
Measure: Proportion of patients without dyspnea Time: Within 14 days after enrollmentDescription: Proportion of patients without cough
Measure: Proportion of patients without cough Time: Within 14 days after enrollmentDescription: Proportion of patients without oxygen treatment
Measure: Proportion Time: Within 14 days after enrollmentDescription: The negative conversion rate of new coronavirus nucleic acid
Measure: The negative conversion rate of new coronavirus nucleic acid Time: Within 14 days after enrollmentDescription: Proportion of patients hospitalized/hospitalized in ICU
Measure: Proportion Time: within 28 days after enrollmentDescription: Frequency of serious adverse drug events.
Measure: Frequency of serious adverse drug events. Time: within 28 days after enrollmentIn December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.
Description: The time from study drug use to complete fever reduction and cough recovery is measured in hours.
Measure: Clinical recovery time Time: Up to Day 28A randomized controlled trial in which nurses will be randomized to either medical masks or N95 respirators when providing care to patients with COVID-19.
Description: Number of participants with RT-PCR confirmed COVID-19 infection
Measure: RT-PCR confirmed COVID-19 infection Time: 6 monthsDescription: Number of participants with acute respiratory illness
Measure: Acute respiratory illness Time: 6 monthsDescription: Number of participants with absenteeism
Measure: Absenteeism Time: 6 monthsDescription: Number of participants with lower respiratory infection
Measure: Lower respiratory infection Time: 6 monthsDescription: Number of participants with pneumonia
Measure: Pneumonia Time: 6 monthsDescription: Number of participants with ICU admission
Measure: ICU admission Time: 6 monthsDescription: Number of participants needing mechanical ventilation
Measure: Mechanical ventilation Time: 6 monthsDescription: Number of participants that died
Measure: Death Time: 6 monthsCurrently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.
Description: The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.
Measure: Determine the number of Covid-19 patients who were unable to complete SCE Therapy Time: 4 weeksDescription: Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Measure: Examine the percentage of activated T cells after SCE therapy by flow cytometry Time: 4 weeksDescription: Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Measure: Assess the percentage of Th17 cells after SCE therapy by flow cytometry Time: 4 weeksDescription: Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
Measure: Chest imaging changes by computed tomography (CT) scan of the chest Time: 4 weeksDescription: To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.
Measure: Quantification of the SARS-CoV-2 viral load by real time RT-PCR Time: 4 weeksDisease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other staff working in a facility where there are cases of either proven, or suspected, COVID-19, who can be followed reliably for 5 months. 40,000 participants will be recruited and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.
Description: Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
Measure: Number of symptomatic COVID-19 infections Time: Approximately 90 daysDescription: Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
Measure: Symptoms severity of COVID-19 Time: Approximately 90 daysDescription: Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.
Measure: Number of asymptomatic cases of COVID-19 Time: Approximately 90 daysDescription: Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Measure: Number of symptomatic acute respiratory illnesses Time: Approximately 90 daysDescription: Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Measure: Severity of symptomatic acute respiratory illnesses Time: Approximately 90 daysDescription: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.
Measure: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity. Time: Approximately 90 daysDescription: Number of days lost to work in relation to the treatment arm
Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic. Time: Approximately 90 daysDescription: The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.
Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs Time: Approximately 90 daysDescription: The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.
Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L) Time: Approximately 90 daysThe scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
Description: The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.
Measure: Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation Time: 28 daysDescription: Proportion of deaths from all causes
Measure: Mortality Time: 28 daysDescription: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.
Measure: Time to clinical recovery Time: 28 daysDescription: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.
Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract Time: 7 daysSevere acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded randomized controlled trial with 1:1 individual allocation
Description: Difference within groups in terms of PaO2/FiO2 ratio. If a patient dies during the first 48 hours of treatment, the last available blood gas analysis will be used.
Measure: Change of arterial oxygenation at 48 hours from enrollment Time: 48 hoursDescription: Time to recover gas exchange to a PaO2/FiO2 =/> 300 for at least 24 hours during the first 28 days after enrollment, within each group and comparison between groups. If the patient dies before day 28, the patient will be considered as "never recovered".
Measure: Time to reach normoxemia during the first 28 days after enrollment Time: 28 daysDescription: Daily proportion of patients with a PaO2/FiO2 ratio > 300 for at least 24 hours within each group and comparison between groups. If a patient dies before day 28, the patient will be considered as "never recovered".
Measure: Proportion of SARS-nCoV-2 free patients during the first 28 days after enrollment Time: 28 daysDescription: Proportion of patients surviving at 28 days within each group and comparison between groups.
Measure: Survival at 28 days from enrollment Time: 28 daysDescription: Proportion of patients surviving at 90 days within each group and comparison between groups.
Measure: Survival at 90 days from enrollment Time: 90 daysDescription: Expressed as PaO2/FiO2 ratio within each group and comparison between groups.
Measure: Daily oxygenation in the two groups until day 28 Time: 28 daysDescription: Proportion of patients needing RRT within each group and comparison between groups.
Measure: Need for new renal replacement therapy during the first 28 days Time: 28 daysDescription: Proportion of patients needing (i.e., ECMO, intra-aortic balloon pump, VADs) within each group and comparison between groups.
Measure: Mechanical support of circulation during the first 28 days Time: 28 daysDescription: Average days without need for vasopressors within each group and comparison between groups.
Measure: Days free of vasopressors during the first 28 days Time: 28 daysDescription: Average days without need for mechanical ventilation within each group and comparison between groups.
Measure: Ventilator-free day at 28 days Time: 28 daysDescription: Time to obtain first negative upper respiratory trait sample in the 2019-nCoV rt-PCR assay. Average within groups and comparison between groups.
Measure: Time to SARS-CoV-2 rt-PCR negative in upper respiratory tract specimen Time: 28 daysDescription: Average days out of ICU within each group and comparison between groups.
Measure: ICU-free days at 28 days Time: 28 daysDescription: Average days of ICU admission within each group and comparison between groups.
Measure: ICU length of stay Time: 90 daysIn December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe. No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19). The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.
Description: Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome
Measure: Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection Time: 1-6 monthsDescription: How many patients died during the hospitalization
Measure: in-hospital mortality Time: 1 monthDescription: How many patients died 30 days after the discharge
Measure: 30 days mortality Time: 1 monthDescription: How many patients died 6 months after the discharge
Measure: 6 months mortality Time: 6 monthsDescription: How many patients were intubated during the hospitalization
Measure: Intubation rate Time: 7 daysDescription: How many days/hours from admittance to intubation
Measure: Time to Intubation Time: 7 daysDescription: How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Measure: Time to ventilation Time: 7 daysDescription: How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Measure: Non invasive to Invasive time Time: 7 daysDescription: How many patients were healed from the infection and discharged
Measure: Recovery rate Time: 1 monthDescription: How many patients underwent re-infection after previous recovery from COVID19
Measure: Recurrence rate Time: 1 monthDescription: Assessment of the risk factors for the infection and the admission to the hospital
Measure: Risk factor for COVID19 Time: retrospectiveDescription: What serological parameter could be used as predictor of good or negative prognosis.
Measure: Blood tests and outcome Time: 1 monthDescription: Impact of antiviral therapy on the clinical course of the disease
Measure: Antiviral therapy Time: 1 monthDescription: Assessment of bacterial, fungal or other coinfections rate
Measure: Coinfections Time: 1 monthDescription: Impact of radiological findings on the clinical course and the outcome
Measure: Radiological findings Time: 1 monthDescription: Impact of ultrasound findings on the clinical course and the outcome
Measure: Ultrasound findings Time: 1 monthDescription: Assessment of the evidence of myocardial injury in covid19+ patients
Measure: Myocardial injury Time: 1 monthDescription: impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.
Measure: Medical management Time: 1 monthIn vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.
Description: Area under the curve (AUC) of Ct value or viral copies number per mL
Measure: Viral load Time: hospital day 3, 5, 7, 10, 14, 18Description: Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
Measure: Viral load change Time: hospital day 3, 5, 7, 10, 14, 18Description: Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours
Measure: Time to clinical improvement (TTCI) Time: up to 28 daysDescription: Percentage of progression to supplemental oxygen requirement by day 7
Measure: Percentage of progression to supplemental oxygen requirement by day 7 Time: hospital day 7Description: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Measure: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 Time: hospital day 7Description: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Measure: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission Time: up to 28 daysDescription: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Measure: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 Time: hospital day 7Description: Safety and tolerability, as assessed by adverse effects
Measure: adverse effects Time: up to 28 daysDescription: Concentration of Lopinavir/ritonavir and hydroxychloroquine
Measure: Concentration of Lopinavir/ritonavir and hydroxychloroquine Time: 1, 2, 4, 5, 12 hours after taking intervention medicineStudy Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
Description: Number of participants at 14 days post enrollment with active COVID19 disease.
Measure: Incidence of COVID19 Disease among those who are asymptomatic at baseline Time: 14 daysDescription: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline Time: 14 daysDescription: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Measure: Incidence of Hospitalization Time: 14 daysDescription: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
Measure: Incidence of Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.
Measure: Incidence of Confirmed SARS-CoV-2 Detection Time: 14 daysDescription: Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.
Measure: Incidence of Symptoms Compatible with COVID19 (possible disease) Time: 90 daysDescription: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal Time: 14 daysDescription: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall symptom severity at 5 and 14 days Time: 5 and 14 daysDescription: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Measure: Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry Time: 14 daysThe purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 3 monthsThis is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).
Description: Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.
Measure: Hospital Admission Time: 15 daysDescription: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. There is no validated, unified single score and each item is evaluated individually.
Measure: Change in PROMIS Dyspnea scale Time: 10 daysDescription: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.
Measure: Change in SF-12 Physical Composite Score Time: 10 daysDescription: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measure: Change in SF-12 Mental Composite Score Time: 10 daysDescription: Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.
Measure: Daily Maximum Temperature Time: 10 daysDescription: Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.
Measure: Emergency Department/Clinic Presentations Time: 28 daysDescription: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Disease Severity Rating Day 7 Time: 7 daysDescription: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Disease Severity Rating Day 15 Time: 15 daysDescription: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Disease Severity Rating Day 28 Time: 28 daysDescription: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measure: Viral Load by Oropharyngeal Swab Day 9 Time: 9 daysDescription: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measure: Viral Load by Oropharyngeal Swab Day 15 Time: 15 daysDescription: Outcome reported as the mean number of days participants in each arm did not require ventilator use.
Measure: Ventilator-Free Days Time: 28 daysDescription: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use.
Measure: Therapeutic Oxygen-Free Days Time: 28 daysDescription: Outcome reported as the percent of participants in each arm who require hospital admission by day 15 following randomization.
Measure: Need for Hospital Admission at 15 Days Time: 15 daysDescription: Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.
Measure: Need for Oxygen Therapy at 15 Days Time: 15 daysOur project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.
Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI (aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.
Description: Cumulative distribution of the time to respiratory failure resolution with concurrent survival through day 28
Measure: Resolution of Respiratory Failure Time: Day 0 through day 28Description: Achievement of score 6-8 on NIAID Ordinal Scale through day 28
Measure: Improvement on NIAID Scale (key secondary measure) Time: Day 0 through day 28Description: Survival probability on Kaplan Meier lifetable through day 28 and day 60
Measure: Survival through day 28 and day 60 Time: Day 0 through day 28Description: Time to discharge from Intensive Care Unit
Measure: Time to ICU discharge Time: Day 0 through day 28Description: Time on mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen
Measure: Time on ventilation Time: Day 0 through day 28Description: Time to extubation (for those initially on mechanical ventilation)
Measure: Time to extubation Time: Day 0 through day 28Description: Time to discharge alive
Measure: Time to discharge alive Time: Day 0 through day 28 and day 60Description: Days free of multisystem organ failure
Measure: Multi-organ failure free days Time: Day 0 through day 28Description: PaO2:FiO2 ratio
Measure: Respiratory Distress while on mechanical ventilation Time: Day 0 through day 28Description: Oxygenation index
Measure: Oxygenation index Time: Day 0 through day 28Description: Improvement in chest x-ray by RALES score
Measure: Improvement in chest x-ray Time: Day 0 through day 28Description: Improvement in IL-6, TNF alpha, and other inflammatory markers
Measure: Improvement in inflammatory markers Time: Day 0 through day 28This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.
Description: Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.
Measure: Difference in Estimated (PEEP adjusted) P/F Ratio at 7 days Time: 7 daysDescription: Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.
Measure: Daily Hypotensive Episodes Time: 10 daysDescription: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Measure: Hypotension Requiring Vasopressors Time: 10 daysDescription: Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.
Measure: Acute Kidney Injury Time: 10 daysDescription: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.
Measure: Sequential Organ Failure Assessment (SOFA) Total Score Time: 10 daysDescription: Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.
Measure: Oxygen Saturation / Fractional Inhaled Oxygen (F/S) Time: 10 daysDescription: Outcome reported as the number of participants who have expired at 28 days post enrollment.
Measure: 28-Day Mortality Time: 28 daysDescription: Outcome reported as the number of participants who have expired at 90 days post enrollment.
Measure: 90-Day Mortality Time: 90 daysDescription: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Measure: ICU Admission Time: 10 daysDescription: Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Measure: Number of Ventilator-Free Days Time: 10 daysDescription: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.
Measure: Number of Therapeutic Oxygen-Free Days Time: 10 daysDescription: Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.
Measure: Number of Vasopressor-Free Days Time: 10 daysDescription: Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Measure: Length of ICU Stay Time: 10 daysDescription: Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
Measure: Length of Hospital Stay Time: 10 daysDescription: Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.
Measure: Incidence of Respiratory Failure Time: 10 daysDescription: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. There is no validated, unified single score and each item is evaluated individually.
Measure: Change in PROMIS Dyspnea scale Time: 10 daysDescription: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measure: Change in SF-12 Physical Composite Score Time: 10 daysDescription: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measure: Change in SF-12 Mental Composite Score Time: 10 daysDescription: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Disease Severity Rating Time: 10 daysDescription: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measure: Viral Load by Nasopharyngeal Swab Day 9 Time: 9 daysDescription: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measure: Viral Load by Nasopharyngeal Swab Day 15 Time: 15 daysDescription: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measure: Viral Load by Blood Day 9 Time: 9 daysDescription: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.
Measure: Viral Load by Blood Day 15 Time: 15 daysAll patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation，all the oxygen therapy will be used as part of the standard of care. Each group will enroll 10 patients, the treatment of all patients will be continuously optimized during observation, and the incidence of respiratory failure, intubation rate, 28 day mortality rate, ICU hospitalization days, etc will be recorded and analyzed so to optimize the treatment time window of sequential oxygen therapy
Description: Incidence of respiratory failure at day 28 after enrollment
Measure: Incidence of respiratory failure Time: 28 dayDescription: mortality rate at day 28 after enrollment
Measure: 28 day mortality rate Time: 28 dayThousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.
Description: Percentage of subjects with COVID-19 diagnosis in the two groups
Measure: COVID-19 diagnosis Time: 14 daysDescription: Percentage of subjects with a positive test in the two groups
Measure: Positive SARS-CoV-2 rt-PCR test Time: 14 daysDescription: Mean/ Median in the two groups
Measure: Total number of quarantine days Time: 14 daysDescription: Percentage in the two groups
Measure: Proportion of healthcare providers requiring quarantine Time: 14 daysCovid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.
Description: Combined outcome measure of either ICU admission or death
Measure: Number of participants with ICU admission or death Time: From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)Description: ICU admission
Measure: Number of participants with ICU admission Time: From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)Description: Hospital mortality
Measure: Number of participants with death from all causes Time: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)Description: Total time admitted to the ICU
Measure: Total duration of ICU stay Time: From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.
Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission
Measure: Maternal and perinatal outcomes Time: during gestation and at the time of delivery of the babyDouble blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.
Description: incidence of all-cause mortality
Measure: All-cause hospital mortality Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: Days from ER admission to hospital discharge
Measure: Length of hospital stay Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: need of invasive or non invasive mechanical ventilation
Measure: Need of mechanical ventilation Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Measure: Ventilator free days Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: Adverse Reactions
Measure: Grade 3-4 adverse reaction Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysThis study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. Adults (≥18 year-old) hospitalized for COVID-19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC (this treatment arm has been ceased since June 29, 2020) + Lopinavir/Ritonavir plus interferon ß-1a versus SoC (this treatment arm has been ceased since June 29, 2020) + Hydroxychloroquine (this treatment arm has been ceased since May 24, 2020). Randomization will be stratified by European region and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.
Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Percentage of subjects reporting each severity rating on a 7-point ordinal scale Time: Day 15Description: Time to an improvement of one category from admission on an ordinal scale. Time to an improvement of two categories from admission on an ordinal scale. Time to discharge (categories 1 or 2 of ordinal scale) from admission. Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29. Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline.
Measure: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale Time: Days 3, 5, 8, 11, 15 and 29Description: • Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS.
Measure: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Time: Days 3, 5, 8, 11, 15 and 29Description: • Duration of hospitalization (days).
Measure: Hospitalization Time: 29 daysDescription: Rate of mortality
Measure: Mortality Time: In hospital, Day 28, Day 90Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of lopinavir Time: Days 1, 3, 5, 8 and 11Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of hydroxychloroquine Time: Days 1, 3, 5, 8 and 11In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.
Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples
Measure: Rate of decline in SARS-CoV-2 viral load Time: Baseline (at randomization) and at 96 hoursDescription: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.
Measure: Change in National Early Warning Score score Time: Baseline (at randomization) and at 96 hoursDescription: Transfer from regular ward to intensive care unit during index admission
Measure: Admission to intensive care unit Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality during index admission
Measure: In-hospital mortality Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Measure: Duration of hospital admission Time: During index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality assessed at 30 and 90 days
Measure: Mortality at 30 and 90 days Time: At follow-up 30 and 90 daysDescription: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities
Measure: Clinical status Time: 14 days after randomizationDescription: Change in C-reactive protein concentrations from randomization to 96 hours after randomization
Measure: Change in C-reactive protein concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in alanine aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in aspartate aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in bilirubin concentrations from randomization to 96 hours after randomization
Measure: Change in bilirubin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization
Measure: Change in estimated glomerular filtration rate Time: Baseline (at randomization) and at 96 hoursDescription: Change in cardiac troponin concentrations from randomization to 96 hours after randomization
Measure: Change in cardiac troponin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization
Measure: Change in natriuretic peptide concentrations Time: Baseline (at randomization) and at 96 hoursThis study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.
Description: Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test
Measure: Number of patients with constant negative results Time: 30 daysDescription: Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive
Measure: Number of patients with positive test with a positive PCR for COVID-19 Time: 30 daysDescription: Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR
Measure: Overall Number of patients positive for COVID-19 Time: six monthsDescription: Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR
Measure: Overall Number of patients negative for COVID-19 Time: six monthsDescription: Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR
Measure: Number of patients with contrasting results Time: 30 daysDescription: Number of Invalid results
Measure: Reliability of the test Time: 30 daysDescription: Number of healthcare workers that become positive for COVID-19 IgM or IgG
Measure: Positive HCW Time: 60 daysDescription: Number of Chronic Patients that become positive for COVID-19 IgM or IgG
Measure: Number of Chronic Patients Time: 60 daysTriple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
Description: Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.
Measure: Symptomatic COVID-19 infection rate Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment startDescription: Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.
Measure: Symptomatic non-COVID viral infection rate Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment startDescription: Number of days absent from labor due to COVID-19 symptomatic infection
Measure: Days of labor absenteeism Time: From date of randomization until study completion 60 days after treatment startDescription: Absenteeism from labor rate due to COVID-19 symptomatic infection
Measure: Rate of labor absenteeism Time: From date of randomization until study completion 60 days after treatment startDescription: Rate of severe respiratory COVID-19 disease in healthcare personnel
Measure: Rate of severe respiratory COVID-19 disease in healthcare personnel Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment startModelling repurposed from pandemic influenza is currently informing all strategies for SARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will be important to understand subsequent disease waves, vaccine development and therapeutics. For this reason, ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium) was set up in advance. This focuses on hospitalised and convalescent serum samples to understand severe illness and associated immune response. However, many subjects are seroconverting with mild or even subclinical disease. Information is needed about subclinical infection, the significance of baseline immune status and the earliest immune changes that may occur in mild disease to compare with those of SARS-CoV-2. There is also a need to understand the vulnerability and response to COVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort with likely higher exposure and seroconversion rates than the general population, but who can be followed up with potential for serial testing enabling an insight into early disease and markers of risk for disease severity. We have set up "COVID-19: Healthcare worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2". This urgent fieldwork aims to secure significant (n=400) sampling of healthcare workers (demographics, swabs, blood sampling) at baseline, and weekly whilst they are well and attending work, with acute sampling (if hospitalised, via ISARIC, if their admission hospital is part of the ISARIC network) and convalescent samples post illness. These will be used to address specific questions around the impact of baseline immune function, the earliest immune responses to infection, and the biology of those who get non-hospitalized disease for local research and as a national resource. The proposal links directly with other ongoing ISARIC and community COVID projects sampling in children and the older age population. Reasonable estimates suggest the usable window for baseline sampling of NHS HCW is closing fast (e.g. baseline sampling within 3 weeks).
Description: Home-isolation or hospital admission
Measure: Seroconversion to SARS-CoV-2 positivity Time: Within 6 monthsCollection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions
Description: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response
Measure: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response Time: Hospital stay (2-3 weeks)The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.
Description: This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.
Measure: Number of participants with symptomatic, lab-confirmed COVID-19. Time: Date of enrollment to 14 days post-enrollment dateThe overall purpose of this project is to better understand the incidence, risk factors, etiology, clinical manifestations and outcome of tCOVID19 in solid organ transplant recipients. The results obtained will allow us to gain insight on the need of antiviral treatment, on the strategy for complications surveillance, on how to adjust the immunosuppressant therapy and on the level of care in which each patient should be treated. In order to attain the objectives previously described we will develop a multicenter prospective study of consecutive cases of COVID-19 among solid organ transplant recipients.
Description: Number of Solid Organ Transplant Recipients positive to coronavirus
Measure: Incidence of coronavirus infection in Solid Organ Transplant Recipients Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirusDescription: Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients
Measure: Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirusDescription: Gathering possible risk factors in coronavirus infection in Solid Organ Transplant
Measure: Presence of other risk factors Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirusDescription: Establish the frequency and type of complications related to the net state of the patient immunosuppression
Measure: Establish the frequency and type of complications related to the net state of the patient immunosuppression Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirusDescription: Another infections at the time of coronavirus positive infection will be gathered
Measure: Frequency of co-infections Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirusDescription: Number of deaths caused or complicated by coronavirus infection in patients who has recceived Solid Organ Transplant
Measure: Mortality Time: From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-upDescription: Biochemical analysis, hemogram,
Measure: Laboratory characteristics Time: At inclusion and at 28 days of follow upDescription: Nasopharyngeal swabs
Measure: Determination of coronavirus viral load Time: At inclusion at 14 days and at 28 daysDescription: According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia
Measure: Microbiological testing Time: At inclusion at 14 days and at 28 daysThe aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.
Description: The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts.
Measure: International Physical Activity Questionnaire (IPAQ) Time: 4 weeksDescription: Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. SF-12 is an easy-to-apply 12-question scale that has been validated and reliable and obtained by shortening and simplifying SF-36, which evaluates the last 4 weeks.
Measure: Health-Related Quality of Life SF-12 Scale Time: 4 weeksDescription: The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3.
Measure: Beck Depression Scale Time: 4 weeksThe investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.
Description: new-onset coronavirus disease-2019
Measure: new-onset COVID-19 Time: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.Description: new-onset fever or respiratory symptoms but with negative pulmonary images evidence.
Measure: Number of Participants with coronavirus related symptoms Time: during 28-day intervention.Description: adverse effect of interferon α
Measure: Number of Participants with adverse effect Time: during 28-day intervention.The goal of this study is to evaluate if CT (Computerized Tomography) can effectively and accurately predict disease progression in patients with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). You may be eligible if you have been diagnosed with SARS-CoV-2, are an inpatient at Beaumont Hospital-Royal Oak and meet eligibility criteria. After consent and determination of eligibility, enrolled patients will have a CT scanning session. After the CT scan, patients are followed for 30 days by reviewing their medical records and by phone after discharge from hospital.
Description: Disease progression will be characterized as requiring mechanical ventilator support, non-invasive positive pressure ventilation, high flow nasal cannula or mortality within 30 days.CT-V and PBM scores will be calculated at a voxel level from inhalation-exhalation CT scan. Several CT-V pulmonary function metrics, including the volume of identified "cold spots" (areas with decreased ventilation and perfusion), total ventilation and perfusion and radiographic fibrosis score will be calculated to assess regional ventilation/perfusion and compared to disease progression. The number of participants with correlation between these factors will be reported.
Measure: Predictive association between CT-V, PBM score and disease progression Time: 30 daysThe project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.
Description: Diagnosed with serology or direct viral detection
Measure: Rate of COVID-19 infection Time: 1 yearSARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.
Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale
Measure: Cohort 1: Days to clinical improvement from study enrolment Time: 30 daysDescription: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)
Measure: Cohort 2: Days to clinical improvement from study enrolment Time: 30 daysDescription: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30 Time: 30 daysDescription: Mortality
Measure: Cohort 1: Day 30 mortality Time: 30 daysDescription: NEWS2
Measure: Cohort 1: Change in NEW(2) score from baseline to day 30 Time: 30 daysDescription: ICU
Measure: Cohort 1: Admission to ICU Time: 30 daysDescription: invasive mechanical ventilation or ECMO
Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO Time: 30 daysDescription: Nasal or high-flow oxygen
Measure: Cohort 1: Duration of supplemental oxygen (days) Time: 30 daysDescription: Subjective clinical improvement
Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 Time: 30 daysDescription: No of new COVID-19 infections in the household
Measure: Cohort 2: Number participant-reported secondary infection of housemates Time: 30 daysDescription: Hospital admission
Measure: Cohort 2: Time to hospital admission related to COVID-19 infection Time: 30 daysCOVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.
Description: The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.
Measure: Microbiologic evidence of infection Time: 14 daysDescription: a) Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 & 90 days
Measure: Adverse events Time: 90 daysDescription: fever, cough or other respiratory/ systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhea) by day 14 in a patient with laboratory confirmed infection, combined with microbiologic confirmation of COVID-19 infection in the participant.
Measure: Symptomatic COVID-19 disease Time: 14 daysDescription: Reactive serology to SARS-CoV-2
Measure: Seropositivity Time: 28 daysDescription: The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90
Measure: Days of hospitalization attributable to COVID-19 disease Time: 90 daysDescription: The number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation will be tabulated both at day 28 and day 90.
Measure: Respiratory failure requiring ventilatory support attributable to COVID-19 disease Time: 90 daysDescription: Death attributable to COVID-19 disease and all-cause mortality
Measure: Mortality Time: 90 daysDescription: Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16.
Measure: Short-term psychological impact of exposure to COVID-19 disease Time: 28 daysDescription: Long-term impact will be measured at day 90 using the Impact of Event Scale, a validated measure of traumatic stress response, using a standard cutoff score of ≥26
Measure: Long-term psychological impact of exposure to COVID-19 disease Time: 90 daysDescription: Health-related quality of life will be measured using the EQ-5D-5L (EuroQol-5D). The EQ-5D consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The tool will be administered to participants at 1, 14, 28 and 90 days.
Measure: Health-related quality of life Time: 90 daysThe Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.
Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
Measure: Evaluation of the clinical status Time: 15 days after randomizationDescription: All-cause mortality rates at 29 days after randomization
Measure: All-cause mortality Time: 29 days after randomizationDescription: Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
Measure: Evaluation of the clinical status Time: 7 and 29 days after randomizationDescription: Number of days free from mechanical ventilation at 29 days after randomization
Measure: Number of days free from mechanical ventilation Time: 29 days after randomizationDescription: Number of days that the patient was on mechanical ventilation after randomization
Measure: Duration of mechanical ventilation Time: 29 days after randomizationDescription: Length of hospital stay on survivors
Measure: Duration of hospitalization Time: 29 days after randomizationDescription: Presence of other secondary infections
Measure: Other secondary infections Time: 29 days after randomizationDescription: Time from treatment start to death
Measure: Time from treatment start to death Time: 29 days after randomizationDescription: Morbimortality, daily life activities, mental health, and quality of life
Measure: Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life Time: 3, 6, 9 and 12 monthsDescription: Leucocyte transcriptome
Measure: Assess whether the tested therapies may be affected by leucocyte phenotype Time: BaselineDescription: Occurrence of QT interval prolongation
Measure: QT interval prolongation Time: 29 days after randomizationDescription: Occurrence of gastrointestinal intolerance
Measure: Gastrointestinal intolerance Time: 29 days after randomizationDescription: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin
Measure: Laboratory abnormalities Time: 29 days after randomizationDescription: Occurrence of adverse events related to the use of the investigational products
Measure: Adverse events Time: 29 days after randomizationThe (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.
Description: All cause in-hospital mortality
Measure: In-hospital mortality Time: 3 weeksBackground: During the current COVID-19 pandemic there is urgent need for information about the natural history of the infection in non-hospitalized patients, including the severity and duration of symptoms, and outcome from early in the infection, among different subgroups of patients. In addition, a large, real-world data registry can provide information about how different concomitant medications may differentially affect symptoms among patient subgroups. Such information can be invaluable for clinicians managing chronic diseases during this pandemic, as well as identify interventions undertaken in a naturalistic setting that have differential effects. Such factors may include patient diet, over the counter or prescription medications, and herbal and alternative treatments, among others. Identifying the natural disease history in patients from different demographic and disease subgroups will be important for identifying at-risk patients and effectiveness of interventions undertaken in the community. Objectives: The purpose of this study is to understand at the population level the symptomatic course of known or suspected COVID-19 patients while sheltering-in-place or under quarantine. Symptoms will be measured using a daily report derived from the CTCAE-PRO as well as free response. Outcomes will be assessed based on the duration and severity of infection, hospitalization, lost-to-follow-up, or death. As a patient-centric registry, patients themselves may propose, suggest, and/or submit evidence or ideas for relevant collection.
Description: Daily survey of symptoms known or reported to be associated with COVID-19 infection based including: Headache, Sore throat, Runny nose, Stuffy nose, Gritty/itch eyes, Watery eyes, Nausea, Vomiting, Diarrhea, Sneezing, Coughing, Shortness of breath, Difficulty breathing, Pain or pressure in your chest, Fever, Chills, Body aches, Fatigue, or other issues. Symptoms are rated by participants on a scale of none, mild, moderate, severe, or very severe.
Measure: Define Natural Symptom Course Time: Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days)Description: Time (in days) from onset of symptoms to hospitalization
Measure: Time to Hospitalization Time: Realistic timeframe of 14 daysDescription: Time (in days) from onset of symptoms to resolution of symptoms
Measure: Time to Symptomatic Recovery Time: Realistic timeframe of 14 daysThe additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.
Description: The primary endpoint will be the composite of the rate of the followings in COVID-19 positive cases (verified by an accredited laboratory): the number of pariticipants with ICU (intensive care unit) admission; 48 hours of hospitalisation and/or death. 48 hours of hospitalisation for the following reasons: (I) arrhythmia (causing hemodynamic instability and requiring continuous monitoring and/or cardiac support, as indicated by mean arterial pressure <65 mm Hg, and/or serum lactate >2 mmol/L) and/or (II) Acute Respiratory Distress Syndrome (ARDS): severe hypoxaemic respiratory failure indicated by a Partial Pressure of Oxygen (PaO2)/Fraction of inspired oxygen (FiO2) <300 mmHg according to the Berlin definition and/or (III) circulatory shock (the requirement of continuous vasopressor support to maintain mean arterial pressure <65 mmHg and/or serum lactate >2 mmol/L)
Measure: Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases Time: 12 monthsDescription: The number of participants, who required general practitioner visit assessed by the investigator.
Measure: The number of general practitioner visits Time: 12 monthsDescription: The number of participants, who required the admission to each type of level of care assessed by the investigator.
Measure: The number of emergency, hospital admission and intensive care admission Time: 12 monthsDescription: The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.
Measure: Length of hospitalization and intensive care unit stay Time: 12 monthsDescription: The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.
Measure: Organ dysfunction Time: 12 monthsDescription: The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire. The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress. One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.
Measure: Lifestyle changes Time: 12 monthsDescription: The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.
Measure: The cost of care Time: 12 monthsInvestigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.
Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Clinical status of subject at day 15 (on a 7 point ordinal scale). Time: Up to 15 daysDescription: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180. Time: Up to 180 daysDescription: Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.
Measure: Length of time to clinical improvement Time: Up to 29 daysDescription: Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission
Measure: Length of time to clinical progression Time: Up to 29 daysDescription: Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours
Measure: Length of time to normalization of fever Time: Up to 29 daysDescription: Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.
Measure: Length of time to normalization of oxygen saturation Time: Up to 29 daysCoronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now spreading to several countries in the world, including Brazil. Hydroxychloroquine and azithromycin may be useful for treating those patients. COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19. COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal endpoint of status at 15 days will be the primary endpoint.
Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead
Measure: Evaluation of the clinical status Time: 15 days after randomizationDescription: Evaluation of the clinical status of patients on the 7th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead
Measure: Ordinal scale in 7 days Time: 7 days after randomizationDescription: Need of intubation and mechanical ventilation up to the 7th day after randomization
Measure: Need of intubation and mechanical ventilation Time: 7 days after randomizationDescription: Use of mechanical ventilation during hospital stay
Measure: Use of mechanical ventilation during hospital stay Time: 15 days after randomizationDescription: Use of non-invasive ventilation up to the 7th day after randomization
Measure: Use of non-invasive ventilation Time: 7 days after randomizationDescription: Hospital Length of Stay
Measure: Hospital Length of Stay Time: 28 days after randomizationDescription: All-cause mortality rates during hospital stay
Measure: All-cause mortality Time: 28 days after randomizationDescription: Occurrence of thromboembolic complications such as: Deep vein thrombosis Pulmonary Embolism Stroke
Measure: Thromboembolic complications Time: 15 days after randomizationDescription: Occurrence of renal dysfunction, defined as an increase in creatinine above 1.5 times the baseline value
Measure: Acute renal disfunction Time: 15 days after randomizationDescription: Number of days alive and free of respiratory support up to 15 days (DAFOR15), defined as the sum of days patients did not require supplementary oxygen, non-invasive ventilation, high-flow nasal catheter neither mechanical ventilation at 15 -days. Patients that perished during the 15-day window will receive zero DAFOR15.
Measure: Number of days alive and free of respiratory support up to 15 days Time: 15 daysDescription: Corrected QT interval
Measure: Safety outcome on corrected QT interval Time: At day 3 and 7 after enrollmentThis observational study will collect data from patients treated with siltuximab program for treatment of SARS-CoV-2 infection complicated with serious respiratory complications. This observational study will group the patients into two cohorts receiving siltuximab.. Outcome of patients will be compared to a cohort of patients receiving standard treatment without siltuximab. The patients will be divided into 2 cohorts. Those contained in Cohort A were treated after the use of continuous positive airways pressure (CPAP) or non-invasive ventilation (NIV). Patients in Cohort B were treated after intubation
Description: The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort
Measure: mortality in siltuximab treated patients Time: 30 daysDescription: Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort
Measure: the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support Time: 30 daysDescription: Describe the clinical course of patients treated with siltuximab (Cohort A and B) in terms of ventilatory support and compare the results with the control cohort
Measure: clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy Time: 30 daysDescription: Safety of siltuximab treatment
Measure: Safety Improvement of the lung function assessed by radiologic findings Time: 30 daysDescription: Evaluate the effect of siltuximab on inflammatory parameters (CRP)
Measure: the effect on inflammatory parameters Time: 30 daysDescription: Correlation of outcomes with IL-6 levels
Measure: Correlation of outcomes with IL-6 levels Time: 30 daysIn December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection. In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers. The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition. This include both children and adult subjects, subject without social security, and healthcare workers.
Description: Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
Measure: Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case. Time: 30 days (+/-7)Description: Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay
Measure: Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7); Time: 30 days (+/-7)Description: ELISA, microneutralisation assay
Measure: Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology. Time: 365 days (+/-30)In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.
Description: All cause mortality
Measure: Mortality rate Time: up to 30 daysDescription: mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2>93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS
Measure: Clinical status evaluated in agreement with guidelines Time: up to 30 daysDescription: Pulse Oxygen Saturation(SpO2)>93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）
Measure: The differences in oxygen intake methods Time: up to 30 daysDescription: days
Measure: Time of hospitalization (days) Time: up to 30 daysDescription: days
Measure: Time of hospitalization in intensive care units Time: up to 30 daysDescription: forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge
Measure: Pulmonary function Time: up to 3 months after dischargeThis study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Measure: Categorization of hospitalization status Time: 14 daysDescription: Delta PaO2 measured in arterial puncture
Measure: Change in patient's oxygen partial pressure Time: 4 daysDescription: Delta PaCO2 measured in arterial puncture
Measure: Change in patient's carbondioxid partial pressure Time: 4 daysDescription: pH measured in arterial puncture
Measure: Level of pH in blood Time: 4 daysAcute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.
Description: Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients
Measure: Biomarkers expression Time: up to 30 daysDescription: Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy
Measure: Liver Biomarkers expression Time: up to 30 daysDescription: Changes in biomarkers in covid-19 patients before and after standard treatment
Measure: biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment Time: 60 daysCytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear. Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].
Description: Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale
Measure: Clinical improvement Time: Day 28Description: Live discharge from the hospital (whatever comes first)
Measure: Hospital discharge Time: Day 28Description: Number of death patients
Measure: Death Time: Day 28Description: 7-category ordinal scale
Measure: Clinical status Time: Day 7, Day 14Description: Number of patients with mechanical ventilhation
Measure: Mechanical ventilhation Time: Day 28Description: Days of hospitalization
Measure: Hospitalization Time: Day 28Description: Days to death from treatment initiation
Measure: Time from treatment initiation to death Time: Day 28Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Time to Negativization COVID 19 Time: Day 21Description: Time to remission of fever in patients with T>37.5°C at enrollment
Measure: Fever Time: Day 1,4,7,14,21,28This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.
Description: The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.
Measure: Number of participants who die or require hospitalization due to COVID-19 infection Time: 30 days post randomizationDescription: The secondary endpoint is the occurrence of death in the 30 days following randomization.
Measure: Number of participants who die Time: 30 days post randomizationDescription: The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.
Measure: Number of participants requiring hospitalization due to COVID-19 infection Time: 30 days post randomizationDescription: The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.
Measure: Number of participants requiring mechanical ventilation Time: 30 days post randomizationThe novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) has been discovered recently in December 2019 from wuhan city in China to spread in more than 40 countries allover the world. This disease has gain the attention of all nations after it has been stated as a pandemic by the World Health Organization (WHO) in March 12, 2020. Currently no treatment has been proved to be efficient in the treatment of infected patients by COVID-19. Natural honey has been demonstrated as potent antimicrobial in many research investigations and has been considered a good alternative for antiviral drugs for the treatment of some viral infections. The investigators aim to study the efficacy of natural honey in the treatment of COVID-19 patients in this randomized , multicenter, controlled trial, comparing honey in one arm to standard care in the other arm.
Description: Percentage of patients turned from positive to negative swaps at day 14
Measure: Rate of recovery from positive to negative swaps Time: 14 daysDescription: Number of days till no fever
Measure: Fever to normal temperature in days Time: 14 daysDescription: Number of days till lungs recovery in chest X ray or CT
Measure: Resolution of lung inflammation in CT or X ray Time: 30 daysDescription: mortality rate in each group at 30 days
Measure: 30 days mortality rate Time: 30 daysDescription: Number of days from initiation of intervention till changing of the swap test result from positive to negative
Measure: Number of days till reaching negative swab results Time: 30 daysIn December 2019, the Municipal Health Committee of Wuhan, China, identified an outbreak of viral pneumonia of unknown cause. This new coronavirus was called SARS-CoV-2 and the disease caused by that virus, COVID-19. Recent numbers show that 222,643 infections have been diagnosed with 9115 deaths, worldwide. Currently, there are no approved therapeutic agents available for coronaviruses. In this scenario, the situation of a global public health emergency and evidence about the potential positive effect of chloroquine (CQ) in most coronaviruses, including SARS-CoV-1, and recent data on small trials on SARS-CoV-2, the investigators intend to investigate the efficacy and the safety of CQ diphosphate in the treatment of hospitalized patients with severe acute respiratory syndrome in the scenario of SARS-CoV2. Preliminary in vitro studies and uncontrolled trials with low number of patients of CQ repositioning in the treatment of COVID-19 have been encouraging. The main hypothesis is that CQ diphosphate will reduce mortality in 50% in those with severe acute respiratory syndrome infected by the SARS-COV2. Therefore, the main objective is to assess whether the use of chloroquine diphosphate reduces mortality by 50% in the study population. The primary outcome is mortality in day 28 of follow-up. According to local contingency plan, developed by local government for COVID-19 in the State of Amazonas, the Hospital Pronto-Socorro Delphina Aziz, located in Manaus, is the reference unit for the admission of serious cases of the new virus. The unit currently has 50 ICU beds, with the possibility of expanding to 335 beds, if needed. The hospital also has trained multiprofessional human resources and adequate infrastructure. In total, 440 participants (220 per arm) will receive either high dose chloroquine 600 mg bid regime (4x150 mg tablets, every 12 hours, D1-D10) or low dose chloroquine 450mg bid regime (3x150mg tablets + 1 placebo tablet every 12 hours on D1, 3x150mg tablets + 1 placebo followed by 4 placebo tablets 12h later from D2 to D5, and 4 placebo tablets every 12 hours, D6-D10). Placebo tablets were used to standardize treatment duration and blind research team and patients. All drugs administered orally (or via nasogastric tube in case of orotracheal intubation). Both intervention and placebo drugs will be produced by Farmanguinhos. Clinical and laboratory data during hospitalization will be used to assess efficacy and safety outcomes.
Description: proportion of deaths at day 28 between groups compared
Measure: Mortality rate reduction of 50% by day 28 Time: 28 days after randomizationDescription: number of deaths at days 7 and 14 between groups compared
Measure: Absolute mortality on days 7 and 14 Time: 7 and 14 days after first doseDescription: clinical status
Measure: Improvement in overall subject's clinical status assessed in standardized clinical questionnaires on days 14 and 28 Time: 14 and 28 days after first doseDescription: clinical status
Measure: Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization Time: during and after intervention, up to 28 daysDescription: supplemental oxygen
Measure: Duration of supplemental oxygen (if applicable) Time: during and after intervention, up to 28 daysDescription: mechanical ventilation
Measure: Duration of mechanical ventilation (if applicable) Time: during and after intervention, up to 28 daysDescription: hospitalization
Measure: Absolute duration of hospital stay in days Time: during and after intervention, up to 28 daysDescription: adverse events grade 3 and 4
Measure: Prevalence of grade 3 and 4 adverse events Time: during and after intervention, up to 28 daysDescription: adverse events
Measure: Prevalence of serious adverse events Time: during and after intervention, up to 28 daysDescription: increase or decrease in serum creatinine compared to baseline
Measure: Change in serum creatinine level Time: during and after intervention, up to 28 daysDescription: increase or decrease in serum troponin I compared to baseline
Measure: Change in serum troponin I level Time: during and after intervention, up to 28 daysDescription: increase or decrease in serum aspartate aminotransferase compared to baseline
Measure: Change in serum aspartate aminotransferase level Time: during and after intervention, up to 28 daysDescription: increase or decrease in serum aspartate aminotransferase compared to baseline
Measure: Change in serum CK-MB level Time: during and after intervention, up to 28 daysDescription: virus clearance from respiratory tract secretion
Measure: Change in detectable viral load in respiratory tract swabs Time: during and after intervention, up to 28 daysDescription: viremia in blood detected through RT-PCR
Measure: Viral concentration in blood samples Time: during and after intervention, up to 28 daysDescription: death
Measure: Absolute number of causes leading to participant death (if applicable) Time: during and after intervention, up to 28 daysCOVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day. A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg. The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).
Description: We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.
Measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 Time: 28 daysDescription: We reported below the number of participants who died within 28 days, during the hospital stay.
Measure: In-hospital Death Within 28 Days Time: 28 daysDescription: We reported below the number of participants admitted to ICU within 28 days.
Measure: Admission to Intensive Care Unit (ICU) Time: 28 daysDescription: We reported below the number of participants who needed endotracheal intubation during ICU admission
Measure: Endotracheal Intubation (Invasive Mechanical Ventilation) Time: 28 daysDescription: Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.
Measure: Change in C-reactive Protein (CRP) Time: 7 daysDescription: number of days free from mechanical ventilation (both invasive and non-invasive) by day 28
Measure: Number of Days Free From Mechanical Ventilation Time: 28 daysCovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.
Description: Death up to 30-days post surgery
Measure: 30-day mortality Time: 30 daysDescription: Death up to 7-days post surgery
Measure: 7-day mortality Time: 7 days post surgeryDescription: Reoperation up to 30-days post surgery
Measure: 30-day reoperation Time: Up to 30-days post surgeryDescription: Admission to ICU post surgery
Measure: Postoperative ICU admission Time: Up to 30 days post surgeryDescription: Respiratory failure post surgery
Measure: Postoperative respiratory failure Time: Up to 30 days post surgeryDescription: Acute respiratory distress syndrome post surgery
Measure: Postoperative acute respiratory distress syndrome (ARDS) Time: Up to 30 days post surgeryDescription: Sepsis post surgery
Measure: Postoperative sepsis Time: Up to 30 days post surgeryEvaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.
Description: Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
Measure: Efficacy of treatment at Day 28 Time: Day 28Description: Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and Acute Respiratory Distress Syndrome during the study period.
Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 1 Time: Up to Day 28Description: Cumulative incidence of grade 3 and 4 adverse events during the study period
Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 2 Time: Up to Day 28Description: Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28): Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection
Measure: Cumulative incidence of disease severity Time: up to Day 28Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day -1 or day 0 (baseline).
Measure: Anti-SARS-CoV-2 titers Day 0 Time: Day 0Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 1.
Measure: Anti-SARS-CoV-2 titers Day 1 Time: Day 1Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 7.
Measure: Anti-SARS-CoV-2 titers Day 7 Time: Day 7Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 14.
Measure: Anti-SARS-CoV-2 titers Day 14 Time: Day 14Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 90.
Measure: Anti-SARS-CoV-2 titers Day 90 Time: Day 90Description: Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.
Measure: Rates of SARS-CoV-2 PCR positivity Time: Up to day 28Description: Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.
Measure: Duration of SARS-CoV-2 PCR positivity Time: Up to day 28Description: Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 1, 7, 14 and 28 days.
Measure: Peak quantity levels of SARS-CoV-2 RNA Time: Up to day 28PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.
Description: presenting symptoms and testing
Measure: Clinical presentation Time: Baseline to 12 monthsDescription: Clinical outcomes with resolution of illness
Measure: Disease prognosis outcomes Time: Baseline to 12 monthsDescription: Pregnancy outcomes among women infected with COVID-19
Measure: Pregnancy outcomes Time: Baseline to 12 monthsDescription: Obstetric outcomes among women infected with COVID-19
Measure: Obstetric outcomes Time: Baseline to 12 monthsDescription: Neonatal outcomes among infants born to women with COVID-19
Measure: Neonatal outcomes Time: Baseline to 12 monthsDescription: Transmission of COVID-19 from mother to infant
Measure: Modes of transmission of COVID-19 Time: Baseline to 12 monthsThe overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. The specific aims of this Covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with COVID-19 pneumonia. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design.
Description: Overall Survival
Measure: Survival Time: 14 daysDescription: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale COVID 19 Time: 14 daysThe overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of ventilator utilization at day 14. Time: 14 daysDescription: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale <=5 at day 4 Time: 4 daysDescription: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 Time: 14 daysDescription: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event. Scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9
Measure: WHO progression scale at day 4 Time: 4 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale Time: 7 and 14 daysDescription: Overall survival
Measure: Survival Time: 14, 28 and 90 daysDescription: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
Measure: respiratory acidosis at day 4 Time: 4 daysDescription: evolution of PaO2/FiO2 ratio
Measure: PaO2/FiO2 ratio Time: day 1 to day 14Description: time to oxygen supply independency
Measure: time to oxygen supply independency Time: 14 daysDescription: duration of hospitalization
Measure: duration of hospitalization Time: 90 daysDescription: time to negative viral excretion
Measure: time to negative viral excretion Time: 90 daysDescription: time to ICU discharge
Measure: time to ICU discharge Time: 90 daysDescription: time to hospital discharge
Measure: time to hospital discharge Time: 90 daysACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
Description: composite of hospitalization or death
Measure: Outpatient trial - Colchicine vs. control and Aspirin vs. control Time: 45 days post randomizationDescription: invasive mechanical ventilation or death
Measure: Inpatient trial - Interferon-β vs. control and Colchicine vs. control Time: 45 days post randomizationDescription: invasive mechanical ventilation or death
Measure: Inpatient trial - Aspirin and rivaroxaban vs. control Time: 45 days post randomizationDescription: disease progression by 2 points on a 7-point scale
Measure: Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control Time: 45 days post randomizationDescription: composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale
Measure: Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control Time: 45 days post randomizationIn December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).
Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)
Measure: interleukin-6 (IL-6) level after 72 hours Time: 72 hoursDescription: survival after 30 days
Measure: 30-day-survival Time: 72 hoursDescription: needed dosage of norepinephrine and other vasopressors
Measure: vasopressor dosage Time: 72 hoursDescription: fluid balance levels during cytokine adsorption
Measure: fluid balance Time: 72 hoursDescription: serum-lactate levels during cytokine adsorption
Measure: lactate Time: 72 hoursA phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm
Description: Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases Time: 6 monthsDescription: Occurrence of serious adverse events (SAEs) throughout the study duration
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs) Time: 6 monthsDescription: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms Time: 7 days following vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms Time: 7 days following vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs) Time: 28 days following vaccinationDescription: Change from baseline for safety laboratory measures (haematology and biochemistry blood results)
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests Time: 6 monthsDescription: Occurrence of disease enhancement episodes
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes Time: 6 monthsDescription: Number of hospital admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions Time: 6 monthsDescription: Number of intensive care unit admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions Time: 6 monthsDescription: Number of deaths associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related deaths Time: 6 monthsDescription: Occurrence of severe COVID-19 disease (defined according to clinical severity scales)
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates Time: 6 monthsDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays Time: 6 monthsDescription: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 Time: 6 monthsDescription: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays Time: 6 monthsDescription: All safety, reactogenicity, immunogenicity and efficacy endpoints
Measure: Assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol Time: 6 monthsDescription: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) post boost
Measure: Assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost Time: 6 monthsDescription: Differences in viral shedding on stool between vaccine and comparator arms at 7 days and beyond post SARS-CoV-2 PCR or NAAT positivity
Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive individuals Time: 6 monthsCOVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death. Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies. This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.
Description: Prevalence of severe forms among all COVID-19 patients with diabetes
Measure: Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19 Time: 1 monthDescription: Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.
Measure: describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19 Time: 1 monthDescription: death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit
Measure: describe the prognosis of hospitalized subjects with diabetes and COVID-19 Time: 1 monthDescription: care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7
Measure: describe the care management of hospitalized subjects with diabetes and COVID-19 Time: 1 monthThis study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.
Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.
Description: patient voice that is recorded during the study will be anylaysis with specific algorithms
Measure: Voice anaysis Time: 1-2 yearsCAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests. Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development. This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2. As soon as it is available, serology will be performed on the collected samples.
Description: Description of the serological status of individuals by different detection tests
Measure: Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. Time: One yearDescription: Proportion of asymptomatic subjects into seropositive population
Measure: Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies Time: One yearResearchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
Description: Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
Measure: RNA in SARS-CoV-2 Time: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusionDescription: Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Measure: ICU Admissions Time: 90 days after transfusionDescription: Total number of subject deaths.
Measure: Hospital Mortality Time: 90 days after transfusionDescription: The total number of days subjects were admitted to the hospital.
Measure: Hospital Length of Stay (LOS) Time: 90 days after transfusionDescription: The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
Measure: Type of respiratory support Time: 90 days after transfusion or until hospital discharge (whichever comes first)Description: The total number of days subjects required respiratory support.
Measure: Duration of respiratory support Time: 90 days after transfusion or until hospital discharge (whichever comes first)A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated. Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening. The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.
Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 14 Time: Day 14Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28. Time: Day 28Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.
Description: the treatment failure rate of HFNC/HFNC+PP support and clinical requirement for advanced respiratory support
Measure: Treatment failure Time: 28 daysDescription: the improvement of SpO2/FIO2 or PaO2/FiO2 from HFNC alone to HFNC+PP
Measure: Efficacy of PP Time: 28 daysCOVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19. Arm 1: We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate. Arm 2: The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study. Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls. Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.
Description: Patients' treatment and management during hospitalization.
Measure: Clinical Time: 6 monthsDescription: Serial viral load changes during hospitalization.
Measure: Virological Time: 6 monthsDescription: Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.
Measure: Microbiological Time: 6 monthsCOVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 monthDescription: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
Measure: Pulmonary Function Analysis Time: baseline, 3 Month, 6 monthsDescription: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 monthsAn open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.
Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.
Measure: Dataset size Time: 14 daysDescription: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity
Measure: Cough sound identification Time: 14 daysDescription: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%
Measure: Improvement of the existing model Time: 14 daysDescription: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.
Measure: Evaluate the usability of the application Time: 14 daysCOVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.
Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard
Measure: SAMBA COVID-19 POC PCR Test Time: 28 daysDescription: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale
Measure: Patient acceptability Time: 28 daysDescription: Time to positive IgM/IgG test positivity
Measure: Immune Response Positivity Time: 40 daysThis is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.
Description: The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
Measure: Pulse oximetry level Time: Change from Baseline pulse oximetry level at 15 minutes post treatmentDescription: Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.
Measure: Systemic carbon dioxide Time: Change from Baseline clinical measurements at 15 minutes post treatmentHealthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.
Description: persons who took this medication should not have an infection
Measure: Protection against COVID-19 Time: 4 monthsPhase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.
Description: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: COVID-19 disease incidence Time: Measured over the 6 months following randomisationDescription: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant (*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. (*) "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities". (**) "I do not feel physically well enough to go to work"
Measure: Severe COVID-19 disease incidence Time: Measured over the 6 months following randomisationDescription: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: COVID-19 incidence by 12 months Time: Measured over the 12 months following randomisationDescription: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant(*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. * "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities" ** "I do not feel physically well enough to go to work"
Measure: Severe COVID-19 incidence by 12 months Time: Measured over the 12 months following randomisationDescription: Time to first symptom of COVID-19 in a participant who subsequently meets the case definition: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: Time to first symptom of COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of episodes of COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: Episodes of COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of participants with asymptomatic SARS-CoV-2 infection defined as Evidence of SARS-CoV-2 infection (by PCR or seroconversion) Absence of respiratory illness (using self-reported questionnaire) No evidence of exposure prior to randomisation (inclusion serology negative)
Measure: Asymptomatic SARS-CoV-2 infection Time: Measured over the 12 months following randomisationDescription: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: Work absenteeism due to COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: Bed confinement due to COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: Symptom duration of COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: SARS-CoV-2 pneumonia Time: Measured over the 12 months following randomisationDescription: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Oxygen therapy with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Critical care admissions with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Critical care admission duration with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test
Measure: Mechanical ventilation with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of days that participants needed mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test
Measure: Mechanical ventilation duration with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).
Measure: Hospitalisation duration with COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of deaths (from death registry) associated with a positive SARS-CoV-2 test
Measure: Mortality with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of participants with fever or respiratory illness will be defined as: fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Fever or respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of episodes of fever or respiratory illness, defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Episodes of fever or respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Work absenteeism due to fever or respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days confined to bed (using self-reported questionnaire) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Bed confinement due to fever or respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days with symptoms in any episode of illness that meets the case definition for fever or respiratory illness: fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Symptom duration of fever or respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records)
Measure: Pneumonia Time: Measured over the 12 months following randomisationDescription: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)
Measure: Oxygen therapy Time: Measured over the 12 months following randomisationDescription: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)
Measure: Critical care admissions Time: Measured over the 12 months following randomisationDescription: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)
Measure: Mechanical ventilation Time: Measured over the 12 months following randomisationDescription: Number of deaths (from death registry)
Measure: Mortality Time: Measured over the 12 months following randomisationDescription: Number of days of hospitalisation due to fever or respiratory illness (using self-reported questionnaire, medical/hospital records and/or government registries)
Measure: Hospitalisation duration with fever or respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)
Measure: Unplanned work absenteeism Time: Measured over the 12 months following randomisationDescription: Cost of hospitalisation due to COVID-19 will be reported and compared between groups (using hospital administrative linked costing records held by individual hospitals and state government routine costing data collections to provide an estimate of the cost to hospitals for each episode of COVID-19 care)
Measure: Hospitalisation cost to treat COVID-19 Time: Measured over the 12 months following randomisationDescription: Type and severity of local and systemic adverse events will be collected in self-reported questionnaire and graded using toxicity grading scale.
Measure: Local and systemic adverse events to BCG vaccination in healthcare workers Time: Measured over the 3 months following randomisationCoronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial
Description: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Measure: Mortality changes in day 10 Time: 10 days after plasma transmissionDescription: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Measure: Mortality changes in day 30 Time: 30 days after plasma transmissionDescription: Measurement of CRP
Measure: Changes of C-reactive protein Time: Day 1Description: Measurement of CRP
Measure: Changes of C-reactive protein Time: Day 3Description: Measurement of CRP
Measure: Changes of C-reactive protein Time: Day 7Description: Measurement of IL-6
Measure: Changes of Interleukin 6 Time: Day 1Description: Measurement of IL-6
Measure: Changes of Interleukin 6 Time: Day 3Description: Measurement of IL-6
Measure: Changes of Interleukin 6 Time: Day 7Description: Measurement of TNF-α
Measure: Changes of tumor necrosis factor-α Time: Day 1Description: Measurement of TNF-α
Measure: Changes of tumor necrosis factor-α Time: Day 3Description: Measurement of TNF-α
Measure: Changes of tumor necrosis factor-α Time: Day 7Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen
Measure: Changes of PaO2/FiO2 Ratio Time: Day 1Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen
Measure: Changes of PaO2/FiO2 Ratio Time: Day 3Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen
Measure: Changes of PaO2/FiO2 Ratio Time: Day 7Description: Computed tomography Scan and Chest X-Ray
Measure: Radiological findings Time: Within 2 hours after admissionDescription: Computed tomography Scan and Chest X-Ray
Measure: Radiological findings Time: Day 14Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19 Secondary Objectives: - Evaluate the 28-day survival rate - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity - Evaluate changes in the National Early Warning Score 2 (NEWS2) - Evaluate the duration of predefined symptoms and signs (if applicable) - Evaluate the duration of supplemental oxygen dependency (if applicable) - Evaluate the incidence of new mechanical ventilation use during the study - Evaluate the duration of new mechanical ventilation use during the Study - Evaluate the proportion of patients requiring rescue medication during the 28-day period - Evaluate need for admission into intensive care unit (ICU) - Evaluate duration of hospitalization (days) - The secondary safety objectives of the study are to evaluate the safety of sarilumab through hospitalization (up to day 29 if patient is still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events (SAEs) - Major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia - Grade ≥2 infusion related reactions - Grade ≥2 hypersensitivity reactions - Increase in alanine transaminase (ALT) ≥3X upper limit of normal (ULN) (for patients with normal baseline) or >3X ULN AND at least 2-fold increase from baseline value (for patients with abnormal baseline) - Major or opportunistic bacterial or fungal infections
Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.
Measure: Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale Time: Baseline to Day 29Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.
Measure: Proportion of patients with one point improvement from baseline in clinical status assessment at days 4, 7, 15, 21, 29 using the 7-point ordinal scale Time: Baseline to Days 4, 7, 15, 21, 29Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.
Measure: Mean change in the 7-point ordinal scale from baseline to Days 4, 7, 15, 21, and 29 (or until discharge) Time: Baseline to Days 4, 7, 15, 21, 29 (or until discharge)Description: Defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner.
Measure: Time to resolution of fever Time: Baseline to Day 29Description: Resolution of both fever and improvement in oxygenation. Resolution of fever is defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner. Improvement in oxygenation is defined as SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours, or until discharge, whichever is sooner.
Measure: Time to resolution of fever and improvement in oxygenation Time: Baseline to Day 29Description: Fever is defined as >37.4°C (axilla), or >38.0 °C (oral), or >38.4°C (rectal or tympanic) based on maximum value observed during a 24-hour period.
Measure: Days with fever Time: Baseline to Day 29Description: The National Early Warning Score (NEWS2) is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.
Measure: Time to change in NEWS2 from baseline Time: Baseline to Day 29Description: The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.
Measure: Time to NEWS2 of <2 and maintained for 24 hours Time: Baseline to Day 29Description: The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.
Measure: Mean change from baseline to days 4, 7, 15, 21, and 29 in NEWS2 Time: Baseline to days 4, 7, 15, 21, and 29Description: SpO2/FiO2 of 50 or greater compared to the nadir for at least 48 hours, or until discharge, whichever is sooner. SpO2 is oxygen saturation and FiO2 is the fraction of inspired oxygen.
Measure: Time-to-improvement in oxygenation Time: Baseline to Day 29Description: Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.
Measure: Alive off supplemental oxygen at day 29 Time: Day 29Description: Hypoxemia is defined as SpO2 <93% on room air, or requiring supplemental oxygen, or mechanical ventilatory support.
Measure: Days of hypoxemia Time: Baseline to Day 29Description: Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.
Measure: Days of supplemental oxygen use Time: Baseline to Day 29Description: For those not requiring these interventions at baseline.
Measure: The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula Time: Baseline to Day 60Description: For patients are not in ICU at baseline
Measure: The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available) Time: Baseline to Day 60The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.
Description: Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.
Measure: Ventilator-free days Time: 28 days after randomizationDescription: Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.
Measure: Evaluation of the clinical status Time: 15 days after randomizationDescription: All-cause mortality rates at 28 days after randomization.
Measure: All-cause mortality Time: 28 days after randomizationDescription: Number of days of mechanical ventilation from randomization to day 28.
Measure: Mechanical ventilation duration Time: 28 days after randomizationDescription: Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: Score at 48 hours, 72 hours and 7 days after randomizationDescription: Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.
Measure: Intensive Care Unit free days Time: 28 days after randomizationCOVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality. The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.
Description: The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU
Measure: ICU admission Time: Through study completion 30 daysDescription: Proportion of subjects with 30-day mortality, all cause Mortality, from day 1 to day 30.
Measure: 30-day mortality Time: Through study completion 30 daysDescription: Time-to-Intubation, i.e. cumulative days free of invasive mechanical ventilation, from day 1 to day 30
Measure: Time-to-intubation Time: Through study completion 30 daysDescription: Time-to-ICU, i.e. cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30.
Measure: Time-to-ICU Time: Through study completion 30 daysDescription: Mean change in inflammatory response from day 1 to day 30. White cell count + differentiation Procalcitonin C-Reactive protein Cytokines (IL-6) (if available at local laboratory) Ferritin D-Dimer LDH
Measure: Inflammatory response Time: Through study completion 30 daysDescription: Overall survival (Kaplan-Meier)
Measure: Overall survival Time: Through study completion 30 daysDescription: Hospital mortality of any cause, proportion of subjects, from day 1 to day 30.
Measure: Hospital mortality Time: Through study completion 30 daysDescription: Proportion of subjects with ICU mortality, Mortality of any cause in ICU, from day 1 to day 30.
Measure: ICU mortality Time: From ICU admission to study completion 30 daysDescription: Time-to-stop of intubation/invasive mechanical ventilation, from ICU admission to day 30.
Measure: Time in Invasive Ventilation Time: From ICU admission to study completion 30 daysDescription: Mean daily NEWS from day 1 to day 30.
Measure: NEWS Time: Through study completion 30 daysDescription: Mean change in PaO2/FiO2 (PFI), from day 1 to day 2, … to day 30.
Measure: PaO2/FiO2 (PFI) Time: Through study completion 30 daysDescription: Proportion of HBO treatments given vs planned. Proportion of subjects with HBO treatment administered within 24h after enrolment.
Measure: HBO Compliance Time: Day 1 to day 7Description: Time-to-discharge from hospital
Measure: Hospital discharge Time: Through study completion 30 daysDescription: Mean oxygen dose per day including HBO and cumulative pulmonary oxygen toxicity expressed as Units of oxygen pulmonary toxicity dose (UPTD) and Cumulative pulmonary toxicity dose (CPTD) from day 1 to day 30.
Measure: Oxygen dose Time: Through study completion 30 daysDescription: Median number of HBO treatments and dose of HBO given, from day 1 to day 7
Measure: HBO dose Time: Day 1 to day 7Description: Change in expression of Micro RNA in plasma from day 1 to day 30
Measure: Micro RNA Time: Through study completion 30 daysDescription: Change in gene expression and Micro RNA interactions in Peripheral Blood Mononuclear Cells (PBMC) (20 Subjects) from day 1 to day 30
Measure: Hypoxic response Time: Through study completion 30 daysDescription: Immunological response (20 subjects) from day 1 to day 30 in the following. Cytokines extended including (IL-1β, IL-2, IL-6, IL33 and TNFα) Lymphocyte profile Flowcytometry with identification of monocyte/lymphocyte subsets including but not limited to CD3+/CD4+/CD8+ and CD4+/CD8+ ratio FITMaN panel/Flow cytometry, Interleukins (IL-1β, IL-2, IL-6, IL33 and TNFα), T-reg cells (CD3+/CD4+/CD25+/CD127+) Monocyte proliferation markers, Ex vivo monocyte function
Measure: Immunological response Time: Through study completion 30 daysDescription: Mean change in routine biomarkers for organ dysfunction, from day 1to day 30.
Measure: Multi organ dysfunction Time: Through study completion 30 daysDescription: Viral load, review of records from day 1 to day 30.
Measure: Viral load Time: Through study completion 30 daysDescription: Number of secondary infections, review of records, number of events and patients from day 1 to day 30.
Measure: Secondary infections Time: Through study completion 30 daysDescription: Diagnosed PE needing treatment, review of records, number of events and patients from day 1 to day 30.
Measure: Pulmonary embolism Time: Through study completion 30 daysDescription: Changes on Pulmonary CT, review of records from day 1 to day 30.
Measure: Pulmonary CT Time: Through study completion 30 daysDescription: Changes on Chest X-ray, review of records from day 1 to day 30.
Measure: Chest X-ray Time: Through study completion 30 daysDescription: Changes in Lung ultrasound, review of records from day 1 to day 30.
Measure: Lung ultrasound Time: Through study completion 30 daysThe COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.
Description: Description of clinical, laboratory and radiological features of illness and complications.
Measure: Clinical Features Time: 6 monthsDescription: Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.
Measure: Immune host response at systemic level Time: 6 monthsDescription: Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).
Measure: Immune host response at local level Time: 6 monthsDescription: Identification of host genetic variants that are associated with severity of disease.
Measure: Host genetic variation Time: 6 monthsDescription: Differences in baseline factors
Measure: Comparison severe and non-severe COVID-19 hospitalised patients Time: 6 monthsDescription: Differences in immune characteristics
Measure: Comparison severe and non-severe COVID-19 hospitalised patients Time: 6 monthsDescription: Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy
Measure: Correlation of findings with outcome Time: 6 monthsDescription: Correlation of immune profiling with microbiome analysis of patients
Measure: Correlation of immune profiling - microbiome Time: 6 monthsMinimal risk research study: 1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus; 2. Quantifying the development and trajectory of the disease through clinic visits and blood values.
Description: Measure the agreement between the detection of SARS-CoV-2 virus using a foam nasal swab tested directly after collection, a polyester nasal swab tested directly after testing, and a polyester nasal swab stored at room temperature for four days without saline or VTM before being tested.
Measure: Detection of SARS-CoV-2 virus Time: 42 daysDescription: Longitudinal blood samples from SARS-CoV-2 patients to gain a better understanding of the trajectory of COVID-19 and antibody development
Measure: Trajectory of COVID-19 and antibody development Time: 2 monthsThis study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in tropical regions such as French Guiana, Guadeloupe and New-Caledonia.
Description: The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus
Measure: Evaluation of the extent of the virus transmission within households Time: 2 yearsDescription: The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household
Measure: Characterization of the secondary cases Time: 2 yearsDescription: The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.
Measure: Characterization of the secondary cases Time: 2 yearsDescription: The extent of the virus transmission within contact persons will be assessed by evaluating the rate of extended-contact secondary transmission of the virus
Measure: In New-Caledonia, evaluation of the extent of the virus transmission within contact persons Time: 2 yearsAs of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.
Description: The primary outcome is the time to negative conversion of coronavirus
Measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2 Time: 1 monthDescription: The time of hospitalization
Measure: Length of stay in hospital Time: 1 monthDescription: The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked.
Measure: Survival Time: 1 monthDescription: The rate of intubation within hospitalization of these patients will be tracked
Measure: Intubation Time: 1 monthObjective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.
Description: Outcome reported as the percent of participants in each arm who are COVID-19-free at the end of study treatment.
Measure: COVID-19-free survival Time: up to 12 weeksDescription: Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.
Measure: Incidence of confirmed SARS-CoV-2 detection Time: up to 12 weeksDescription: Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment.
Measure: Incidence of possible COVID-19 symptoms Time: up to 12 weeksDescription: Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.
Measure: Incidence of all-cause study medicine discontinuation Time: up to 12 weeksDescription: Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.
Measure: Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end Time: up to 12 weeksDescription: Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.
Measure: Incidence of Hospitalization for COVID-19 or death Time: up to 12 weeksDescription: Outcome reported as the percent of participants in each arm who experience medication-related side effects during study treatment.
Measure: Incidence of study medication-related side effects Time: up to 12 weeksThis is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days
Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection Time: Day 1 through Day 14 after enrolmentDescription: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection Time: Day 28 after enrolmentDescription: Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
Measure: Rate of participant-reported adverse events Time: 28 days from start of Hydroxychloroquine therapyDescription: PCR-confirmed COVID-19 diagnosis
Measure: Incidence rates of COVID-19 through study completion Time: 28 days from enrolmentCoronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.
Description: Time from randomization to the first occurrence of any of the clinical events above
Measure: Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV) Time: 12 monthsDescription: Time from randomization to the first occurrence of above
Measure: Number of Covid-19 positive participants who die Time: 12 monthsDescription: Time from randomization to the first occurrence of above
Measure: Number of Covid-19 positive participants who require intubation in intensive care unit (ICU) Time: 12 monthsDescription: Time from randomization to the first occurrence of above
Measure: Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV) Time: 12 monthsDescription: Time from randomization to the first occurrence of above
Measure: Number of SARS-CoV-2 positive participants Time: 12 monthsDescription: Performed in a random sub-sample of the cohort (both study arms)
Measure: 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring Time: 12 monthsDescription: Time from randomization to the first occurrence of above
Measure: All-cause mortality Time: 12 monthsThe purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.
Description: We will track the number of participants who fill out the survey for the 12 month duration of the study and the number of participants who participate in the semi-structured telephone interviews.
Measure: Number of participants who fill out the survey and participate in the semi-structured interviews. Time: 12 MonthsThe overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.
Description: Group 1. Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of ventilator utilization at day 14. Group 1 Time: 14 daysDescription: Group 1. Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale <=5 at day 4. Group 1. Time: 4 daysDescription: Group 2. Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Group 2. Time: 14 daysDescription: Group 2 Early end point : proportion of patients with a decrease of WHO score of at least 1 point at day 4. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at day 4. Group 2. Time: 4 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale Time: 7 and 14 daysDescription: Overall survival
Measure: Survival Time: 14, 28 and 90 daysDescription: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
Measure: respiratory acidosis at day 4 Time: 4 daysDescription: evolution of PaO2/FiO2 ratio
Measure: PaO2/FiO2 ratio Time: day 1 to day 14Description: time to oxygen supply independency
Measure: time to oxygen supply independency Time: 14 daysDescription: duration of hospitalization
Measure: duration of hospitalization Time: 90 daysDescription: time to negative viral excretion
Measure: time to negative viral excretion Time: 90 daysDescription: time to ICU discharge
Measure: time to ICU discharge Time: 90 daysDescription: time to hospital discharge
Measure: time to hospital discharge Time: 90 daysThis is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.
Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.
Description: Copies of COVID-19 per ml
Measure: Change in Viral Load Time: Days 0, 4, 7, 14 and 28Description: Immunoglobulin M COVID-19 antibodies
Measure: Change in Immunoglobulin M COVID-19 antibodies Titers Time: Days 0, 4, 7, 14 and 28Description: Immunoglobulin G COVID-19 antibodies
Measure: Change in Immunoglobulin G COVID-19 antibodies Titers Time: Days 0, 4, 7, 14 and 28Description: Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)
Measure: Intensive Care Unit Admission Time: Days 7, 14 and 28Description: Days of Intensive Care Unit management (days 7, 14 and 28)
Measure: Length of Intensive Care Unit stay Time: Days 7, 14 and 28Description: Days of Hospitalization (days 7, 14 and 28)
Measure: Length of hospital stay (days) Time: Days 7, 14 and 28Description: Proportion of patients with mechanical ventilation (days 7, 14 and 28)
Measure: Requirement of mechanical ventilation Time: Days 7, 14 and 28Description: Days with mechanical ventilation (days 7, 14 and 28)
Measure: Duration (days) of mechanical ventilation Time: Days 7, 14 and 28Description: 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)
Measure: Clinical status assessed according to the World Health Organization guideline Time: Days 7, 14 and 28Description: Proportión of death patients at days 7, 14 and 28
Measure: Mortality Time: Days 7, 14 and 28Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.
Description: composite outcome of mortality and necessity of mechanical ventilation
Measure: ventilator free days Time: 28 daysDescription: number of days free from intensive care unit
Measure: ICU free days Time: trough study completion, on average 40 daysDescription: Hospital length of stay
Measure: Hospital length of stay Time: through study completion, on average 60 daysDescription: Time to wean from mechanical ventilation
Measure: Time to wean from mechanical ventilation Time: through study completion, on average 14 daysDescription: PaO2/FiO2 changes during drug administration
Measure: PaO2/FiO2 changes during drug administration Time: 48 hoursDescription: US confirmed deep vein thrombosis
Measure: Deep vein thrombosis incidence Time: through study completion, on average 30 daysDescription: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gamma
Measure: Changes in inflammatory markers Time: at randomization, 48 hours after randomization and 72 hours after randomizationDescription: Ang II and Ang-(1-7) plasmatic levels
Measure: RAS effectors levels Time: at randomization, 48 hours after randomization and 72 hours after randomizationDescription: Chest x-ray or CT scan changes
Measure: Radiological findings Time: through study completion, on average 30 daysDescription: phase 2b = principal safety outcome; phase 3 = secondary outcome
Measure: Rate of serious adverse events Time: study drug administration/day 28 or ICU discharge or deathConvalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks
Description: Copies of COVID-19 per ml
Measure: Change in Viral Load Time: Days 0, 4, 7, 14 and 28Description: Immunoglobulin G COVID-19 antibodies
Measure: Change in Immunoglobulin G COVID-19 Titers Time: Days 0, 4, 7, 14 and 28Description: Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)
Measure: Intensive Care Unit Admission Time: Days 7, 14 and 28Description: Days of Intensive Care Unit management (days 7, 14 and 28)
Measure: Length of Intensive Care Unit stay Time: Days 7, 14 and 28Description: Days of Hospitalization (days 7, 14 and 28)
Measure: Length of hospital stay (days) Time: Days 7, 14 and 28Description: Proportion of patients with mechanical ventilation (days 7, 14 and 28)
Measure: Requirement of mechanical ventilation Time: Days 7, 14 and 28Description: Days with mechanical ventilation (days 7, 14 and 28)
Measure: Duration (days) of mechanical ventilation Time: Days 7, 14 and 28Description: 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)
Measure: Clinical status assessed according to the World Health Organization guideline Time: Days 7, 14 and 28Description: Proportion of death patients at days 7, 14 and 28
Measure: Mortality Time: Days 7, 14 and 28ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
Description: We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)
Measure: COVID Ordinal Outcomes Scale on Day 15 Time: assessed on study day 15Description: Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy
Measure: all-location, all-cause mortality assessed on day 15 Time: assessed on study day 15Description: Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy
Measure: all-location, all-cause mortality assessed on day 29 Time: assessed on study day 29Description: We will determine the COVID Ordinal Scale for all patients on study day 3
Measure: COVID Ordinal Outcomes Scale on Study Day 3 Time: assessed on study day 3Description: We will determine the COVID Ordinal Scale on study day 8
Measure: COVID Ordinal Outcomes Scale on Study Day 8 Time: assessed on study day 8Description: We will determine the COVID Ordinal Scale on study day 29
Measure: COVID Ordinal Outcomes Scale on Study Day 29 Time: assessed on study day 29Description: We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28
Measure: Number of patients dead or with receipt of ECMO between enrollment and Day 28 Time: Enrollment to Day 28Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.
Measure: Oxygen-free days through Day 28 Time: 28 days after randomizationDescription: Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.
Measure: Ventilator-free days through Day 28 Time: 28 days after randomizationDescription: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.
Measure: Vasopressor-free days through Day 28 Time: 28 days after randomizationDescription: The number of days spent out of the ICU to day 28.
Measure: ICU-free days to Day 28 Time: 28 days after randomizationDescription: Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.
Measure: Hospital-free days to Day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience seizure between randomization and day 28
Measure: Number of patients with seizures to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28
Measure: Number of patients with atrial or ventricular arrhythmia to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience cardiac arrest between randomization and day 28
Measure: Number of patients with cardiac arrest to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28
Measure: Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience acute pancreatitis between randomization and day 28
Measure: Number of patients with acute pancreatitis arrest to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience acute kidney injury between randomization and day 28
Measure: Number of patients with acute kidney injury to day28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience renal replacement therapy between randomization and day 28
Measure: Number of patients with receipt of renal replacement therapy to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28
Measure: Number of patients with symptomatic hypoglycemia to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28
Measure: Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28 Time: 28 days after randomizationDescription: We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28
Measure: Number of patients with severe dermatologic reaction to day 28 Time: 28 days after randomizationDescription: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge
Measure: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge Time: 28 days after randomizationWhereas the pandemic due do Covid-19 continues to spread, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes Severe Acute Respiratory Distress Syndrome in 30% of patients with a 30%-60% mortality rate for those requiring hospitalization in an intensive care unit. The main physio-pathological hallmark is an acute pulmonary inflammation. Currently, there is no treatment. Mesenchymal stem cells (MSC) feature several attractive characteristics: ease of procurement, high proliferation potential, capacity to home to inflammatory sites, anti-inflammatory, anti-fibrotic and immunomodulatory properties. If all MSC share several characteristics regardless of the tissue source, the highest productions of bioactive molecules and the strongest immunomodulatory properties are yielded by those from the Wharton's jelly of the umbilical cord. An additional advantage is that they can be scaled-up to generate banks of cryofrozen and thus readily available products. These cells have already been tested in several clinical trials with an excellent safety record. The objective of this project is to treat intubated-ventilated patients presenting with a SARS-CoV2-related Acute Respiratory Distress Syndrome (ARDS) of less than 96 hours by three intravenous infusions of umbilical cord Wharton's jelly-derived mesenchymal stromal cells (UC-MSC) one every other day (duration of the treatment: one week). The primary endpoint is the PaO2/FiO2 ratio at day 7. The evolution of several inflammatory markers, T regulatory lymphocytes and donor-specific antibodies will also be monitored. The trial will include 40 patients, of whom 20 will be cell-treated while the remaining 20 patients will be injected with a placebo solution in addition to the standard of care. Given the pathophysiology of SARS-CoV2, it is thus sound to hypothesize that the intravenous administration of UC-MSC during the initial phase of ARDS could control inflammation, accelerate its recovery with improved oxygenation, reduced mechanical ventilation and ventilation weaning time and therefore reduced length of stay in intensive care. The feasibility of the project is supported by the expertise of the Meary Cell and Gene Therapy Center, which is approved for the production of Advanced Therapy Medicinal Products and has already successfully prepared the first batches of cells, as well as by the involvement of a cardiac surgery team which will leverage its experience with stem cells for the treatment of heart failure to make it relevant to the Stroma-Cov-2 project.
Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.
Description: Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29
Measure: Proportion of subjects alive and free of respiratory failure Time: 29 daysDescription: Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29
Measure: Proportion of subjects discharged home alive Time: 29 daysDescription: Proportion of patients experiencing AEs
Measure: Treatment-emergent adverse events (AEs) Time: 29 daysDescription: • Clinical status at Day 29 on NIAID 8-point ordinal scale (NIH 2020): Not hospitalized, no limitations Not hospitalized, with limitations Hospitalized, no active medical problems Hospitalized, not on oxygen Hospitalized, on oxygen Hospitalized, on high-flow oxygen or noninvasive mechanical ventilation Hospitalized, on mechanical ventilation or ECMO Death
Measure: Clinical status Time: 29 daysDescription: Time (days) to improvement of 2 points on 7-point ordinal clinical scale
Measure: Time to improvement Time: 29 daysDescription: Proportion of patients who require mechanical ventilation
Measure: Incidence of mechanical ventilation Time: 29 daysDescription: Ventilator-free days to Day 29
Measure: Ventilator-free days Time: 29 daysDescription: Proportion of patients who require ICU admission
Measure: Incidence of Intensive Care Unit (ICU) admission Time: 29 daysDescription: Duration (days) of ICU stay
Measure: Duration of ICU stay Time: 29 daysDescription: Time (days) to hospital discharge
Measure: Time to hospital discharge Time: 29 daysDescription: Duration (days) of need for supplemental oxygen
Measure: Duration of need for supplemental oxygen Time: 29 daysDescription: Time (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling
Measure: Time to virus negativity Time: 29 daysDescription: SARS-CoV-2 viral load (number of copies) by quantitative RT-PCR
Measure: SARS-CoV-2 viral load Time: 29 daysDescription: Proportion of patients experiencing AEs leading to early discontinuation of trial treatment
Measure: AEs leading to withdrawal Time: 29 daysDescription: Proportion of patients experiencing SAEs
Measure: Treatment-emergent serious AEs (SAEs) Time: 29 daysDescription: Proportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs
Measure: Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs) Time: 29 daysDescription: Proportion of patients who meet study safety-related stopping rules
Measure: Incidence of meeting safety-related stopping rules Time: 29 daysDescription: Plasma concentrations over time of piclidenoson
Measure: Pharmacokinetics of piclidenoson in this patient population Time: 5 daysDescription: Change from baseline in serum concentrations of cytokines
Measure: Serum cytokine levels Time: 29 daysTo investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
Measure: Viral nucleic acid test negative conversion rate Time: 5 monthsDescription: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 5 monthsPrimary Objective: To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19 Secondary Objectives: - To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19 - To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19
Description: Viral load assessed by PCR from a nasopharyngeal swab
Measure: Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available) Time: Baseline to Day 3Description: Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab
Measure: Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available) Time: Baseline to Day 3Description: Viral load assessed by PCR from a nasopharyngeal swab
Measure: Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load Time: Baseline to Day 5Description: Viral load assessed by PCR from a nasopharyngeal swab
Measure: Number of participants by PCR result status (positive or negative) Time: Baseline to end of study (Day14)Description: COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe)
Measure: Number of participants with COVID-19 symptoms by severity Time: Baseline to end of study (Day14)Description: COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe). Resolution of a symptom is defined as when a symptom previously scored ≥ 1 on the scale is scored as 0
Measure: Time to resolution of COVID-19 Symptoms Time: Baseline to end of study (Day14)Description: Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C
Measure: Time to resolution of fever Time: Baseline to end of study (Day14)Description: Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C
Measure: Percentage of participants with resolution of fever Time: Baseline to end of study (Day14)The current health crisis at COVID-19 is forcing us to profoundly rethink our social organizations, especially towards our most fragile seniors. Prohibitions on visits to Nursing Homes and care services, although essential to control the epidemic, are also becoming a major source of social isolation and loneliness for these fragile populations. The only source of residual social ties during a period of confinement remains dematerialised communication via the various existing communication channels (in particular telephone calls or video telephony). As soon as the COVID-19 crisis began and the first visiting restrictions were imposed on patients in the geriatric department of the Angers Univesity Hospital and the Retirement Home / long-term care unit, acute care geriatric unit of Angers offered patients and residents the opportunity to organize communication with their relatives via videophone calls. Initial feedback from the field shows us that, contrary to our intuition, patients and residents are not necessarily asking for communication to the outside world and, when they are, the preferred channel is not necessarily video telephony but often a simple phone call with relatives. Even though the vast majority of projects aimed at setting up communication aids for the elderly now rely on videophonic support, these initial observations in everyday care situations raise questions about the directions taken in this area. Also, the investigators ask themselves the following question: in the absence of a physical meeting, what is the preferred means of communication for elderly people in isolation in hospital or in Retirement Home? This study will make it possible to propose the most appropriate solutions for breaking isolation for the hospitalized or institutionalized geriatric population in order to limit as much as possible the increase in social isolation imposed by restrictions on movement during epidemics.
Description: Choice between videophony, telephony or neither.
Measure: Preferred means of communication for elderly people in isolation, hospitalized in the acute care geriatric unit or residing at St Nicolas nursing home (Angers UH). Time: at baseline (day 0)Description: Aid received or not (by a caregiver) in connecting with the relative.
Measure: proportion of elderly people with loss of functional independence to communicate with their relatives. Time: at baseline (day 0)Description: The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 6 points from 1 to 6. Patients will be considered as satisfied if the mean score is over 4 on 6.
Measure: level of satisfaction of patients who have benefited from a telephone call. Time: at baseline (day 0)Description: The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 6 points from 1 to 6. Patients will be considered as satisfied if the mean score is over 4 on 6.
Measure: level of satisfaction of patients who have benefited from a videophone call. Time: at baseline (day 0)Description: The satisfaction averages of the two groups wishing to use a means of communication (telephony or videophony) will be compared by a Student t-test.
Measure: satisfaction level of older people according to the means of communication used. Time: at baseline (day 0)In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α. Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells. This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.
Description: Presence of recovery of pneumonia characterized by cease of respiratory symptoms
Measure: Recovery of Pneumonia Time: 14 daysDescription: Increment or decrease in mg/ml of C-reactive protein
Measure: Response of C-reactive protein Time: 14 daysDescription: Increment or decrease in ng/ml of ferritin
Measure: Response of Ferritin Time: 14 daysDescription: Increment or decrease in mg/ml of D-dimer
Measure: Response of D-dimer Time: 14 daysDescription: Requirement of Intensive Care Unit on the patients under treatment
Measure: Rate of ICU admission Time: 14 daysDescription: Requirement of mechanical ventilation on the patients under treatment
Measure: Rate of mechanical ventilation Time: 14 daysDescription: Time since the diagnosis to the last follow up (recovery or death)
Measure: Overall Survival Time: 1 monthDescription: Rate of adverse events associated with ruxolitinib
Measure: Toxicity Rate Time: 1 monthTo evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Description: Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Measure: Changes in high-resolution computer tomography of the lung Time: 3 monthsDescription: St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.
Measure: Changes in the scores of the St. George's Hospital Respiratory Questionnaire Time: 3 monthsDescription: mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.
Measure: Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores Time: 3 monthsDescription: Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
Measure: Changes in vital capacity of the lung Time: 3 monthsIn December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.
Description: One of the evaluation parameters created to evaluate the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile is the Physical Activity Scale for the Elderly. The minimum score that can be obtained from the scale is 0 and the maximum score is 400. The higher score on the scale indicates a better level of physical activity.
Measure: Physical Activity Scale for the Elderly Time: 2 weeksDescription: Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.
Measure: Nottingham Health Profile Time: 2 weeksDescription: It was created by Gierveld and Kamphuis in 1985 to evaluate the sense of loneliness in older individuals and was revised in 1999 by Tilburg and Gierveld. It consists of 11 items in total and two subtitles.
Measure: Loneliness Scale for the Elderly Time: 2 weeks.This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy Time: 12 weeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or Progression of Symptomatic Days Time: 12 weeksDescription: Assess the symptom response to study therapy as measured by the survey in the EDC
Measure: Assess the safety of Quintuple Therapy Time: 12 weeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via pulse Time: 12 weeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via oxygen saturation Time: 12 weeksDescription: EKG response from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via EKG Time: 12 weeksDescription: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Measure: Assess Tolerability of Quintuple Therapy Time: 12 weeksThe study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.
Description: Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]
Measure: Disease progression Time: 14 daysDescription: Time to mechanical ventilation (or need of)
Measure: Time to mechanical ventilation Time: 14 daysHealthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.
Description: assessed by: No symptoms Mild symptoms: general malaise, fever, cough, myalgia, asthenia. Moderate symptoms: mild symptoms plus shortness of breath, Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation
Measure: Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19) Time: 12 weeksThis study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19
Description: This outcome will be assessed by comparing the percentages of enrolled patients that are hospitalized in the treatment and control arms.
Measure: Total Hospitalization Time: 14 daysDescription: This outcome will be assessed by comparing the percentages of enrolled patients that have received mechanical ventilation in the treatment and control arms.
Measure: Total Mechanical Ventilation Time: 14 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 2 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 5 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 10 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 14 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 2 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 5 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 10 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 14 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 2 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 5 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 10 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 14 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 2 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 5 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 10 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 14 daysDescription: Number of enrolled patients who have died within the specified time frame
Measure: Total mortality Time: 28 daysThe mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the immune system to the virus, causing a cytokine storm with features of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and low platelets. There is increasing data that cytokine-targeted biological therapies can improve outcomes in CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been approved for the treatment of CRS and is used in patients with MAS. Based on these data, it is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS and ARDS. The overall purpose of this study is to evaluate whether treatment with TCZ reduces the severity and mortality in patients with COVID-19.
Description: Assessed by the 8-point WHO scale
Measure: Illness severity Time: At days 2, 7, 14, 28 after randomisationDescription: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale
Measure: Number of patients with clinical improvement Time: At days 2, 7, 14, 28 after randomisationDescription: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale
Measure: Time to clinical improvement (days) Time: Up to day 28 after randomisationDescription: Events of special interest are defined as secondary infections, acute kidney failure, hepatic, and cardiac failure
Measure: Number of patients with events of special interest Time: Within 28 days after randomisationThis is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
Measure: Prevention of COVID-19 symptoms as recorded in a daily diary Time: 24 weeksDescription: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.
Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events Time: 24 weeksRationale: The current SARS-CoV-2 pandemic has a high burden of morbidity and mortality due to development of the so-called acute respiratory distress syndrome (ARDS). The renin-angiotensin-system (RAS) plays an important role in the development of ARDS. ACE2 is one of the enzymes involved in the RAS cascade. Virus spike protein binds to ACE2 to form a complex suitable for cellular internalization. The downregulation of ACE2 results in the excessive accumulation of angiotensin II, and it has been demonstrated that the stimulation of the angiotensin II type 1a receptor (AT1R) increases pulmonary vascular permeability, explaining the increased lung pathology when activity of ACE2 is decreased. Currently available AT1R blockers (ARBs) such as valsartan, have the potential to block this pathological process mediated by angiotensin II. There are presently two complementary mechanisms suggested: 1) ARBs block the excessive angiotensin-mediated AT1R activation, and 2) they upregulate ACE2, which reduces angiotensin II concentrations and increases the production of the protective vasodilator angiotensin 1-7. In light of the above, ARBs may prevent the development of ARDS and avert morbidity (admission to intensive care unit (ICU) and mechanical ventilation) and mortality. Objective: To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Death. Study design: A double-blind, placebo-controlled 1:1 randomized clinical trial Study population: Adult hospitalized SARS-CoV-2-infected patients (n=651). Intervention: The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160mg b.i.d. and the placebo arm will receive a matching placebo also titrated to blood pressure. Treatment duration will be 14 days or up to hospital discharge < 14 days or occurrence of the primary endpoint if < 14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death.
Description: Death is defined as all-cause mortality
Measure: first occurrence of intensive care unit admission, mechanical ventilation or death Time: within 14 daysDescription: All-cause mortality; and time to all-cause mortality
Measure: Death Time: Within 14 days, 30 days, 90 days and at 1 yearDescription: Occurrence of mechanical ventilation and time to ventilation
Measure: Mechanical ventilation Time: within 14 daysDescription: Occurrence of ICU admission and time to admission
Measure: Intensive care unit admission Time: within 14 daysDescription: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2
Measure: Occurrence of acute kidney injury Time: Within 14 daysThe specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system in healthcare settings and HCW (healthcare worker) households. Investigators propose to address this hypothesis by recruiting and longitudinally following 500 HCW and 250 age- and sex-matched NHCW (Non-healthcare workers) within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a six-month period and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at nine time points, investigators can uniquely characterize Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmission and risk factors for Coronavirus Disease 19 (COVID-19) among health care workers and their families
Description: Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
Measure: Prevalence Time: up to 24 weeksDescription: Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
Measure: Incidence Time: up to 24 weeksThe objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study.
Description: Mortality 30 days following hospital admission
Measure: Hospital mortality Time: 30 daysDescription: The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge
Measure: Length of stay in the intensive care unit Time: Through study completion, an average of 30 daysThis is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.
We hypothesized: During the COVID-19 pandemic, the sleep quality of pregnant women decreases. During the COVID-19 epidemic, the stress level of pregnant women increases. During the COVID-19 epidemic, the level of physical activity of pregnant women decreases. Aims: The aim of the study is to determine the sleep quality, stress level and physical activity level of pregnant women who maintain the home quarantine during the COVID-19 pandemic.
Description: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days) 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week
Measure: International Physical Activity Questionnaire Time: Baseline of the studyDescription: The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.
Measure: Pittsburgh Sleep Quality Index Time: Baseline of the studyDescription: The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.
Measure: Perceived Stress Scale Time: Baseline of the studyDescription: The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale rates the pain from 0 (no pain) to 10 (worst pain).
Measure: Numerical Pain Rating Scale Time: Baseline of the studyThe aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%. We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later). This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.
Description: demonstrate overactivity of RAS in patients hospitalised in intensive car secondary to COVID-19 compared to control patients (COVID -19 hospitalised patients without complications ).
Measure: overactivity of the renin / aldosterone system Time: 7 daysWe are aiming to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If we can identify sick participants early, participants are more likely to have better outcomes; we believe that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.
Description: Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)
Measure: Deterioration resulting in healthcare review Time: 1 yearDescription: Deterioration resulting in hospitalisation
Measure: Hospitalisation Time: 1 yearDescription: General Anxiety Disorder (GAD-7) questionnaire (responses noted on Likert scales); min score 0 and max score 21. Higher score associated with greater anxiety
Measure: Participant anxiety Time: 1 yearDescription: Patient Health Questionnaire (PHQ-9) questionnaire (responses noted on Likert scales); min score 0 and max score 27. Higher score associated with greater depression.
Measure: Participant depression Time: 1 yearTo develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).
Description: AUC, accuracy, sensitivity, and specificity
Measure: Predictive performance Time: Janunary 1, 2020, to February 13, 2020Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020. Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.
This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.
Description: Measure the proportion of subjects with either swab positive COVID-19 or presentation of clinical symptoms as measured by fatigue with either fever >37.2 (oral)and/or a persistent cough.
Measure: Prevention Study: Measure the effect of NORS on the prevention of COVID-19 infection among health care professionals at risk of exposure to COVID-19 Time: 14 daysDescription: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.
Measure: Treatment Sub Study: Measure the efficacy of NORS at reducing the progression of COVID- 19 Time: 21 daysDescription: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.
Measure: Prevention Study: Measure the effect of NORS on the prevention of progression of COVID- 19 Time: 21 daysDescription: Measure the tolerability of the NORS treatments as determined by number of adverse events, pain, discomfort or discontinuations of treatment.
Measure: Prevention Study: Measure the tolerability of NORS treatments Time: 21 daysDescription: Measure the median number of days to negative conversion of SARS-CoV-2 RT-PCR from a nasopharyngeal swabs.
Measure: Treatment Sub Study: Measure the virucidal effect of NORS Treatments Time: 21 daysDescription: Determine the time to clinical recovery in participants with COVID-19 by measuring the median number of days from enrollment to discharge (if admitted), or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air).
Measure: Treatment Sub Study: Determine effect of NORS on the speed of clinical recovery Time: 21 daysDescription: Measure the reduction clinical symptoms in participants with COVID- 19 by the magnitude of the change in Modified Jackson Cold Score Diary Score (5-unit change is a substantial clinical benefit).
Measure: Treatment Sub Study: Determine the reduction in clinical symptoms Time: 21 daysDescription: Measure the proportion of participants that have a positive sero-conversion for SARS-CoV-2
Measure: Treatment & Sub Study: Determine positive sero-conversion for SARS-CoV-2 Time: 21 daysThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Hypertension and cardiovascular disease are risk factors for death in COVID-19. Angiotensin converting enzyme 2 (ACE2), an important component of the renin-angiotensin system, serves as the binding site of SARS-CoV-2 and facilitates host cell entry in the lungs. In experimental models, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been shown to increase ACE2 expression in several organs, potentially promoting viral cell invasion, although these findings are not consistent across studies. Alternatively, ACEIs and ARBs may actually improve mechanisms of host defense or hyperinflammation, ultimately reducing organ injury. Finally, ACEIs and ARBs may have direct renal, pulmonary and cardiac protective benefits in the setting of COVID-19. Therefore, it is unclear if ACEIs and ARBs may be beneficial or harmful in patients with COVID-19. Given the high prevalence of hypertension, cardiovascular and renal disease in the world, the high prevalence of ACEIs or ARBs in these conditions, and the clinical equipoise regarding the continuation vs. discontinuation of ACEIs/ARBs in the setting of COVID, a randomized trial is urgently needed. The aim of this trial is to assess the clinical impact of continuation vs. discontinuation of ACE inhibitors and angiotensin receptor blockers on outcomes in patients hospitalized with COVID-19.
Description: The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to four factors: (1) time to death, (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), (3) the number of days supported by renal replacement therapy or pressor/inotropic therapy, and (4) a modified sequential Organ Failure Assessment (SOFA) score. The modified SOFA score will include the cardiac, respiratory, renal and coagulation domains of the SOFA score.
Measure: Hierarchical composite endpoint Time: Up to 28 daysDescription: The Area Under the Curve of the modified SOFA (AUC SOFA) from daily measurements, weighted to account for the shorter observation period among patients who die in-hospital.
Measure: AUC SOFA Time: Up to 28 daysDescription: Composite
Measure: Intensive care unit admission or respiratory Failure Requiring Mechanical Ventilation. Time: Up to 28 daysDescription: Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support (ventricular assist device or intra-aortic balloon pump).
Measure: Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support Time: Up to 28 daysDescription: Number of days in 28-day period feee of invasive or non-invasive mechanical ventilation.
Measure: Number of 28-Day Ventilator-Free Days. Time: Up to 28 daysDescription: Difference between NT-proBNP at the time of randomization and the maximum value
Measure: Maximal change in NT-proBNP from baseline Time: 28 days from enrollmentDescription: as above
Measure: Change in serum creatinine between randomization and discharge (or time of death) Time: Up to 28 daysDescription: defined as Kidney Disease Improving Global Outcomes Stage 2 or higher or initiation of renal replacement therapy
Measure: Acute kidney injury during hospitalization Time: Up to 28 daysDescription: Proteinuria or Hematuria detected on urinalysis
Measure: Proteinuria or Hematuria Time: Up to 28 daysCOVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue. While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation. Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients. Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date. Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.
Description: To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14. Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion. We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.
Measure: Risk of unfavourable outcome at D14 Time: 14 daysDescription: To evaluate, in patients with a confirmed or probable SARS-CoV-2 infection, whether POCUS score performances vary as a function of time, between D1 and D14, and, if so, until which time horizon its performances are clinically relevant. In this purpose, we will determine the time period for which the lower limit of the 95% confidence interval of the AUC of the POCUS score ROC curve is at least 0.7.
Measure: Risk of unfavourable outcome over time Time: 14 daysDescription: To identify the threshold values of POCUS score to perform risk-stratification in three groups of patients: low-risk patients, intermediate-risk patients, high-risk patients. In this purpose, we will determine two threshold values on the inflection points of the ROC curve: maximizing the specificity for a sensitivity of at least 95%, maximizing the sensitivity for a specificity of at least 95%.
Measure: Risk-stratification threshold values Time: 14 daysDescription: To study the impact of adding the result of POCUS evaluation to several risk-stratification clinical rules for pulmonary infection or sepsis: qSOFA, CRB 65 and CURB 65 In this purpose, we will attribute 0, 1 or 2 points to POCUS score according to the predefined threshold values and will assess : sensitivities of qSOFA with and without addition of POCUS score result, specificities of qSOFA with and without addition of POCUS score result; sensitivities of CRB 65 with and without addition of POCUS score result, specificities of CRB 65 with and without addition of POCUS score result; sensitivities of CRB 65 with and without addition of POCUS score result, specificities of CRB 65 with and without addition of POCUS score result.
Measure: Adding value of POCUS score to previous risk-stratification clinical rules Time: 14 daysDescription: To assess, the capacity of POCUS score at D0 to predict patient clinical status at D14 In this purpose, we will determine the correlation coefficient between the POCUS score at D0 and the clinical status of patients at day 14 according to the WHO Ordinal Scale for Clinical Improvement for COVID-19 patients.
Measure: POCUS score and patient clinical status at D14 Time: 14 daysDescription: To study the correlation between POCUS and CT scan assessment of lung damage. In this purpose, we will determine the intra-class correlation coefficient between POCUS assessment according to the number of affected areas among 12 and CT scan assessment according to the quantification proposed by the French Society of Radiology: 0 - normal; 1 - minor (< 10%), 2 - moderate (10-25%), 3 - important (25-50%), 4 - severe (50-75%), 5 - critical (> 75%)
Measure: POCUS and CT scan correlation Time: 14 daysDescription: To compare the diagnostic performances of POCUS with that of chest computed tomography to identify patients with unfavourable outcome. In this purpose, we will compare the AUC of the ROC curves of POCUS score and CT scan quantification of lung damage to identify patients with unfavourable outcome (intubation and mechanical ventilation requirement or death)
Measure: POCUS versus CT scan risk-stratification performances Time: 14 daysDescription: To evaluate, in the subgroup of hospitalized patients having a second chest ultrasonography at Day 5 +/- 3 of inclusion, the performances of the evolution of the POCUS score between the first and the second assessment to identify patients with unfavourable outcome. In this purpose, we will calculate the delta between the first and second POCUS score and determine the AUC of the ROC curve and its 95% confidence interval.
Measure: POCUS score evolution performances Time: 14 daysCOVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).
Description: Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.
Measure: the composite rate of adverse outcomes Time: day 7Description: The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission. It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.
Measure: The rate of hospitalization Time: 24 hoursThe investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.
Description: Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die.
Measure: Suitable for discharge Time: Duration of participation in cohort, expected to be between 1 day and 20 days.Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.
Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8
Measure: Change of baseline total sequential organ failure assessment (SOFA) score Time: Visit study day 8Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8
Measure: Improvement of lung involvement measurements Time: Visit study day 8Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8
Measure: Increase of pO2/FiO2 ratio Time: Visit Study Day 8Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of sequential organ failure assessment (SOFA) score Time: Day 28Description: Mortality on day 28
Measure: Rate of Mortality Time: Day 28Description: Mortality on day 90
Measure: Rate of Mortality Time: Day 90Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Cytokine stimulation Time: Screening, Day 4Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Gene expression Time: Screening, Day 4Description: Change of serum/plasma proteins between days 0 and 4
Measure: Serum/plasma proteins Time: Screening, Day 4Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation
Measure: Classification of the immune function Time: ScreeningSpecific Aims: 1. The investigators will prospectively evaluate and analyze changes in the appearance of the lungs and heart through serial acquisition of focused point-of-care ultrasound images in a cohort of patients with or under investigation for COVID-19. 2. The investigators will correlate changes noted in ultrasound with clinical course and diagnostic evaluation to ascertain whether changes on ultrasound could improve care through earlier diagnosis or identification of patients at high risk of disease progression.
Description: POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the lungs. Higher scores indicate greater malady. Pulmonary POCUS Evaluation: B lines: absent (< 3 lines), present (> 3 lines), fused Consolidation: yes or no a. Bilateral: yes or no Pleural Effusion: yes or no Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities
Measure: POCUS Score - Lungs Time: up to 14 daysDescription: POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the heart. Higher scores indicate greater malady. Cardiac POCUS Evaluation: Parasternal long axis Parasternal short axis Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm) Left ventricular (LV) mass approximation by septal thickness Left Ventricular Chamber Size by internal diameter at diastole Score each finding based on degree of abnormalities and number of sites with abnormalities
Measure: POCUS Score - Heart Time: up to 14 daysThe purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19. Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma. Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers. Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.
Description: Feasibility will be measured by (number of donors from whom convalescent plasma is harvested/number of interested donors) and number of patients who receive convalescent plasma at day 28.
Measure: Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting convalescent plasma, application for FDA eIND and administering convalescent plasma to the patients Time: 28 days after plasma administrationDescription: Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.
Measure: Type of respiratory support Time: 28 days after plasma administrationDescription: This will be a continuous outcome defined by the amount of time between plasma administration and cardiac arrest.
Measure: Cardiac arrest Time: 28 days after plasma administrationDescription: This will be a continuous outcome defined by the amount of time between plasma administration and transfer to ICU.
Measure: Transfer to ICU Time: 28 daysDescription: This will be a binary outcome defined by the amount of time between plasma administration and mortality in the ICU.
Measure: ICU mortality Time: 28 daysDescription: This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.
Measure: ICU length of stay Time: 28 daysDescription: This will be a binary outcome defined by the amount of time between plasma administration and in-hospital mortality.
Measure: Hospital mortality Time: 28 daysDescription: This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.
Measure: Hospital length of stay Time: 28 daysDescription: This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.
Measure: Ventilator-free days Time: 28 daysDescription: 28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.
Measure: Overall survival (28-day mortality) Time: 28 daysSince December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Description: Mortality at day 28
Measure: Mortality at day 28 Time: day 28Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measure: severe complications Time: up to day 28Description: Delay in imaging in hours
Measure: Imaging Time: day 1Description: delay in microbiological diagnosis in hours
Measure: Delay in Microbiological diagnosis Time: day 1Description: Antiviral therapy Yes / no
Measure: Antiviral therapy Time: up to day 28Description: Antibiotic therapy Yes / No
Measure: Antibiotic therapy Time: day 28Description: Covid-19 treatments Yes / No
Measure: Covid-19 treatments Time: up to day 28Description: number
Measure: Patients receiving renal replacement therapy Time: up to day 28Description: number
Measure: Patients receiving mechanical ventilation Time: up to day 28Description: Patient alive at day 28 : yes / No
Measure: Vital status Time: day 28The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
Description: Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
Measure: Mechanical ventilation Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysDescription: Number of subjects transferred from non-ICU bed to an ICU bed
Measure: ICU transfer Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysDescription: Number of days requiring oxygen therapy
Measure: Oxygen therapy Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysThis is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.
The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.
Description: Inpatients are considered as clinically improved if they have gained at least 2 points on the following clinical evaluation scale, or if they went back home Clinical evaluation scale :1. Outpatient back to normal activities / 2. Outpatient without normal activities / 3. Inpatient without oxygen therapy / 4. Inpatient with oxygen therapy/ 5. Inpatient requiring either nasal high-flow oxygen therapy or non-invasive respirator or both / 6. Inpatient, requiring either ExtraCorporeal Membrane Oxygenation (ECMO) or invasive artificial respirator, or both / 7. Deceased.
Measure: Comparison of the percentage of clinically improved inpatients between D0 and D14 Time: 14 day after interventionThis is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.
Description: We will measure the difference in new cases of COVID-19 disease between randomized treatment arms. Plan statistical analyses will include the assumption that up 10% of HCW at risk will become infected if no prophylactic treatment is provided. Therefore we expect that HCQ treatment arm will provide a reduction in the number of SARS-CoV 2 infections by 30%, with an expected study retention rate of 90%, a sample size of ~1500 participants per group, will have an 80% power to detect the difference at p=0.05.
Measure: To determine if the use of hydroxychloroquine as preventive therapy decreases the rate of acquisition of SARS-CoV 2 infections and clinical COVID-19 disease in Study Participants for each randomized treatment arm as compared to placebo. Time: 8 WeeksDescription: Compare the rates of SARS-CoV 2 infections between the randomized treatment arms and the control arms to determine the effect of HCQ dose in the prevention of COVID-19 viremia and disease as determined by study visits, weekly questionnaires, and blood samples.
Measure: Determine the effect of hydroxychloroquine dose in the prevention of COVID-19 viremia and disease. Time: 8 WeeksDescription: Comparison of the rates of SARS-CoV 2 infections in the non-randomized comparator arm to the randomized groups to assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention via weekly questionnaire and/or blood samples.
Measure: Assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention. Time: 8 WeeksDescription: Measurement of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo via blood samples.
Measure: Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo. Time: 8 WeeksDescription: Measurement of the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo via blood samples.
Measure: Compare the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo. Time: 8 WeeksDescription: Measurement of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm and via weekly questionnaire and/or blood samples.
Measure: Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm. Time: 8 WeeksDescription: Review of the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care via weekly questionnaire.
Measure: To examine the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care. Time: 8 WeeksDescription: Measurement of the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events reported via weekly questionnaire.
Measure: Determine the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events. Time: 8 WeeksDescription: Examination of other clinical determinants contributing to the risk of SARS-CoV 2 infection including demographics, work type and location, positive COVID-19 partners, possible exposures and clinical symptoms via study visits and weekly questionnaire.
Measure: To examine other clinical determinants contributing to the risk of SARS-CoV 2 infection in healthcare workers and first responders. Time: 8 WeeksDescription: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results via weekly questionnaire and/or blood samples.
Measure: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results. Time: 8 WeeksDescription: Identification of immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease via study visits, weekly questionnaire, and blood samples.
Measure: identify immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease. Time: 8 weeksCoronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.
Description: Percentage of patients COVID-19 positive that required mechanical ventilation
Measure: Mechanical ventilation requirement Time: Since the diagnosis until two weeks afterCoronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
Description: Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411
Measure: PTSD Family members sup 22 Time: 90 daysDescription: Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measure: PTSD Family members Time: 90 daysDescription: Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measure: PTSD Patients Time: 90 daysDescription: Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measure: PTSD healthcare providers Time: 2 months after official end of the Covid-19 peakDescription: Among Family members Symptoms of anxiety and depression using the HADS scale
Measure: HADS Family members Time: 90 daysDescription: Among Patients Symptoms of anxiety and depression using the HADS scale
Measure: HADS Patients Time: 90 daysDescription: Among Patients Mental and physical health-related quality of life as assessed by the SF36
Measure: SF36 Patients Time: 90 daysDescription: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization
Measure: Questionnaire Family members Time: 90 daysDescription: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization
Measure: Questionnaire Patients Time: 90 daysDescription: Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization
Measure: Questionnaire healthcare providers Time: 2 months after official end of the Covid-19 peakDescription: Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers
Measure: MBI healthcare providers Time: 2 months after official end of the Covid-19 peakDescription: Job Strain as assessed by the Karasec instrument
Measure: Karasec instrument healthcare providers Time: 2 months after official end of the Covid-19 peakThe overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of ventilator utilization at day 14 Time: 14 daysDescription: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.
Measure: WHO progression scale ≤ 5 Time: 4 daysDescription: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14 Time: 14 daysDescription: Proportion of patients with a decrease of WHO score of at least 1 point at day 4
Measure: Decrease of at least one point in WHO progression scale score Time: 4 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10.
Measure: WHO progression scale Time: 7 and 14 daysDescription: Overall survival.
Measure: Survival Time: 14, 28 and 90 daysDescription: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.
Measure: Respiratory acidosis Time: 4 daysDescription: Evolution of PaO2/FiO2 ratio.
Measure: PaO2/FiO2 ratio Time: day 1 to day 14Description: Time to oxygen supply independency.
Measure: Time to oxygen supply independency Time: 14 daysDescription: Duration of hospitalization.
Measure: Duration of hospitalization Time: 90 daysDescription: Time to negative viral excretion.
Measure: Time to negative viral excretion Time: 90 daysDescription: Time to ICU discharge.
Measure: Time to ICU discharge Time: 90 daysDescription: Time to hospital discharge.
Measure: Time to hospital discharge Time: 90 daysThis Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
Measure: Hours to recovery Time: 42 daysDescription: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications
Measure: Time fever resolution Time: 42 daysThere is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting. In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources. This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.
Description: Secondary aggravation is defined as : a re-hospitalization or aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death
Measure: Rate of secondary aggravation Time: an average at 30 days (- 2 days +3 days) of admission to the emergency departmentDescription: the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.
Measure: Change of standart biological parameters Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency departmentThe purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
Description: Change in glucose control will be assessed via glucose levels obtained from blood serum samples
Measure: Changes in Glucose Llevels Time: Baseline, up to 2 weeksDescription: changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method
Measure: Changes in SpO2 levels Time: Baseline, up to 2 weeksDescription: Changes in IL 6 will be assessed from blood serum samples
Measure: Changes in Interleukin 6 (IL6) Time: Baseline, up to 2 weeksDescription: Changes in Chest radiography (X-ray)
Measure: Changes in chest structures Time: Baseline, up to 2 weeksThe Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed cases, there is still no effective way to contain the disease. The transmission of COVID-19 occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of confirmed cases is about 4%. These at-risk individuals are identified through contact tracing and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has yet to be a single effective, safe, and affordable pharmacological agent with such capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the invasion and intracellular replication of the virus. Existing studies have reported efficacy of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of patients suffering from significant side effects. However, existing studies are largely limited by their small sample sizes. Furthermore, there has yet to be a published trial on HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP (treatment group) and no treatment (control group). Subjects will be followed up over a course of 28 days, with daily symptom monitoring conducted over phone calls. Positive outcomes from this study will provide a means for us to battle the COVID-19 pandemic.
Description: COVID-19 infection
Measure: positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28. Time: Until day 28Description: Serology
Measure: Positive serology at day 28. Time: 28 daysDescription: COVID-19
Measure: Symptoms of COVID-19. Time: Until day 28A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.
Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.
Description: The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.
Measure: Number of antibodies against coronaviruses isolated and identified from patient samples Time: Up to 12 months after collection visitThis is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
Description: Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
Measure: Proportion of patients with onset of severe acute respiratory syndrome (SARS) Time: 7 days after randomizationDescription: Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
Measure: Mortality rate Time: after randomization, up to 28 daysDescription: Proportion of participants in need and duration of intensive care support after randomization
Measure: Number of participants in need of intensive care support Time: during and after intervention, up to 28 daysDescription: Viral load change in blood and oropharyngeal swab samples
Measure: Viral concentration Time: After randomization, up to 7 daysDescription: Incidence of serious adverse events during and after treatment
Measure: Cumulative incidence of serious adverse events Time: During and after intervention, up to 28 daysDescription: Incidence of grade 3 and 4 adverse events during and after treatment
Measure: Cumulative incidence of grade 3 and 4 adverse events Time: During and after intervention, up to 28 daysDescription: proportion of discontinuation or temporary suspension of treatment (for any reason)
Measure: Proportion of patients with discontinued treatment Time: after randomization, up to 28 daysDescription: proportion of patients with increased levels of troponin I
Measure: Incidence of cardiac lesions Time: after randomization, up to 120 daysDescription: proportion and magnitude of QTcF interval increases higher than 500ms
Measure: Incidence of cardiac disfunctions Time: after randomization, up to 120 daysDescription: Changes measured on day 120 will be compared to baseline, through spirometry.
Measure: Change in respiratory capacity Time: Day 120 after randomizationThe purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.
Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.
Measure: Time to clinical worsening Time: RCT (approximately 15 days)Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.
Measure: clinical deterioration on a Likert-type scale (1-6) Time: RCT (approximately 15 days)Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.
Measure: clinical deterioration measured by number of days Time: RCT (approximately 15 days)Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.
Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe) Time: RCT (approximately 15 days)The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.
Description: Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day
Measure: Symptom Reduction Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6
Measure: Symptom Resolution: Fever Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe
Measure: Symptom Resolution: Cough Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities
Measure: Symptom Resolution: Shortness of Breath Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale: 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measure: Symptom Resolution: Fatigue Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.
Measure: Symptom Resolution: Muscle/body aches Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.
Measure: Symptom Resolution: Headache Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.
Measure: Symptom Resolution: New loss of taste Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.
Measure: Symptom Resolution: New loss of smell Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .
Measure: Symptom Resolution: Congestion/ runny nose Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.
Measure: Symptom Resolution: Nausea Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.
Measure: Symptom Resolution: Vomiting Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.
Measure: Symptom Resolution: Diarrhea Time: 28 daysDescription: Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measure: Day 5 Symptoms Time: 5 daysDescription: Differences in hospitalization events between the study arms
Measure: Hospitalizations Time: 28 daysDescription: Differences in severity of symptoms between study arms
Measure: Severity of Symptoms Time: 28 daysDescription: Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms
Measure: Adjunctive Medications Time: 28 daysDescription: Differences in number of patients in study arms who experienced side effects from the supplements.
Measure: Supplementation Side Effects Time: 28 daysThe purpose of this research is to collect information about the North Carolina community's coronavirus exposures, symptoms, and health care visits due to the virus. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.
Description: Percent of volunteers who are 2019-nCoV Ab test positive
Measure: Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina Time: baselineDescription: Percent of volunteers who are 2019-nCoV Ab test positive
Measure: Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina Time: baselineThe present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes
Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Measure: on-treatment platelet reactivity Time: early stage of disease (first 96 hours)Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Measure: on-treatment platelet reactivity Time: mid stage of disease (96 hours - 14 days)Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Measure: on-treatment platelet reactivity Time: late stage of disease (>14 days)Description: patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
Measure: apoptosis rate in human umbilical vein endothelial cells (HUVEC) Time: early stage of disease (first 96 hours)Description: patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
Measure: apoptosis rate in human umbilical vein endothelial cells (HUVEC) Time: mid stage of disease (96 hours - 14 days)Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Measure: Nitric oxide (NO) intracellular levels Time: late stage of disease (>14 days)Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Measure: Nitric oxide (NO) intracellular levels Time: early stage of disease (first 96 hours)Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Measure: Nitric oxide (NO) intracellular levels Time: mid stage of disease (96 hours - 14 days)Description: patterns and changes of ROS
Measure: reactive oxygen species (ROS) levels Time: early stage of disease (first 96 hours)Description: patterns and changes of ROS
Measure: reactive oxygen species (ROS) levels Time: mid stage of disease (96 hours - 14 days)Description: patterns and changes of ROS
Measure: reactive oxygen species (ROS) levels Time: late stage of disease (>14 days)Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Measure: coagulation factors levels Time: early stage of disease (first 96 hours)Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Measure: coagulation factors levels Time: mid stage of disease (96 hours - 14 days)Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Measure: coagulation factors levels Time: late stage of disease (>14 days)Description: values of FEV1% as assessed by spirometry
Measure: respiratory function Time: 6-monthDescription: values of FEV1% as assessed by spirometry
Measure: respiratory function Time: 12-monthDescription: values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
Measure: cardiac function Time: 6-monthDescription: values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
Measure: cardiac function Time: 12-monthDescription: occurrence of death, myocardial infarction, stroke and other major adverse events
Measure: clinical outcome Time: 12-monthThe purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Description: Mortality within 28 days
Measure: Mortality Time: Up to 28 daysDescription: Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Measure: Viral Load Time: Day 0, Day 3, Day 5, and Day 7Description: Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
Measure: Serum Antibody Titers Time: Day 0, Day 3, Day 5, and Day 7This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Description: Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
Measure: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) Time: Day 14Description: This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
Measure: Change from baseline in National Early Warning Score 2 (NEWS2) Time: Days 3, 7, and 14Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.
Measure: Change from baseline in the patient's health status on a 7-category ordinal scale Time: Days 3, 7, and 14This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).
Description: Mortality rate on day 28, after randomization
Measure: Mortality rate at day 28 Time: on day 28, after randomizationDescription: Proportion of patient that died on days 7, 14 and 28.
Measure: Mortality rate on days 7, 14 and 28 Time: after randomization, up to 28 days.Description: proportion of patients requiring orotracheal intubation
Measure: Incidence of orotracheal intubation Time: after randomization, up to 7 days.Description: Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.
Measure: Change in oxygenation index Time: after randomization, up to 7 days.Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator. In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths. Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS). Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections. High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status. Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now. We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.
Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 14 based on the change of the WHO Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 Time: Day 14Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19 Time: Day 28Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD <25nmol/L) at baseline Time: Day 14Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at baseline Time: Day 28Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L) Time: Day 14Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on serum vitamin D concentration achieved at day 7 (25-OHD<75nmol/L or 25-OHD≥75nmol/L) Time: Day 28Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L) Time: Day 14Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, in patients with severe hypovitaminosis D (25-OHD<25nmol/L) at day 0, depending on serum vitamin D concentration achieved at day 7 (<75nmol/L or ≥75nmol/L) Time: Day 28Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 14 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7 Time: Day 14Description: OSCI ranges from 0 to 8, higher score meaning poorer outcome
Measure: Clinical evolution between day 0 and day 28 based on the change of the OSCI for COVID-19, depending on evolution of serum vitamin D concentration between day 0 and day 7 Time: Day 28The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.
Description: PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.
Measure: Proportion of "responder" patients to prone position Time: 1 hourDescription: PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.
Measure: proportion of "persistent responders" patients after prone position Time: 1 dayDescription: PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.
Measure: Evolution of PaO2 Time: 1 dayDescription: Look for an association between the time spent in Prone positione and persistent responder or not;
Measure: Duration of prone positioning and PaO2 evolution Time: 2 daysDescription: proportion of patients improving their arterial saturation within 1 hour of Prone Position
Measure: Evolution of Spo2 Time: 1 hourDescription: evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position
Measure: EVA Dyspnea Time: 1 dayDescription: proportion of patients intolerant to prone position (Prone Position <1h);
Measure: Intolerance to prone positioning Time: 1 dayDescription: proportion of patients who can maintain prone position for more than 3 h.
Measure: Tolerance to prone positioning Time: 1 dayBackground: The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19. Researchers want to collect plasma from adults who have recovered from COVID-19, which may help them develop treatments. Objective: To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19. Eligibility: Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study. Design: This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part alone (either screening or plasma collection only) or both parts (screening and plasma collection). For screening part: Participants will be screened for their eligibility to join this research study with a medical history and physical exam. Their vital signs (blood pressure, heart rate, temperature, respiration rate) will be taken. Their weight and height will be recorded. They will give a blood sample for clinical laboratory tests of their general health and a research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate plasma. For plasma collection part: Subjects meeting criteria for plasma donation and found to have high neutralizing antibody titers and who plan to donate plasma under this part of the study will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less than 7 days apart. Prior to each donation, participants will have a brief physical exam and complete a donor history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms. At each donation, plasma will be taken through a standard apheresis procedure. For this, blood will be withdrawn through a needle placed in the participant's arm vein. A machine will separate the plasma from the red cells. The red cells will be returned to the participant, either through the same needle or through a second needle in the other arm. Participation may last up to 240 days.
Description: Donors screened and identified and anti-SARS-CoV-2 immune plasma collected
Measure: Identification of eligible donors and collection of anti-SARS-CoV-2 immune plasma Time: Screening, Days 120 or 240CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
Description: Composite outcome
Measure: All-cause mortality or need of invasive mechanical ventilation Time: 28 daysDescription: Number of participants with adverse events with possible relation to study drug
Measure: Frequency of adverse events Time: 90 daysDescription: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Measure: Frequency of severe adverse events Time: 90 daysDescription: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities
Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status Time: 90 daysDescription: Number of days without mechanical ventilation
Measure: Ventilator-free days Time: 28 daysDescription: Number of days without organ-failure
Measure: Organ failure-free days Time: 28 daysDescription: Number of days in ICU
Measure: Duration of ICU stay Time: 90 daysDescription: Number of deaths by any cause
Measure: Mortality rate Time: 7, 14, 21, 28 and 90 daysDescription: Days from the date of hospital admission for COVID-19 to the date of discharge
Measure: Length of hospital stay Time: 90 daysDescription: Days requiring supplement oxygen
Measure: Duration of supplemental oxygen Time: 90 daysDouble blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.
Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)
Measure: Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment). Time: up to Day 11Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29
Measure: Clinical status assessed by ordinal scale Time: up to Day 29Description: Necessity for transfer to Intensive care unit
Measure: transfer to ICU Time: up to Day 29Description: days from admission to hospital discharge
Measure: Length of hospital day Time: up to Day 29Description: incidence of all-cause mortality
Measure: Hospital Mortality Time: Day 29Description: Need to mechanical ventilation
Measure: Need to Mechanical Ventilation Time: up to Day 29Description: adverse reactions
Measure: Occurence of grade 3-4 adverse event Time: up to Day 29Description: ECG
Measure: QTc Lengthening Time: up to Day 11Description: Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework
Measure: Evolution of pulmonary CT scan images Time: up to Day 11This is an exploratory study that will be performed on confirmed positive COVID-19 samples to identify the dominant viral genome strain in Egyptians using next generation sequencing (NGS).
Description: Identify the dominant viral genome strain in Egyptians With COVID-19 infection using next generation sequencing (NGS)
Measure: Dominant viral genome strain Time: 9 monthsRetrospective study from November 2019 -Febrauary 2020 on severe respiratory illness to access the presence or absence of COVID-19 in patients samples by real-time PcR
Description: Exploring the presence of COVID-19 in very well preserved oropharyngeal samples since November 2019
Measure: Exploring the presence of COVID-19 Time: 9 monthsCoronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Description: Evaluation of pneumonia improvement
Measure: Changes of oxygenation index (PaO2/FiO2) Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.Description: Proportion of participants with treatment-related adverse events
Measure: Side effects in the BM-MSCs treatment group Time: Baseline through 6 monthsDescription: Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
Measure: Clinical outcome Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.Description: days of the patients in hospital
Measure: Hospital stay Time: Baseline through 6 monthsDescription: Evaluation of pneumonia improvement
Measure: CT Scan Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.Description: (deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)
Measure: Changes in viral load Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.Description: Immunological status
Measure: Changes of CD4+, CD8+ cells count and concentration of cytokines Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.Description: Marker for efficacy
Measure: Rate of mortality within 28-days Time: From baseline to day 28Description: Markers of Infection
Measure: Changes of C-reactive protein Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.The 2019 outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID 19), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite any attempted treatment.. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Plasma-exchange is expensive and requires large volumes of substitution fluid. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The aforementioned limitations of plasma therapy can be overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP).DFPP is a modality of plasma purification that performs an initial plasma separation from blood, and the subsequent separation of specific molecules, on the basis of their specific molecular weight (cut-off), by using a fractionation filter. The Fractionation Filter 2A20, because of its membrane sieving cut-off, retains larger molecules and returns plasma along with smaller molecules to the circulation, including the major part of the albumin. The selection of the membrane 2A20 is related to the appropriate Sieving Coefficient for IgG that allows to efficiently collect antibodies from patients which are recovered from COVID-19, with negligible fluid losses and limited removal of albumin. The total amount of antibodies obtained during one DFPP session exceeds by three to four times the total amount provided to recipients with one unit of plasma obtained during one plasma-exchange session from one COVID-19 convalescent donor. This should result in more effective viral inhibition and larger benefit for the patient achieved with one unit of enriched immunoglobulin solution obtained with DFPP than with one unit of plasma obtained with plasma exchange. These observations provide the background for a pilot study aimed to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for critically ill patients with severe coronavirus (COVID-19) pneumonia requiring mechanical ventilation.
Description: Marker of complement activation in plasma.
Measure: C5a concentration Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.Description: Marker of complement activation in plasma.
Measure: C3a concentration Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.Description: Marker of complement activation in plasma.
Measure: Serum C5b-9 concentration Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.
Description: Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Measure: RT-PCR negative status Time: 6-7 daysDescription: Time to progression to next stage of SARS-CoV-2 disease severity index
Measure: Progression of symptoms Time: 7 daysDescription: Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
Measure: Development of Symptoms Time: 7 daysDescription: Drug related adverse events as determined by data safety and monitoring board (DSMB)
Measure: Adverse events Time: 7 daysIn December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country. It did not take long for this epidemic to spread to the world. After that, World Health Organization declared this epidemic disease as a pandemic. As of now, the number of coronavirus deaths increased to 108,281 worldwide. Total number of cases approached 1,800,000 according to the latest information. While the number of healed patients was highest in China, 77,525 people with COVID-19 recovered. COVID-19 is a highly contagious respiratory infectious disease that can cause respiratory, physical and psychological dysfunction in patients. Respiratory rehabilitation reduces the patient's symptoms of dyspnea, relieves anxiety and depression, reduces the patient's need to apply to the hospital, increases functional capacity and improves the patient's quality of life. Respiratory rehabilitation, according to the feedback from China, is very important for patients in the clinical treatment and recovery process after treatment. Rehabilitation of people with mild disease after discharge is mainly based on improving physical fitness and psychological adaptation. It is also aimed to gradually restore the individual's ability to the activity before the disease and return to the community as soon as possible. Individuals with COVID-19 who have respiratory and / or limb dysfunction and chronic disease after discharge should receive respiratory rehabilitation therapy. According to the current findings of the patients discharged from severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS) and the clinical experience of patients with Acute Respiratory Distress Syndrome (ARDS) patients who recovered after discharge, COVID-19 patients may have physical fitness, dyspnea after activity, and muscle atrophy. (Including respiratory muscles and trunk muscles) It is recommended to use respiratory videos and booklets as the main method for respiratory rehabilitation in isolated patients at home. Telerehabilitation method is also a different recommendation option for rehabilitation. The purpose of this study is to investigate the effects of exercises performed by telerehabilitation in patients diagnosed with COVID-19 followed at home. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.
Description: Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The VAS dyspnea score uses "no shortness of breath at all" and "maximum shortness of breath" . The patient marks on the line the point that they feel represents the perception of their current state. The distance (mm) between the beginning of the horizontal line and this mark represents the degree of dyspnea perception
Measure: Visual Analogue Scale Time: 2 weeksDescription: This scale used was a modified Borg scale of perceived exertion adapted to be appropriate for measuring fatigue. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. (0 = no fatigue , 10 = maximal fatigue)
Measure: Modified Borg Scale Time: 2 weeksDescription: Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score. It generally takes about 5 minutes to be completed and it is designed for adults
Measure: Leicester Cough Questionnaire Time: 2 weeksDescription: The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require
Measure: Timed Up and Go Time: 2 weeksDescription: The 30-s Chair Stand Test consists of standing up and sitting down from a chair as many times as possible within 30 seconds. A standard chair without backrest, but with armrests is used. Initially, the person is seated on the chair with his backs upright. They are told to look forward with their arms folded in their chest and rise at their preferred speed after the command "1, 2, 3, go". All trials must be carried out using the same chair and similar environmental conditions.
Measure: 30 Second Chair Stand Test Time: 2 weeksDescription: The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Two subscales include a cognitive-affective subscale and a somatic-performance subscale
Measure: The Beck Depression Inventory Time: 2 weeksDescription: The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.The questions used in this measure ask about common symptoms of anxiety . It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults
Measure: The Beck Anxiety Inventory Time: 2 weeksIn December 2019, new coronavirus pneumonia (COVID-19) broke out in Wuhan (Hubei, China), and it spread rapidly from one city to the whole country in just 30 days, and then worldwide cases began to appear. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared as "pandemic". Apart from compulsory situations, non-home and social isolation are the primary measures. However, not leaving the house and social isolation brings with it the restriction of physical activity. According to World Health Organization (WHO), in order to obtain health benefits, adult individuals between the ages of 18-64 should perform at least 150 minutes of physical activity per week (30 minutes a day for 5 days a week) or intensive physical activity for at least 75 minutes a week. For additional health benefits, adults should increase their moderate-intensity physical activities to at least 300 minutes a week or equivalent. Physical activity; It is directly related to the prevention of chronic diseases, increasing fitness, strengthening the muscles and increasing the quality of life. It is reported that one of the ten main risk factors in terms of mortality in the world is insufficient physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. Practical and innovative interventions are needed to reduce physical performance and decrease in muscle mass, strength and physical performance in the aging population. Considering today's conditions and current COVID-19 Pandemic, technology-supported exercise programs are effective in increasing the motivation for physical activity. The purpose of this study; In order to prevent the spread of the COVID-19 pandemic, social isolation, which is one of the measures taken in our country, is to evaluate the physical activity level of adults and to investigate the effectiveness of home exercises. It is aimed to use a model based on the video supported by a home-based exercise program.
Description: The International Physical Activity Questionnaire -Short Form (IPAQ-SF) measures the frequency and duration of moderate physical activity, vigorous physical activity, walking, and sedentary behavior using 7 questions and is considered more suitable for population surveillance and large-scale studies compared with the long form . The IPAQ-SF was validated for adults.According to the score obtained, the physical activity levels of individuals are determined. It indicates lower physical activity level below 600 Metabolic Equivalent Threshold (MET)-min per week, medium physical activity level between 600-3000 Metabolic Equivalent Threshold (MET)-min per week and high physical activity level between 600-3000 Metabolic Equivalent Threshold (MET)-min per week.
Measure: International Physical Activity Questionnaire - Short Form Time: 2 weeksDescription: Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.
Measure: Nottingham Health Profile Time: 2 weeksDescription: It is among the most used scales to measure depression all over the world. It consists of 21 questions in total. Each item gets points between 0-3. 11-17 points indicate mild depression, 18-29 points indicate moderate depression, and 30-63 points indicate severe depression.
Measure: Beck Depression Inventory Time: 2 weeks.Description: It is used to evaluate the anxiety symptoms experienced by individuals due to social isolation. It consists of 21 items and is scored between 0-3. It indicates low anxiety of 0-21 points, moderate anxiety of 22-35 points and high anxiety of 36 points and above.
Measure: Beck Anxiety Inventory Time: 2 weeksDescription: It is a scale that provides information about sleep quality and type and severity of sleep disorder in the last month. The sleep quality of the person on this scale; sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. Each question is given a score of 0-3. High scores reflect poor sleep quality. If the total score obtained from the scale is less than 5, it is defined as "Good sleep quality" and 5 and above is defined as "Bad sleep quality".
Measure: Pittsburgh Sleep Quality Index Time: 2 weeksDescription: Used for mobility assessment. The test begins while the person is sitting in the chair. The person is asked to get up from the chair, walk 3 meters, come back and sit on the chair again, and the time is recorded. If an elderly person completes the test for more than 12 seconds, there is a risk of falling.
Measure: Timed Get Up and Go Test Time: 2 weeksDescription: Flamingo Balance Test will be used to evaluate the static balance of the individuals who will participate in the study. This test is done on one foot. While individuals are in balance with one foot, time begins and tries to stay in balance for 1 minute. The time is stopped when the balance is disturbed. When the time is completed, each individual attempt to balance is counted and this number is recorded as the individual's score at the end of the test. If the individual tries to balance 15 times in the first 30 seconds, the test is stopped and zero points are given.
Measure: Flamingo Balance Test Time: 2 weeksThe purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
Description: Day 0 refers to the data of randomization/first treatment.
Measure: All-cause mortality at Day 28 Time: Day 28Description: Day 0 refers to the data of randomization/first treatment.
Measure: All-cause mortality at Day 14 Time: Day 14Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) Time: Day 14Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) Time: Day 28Description: The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
Measure: Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Time: Day 14To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).
Description: Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
Measure: Severity of symptoms progression Time: upto max 14 daysDescription: Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.
Measure: Duration of Hospital Saty Time: upto max 14 dayDescription: 30 days mortality rate in each arm
Measure: 30 day mortality Time: 30 daysDescription: grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death).
Measure: Clinical Grade Status Time: 0, 4, 6, 8, 10 and 12 dayDescription: Degree of fever
Measure: Fever Time: 13 daysIt is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.
A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.
Description: To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals
Measure: Risk categorization of healthcare workers Time: 9 monthsDescription: To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.
Measure: COVID-19 infection rate among health care workers Time: 9 monthsDescription: To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.
Measure: Risk factors for COVID-19 among health care workers Time: 9 monthsDescription: To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.
Measure: Adherence of health care workers to infection prevention Time: 9 monthsDescription: To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.
Measure: Validity of the available rapid serological test for detecting COVID-19 virus infection Time: 9 monthsDescription: To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.
Measure: Clinical spectrum of COVID-19 Time: 9 monthsDescription: To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals
Measure: Effectiveness of infection prevention in the health care facility Time: 9 monthsDescription: To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals
Measure: Emergency infection prevention and control needs Time: 9 monthsDescription: To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.
Measure: Isolation rate and emergency health care worker replacement needs Time: 9 monthsDescription: To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.
Measure: Rate of seroconversion Time: 9 monthsSARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period
Measure: Incidence of COVID 19 Infection Time: 6 monthsDescription: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.
Measure: Disease Severity Time: up to 6 monthsCOVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.
Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 7 from randomization.
Measure: Percentage of patients who develop severe respiratory failure. Time: 7 daysDescription: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 14 from randomization.
Measure: Percentage of patients who develop severe respiratory failure. Time: 14 daysDescription: Time from ICU admision to ICU discharge.
Measure: Length of ICU stay. Time: 28 daysDescription: Time from hospital admision to hospital discharge.
Measure: Length of hospital stay Time: 28 daysDescription: Percentage of patients alive at 6 months
Measure: Survival rate at 6 months Time: 6 monthsDescription: Percentage of patients alive at 12 months
Measure: Survival rate at 12 months Time: 12 monthsDescription: Percentage of patients who died from any cause 28 days after inclusion in the study
Measure: Survival rate at 28 days Time: 28 daysDescription: Percentage of patients with each AE by grade in relation with total number of treated patients
Measure: Percentage of patients with each AE by grade Time: 28 daysDescription: Percentage of patients who discontinued due to AEs in relation with total number of treated patients
Measure: Percentage of patients who discontinued due to AEs Time: 28 daysProspective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days
Description: Two successive negative COVID-19 PCR analysis tests 72 hours apart
Measure: viral COVID-19 clearance Time: 14 daysDescription: The percentage of decrease of radiological abnormalities at day 14
Measure: Decrease of radiological abnormalities Time: 14 daysDescription: Clinical improvement in form of normal body temperature for 48 hours
Measure: Clinical improvement Time: 14 daysThe main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo.
The purpose of this study is to determine how peoples' bodies respond to exposure to COVID-19. Employees of Beaumont Health in Michigan who are older than 18 years may be eligible to participate. Participants from other high-risk groups who are not Beaumont employees may also be recruited, as may family members of Beaumont employees who have tested positive for COVID-19. Participants will have blood drawn two or more times for serology testing. This serology test will determine if participants have detectable levels of the antibodies that our bodies develop to fight COVID-19 infection. Participants will fill out a questionnaire each time they provide a blood sample. The questionnaires include questions about participants' personal traits; their health; general questions about their risk to exposure; job and risk of exposure; symptoms, diagnosis, treatment of COVID-19 since last blood draw. Researchers will monitor participants' medical records in a confidential manner for one year after the last blood draw to help determine if people who develop antibodies to COVID-19 are protected against developing a COVID-19 infection in the future.There may be no direct benefits for participants; however, information from this study may benefit other people by increasing our understanding of COVID-19, how it spreads from person to person, and how people respond to fight off the infection.The results of the serology test are used for research only and will not affect clinical decisions regarding participants' treatment or quarantine
Description: Number of participants testing positive for the presence of IgG or IgA antibodies to SARS-CoV-2 using the EUROIMMUN Serology testing platform. Serology testing of Beaumont Health employees will allow an estimation of asymptomatic carriage and help determine level of nosocomial spread of COVID-19 within our institution among its employees. All participants will provide a minimum of 2 blood draws between 2 and 4 weeks apart to determine the presence of antibodies to COVID-19. Participants at medium risk for exposure in their job function at Beaumont will have 3 draws 2-4 weeks apart and people considered the highest risk, those who provide the direct patient care to COVID-19 patients, will be tested 2-4 weeks apart until the pandemic in Michigan is under control (estimated to be 8 blood draws).
Measure: Prevalence COVID antibodies in employees of Beaumont Health Time: 1 yearDescription: Number of participants with positive detection of anti-SARS-CoV-2 antibodies using the EUROIMMUN Serology testing platform, who later develop a COVID-19 infection as documented in Beaumont Health electronic medical records
Measure: COVID-19 re-infection in participants positive for antibodies to SARS-CoV-2 Time: 1 yearDescription: Number of participants with positive SARS-CoV-2 serum IgG antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test positive for anti-SARS-CoV-2 IgG antibodies using dried blood spot samples
Measure: Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgG antibodies Time: 1 yrDescription: Number of participants with negative SARS-CoV-2 serum IgG antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test negative for anti-SARS-CoV-2 IgG antibodies using dried blood spot samples
Measure: Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgG antibodies Time: 1 yrDescription: Number of participants with positive SARS-CoV-2 serum IgA antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test positive for anti-SARS-CoV-2 IgA antibodies using dried blood spot samples
Measure: Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgA antibodies Time: 1 yrDescription: Number of participants with negative SARS-CoV-2 serum IgA antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test negative for anti-SARS-CoV-2 IgA antibodies using dried blood spot samples
Measure: Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgA antibodies Time: 1 yrDescription: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from separate blood spot samples collected on the same day
Measure: Reproducibility of SARS-CoV-2 IgG antibody detection from dried blood spots Time: 1 yrDescription: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from blood spots collected on the same day but tested after 7 to 28 days of storage
Measure: Stability of dried blood spots for SARS-CoV-2 IgG antibody detection Time: 1 yearDescription: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from dried blood spot samples processed at Beaumont Health and those shipped to EUROIMMUN (Lubeck, Germany) for testing
Measure: Effect of shipping on dried blood spot samples for SARS-CoV-2 IgG antibody detection Time: 1 yrDescription: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from dried blood spot samples collected by a phlebotomist and those self-collected by the participant using an instructional information sheet
Measure: Accuracy of participant-performed blood spot collection for SARS-CoV-2 IgG antibody detection Time: 1 yrDescription: Ease of following an instructional information sheet to self-collect blood spots will be rated by the participant on a 10 point scale where 1 indicates complete comfort and understanding the collection procedure and 10= extreme difficulty with understand the information sheet and collecting blood spots
Measure: Ease of participant-performed blood spot collection Time: 1 yrDescription: Number of immediate family member participants testing positive for SARS-CoV-2 IgG antibodies using the EUROIMMUN Serology testing platform following a SARS-CoV-2 IgG antibody positive assay in a Beaumont Health employee participant
Measure: Correlation of SARS-CoV-2 antibodies between immediate family members Time: 1 yrRandomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.
Description: Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Measure: Viral clearance Time: 14 daysDescription: Normal body temperature for 48 hours
Measure: Clinical improvement Time: 14 daysDescription: Improvement of radiological abnormalities at day 14
Measure: Radiological Improvement Time: 14 daysGiven the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.
Description: Time that it takes for symptoms to be resolved in those who were treated vs untreated
Measure: Time to resolution of symptoms Time: up to 4 weeksThe aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.
Description: Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
Measure: Endotracheal intubation Time: within 30 days of randomizationDescription: Death
Measure: Mortality Time: 60 daysDescription: Number of days not receiving mechanical ventilation
Measure: Invasive mechanical ventilation free days Time: 30 DaysDescription: Number of days not receiving non-invasive mechanical ventilation
Measure: Non-invasive ventilation free days Time: 30 daysDescription: Number of days admitted to ICU
Measure: ICU length of stay Time: 30 DaysDescription: Number of days admitted to the hospital
Measure: Hospital length of stay Time: 30 daysDescription: defined as the difference in SpO2: FiO2 ratio. The difference in SpO2: FiO2 ratio.
Measure: Change in oxygenation Time: 30 daysDescription: Includes any of the following: accidental removal of intravenous access, vomiting, falls from bed, pressure injuries, or cardiac arrest.
Measure: Complications from proning, Time: 30 daysPhase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
Description: Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
Measure: incidence of confirmed COVID-19 Time: 9 monthsDescription: Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection by detecting any positive cases among vaccinated healthscare workers
Measure: Effectiveness of BCG vaccine Time: 9 monthsThe primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and reduce the time to recovery in hospitalized subjects with severe or critical COVID-19 pneumonia.
Description: Time to recovery is defined as the first day on which a subject satisfies one of the following 3 categories from the 8-point ordinal scale (Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).
Measure: Time to Recovery Time: Up to 28 daysDescription: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measure: Percentage of Participants Experiencing Adverse Events Time: Up to 60 daysDescription: Using the NCI CTCAE version 5.0
Measure: Percentage of Participants Experiencing Serious Adverse Events Time: Up to 60 daysDescription: NEWS2 consists of: Physiological Parameters: respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), use of air or oxygen, systolic blood pressure (mmHg), pulse (per minute), consciousness and temperature (°C)
Measure: Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours Time: Up to Day 28This study is to gain critical knowledge to understand the factors influencing the outcome of a pandemic virus within the city of Basel.
Description: Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no)
Measure: Identification of factors associated with (i) infection (binary, yes/no), (ii) hospitalization (binary, yes/no), (iii) requirement for ICU treatment (binary, yes/no) Time: at baselineDescription: duration of hospitalization (in days)
Measure: duration of hospitalization (in days) Time: at baselineDescription: duration of ICU stay (in days)
Measure: duration of Intensive Care Unit (ICU) stay (in days) Time: at baselineDescription: in-hospital mortality (binary, yes/no)
Measure: in-hospital mortality (binary, yes/no) Time: at baselineDescription: Number of infected cases confirmed either by nucleic acid test (NAT) or by positive serology within the city of Basel expressed as incidence per statistical block
Measure: Number of infected cases within the city of Basel Time: at baselineDescription: Number, type, and complexity of viral genome variants and quasispecies identified by deep-sequencing during rise, peak, and contraction of the pandemic in patients and geographic areas.
Measure: whole genome sequencing to study pathogen evolution (number, type, and complexity of viral genome) Time: at baselineDescription: Identification which treatment modality is associated with adverse events (binary, yes/no)
Measure: Identification which treatment modality is associated with adverse events (binary, yes/no) Time: at baselineDescription: Identification which treatment modality is associated with pulmonary recovery(binary, yes/no)
Measure: Identification which treatment modality is associated with pulmonary recovery (binary, yes/no) Time: after 30 and 90 daysThe Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine, lopinavir/ritonavir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure >120/80mmHg), and substudy C (clazakizumab vs standard of care, for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.
Description: The primary endpoint is time to clinical improvement which is defined as time from randomization to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomization measured on a seven-category ordinal scale (proposed by WHO). The 7-categories of the World Health Organization proposed scale, as follows: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death. During hospitalization this score will be determined daily (till day 29). If a patient is released from the hospital before day 29, the score will be determined at day 11 and 29 after randomization (depending when the patient was released or by telephone call).
Measure: sustained improvement (>48h) of one point on the WHO Scale Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: Time to improvement on WHO Scale Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: Mean change in the ranking on an ordinal scale from baseline Time: Inclusion to day 29, daily evaluationDescription: the National Early Warning Score includes respiratory rate, oxygen saturation, use of supplemental oxygen, temperature, systolic blood pressure, heart rate and levels of consciousness (AVPU Scale)
Measure: time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: change from baseline in National Early Warning Score (NEWS) Time: Inclusion to day 29, daily evaluationDescription: new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation
Measure: Incidence of new oxygen use during the trial Time: Inclusion to day 29, daily evaluationDescription: number of days with requirement of mechanical ventilation
Measure: Ventilator free days until day 29 Time: Inclusion to day 29, daily evaluationDescription: obtained by polymerase chain reaction in nasal/oropharyngeal swabs, performed at baseline and then three times a week, if possible
Measure: Viral load/viral clearance Time: Inclusion to day 29, daily evaluationDescription: BMI (kg/m2), within all subjects the impact of obesity on overall mortality will be investigated
Measure: Obesity - mortality Time: BMI at admission, mortality until day 29Description: BMI (kg/m2) , within all subjects the impact of obesity on the duration of hospitalization will be investigated
Measure: Obesity - duration of hospitalization Time: BMI at admission, duration of hospitalization until day 29 or dischargeDescription: BMI (kg/m2) , within all subjects the impact of obesity on ICU admission will be investigated
Measure: Obesity - ICU admission Time: BMI at admission, ICU admission until day 29 or dischargeDescription: BMI (kg/m2) new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation
Measure: Obesity - new oxygen use Time: BMI at admission, new oxygen use until day 29 or dischargeDescription: lopinavir and ritonavir both interact with numerous other drugs by inhibiting the cytochrome enzymes 3A4. Using commercially available drug-interaction programs, the number and severity grading of drug-drug-interactions will be documented (for instance uptodate interaction tool, medscape). This is an exploratory analysis of drug-drug interactions with the above mentioned substances. severity grading usually encompass "contraindicated", "serious", "monitor closely", "minor" interaction.
Measure: Drug-drug interactions with lopinavir/ritonavir Time: Inclusion to day 29, daily evaluationDescription: for sub-study B only: RAS fingerprint measures metabolites involved in the renin-angiotensin-system. The influence of randomized treatment with candesartan (RAS blockade) will be analyzed
Measure: Renin Angiotensin System (RAS) fingerprint Time: Inclusion to day 29, daily evaluationThis observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
Description: Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound
Measure: Diagnosis of COVID-19 on lung ultrasound Time: On day of admission to hospitalDescription: Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings
Measure: Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray Time: On day of admission to hospitalDescription: Primary and blinded scorer diagnosis of alternative condition on lung ultrasound
Measure: Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray Time: On day of admission to hospitalDescription: Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g. supplementary oxygen requirements
Measure: Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19 Time: During hospital admissionDescription: Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis
Measure: Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19 Time: On day of admission to hospitalPatients with COVID-19 usually present in the ED and receive their initial medical check-up here. We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED. The course of the disease prior to admission as well as the momentary health status at presentation to the ED are of interest because they influence risk stratification and decision-making of treating physicians. The ratio of patients with mild or moderate to severe symptoms will help to calculate the need for hospital beds including beds on Intensive Care Units (ICU) and Intermediate Care Units (IMC), as well as the need for other hospital resources.
Description: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.
Measure: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission. Time: 6 monthsDescription: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED
Measure: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED Time: 6 monthsDescription: Identification of the ratio of patients with mild or moderate to severe disease
Measure: Identification of the ratio of patients with mild or moderate to severe disease Time: 6 monthsProspective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock
The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.
Description: Rate of hospitalization
Measure: Sub Study 1: Patients Time: 21 daysDescription: Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months
Measure: Sub Study 2: Health Care Workers Time: 2 monthsDescription: any house hold member who has reported symptoms or test positive for COVID 19 during their 14 day active participation
Measure: Sub Study 1: Patients: Rate of secondary infection of co-inhabitants Time: 14 days after enrollment of the householdDescription: Assessment of any medical events that occur during the 14 day active period that is felt to be related to receipt of HCQ
Measure: Sub Study 1: Patients: Adverse Events Time: 14 day active periodDescription: If a test comes back negative, participant would be notified as such and told to destroy their pills as they are withdrawn
Measure: Sub Study 1: Patients: Negative for COVID-19 Time: up to 5 days after enrollingDescription: Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period
Measure: Sub Study 2:Health Care Workers:Number of shifts missed Time: up to ~60 days after enrollmentDescription: Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ
Measure: Sub Study 2:Health Care Workers:Rate of adverse events Time: up to ~60 days after enrollmentDescription: if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period
Measure: Sub Study 2:Health Care Workers:Rate of hospitalization Time: up to ~60 days after enrollmentThere is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.
Description: Number of confirmed (positive CRP) symptomatic infections in each treatment group
Measure: SARS-CoV 2 infection rate Time: up to 12 weeksCoronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.
Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
Measure: Fibrosis Time: 12 monthsDescription: Decreased functional capacity on ergospirometers
Measure: Ergospirometers Time: 12 monthesTo test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.
Description: Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Measure: Percentage of virus free subjects Time: 7 days after initiation of trialDescription: Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .
Measure: Disease severity Time: 6 daysDescription: Number of subjects in each arm who are hospitalized for Covid 19 infection
Measure: Incidence of hospitalization Time: 14 daysDescription: Number of subjects in each arm who die secondary to Covid-19 infection
Measure: Incidence of Death Time: 70 Days (10 weeks)Description: Number of subjects in each arm who have confirmed Covid-19 infection
Measure: Incidence of confirmed SARS-CoV-2 Detection Time: 14 daysDescription: Number of subjects in each arm who discontinue or withdraw medication use for any reason
Measure: Incidence of all-cause study medication discontinuation or withdrawal Time: 14 daysDescription: Blood tests to determine level of immunity in each subject
Measure: Immunity to Covid-19 Time: 70 days (10 weeks)Chloroquine or hydroxychloroquine in COVID-19 treatment
Description: the number of patients with cure or death
Measure: Number of patients with cure or death Time: 1 monthWe aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.
Description: Clinical associations with human and viral genetics
Measure: Associations with severity and outcomes Time: next 6 monthsAcute kidney injury (AKI) is reported to occur in 0.5-9% of severe acute respiratory distress coronavirus 2-positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of renal outcome of in-hospital patients diagnosed with COVID-19.
Description: As determined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measure: Incidence of chronic kidney disease Time: 6 months post-hospital admissionDescription: Serial biomarker assessment
Measure: Renal function changes during hospital stay Time: from hospital admission til discharge up to 3 monthsDescription: As determined by KDIGO criteria
Measure: Incidence of AKI Time: Within 7 days after admissionContext: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.
Description: To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.
Measure: Antibody status in HCW Time: 4 monthsDescription: To determine how many are actively infected with or without showing symptoms.
Measure: Active virus carriers in HCW Time: 4 monthsDescription: To determine how many employees are in their incubation period during study time.
Measure: Incubation time Time: 4 monthsDescription: To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population.
Measure: Background incidence rate Time: 4 monthsDescription: To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees.
Measure: Occupation associated infection risk Time: 4 monthsCaptopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.
Description: To assess determine the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival
Measure: Efficacy of captopril nebulization addition to standard of care compared to standard of care. Time: 14 DaysRandomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.
Description: composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) at day 15 after initiation of therapeutic intervention
Measure: Proportion of patients in both arms fulfilling the criteria for treatment failure Time: 15 days after treatmentDescription: Yes/no
Measure: ICU admission Time: baseline, day 3, day 7, day 15, day 30Description: yes/no and reason
Measure: ICU refusal Time: baseline, day3, day 7, day 15, day 30Description: infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.
Measure: Occurrence of complications Time: baseline, day3, day 7, day 15, day 30Description: U/L
Measure: lactate dehydrogenase (LDH) Time: at baseline, day 3, day 7, day 15, day 30Description: mg/dL
Measure: C Reactive Protein (CRP) Time: at baseline, day 3, day 7, day 15, day 30Description: ng/mL
Measure: ferritin Time: at baseline, day 3, day 7, day 15, day 30Description: ng/mL
Measure: D-dimer Time: at baseline, day 3, day 7, day 15, day 30Description: x10^9/L
Measure: leukocyte counts Time: at baseline, day 3, day 7, day 15, day 30The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19.
The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).
Description: Safety will be defined by the incidence of pre-specified infusion associated adverse events as assessed by treating physician
Measure: Incidence of pre-specified infusion associated adverse events Time: Day 5Description: Safety will be defined by the incidence of severe adverse events as assessed by treating physician
Measure: Incidence of Severe Adverse Events Time: 90 daysDescription: Number of participants that are alive at 90 days post first infusion follow up.
Measure: Survival rate after 90 days post first infusion Time: 90 daysDescription: Number of days participants were off ventilators within up to 28 days of hospitalization
Measure: Ventilator-Free Days Time: 28 days or hospital discharge, whichever is earlierDescription: Measure the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy).
Measure: Change in Oxygenation Index (OI) Time: 28 daysDescription: Measuring respiratory mechanics in ventilated patients [plateau pressure (Pplat)-positive end-expiratory pressure]
Measure: Plat-PEEP Time: 28 daysDescription: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure)
Measure: Sequential Organ Failure Assessment (SOFA) Scores Time: 28 daysDescription: The SIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The test has a total score ranging from 0-40 Follows scoring key for evaluation. The higher score indicates better outcome.
Measure: Small Identification Test (SIT) scores Time: At baseline, day 18 and day 28.Description: As assessed via serum blood samples.
Measure: Troponin I levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: C-Reactive Protein levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Arachidonic Acid (AA)/Eicosapentaenoic Acid (EPA) Ratio Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: D-dimer levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: 25-Hydroxy Vitamin D levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Alloantibodies levels Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Blood white cell count Time: Baseline, 28 daysDescription: As assessed via serum blood samples.
Measure: Platelets count Time: Baseline, 28 daysInfection with coronavirus SARS-CoV2 (COVID-19 disease) is unique with its speed of propagation, structural medical reorganizations and length of stay in intensive care needed, diversity of the affected population (in particular between young persons or fragile subjects), and impact on physical and mental health generated by confinement of populations. Fatigue is a major component of COVID-19. Global muscular weakness is related to immobility, inflammation, corticosteroids treatment, hypoxemia due to pulmonary and/or cardiac infectious attacks and undernutrition suggests major physical functional repercussions. Thus, patients affected by COVID-19 with acute hospital management require sometimes complex rehabilitation management. Retrospective studies on physical functional capacities in patients infected with SARS CoV1 showed long term physical activity limitations.
Description: Physical functional limitations evaluated using 'sit to stand' test. The patient, seated in a chair without armrest, his arms crossed over his shoulders, should get up and sit down without help of the upper limbs as many times as possible in one minute.
Measure: Physical functional limitations Time: 12 monthsIn adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.
Description: Proportion of participants with an occurrence of death
Measure: Efficacy phase: Death Time: From inclusion (day0) to day 14Description: Proportion of participants who had an indication for oxygen therapy
Measure: Efficacy phase: oxygen therapy Time: From inclusion (day0) to day 14Description: Proportion of participants who had an indication for hospitalization
Measure: Efficacy phase: hospitalization Time: From inclusion (day0) to day 14Description: Proportion of deaths, overall and by cause, in each group
Measure: Death and causes of death Time: From inclusion (day0) to day 28Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
Measure: Haematological markers evolution Time: from inclusion (day 0) to day 7Description: Evolution of Inflammatory markers in each group : PCT, CRP
Measure: Inflammatory markers evolution Time: from inclusion (day 0) to day 7Description: Number and proportion of grade 1,2,3,4 adverse events in each group
Measure: Adverse events Time: from inclusion (day 0) to day 28Description: Number and proportion of grade 1,2,3,4 adverse events in each group
Measure: Adverse reactions Time: from inclusion (day 0) to day 28Description: Acceptability of the treatment by participant will be assessed with an interview
Measure: Acceptability of the treatment Time: from inclusion (day 0) to day 10Description: Proportion of participants who received at least one day of antibiotic therapy
Measure: Antibiotic consumption Time: from inclusion (day 0) to day 28Description: Proportion of participants who experienced a worsening of oxygen saturation
Measure: Oxygen saturation worsening Time: from inclusion (day 0) to day 28Description: Proportion of participants who completed the prescribed protocol treatment
Measure: protocol follow-up Time: from inclusion (day 0) to day 10COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
Description: PaO2/FiO2 relation
Measure: Lung injury Time: 7 daysDescription: Patients survival after therapy
Measure: Overall survival Time: 15-30 daysDescription: Determine the incidence of side effects from plasma administration
Measure: Adverse reactions to plasma Time: 7 daysThe present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100. The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis. Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available. The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).
Description: TP/TP+FN (TP= True Positive; FN = False Negative)
Measure: Sensibility Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.Description: TN/TN+FP (TN= True Negative; FP= False Positive)
Measure: Specificity Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.
Description: The primary study endpoint is the ratio of patients who will develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered achieving the primary endpoint.
Measure: The ratio of patients who will develop serious respiratory failure (SRF) Time: Visit study day 14Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment Time: Visit study day 14Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of SOFA score in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of peripheral mononuclear blood cells' (PBMCs) functionality of enrolled subjects will be compared between days 1 and 7
Measure: Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7
Measure: Change of plasma inflammatory mediators levels between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Mortality on day 30
Measure: Rate of Mortality Time: Visit study day 30Description: Mortality on day 90
Measure: Rate of Mortality Time: Visit study day 90Description: Transcriptional, proteomic and metabolomic change will be compared between days 1 and 7
Measure: Change of gene expression between days 1 nad 7 Time: days 1 and 7The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.
Description: Ideally, the PaO2/FiO2 will be measured with the patient in the same prone/supine position as in baseline, as change in positions may artificially reduce the improvement attributable to the study drug. However, given the pragmatic nature of the trial, the prone/supine position will be determined by the attending physician, in which case, we will use as an outcome the PaO2/FiO2 closest to the 48 hours obtained prior to the change in position as the outcome.
Measure: PaO2/FiO2 improvement from pre-to-post intervention Time: at 48 hours post randomizationDescription: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2 (whatever is lower)
Measure: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2 Time: at 48 hours post randomizationDescription: This score is based on seven clinical features (respiration rate, hypercapnic respiratory failure, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness) and determines the degree of illness of a patient and prompts critical care intervention.
Measure: National Early Warning Score 2 (NEWS2) Time: at 48 hours post randomizationDescription: The ordinal scale is an assessment of the clinical status as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. (combined items 7 and 8 as our study is limited to hospital).
Measure: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale Time: at 48 hours post randomizationDescription: 48 hour mortality for hospitalized patients
Measure: 48 hour in-hospital mortality Time: at 48 hours post randomizationDescription: 14 days mortality for hospitalized patients
Measure: 14 days in-hospital mortality Time: 14 days post randomizationDescription: 28 days mortality for hospitalized patients
Measure: 28 days in-hospital mortality Time: 28 days post randomizationDescription: ICU-free days will be calculated based on (28 - number of days spent in the ICU) formula
Measure: ICU-free days Time: 28 days of hospital stay or until hospital discharge (whichever comes first)Description: In-hospital coagulation-related events include bleeding, stroke, myocardial infarction and venous thromboembolism (VTE). In-hospital coagulation-related event-free (arterial and venous) days will be calculated based on (28 - number of days without coagulation-related event) formula.
Measure: In-hospital coagulation-related event-free (arterial and venous) days Time: 28 days of hospital stay or until hospital discharge (whichever comes first)Description: Ventilator-free days will be calculated based on (28 - number of days on mechanical ventilation) formula.
Measure: Ventilator-free days Time: 28 days of hospital stay or until hospital discharge (whichever comes first)Description: Calculated for patients who was on a mechanical ventilation any period of time during hospitalization. The extubation will be considered successful if no re-intubation occurred for more than 3 days have passed after the initial extubation.
Measure: Successful extubation Time: Day 4 after initial extubationDescription: Calculated for patients who was on paralytics at the time of randomization. The weaning will be considered successful if no paralytics were used for more than 3 days have passed after termination of paralytics.
Measure: Successful weaning from paralysis Time: Day 4 after initial termination of paralyticsDescription: Is counted for the patients who was alive at the time of discharge.
Measure: Survival to discharge Time: 28 days of hospital stay or until hospital discharge (whichever comes first)Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.
Description: Occurrence of adverse events during study drug infusion
Measure: Incidence of adverse events Time: Days 1-4Description: Occurrence of serious adverse events during study drug infusion
Measure: Incidence of serious adverse reactions Time: Days 1-4Description: Occurrence of adverse reactions during study drug infusion
Measure: Incidence of adverse reactions Time: Days 1-4Description: Documented days free off mechanical ventilation the first 28 days post enrollment
Measure: Ventilator-free days Time: Days 1-28Description: Documented days free of ICU admission the first 28 days post enrollment
Measure: ICU-free days Time: Days 1-28Description: Documented days free of hospital admission the first 28 days post enrollment
Measure: Hospital-free days Time: Days 1-28Description: Incidence of mortality at 28 days by all causes
Measure: All-cause mortality Time: Days 1-28Description: SpO2 (% peripheral oxygenation saturation) will be divided by fraction of inspired oxygen (FiO2) at start of study infusion and compared with S/F ratio at end of study infusion
Measure: Change in S/F ratio during HDIVC infusion Time: Days 1-4Description: The difference in serum CRP during HDIVC infusion reported in mg/dL
Measure: C-reactive protein (CRP) Time: Days 1-4Description: The difference in LDH during HDIVC infusion will be reported in IU/L
Measure: Lactate dehydrogenase (LDH) Time: Days 1-4Description: The difference in D-dimer during HDIVC infusion will be reported in ug/mL
Measure: D-dimer Time: Days 1-4Description: The difference in lymphocyte count during HDIVC infusion will be reported in 10e3/uL
Measure: Lymphocyte count Time: Days 1-4Description: The NLR will be calculated by dividing the absolute neutrophil count (10e3/uL) over the absolute lymphocyte count (10e3/uL) and ratio compared with Day 1 versus Day 4
Measure: Neutrophil to Lymphocyte ratio (NLR) Time: Days 1-4Description: The difference in serum ferritin will be calculated from the start of HDIVC infusion to day 4 and reported as ng/mL
Measure: Serum Ferritin Time: Days 1-4The following hypotheses were established in this study: H0: There is no difference in terms of COVID-19 in different age groups in Turkey. H1: There is a difference in terms of COVID-19 in different age groups in Turkey. It is known that social awareness is low because COVID-19 is a new virus. There are protective measures created based on scientific studies conducted during the epidemic, but there is no certainty about how much these measures are known to our society. Based on these aim of our study is that individuals in different age groups throughout Turkey to investigate and compare the new coronavirus awareness
Description: The questionnaire was prepared by the researchers. There are 49 questions in the survey and all of them are multiple choice. The survey assesses the demographic characteristics, awareness and attitudes of the participants towards the COVID-19.
Measure: COVID-19 Awareness Survey Time: once at baseline of studyThe study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.
Description: Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)
Measure: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2. Time: At hospital admissionDescription: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with pulmonary comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
Measure: Sensitivity and specificity of chest CT in patients with pulmonary comorbidities Time: At hospital admissionDescription: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with cardiovascular comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
Measure: Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities Time: At hospital admissionDescription: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with malignancy who are to be admitted to hospital and who are rt-PCR negative for infection with SARS-CoV-2.
Measure: Sensitivity and specificity of chest CT in patients with malignancy Time: At hospital admissionDescription: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with immunodeficiency who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
Measure: Sensitivity and specificity of chest CT in patients with immunodeficiency Time: At hospital admissionDescription: Predictive value of chest CT
Measure: Predictive value of specific chest CT findings for detection of SARS-CoV-2 Time: At hospital admissionThe current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.
Description: The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2
Measure: Covid + Time: 10 daysThe search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support. Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.
For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed
Description: Mesured by STAY Scale
Measure: Anxiety Time: 15 to 45 days after the beginning of the outbreakDescription: Participant suffering of Insomnia
Measure: Insomnia Time: 15 to 45 days after the beginning of the outbreakDescription: Participant suffering of catastrophism
Measure: Catastrophism Time: 15 to 45 days after the beginning of the outbreakIn early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern. According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown. Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19. The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.
Description: any cause mortality during the first 14 days of treatment
Measure: Early all-cause mortality Time: 14 daysDescription: (48-hour sampling interval from day 3 of hospitalization to two consecutive negatives).
Measure: Time in days for SARS-CoV-2 RT-PCR negatives Time: 90 daysDescription: In subjects of both arms at day 0, 3, 7, 14 and 90.
Measure: The serum anti-SARS-CoV-2 antibody titres Time: 90 daysDescription: Comparison of anti-SARS-CoV-2 antibody titers
Measure: Detection of serum antibodies Time: days 0, 3, 7, 14 and 90.The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.
Description: Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas
Measure: Tidal electrical Impedance Time: One hour before turning to prone or supine positioningDescription: Changes in intrapulmonary shunt fraction
Measure: Intrapulmonary shunt Time: One hour before turning to prone or supine positioningDescription: Changes in the phase three slope of the volumetric capnogram
Measure: Volumetric capnography Time: One hour before turning to prone or supine positioningThis study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.
Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.
Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing Time: One yearDescription: To validate the methods used to sequence samples
Measure: Validation of Sequencing Methods Time: One yearWe plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus
Description: Generated using Nanopore-based whole genome sequencing techniques
Measure: To produce whole genome sequences for the SARS-CoV-2 virus from viral RNA samples Time: 2 yearsDescription: Identify mutations and viral strains prevalent within the Wessex region
Measure: To develop a phylogenetic map of the SARS-CoV-2 virus Time: 2 yearsThis randomized open labeled clinical trial will include one hundred healthy healthcare workers who will be randomly assigned into four groups of twenty-five each to receive either levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the incidence of COVID-19 infection. Participants will be followed-up for three months clinically and laboratory. Blood samples will be collected prior to randomization and during follow up.
Description: Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection
Measure: Decrease the incidence of COVID-19 infection or its severity Time: 6 monthsThis treatment protocol is designed to provide a treatment option for patients diagnosed with severe or life-threatening COVID-19 or judged by the subinvestigator (treating physician) to be at high risk of progressing to severe or life threatening disease
The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.
Description: SF-36 score
Measure: Quality of Life score Time: up to 12 months after dischargeDescription: Montreal Cognitive Assessment (MoCA) score
Measure: cognitive dysfunction Time: up to 12 months after dischargeDescription: (FSS-ICU)
Measure: Functional Status Score Time: up to 12 months after dischargeDescription: MRC neuromuscular Assessment
Measure: Physical Disability Time: up to 12 months after dischargeDescription: Impact Event Score
Measure: Psychological Sequelae Time: up to 12 months after dischargeDescription: hospital anxiety and depression scale
Measure: hospital anxiety and depression Time: up to 12 months after dischargeDescription: including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness
Measure: ICU related complications Time: hospitalization up to 6 weeksDescription: measure the location (home, rehabilitation center, nursing home
Measure: hospital discharge location Time: hospital discharge up to 6 weeksDescription: number of days admitted to the ICU
Measure: lCU length of stay Time: hospitalization up to 6 weeksDescription: number of days admitted to the hospital
Measure: hospital length of stay Time: hospitalization up to 6 weeksThe purpose of this study is to evaluate the sensitivity and specificity of several marketed commercial or prototype test kits for antibody to SARS-CoV-2. The focus will be on rapid-format, point-of-care antibody test kits that detect both IgM and IgG antibodies to recombinant viral proteins. Note: No voluntary enrolment into this study will be conducted; all testing is to be conducted anonymously.
Description: Test sensitivity relative to RT-PCR for acute samples; sensitivity relative to ELISA for convalescent samples.
Measure: Test Sensitivity Time: 2020Description: Percent positivity with pre-COVID samples
Measure: Test Specificity Time: 2020The purpose of this research is to collect information about coronavirus exposures, symptoms, and health care visits due to the among Atrium Health clients and health care workers. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.
Description: Percent of volunteers who are 2019-nCoV Ab test positive
Measure: Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina Time: baselineDescription: Percent of volunteers who are 2019-nCoV Ab test positive
Measure: Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina Time: baselineThe purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.
Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneum at the end of the surgical procedure with exsufflation (T4) in COVID-19 patients
Measure: Assessment of the presence of the SARS-COV-2 virus at T4 Time: After surgery, an average of half a dayDescription: Assessment of the presence of the SARS-COV-2 virus by RT-PCR immediately after creation of the pneumoperitoneum just before intraperitoneal surgical exploration (T1) in COVID-19 patients
Measure: Assessment of the presence of the SARS-COV-2 virus at T1 Time: After surgery, an average of half a dayDescription: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneal effusion found during surgical exploration (T2) or in the peritoneal lavage fluid at the end of the surgical procedure before exsufflation (T4) in COVID-19 patients
Measure: Assessment of the presence of the SARS-COV-2 virus in the peritoneal effusion at T2 or T4 Time: After surgery, an average of half a dayDescription: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the pneumoperitoneum during intraperitoneal surgical dissection (T2) with straight blunt/sharp or any kind of energy devices in COVID-19 patients
Measure: Assessment of the presence of the SARS-COV-2 virus at T3 Time: After surgery, an average of half a dayDescription: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the bile at the end of the intervention after specimen extraction (T5), in case a cholecystectomy is performed in COVID-19 patients
Measure: Assessment of the presence of the SARS-COV-2 virus at T5 Time: After surgery, an average of half a dayThe Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.
Description: The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.
Measure: Individual response rate Time: 14 days after randomizationDescription: All-cause mortality rates at Day 28th after randomization
Measure: All-cause mortality Time: 28 days after randomizationDescription: Number of days that the patient was on mechanical ventilation which was under ventilation from basal line
Measure: Duration of mechanical ventilation Time: baselineDescription: Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.
Measure: Proportion of patients which needed mechanical ventilation during study Time: hospitalization within 28 daysDescription: The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: World Health Organization (WHO) Ordinal scale Time: 28 days after inclusion and compared to baselineDescription: Length of hospital stay in days for hospitalization
Measure: Duration of hospitalization Time: hospitalization within 28 daysDescription: Rates of drug discontinuation in all causes under study
Measure: Rates of drug discontinuation Time: hospitalization within 28 daysDescription: Rates of serious adverse events
Measure: Rates of serious adverse events Time: Day 14thBackground: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS). Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.
Description: Number of ventilator-free days (VFDs) at day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment. For patients ventilated 28 days or longer and for ventilated subjects who die, VFD is 0
Measure: Mechanical ventilation-free days Time: up to 28daysThis is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.
Description: This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.
Measure: Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality. Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.
Measure: Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score. Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.Description: The higher the SOFA score the increased likelihood of organ failure.
Measure: Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: A prolonged length of time in ICU increases mortality.
Measure: Difference in patient outcomes - Length of stay in ICU. Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: A prolonged length of time with ventilator support increases mortality.
Measure: Difference in patient outcomes - Length of ventilator support Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: A prolonged length of time with vasopressor support increases recovery time.
Measure: Difference in patient outcomes - length of vasopressor support Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysIt is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.
Description: Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours
Measure: Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 Time: 15 daysDescription: ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.
Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pH Time: 15 daysDescription: ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.
Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2 Time: 15 daysDescription: ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.
Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2 Time: 15 daysDescription: PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations.
Measure: Improvement of respiratory performance - ratio values Time: 15 daysDescription: every 24 hours D-Dimer value in mgr/ml
Measure: Evaluation of known adverse events related to the use of the drug - D-Dimer Time: 15 daysDescription: every 24 hours fibrinogen value in mg/dl
Measure: Evaluation of known adverse events related to the use of the drug - fibrinogen Time: 15 daysDescription: every 24 hours transaminases value in U/L
Measure: Evaluation of known adverse events related to the use of the drug - transaminases Time: 15 daysDescription: every 24 hours aPTT value in seconds
Measure: Evaluation of known adverse events related to the use of the drug - aPTT Time: 15 daysDescription: every 24 hours INR value in %
Measure: Evaluation of known adverse events related to the use of the drug - INR Time: 15 daysDescription: every 24 hours glycemia value in mg/dl
Measure: Evaluation of known adverse events related to the use of the drug - glycemia Time: 15 daysDescription: every 24 hours creatinine serum value in mg/dl
Measure: Evaluation of known adverse events related to the use of the drug - creatinine Time: 15 daysDescription: Total leucocyte as CBC x10e)/L
Measure: Evaluation of known adverse events related to the use of the drug - Leucocytes count Time: 15 daysDescription: formula % on total leucocyte
Measure: Evaluation of known adverse events related to the use of the drug - Leucocytes formula Time: 15 daysDescription: Thoracic imaging, every 48 h: presence, extension and dimension on lung thickening - Chest CT at start and end of treatment, Time elapsed between the onset of clinical symptoms and hospitalization.
Measure: Evaluation of the epidemiological parameters: Chest CT Time: 15 daysDescription: Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization.
Measure: Evaluation of the epidemiological parameters: Eco Chest Time: 15 daysDescription: Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.
Measure: Evaluation of the epidemiological parameters: CHEST X-ray Time: 15 daysDescription: Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h
Measure: Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment Time: 15 daysDescription: Number of AE grade 1 to 4
Measure: Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy Time: 15 daysLIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.
Description: The median age of study participants at enrollment.
Measure: Participant age Time: Baseline visitDescription: The proportion of men and women participating in the baseline visit.
Measure: Participant sex Time: Baseline visitDescription: The proportion of participants from each demographic group.
Measure: Participant race/ethnicity Time: Baseline visitDescription: The proportion of participants who were previously hospitalized.
Measure: Proportion of participants previously hospitalized. Time: Baseline visitThe purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Time: Study Day 15Description: All-location, all-cause 14-day mortality
Measure: All-location, all-cause 14-day mortality Time: Baseline to Study Day 14 (assessed on Study Day 15)Description: All-location, all-cause 28-day mortality
Measure: All-location, all-cause 28-day mortality Time: Baseline to Study Day 28 (assessed on Study Day 29)Description: Number of participants that survived to Day 28
Measure: Survival through 28 days Time: Baseline to Day 28 (assessed on Study Day 29)Description: Number days from admission to discharge thru Day 28
Measure: Time to hospital discharge through 28 days Time: Admission to discharge (assessed on Study Day 29)Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 Time: Baseline to Study Day 3Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 Time: Study Day 8Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 Time: Study Day 29Description: Number of days without use of oxygen
Measure: Oxygen-free days through Day 28 Time: Baseline to Day 28Description: Number of days without use of a ventilator
Measure: Ventilator-free days through Day 28 Time: Baseline to Day 28Description: Number of days without use of vasopressors
Measure: Vasopressor-free days through Day 28 Time: Baseline to Day 28Description: Number of days outside of ICU
Measure: ICU-free days through Day 28 Time: Baseline to Day 28Description: Number of days outside of the hospital
Measure: Hospital-free days through Day 28 Time: Baseline to Day 28Description: Number of participants with Acute kidney injury
Measure: Acute kidney injury Time: Baseline to Day 28Description: Number of participants requiring renal replacement therapy
Measure: Renal replacement therapy Time: Baseline to Day 28Description: Number of participants with documented venous thromboembolic disease (DVT or PE)
Measure: Documented venous thromboembolic disease (DVT or PE) Time: Baseline to Day 28Description: Number of Participants with myocardial infarction or ischemic stroke
Measure: Documented cardiovascular event (myocardial infarction or ischemic stroke) Time: Baseline to Day 28Description: Number of participants with transfusion reaction (fever/rash)
Measure: Transfusion reaction Time: Baseline to Day 28Description: Number of participants with transfusion related acute lung injury (TRALI)
Measure: Transfusion related acute lung injury (TRALI) Time: Baseline to Day 28Description: Number of participants with transfusion associated circulatory overload (TACO)
Measure: Transfusion associated circulatory overload (TACO) Time: Baseline to Day 28Description: Number of participants with transfusion related infection
Measure: Transfusion related infection Time: Baseline to Day 28This is a prospective adaptive cohort study of St. Jude employees to determine the rate of SARS-CoV-2 infections that are asymptomatic and to evaluate immunological responses to SARS-CoV-2 infection. Primary Objectives - To estimate the proportion of asymptomatic infection with SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees - To comprehensively map CD4 and CD8 T cell epitopes and response magnitudes to SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees who acquire SARS-CoV-2 infection Secondary Objectives - To establish seroprevalence of SARS-CoV-2-specific antibodies at baseline, and identify the rate of seroconversion to SARS-CoV-2 in a population of presumably naïve adult St. Jude employees - To identify features of T cell responses at baseline and during SARS-CoV-2 infection that are associated with protection against symptomatic or severe COVID-19 disease in a population of adult St. Jude employees Exploratory Objectives - To establish additional immunological features including host immune or receptor polymorphisms associated with response to SARS-CoV-2 infection - To explore SARS-CoV-2 diversity and specific features in a circumscribed population - To describe the presence, characteristics, and proportion of short-term re-infection - To determine if an association between SARS-CoV-2 viral load in nasal swab specimens and COVID-19 symptoms can be identified in a population of adult St. Jude employees who acquire SARS-CoV-2
Description: The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.
Measure: Proportion of asymptomatic subjects Time: 1 year from enrollmentDescription: A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.
Measure: Positive CD4 and CD8 cell epitope positive response Time: at enrollment, 3 months, 6 months, 9 months and 1 yearDescription: The proportion of participants at each time point who have detectable antibodies that recognize SARS-COV-2.
Measure: Proportion of seroprevalence Time: Baseline, 3 months, 6 months, 9 months and 1 yearDescription: For CD8s, T cell responses will be categorized as cytolytic, cytokine producing, or exhausted. For CD4s they will be grouped as Th1, Th2, Tfh, or Th17. Percentages of cells in each category will be summarized at baseline and during SARS-CoV-2 infection.
Measure: T-cell response Time: Baseline, 3 months, 6 months, 9months and 1 yearACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.
Description: To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.
Measure: Development of population-based models of disease risk Time: Up to 10 yearsDescription: To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.
Measure: Relation between disease burden and geolocation Time: Up to 10 yearsDescription: To specifically identify medications and regimens that address disease symptoms
Measure: Effect of medications on symptoms of COVID19 Time: Up to 10 yearsDescription: To specifically identify medications and regimens that treat and reduce disease severity.
Measure: Effect of medications on disease severity of COVID19 Time: Up to 10 yearsDescription: To identify regional variations in disease incidence and outcomes.
Measure: Rate of COVID19 infection and disease outcomes Time: Up to 10 yearsDescription: To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.
Measure: Effect of COVID19 on health outcomes Time: Up to 10 yearsDescription: To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.
Measure: Long-term follow up and recontact Time: Up to 10 yearsThe most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.
This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.
Description: Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay
Measure: Incidence of symptomatic COVID-19 infection in healthcare workers Time: 12 weeksDescription: Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection
Measure: Absenteeism from work due to COVID-19 Time: 12 weeksDescription: Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging >50% lung involvement, respiratory failure, end organ damage or shock)
Measure: Severity of COVID-19 infection Time: 12 weeksCoronavirus (COVID-19) is a pandemic-like disease caused by a new coronavirus called Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) isolated in China in 2019. Clinical manifestations vary widely from one individual to another, from asymptomatic carrier to a febrile cough that can rapidly lead to acute respiratory distress syndrome. Since the beginning of the COVID-19 epidemic, screening by chest X-ray (RT) and polymerase chain reaction (PCR) SARS-CoV-2 conducted by the Cornwall Hospital Union laboratory has shown that among symptomatic patients and hospital staff suspected of being COVID-19, only 7.8% were attributable to COVID-19. Two nosocomial clusters were also identified, in the emergency department (10 carers) and in the cardiology department (6 carers and one patient). However, direct diagnosis by RT-PCR has sensitivity limits and can lead to false negative results when the subject is indeed suffering from COVID-19. This lack of sensitivity is inherent to the technique on the one hand, but also to the quality of the sample and the kinetics of the infection. Indeed, the virological window during which the virus is present in the respiratory mucous membranes sampled seems relatively narrow, hence a progressive negativation of the respiratory samples as the disease progresses. Moreover, clinical symptoms vary from one individual to another, and it is now recognized that some infected persons are asymptomatic but carry the virus. Thus, the use of a second diagnostic technique is a necessity, and serology could be a relevant diagnostic support. In the literature, several publications report the performance of COVID-19 serology in clusters of cases or cohorts of subjects. The serological techniques employed are variable (target epitopes in particular) and frequently homemade. Serology is mainly studied in comparison or association with RT-PCR in order to highlight the increased performance of COVID-19 diagnosis when the two techniques are combined. Correlation with chest CT imaging data is also encountered. Numerous serological tests are therefore being tested to determine retrospectively whether the individual has been exposed to the virus by looking for specific antibodies to the virus. The supreme health authority has drawn up specifications dated 16 April 2020, defining the methods for evaluating the performance of serological tests detecting antibodies directed against SARSCoV-2 in order to provide a framework for these practices. Several clinical studies are also underway, in particular to assess the kinetics of the appearance of the antibodies, whether these specific antibodies would be protective and whether their appearance would coincide with a cessation of contagiousness. Thus, the main objective of this study is to evaluate the diagnostic performance of the COVID-19 immunoglobulin (IgG) Dia-Pro serological test, in view of its deployment at the Cornish Hospital Union Laboratory. Subsequently, given the low prevalence of COVID-19 in Brittany and the risk of a second epidemic wave when the confinement is lifted, the evaluation of the seroprevalence of the staff of the Cornish Hospital Union is necessary in order to assess the attack rate of COVID-19 within the establishment and particularly within departments where nosocomial clusters have been reported; and to prevent the impact of deconfinement. Indeed, knowledge of the proportion of immunized personnel and its distribution according to services will make it possible to establish internal recommendations and to effectively manage personal protective equipment inventories, in conjunction with the deconfinement strategy that will be implemented by the government. The goal is to protect hospital staff from overexposure to the virus;
Description: The performance of the COVID-19 IgG Dia-Pro serological test is evaluated in terms of sensitivity/specificity.
Measure: Serological test evaluation Time: 1 dayDescription: Population seroprevalence among hospital staff (caregivers and non-caregivers) in Quimper Hospital is assessed
Measure: Population seroprevalence Time: 1 monthThis is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2). The participants will be randomised to receive either: Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).
Description: Group 1:The primary endpoint/outcome measure is the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.
Measure: the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization. Time: within 1 month from randomizationDescription: Group 2: The primary endpoint/outcome measure is the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.
Measure: the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization. Time: within 14 days from randomizationDescription: The proportion of subjects with positive swabs in randomized population of SARS-CoV-2-exposed subjects ( Group 1) within 1 month from randomization in both arms
Measure: The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms Time: within 1 month from randomizationDescription: The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization, in subgroup population identified by stratification factors, class of age and gender.
Measure: The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization Time: within 1 month from randomizationDescription: The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization, in subgroup population identified by stratification factors, class of age and gender.
Measure: The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization. Time: within 14 days from randomizationDescription: The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population identified by stratification factors, class of age and gender.
Measure: The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population Time: within 1 month from randomizationDescription: Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.
Measure: Absolute and relative frequencies of Serious Adverse Events Time: up to 10 monthsDescription: Variation in Quality of Life scores EQ-5D-5L (EQ-5D descriptive system with 5 severity levels from better to worse, and the EQ visual analogue scale (EQ VAS, scale from 100 to 0, high is better) in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.
Measure: Variation in Quality of Life scores in different time points Time: up to 10 monthsThis is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.
Description: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead
Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 14 days Time: 14 days post randomizationDescription: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead
Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 28 days Time: 28 days post randomizationDescription: Anti-SARS-CoV-2 titers (IgM, IgG, IgA)
Measure: Comparison in Anti-SARS-CoV-2 antibody titers Time: 0, 1, 7, 14, 28, 90 days post randomizationDescription: SARS-CoV-2 PCR in nasopharyngeal swabs
Measure: Proportion positive in SARS-CoV-2 RNA Time: 0, 7, 14, 28 days post randomizationDescription: Rate of mortality
Measure: Mortality Time: 7, 14, 28 days post randomizationDescription: Percentage of patients requiring Intensive Care Unit admission
Measure: Rates of Intensive Care Unit admission Time: 7, 14, 28 days post randomizationDescription: Lymphocyte counts
Measure: Changes from baseline in lymphocyte Time: 0, 1, 3, 7, 14 days post randomizationDescription: Neutrophil counts
Measure: Changes from baseline in neutrophils Time: 0, 1, 3, 7, 14 days post randomizationDescription: D-dimer level
Measure: Changes from baseline in D-dimer Time: 0, 1, 3, 7, 14 days post randomizationDescription: Fibrinogen level
Measure: Changes from baseline in fibrinogen Time: 0, 1, 3, 7, 14 days post randomizationDescription: T cell subsets
Measure: Changes from baseline in T lymphocyte subsets Time: 0, 7, 28 days post randomizationDescription: B cell subsets
Measure: Changes from baseline in B lymphocyte subsets Time: 0, 1, 3, 7, 14 days post randomizationSuspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.
Description: The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.
Measure: Median days alive and out of the hospital Time: 30 daysDescription: Cardiovascular outcomes such as progression of COVID-19, mortality (general and cardiovascular), acute myocardial infarction, stroke / TIA, new heart failure or worsening of pre-existing HF, myocarditis, pericarditis, arrhythmias requiring treatment, phenomena thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure. All events will be reported according to CTCAE 4.0
Measure: Number of participants with adverse cardiovascular outcomes and new worsening heart failure Time: 30 daysDescription: Evaluate levels of biomarkers [troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics].
Measure: Cardiovascular biomarkers related to COVID-19 Time: up to 30 daysThis study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 6 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 6 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 6 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 6 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 6 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 6 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysCOVID-19 has a high infection rate and mortality, and serious complications such as heart injury cannot be ignored. Cardiac dysfunction occurred in COVID-19 patients, but the law and mechanism of cardiac dysfunction remains unclear. The occurrence of progressive inflammatory factor storm and coagulation dysfunction in severe and fatal cases of NCP points out a new direction for reducing the incidence of severe and critically ill patients, shortening the length of duration in severe and critically ill patients and reducing the incidence of complications of cardiovascular diseases. Aspirin has the triple effects of inhibiting virus replication, anticoagulant and anti-inflammatory, but it has not received attention in the treatment and prevention of NCP. Although Aspirin is not commonly used in the guidelines for the treatment of NCP, it was widely used in the treatment and prevention of a variety of human diseases after its first synthesis in 1898. Subsequently, aspirin has been confirmed to have antiviral effect on multiple levels. Moreover, one study has confirmed that aspirin can inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and upregulation of type I interferon production. Subsequently, pharmacological studies have found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase (COX). Under certain conditions, the platelet is the main contributor of innate immune response, studies have found that in the lung injury model in dynamic neutrophil and platelet aggregation. In summary, the early use of aspirin in covid-19 patients, which has the effects of inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung injury, is expected to reduce the incidence of severe and critical patients, shorten the length of hospital duration and reduce the incidence of cardiovascular complications.
Description: TTCR is defined as the study treatment (oral aspirin enteric-coated tablet) began to fever, breathing rate, blood oxygen saturation recovery, and cough relieving for at least 72 hours.
Measure: clinical recovery time (TTCR) Time: not more than 14 daysDescription: Time of SARS-CoV2 in upper respiratory tract specimens overcasting detected by RT-PCR.
Measure: the time of SARS-CoV2 overcasting Time: not more than 37 daysIdeal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.
Description: Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation)
Measure: Progression of oxygenation needs Time: up to 1 monthDescription: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
Measure: Renal failure Time: up to 1 monthDescription: Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits
Measure: Liver failure Time: up to 1 monthDescription: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
Measure: Cytokine Storm Time: up to 1 monthDescription: Count of participants who die from COVID-19
Measure: Mortality Time: up to 1 month post hospital dischargeDescription: Length of hospital stay in days
Measure: Length of hospital stay Time: up to 1 monthDescription: Count of patients admitted to the ICU at any time during index hospitalization
Measure: Intensive Care Unit (ICU) admission Time: up to 1 monthDescription: Length of ICU stay in days
Measure: Intensive Care Unit (ICU) duration Time: up to 1 monthDescription: Count of participants requiring intubation
Measure: Intubation Time: up to 1 monthDescription: Length of intubation, measured in days
Measure: Intubation duration Time: up to 1 monthDescription: Time measured in days from hospital admission to determination patient is stable for discharge
Measure: Time until recovery Time: up to 1 monthItaly was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.
Description: Comparison between the two groups
Measure: Delta in the number of patients requiring orotracheal intubation despite treatment Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of crude mortality Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of length of stay for patients in hospital Time: 90 daysDescription: Comparison between the two groups
Measure: delta in the value of interleukin (IL)-1 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-6 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-10 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of CD8+ CD38/ HLA-DR Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of fecal calprotectin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of lipopolysaccharide (LPS) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of zonulin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of alpha1-antitrypsin Time: 21 daysThis phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.
Description: The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.
Measure: Rate of extubation (for intubated patients) Time: Screening up to 28 days after radiation therapyDescription: Temperature in degrees (F)
Measure: Clinical outcome - Temperature Time: Screening up to 28 days after radiation therapyDescription: Heart rate in beats per minutes
Measure: Clinical outcome - Heart Rate Time: Screening up to 28 days after radiation therapyDescription: Systolic blood pressure in mm Hg
Measure: Clinical outcome - Systolic blood pressure Time: Screening up to 28 days after radiation therapyDescription: Oxygen saturation in percentage
Measure: Clinical outcome - Oxygenation Time: Screening up to 28 days after radiation therapyDescription: Respiratory rate in breaths per minute
Measure: Clinical outcome - Respirations Time: Screening up to 28 days after radiation therapyDescription: FI02 in percentage
Measure: Clinical outcome - FiO2 Time: Screening up to 28 days after radiation therapyDescription: Positive end expiratory pressure (PEEP) in cm H20
Measure: Clinical outcome - PEEP Time: Screening up to 28 days after radiation therapyDescription: Tidal volume in mL
Measure: Clinical outcome - Tidal volume Time: Screening up to 28 days after radiation therapyDescription: Extubation/intubation events in percentage
Measure: Clinical outcome - Intubation/Extubation events Time: Screening up to 28 days after radiation therapyDescription: Survival in percentage
Measure: Clinical outcome - Overall survival Time: Screening up to 28 days after radiation therapyDescription: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.
Measure: Radiographic outcome - Chest xray Time: Screening up to 28 days after radiation therapyDescription: CT scans with volume of consolidation measured in cubic centimeters.
Measure: Radiographic outcome - CT can Time: Screening up to 28 days after radiation therapyDescription: White blood cell count in cell count x 10^3/mcL
Measure: Serologic outcome - WBC Time: Screening up to 28 days after radiation therapyDescription: Hemoglobin in gm/dL
Measure: Serologic outcome - Hgb Time: Screening up to 28 days after radiation therapyDescription: Procalcitonin in ng/mL
Measure: Serologic outcome - Procalcitonin Time: Screening up to 28 days after radiation therapyDescription: Absolute neutrophil count in cell count x 10^3/mcL
Measure: Serologic outcome - ANC Time: Screening up to 28 days after radiation therapyDescription: Creatine kinase in units/L
Measure: Serologic outcome - Creatine kinase Time: Screening up to 28 days after radiation therapyDescription: Myoglobin in ng/mL
Measure: Serologic outcome - Myoglobin Time: Screening up to 28 days after radiation therapyDescription: Albumin in gm/dL
Measure: Serologic outcome - Albumin Time: Screening up to 28 days after radiation therapyDescription: Coagulation pathway time in seconds
Measure: Serologic outcome - PT/PTT Time: Screening up to 28 days after radiation therapyDescription: D-Dimer in ng/mL
Measure: Serologic outcome - D-Dimer Time: Screening up to 28 days after radiation therapyDescription: Gamma-glutamyl transferase in units/L
Measure: Serologic outcome - GGT Time: Screening up to 28 days after radiation therapyDescription: Trygliciericdes in mg/dL
Measure: Serologic outcome -Triglycerides Time: Screening up to 28 days after radiation therapyDescription: Ferritin in ng/mL
Measure: Serologic outcome -Ferritin Time: Screening up to 28 days after radiation therapyDescription: Fibrinogen in mg/dL
Measure: Serologic outcome -Fibrinogen Time: Screening up to 28 days after radiation therapyDescription: Immune marker flow cytometry (refractive index)
Measure: Serologic Immune markers flow cytometry Time: Screening up to 28 days after radiation therapyDescription: Bilirubin in mg/dL
Measure: Serologic outcome -Bilirubin Time: Screening up to 28 days after radiation therapyDescription: Lactate Dehydrogenase in units/L
Measure: Serologic outcome - LDH Time: Screening up to 28 days after radiation therapyDescription: Creatinine in mg/dL
Measure: Serologic outcome - Creatinine Time: Screening up to 28 days after radiation therapyDescription: Estimated Glomerular Filtration Rate in mL/min/m2
Measure: Serologic outcome - EGFR Time: Screening up to 28 days after radiation therapyDescription: C-Reactive Protein in mg/L
Measure: Serologic outcome - CRP Time: Screening up to 28 days after radiation therapyDescription: Alanine Aminotransferase in units/L
Measure: Serologic outcome - ALT Time: Screening up to 28 days after radiation therapyDescription: Asparatate Aminotransferase in units/L
Measure: Serologic outcome - AST Time: Screening up to 28 days after radiation therapyDescription: Troponin-I in ng/mL
Measure: Serologic outcome - Troponin-I Time: Screening up to 28 days after radiation therapyDescription: B-Natriuretic Peptid in pg/mL
Measure: Serologic outcome - BNP Time: Screening up to 28 days after radiation therapyDescription: pH (no unit)
Measure: Serologic outcome - Blood Gases pH Time: Screening up to 28 days after radiation therapyDescription: pressure of O2 in mm Hg
Measure: Serologic outcome - Blood Gases pO2 Time: Screening up to 28 days after radiation therapyDescription: pressure of CO2 in mm Hg
Measure: Serologic outcome - Blood Gases pCO2 Time: Screening up to 28 days after radiation therapyDescription: Lactic Acid in mmol/L
Measure: Serologic outcome - Lactic Acid Time: Screening up to 28 days after radiation therapyDescription: Interleukin-6 in pg/mL
Measure: Serologic outcome - IL-6 Time: Screening up to 28 days after radiation therapyDescription: Potassium in mmol/L
Measure: Serologic outcome - Potassium Time: Screening up to 28 days after radiation therapyThe administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness. As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.
Description: Proportion of subjects who enter the Intensive Care Unit
Measure: Admission to Intensive Care Unit Time: At day 28.Description: Proportion of subjects who die.
Measure: Death Time: At day 28.Description: Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
Measure: Time from onset of symptoms to discharge of patients in conventional hospitalization Time: At day 28.Description: In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit
Measure: ICU - Time until admission Time: At day 28.Description: In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.
Measure: ICU - Time mechanical ventilation is removed Time: At day 28.Description: Evaluation of the inflammatory markers related to IL disease. Blood samples will be collected and assessed in order to evaluate interleukins related with the interleukin storm using immunological tests.
Measure: Evaluation of the inflammatory markers related with the disease Time: At day 28.Description: Evaluation of the Vitamin D metabolites.
Measure: Vitamin D metabolites Time: At day 28.Description: Compare the evolution in SatO2
Measure: Evolution in SatO2 Time: At day 28.Description: Compare the evolution in the Sat O2/FiO2 ratio
Measure: Evolution in the Sat O2/FiO2 ratio. Time: At day 28.Description: Compare the evolution in the degree of dyspnea using the analog Borg scale
Measure: Evolution in the degree of dyspnea Time: At day 28.Description: Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial
Measure: Evolution of the improvement of radiological findings by simple radiology Time: At day 28.Description: Incidence of adverse events related to medication and its administration.
Measure: Incidence of adverse events Time: At day 28.Description: Incidence in the appearance of hemorrhagic or thrombotic phenomena.
Measure: Appearance of hemorrhagic or thrombotic phenomena Time: At day 28.This study is a case-control study to characterize the molecular and cellular anomalies of the olfactory epithelium of COVID-19 patients with isolated anosmia, by comparison with the olfactory epithelium of non-infected subjects.
Description: Ratio of olfactory sensory cells in the nasal cytological sample
Measure: Molecular and cellular defects in olfactory epithelium Time: 30 monthsDescription: Multiple measurements will be analyzed to characterize the immune and inflamatory status of the olfactory mucosa (presence of infiltrated immune cells, activation state of the immune cells in the epithelium, cytokine and interleukin level)
Measure: Biological mechanisms involved in the pathogenesis of the disease Time: 30 monthsDescription: Demographic variables (sex, age, blood type), risk factors (tobacco, overweight, diabetes, rhinosinusitis disease, respiratory allergy)
Measure: Epidemiological characteristics Time: 30 monthsDescription: Self-questionnaire taste and smell survey (TTS)
Measure: Olfactory and taste dysfunction Time: 30 monthsDescription: Visual analogue scale (VAS) (units from 0 normal perception to 100 no perception)
Measure: Olfactory and taste dysfunction Time: 30 monthsThe International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.
Description: Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery
Measure: Pregnancy outcomes Time: 1 yearDescription: Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health
Measure: Birth outcomes Time: Birth to 90 days post-partumDescription: Head circumference at birth in centimeters
Measure: Birth outcomes Time: Birth to 90 days post-partumDescription: Length at birth in centimeters
Measure: Birth outcomes Time: Birth to 90 days post-partumElectrocardiographic (ECG) evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infection. The present study involves three different phases of evaluation of the ECG traces of hospitalized patients with SARS-CoV-2 infection. - Phase 1: it is proposed to collect and retrospectively analyze the ECGs of hospitalized patients with severe SARS-CoV-2 infection which led to invasive ventilation or patient death as a consequence and, if available, also possible troponin dosage; - Phase 2: aims to collect and analyze the ECGs of consecutive hospitalized patients with SARS-CoV-2 infection and evaluate their relationship with the course of the disease, cardiac involvement and prognosis; - Phase 3: it is proposed to repeat ECG and to carry out echocardiogram to patients with SARS-CoV-2 infection after 3 months from hospital discharge by simultaneously performing, if deemed clinically indicated, also cardiac magnetic resonance. In this phase, any evolutions of ECG alterations of the acute phase will be described and the relationship with cardiac involvement will be assessed.
Description: Describe the ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection
Measure: Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection Time: 1 monthDescription: To evaluate the correlation between ECG signs and cardiac involvement in the acute phase • Assess the correlation between ECG signs and mortality in the acute phase
Measure: Phase 2: Correlation between ECG signs and needs for invasive mechanical ventilation and/or mortality in the acute phase Time: 6 monthsDescription: To evaluate the correlation between acute phase ECG signs and chronic phase cardiac involvement • evaluate the appearance, in the short-term follow-up, of signs of cardiac involvement (cardiomyopathies and conduction disorders in particular)
Measure: Phase 3: Correlation between ECG signs and cardiac involvement and mortality in the chronic phase Time: 12 monthsThe infectious disease COVID-19, caused by coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has been declared a pandemic and an international healthcare emergency by the World Health Organization (WHO). It has spread across the globe, overwhelming healthcare systems by causing high rates of critical illness. Mortality from COVID-19 exceeds 4%, with older people with comorbidities being extremely vulnerable. It is expected that between 50-80% of the world's population may contract SARS-CoV-2 over the next two years. It is expected that the outcomes will be potentially worse in Africa, because firstly, there is a limited workforce, and secondly there are limited intensive care facilities and critical care resources across Africa to provide sufficient care. It is important therefore to establish what resources, comorbidities and interventions are potentially associated with either mortality or survival in patients with COVID-19 who are referred for critical care in Africa. Rapid dissemination of these findings may help mitigate mortality from COVID-19 in critical care patients in Africa. These points provide the rationale for the African COVID-19 Critical Care Outcomes Study (ACCCOS).
Description: The primary outcome is in-hospital mortality in adult patients referred to intensive care or high-care units following suspected or known COVID-19 infection in Africa.
Measure: In-hospital mortality Time: 8-12 monthsDescription: To determine the risk factors (resources, comorbidities and interventions) associated with mortality in adult patients with suspected or known COVID-19 infection in Africa.
Measure: Risk factors (resources, comorbidities and interventions) associated with mortality Time: 8-12 monthsProspective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.
Description: Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)
Measure: Rate of elevated creatine kinase in hyperacute phase Time: 1 weekDescription: Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Rate of elevated creatine kinase Time: 24 monthsDescription: Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)
Measure: Rate of two-peak elevation of creatine kinase during acute phase Time: 30 daysDescription: Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up
Measure: Rate of myositis-specific antibodies Time: 24 monthsDescription: Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up
Measure: Rate of antimyocardial antibodies Time: 24 monthsDescription: Level of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) assessed by the area under the curve (AUC)
Measure: Area under the curve (AUC) of elevated creatine kinase Time: 24 monthsDescription: Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Peak-levels of elevated creatine kinase Time: 24 monthsDescription: Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)
Measure: Peak-levels of troponin Time: 30 daysDescription: Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)
Measure: Peak-levels of urine myoglobin Time: 30 daysDescription: Muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Rate of muscle hyperechogenicity Time: 24 monthsDescription: Peak-muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Peak-muscle hyperechogenicity Time: 24 monthsCoronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation. The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation. On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis. The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.
Description: Biological analysis using initial blood sampling
Measure: D-DIMERS plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Fibrin monomers plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Antithrombin plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Prothrombin Fragment 1 plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Prothrombin Fragment 2 plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Thrombin generation test plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Microvesicles of platelet plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Cross-linked platelets plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Willebrand Factor plasma levels in blood Time: 1 hour after admissionDescription: Biological analysis using initial blood sampling
Measure: Factor VIII plasma levels in blood Time: 1 hour after admissionPurpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Description: Presence or absence of IgG antibodies to SARS-CoV2
Measure: Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. Time: at enrollmentDescription: swab for presence of SARS-CoV-2 virus
Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. Time: at enrollmentThe novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.
Description: Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.
Measure: Proportion seropositive Time: Up to 12 months after collection visitThis concerns a single-center prospective interventional cohort study. Laboratory-confirmed COVID-19 patients will be asked to donate blood at at least two different timepoints. This will allow us to investigate T and B cell evolutions during the course of infection and recovery. The expected duration of the study is four months or the total duration of the SARS-CoV-2 circulation in Belgium (whichever is shortest).
This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).
Description: Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatment
Measure: P/F ratio Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: PaO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood.
Measure: A-a O2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Number of days on continuous positive end expiratory pressure (CPAP)
Measure: CPAP duration Time: From the first day of study drugs administration (T0) until day 7 post study drugs administrationDescription: Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiation
Measure: In-hospital change in intensity of the respiratory support Time: At baseline and 72 and 168 hours after treatment initiationDescription: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: PaCO2 difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: HCO3- difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment
Measure: Lactate difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.
Measure: Hb difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.
Measure: Plt difference Time: At baseline and 24, 48 and 168 hours after treatment initiationDescription: Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding)
Measure: Adverse effects Time: From the first day of study drugs administration until day 30 post study drugs administrationProphylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Description: assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)
Measure: Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections Time: 12 weeks after initiation of therapyDescription: defined as combined endpoint of hospitalization rate or death
Measure: Number of severe COVID-19 cases Time: 12 weeks after initiation of therapyDescription: grading as outlined by the world health organization (WHO)
Measure: Severity of COVID-19 cases Time: 12 weeks after initiation of therapyDescription: significant clinical and laboratory abnormalities according to CTCAE criteria
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 12 weeks after initiation of therapyDescription: other than COVID-19
Measure: Number of viral and bacterial infections Time: 12 weeks after initiation of therapyDescription: Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test
Measure: Number of participants with azithromycin-resistant bacterial strains in nasal swabs test Time: 12 weeks after initiation of therapySARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome. To test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.
Description: quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 kidney transplant patients.
Measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation Time: 10 monthsTo compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.
Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19. Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children.. Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective
Description: Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.
Measure: Characteristics and outcomes of acute respiratory infections due to COVID-19 in children. Time: Baseline-Day 60Description: Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.
Measure: Clinical risk factors of acute respiratory infection due to COVID-19 in children. Time: Baseline-day 60Description: Immunological (Absolute lymphocyte/monocyte counts (mm3) and Immunoglobin level (mg/dL) response measures, will be summarized with mean, standard deviation, median and range.
Measure: Immunologic response to acute respiratory infection due to COVID-19 in children. Time: Baseline-day 60Description: The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.
Measure: Duration of viral shedding and evolution in children longitudinally. Time: Baseline-Day 60Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. The aim of the study is to determine which messages are most effective at increasing knowledge and changing behaviors that can protect individuals and their communities from the virus. To accomplish this aim, we plan to recruit approximately 20,000 Hispanic and African-American individuals and randomly assign them to videos that vary either the sender or the framing of the message, while providing the relevant public health information.
Description: ratings of the videos by participants
Measure: Video Ratings Time: immediately following the intervention; if funds permit during follow-up as wellBackground: Coronavirus 2019 (COVID-19, or SARS-CoV-2) is a serious public health problem, and genetics may play a role in how serious the illness becomes in certain people. Genes are the instructions that our body uses to grow and develop. Variations in our genes can cause medical conditions and may be the reason why some people get sicker than others. Objective: This study aims to learn more about the genetic contributions to the severity of COVID-19. We hope to use this information to develop therapies that reduce the severity of COVID-19 symptoms in some people. Eligibility: Anyone located in the United States who has tested positive for SARS-CoV-2 infection may be eligible to join (including NIH staff). Design: Participants will complete a questionnaire about their health history and COVID-19 symptoms. Participants will give a blood or saliva sample. It will be about 2 tablespoons of blood, or we will send a saliva collection kit. Researchers will use this blood or saliva sample to study the participant s DNA. The data about participants genes will be stored in a large database. The database will be shared with other qualified researchers who are trying to learn about COVID-19. Participants names and other personal details will not be shared. Instead, the data will be labeled with a code. Participants may be contacted by study team members for up to a year after they join the study. ...
Description: Identify common and rare germline variants associated with host susceptibility to severe or fatal COVID-19 disease using a case-casedesign.
Measure: Molecular etiology of host susceptibility to severe COVID-19 Time: OngoingDescription: Perform exploratory analyses of epigenetic signatures, serologic immune markers and antibody profiles, and other possible techniques to discover other mechanisms of disease.
Measure: Mechanisms of disease Time: OngoingThe objectives of PROVIDE are to: 1. Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive 2. To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms 3. To determine the safety of taking weekly prophylactic hydroxychloroquine
Description: The number of HCW that tested positive for SARS-CoV-2
Measure: Positive for SARS-CoV-2 Time: 8 weeksDescription: The number of HCW that required hospital admission secondary to SARS-CoV-2
Measure: Hospital admissions Time: at any time after first dose to hospital discharge, truncated at 60 daysDescription: The number of HCW that required intensive care unit admission
Measure: Intensive care unit admissions Time: at any time after first dose to hospital discharge, truncated at 60 daysDescription: The number of HCW that required intubation and mechanical ventilation
Measure: Intubation and mechanical ventilation Time: at any time after first dose, truncated at 60 daysDescription: number of days admitted to the ICU
Measure: ICU length of stay Time: from randomization to hospital discharge, truncated at 60 daysDescription: number of days admitted to the hospital
Measure: Hospital length of stay Time: from randomization to hospital discharge, truncated at 60 daysDescription: Death
Measure: Mortality Time: from randomization to 60 daysDescription: Gastrointestinal symptoms (abdominal pain, diarrhea, nausea, vomiting), Hypoglycemia, Abdominal LFTs, Angioedema, Opthalmic (corneal changes, decreased visual acuity, macular degeneration, retinal changes), Bronchospasm
Measure: Incidence of adverse events Time: from randomization to 60 daysCOHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.
Description: To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status.
Measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) Time: At baselineDescription: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.
Measure: Clinical outcomes of symptomatic COVID-19 in PLWH Time: At Day 28Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.
Measure: Clinical outcomes of symptomatic COVID-19 in PLWH Time: At Month 3Description: To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.
Measure: Seroprevalence of COVID-19 in all parent study participants Time: Through study completion, an average of one yearThe coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
Measure: Time to clinical change Time: 28 daysDescription: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.
Measure: Percent of patients with clinical improvement. Time: 28 daysThe aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.
Online Distance Learning (ODL) is an educational delivery system that helps students to join in an educational opportunity without physically existing in the same setting as the teacher. Online learning is known as the education that takes place over the Internet, often referred to as e-Learning, web-based training (WBT), distance learning, or asynchronous learning. When learners participate in an online learning course at different times, it is known as asynchronous learning. online learning involves the umbrella term for any learning that takes place across distance and not in a traditional classroom. WHO recommends Implement social distancing practices that may include; Staggering the beginning and end of the school day and Use of online/e-learning strategies? The coronavirus pandemic has changed how millions around the globe are educated. new shifts in education approaches could widen equality gaps. As of March 13, the Organization for Economic Co-operation estimated that over 421 million students are affected due to school closures announced or implemented in 39 countries. Most faculties in affected areas are finding stop-gap solutions to continue teaching, but the quality of learning is heavily dependent on the level and quality of digital access. Therefore, the current study aimed to assess Nursing students' perception and achievement regarding unplanned shifting the Traditional Classroom-Based to Online Distance Learning as a result of (COVID-19) social distancing measures. H1: Learning perception is lower for nursing students who learned by unplanned Online Distance Learning (μ1) than for those who learned by Traditional Classroom-Based learning (μ2), (H1: μ1 < μ2). H1: Scholar achievement is greater for nursing students who learned by Traditional Classroom-Based learning (μ1) than for those who learned by unplanned Online Distance Learning (μ2), (H1: μ1 > μ2). A quasi-experimental research design will be utilized in the current study with a comparative approach. A purposive sample of adult male and female bachelor's students of nursing will be asked to participate in the current study. Three tools will be adopted to collect data relevant to the current study. 1. A brief demographic self-administrated questionnaire 2. Students' Learning Perception Questionnaire (SLPQ), 3. Modified McVay's Readiness for Online Learning Questionnaire
Description: Electronic online Questionnaire will be utilized using (Jot form) the link of the created Questionnaire is https://www.jotform.com/help/408-understanding-your-account-usage-and-limits Students' Learning Perception Questionnaire (SLPQ), will be utilized in the current study to measure students' perception as a dependent variable, (SLPQ) was adopted, inventory and metric instrument to assess the effectiveness of provided learning methods as perceived by the students. It covers two inventories; students' perceptions of the teaching-learning environment (TLE) (22 items) and students' approaches to learning (SAL) (12 items) (SLPQ) Items will be scored on a five-point Likert scale rated from "totally disagree" (1)" to "Totally agree (5)") . students who obtained less than (25%) will be considered as having a low perception, while who obtained (26 - 75%) will be considered as a moderate perception, and finally who get more than (75%) will be considered as a high perception level.
Measure: Students' Learning Perception Questionnaire (SLPQ), Time: 1 monthDescription: students' GPA, it will be collected from the student affairs of the college to measure the students' scholar achievement as a dependent variable.
Measure: students' scholar achievement. Time: 1 monthDescription: 3- Modified McVay's Readiness for Online Learning Questionnaire. Electronic online Questionnaire will be utilized using (Jot form) the link of created Questionnaire is https://www.jotform.com/help/408-understanding-your-account-usage-and-limits Watkins et al. (2004) developed a 27 items adopted scale that used attitudes and behaviors of the participants as predictors of students' preparedness for online learning and e-learning environments, its reliable tool with Cronbach's Alpha 0.82. This self-administrated instrument identified six dimensions: Technology Access (3 items), Online Skills and Relationships (9 items), Motivation (3 items), Online Audio/Video (3 items), Internet Discussions (4 items) and Importance to your success (5 items). The instrument consisted of a 5-point Likert-type scale response format (1- Completely Disagree, 2-Strongly Disagree, 3- Not Sure, 4-Strongly Agree, 5-Completely Agree).
Measure: Modified McVay's Readiness for Online Learning Questionnaire. Time: 1 monthThe purpose of this study is to test over time immunity to SARS-CoV-2, a recently identified coronavirus responsible for the 2019 world-wide pneumonia outbreak known as COVID-19. Adults and children diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.
Prospective, mono centric study on COVID-19 patients with or without acute respiratory distress syndrome (ARDS) to analyse the dynamics of the immune response and to search for biomarkers of evolution
Description: Blood sample
Measure: Number of increased immune population Time: Month 4Description: Blood sample
Measure: Number of decreased immune population Time: Month 4Description: Blood sample
Measure: Number of statically different phenotypes compared to control patients Time: Month 4Description: Qualitative identification of immune subpopulations showing a significant variation compared to controls and quantification of this variation (at D1 and/or D14)
Measure: Gain or loss of functional phenotypic markers between D1 and D14 Time: Day 14Description: Qualitative identification of immune subpopulations showing a significant variation between acute and mild COVID-19 and quantification of this variation (at D1 and/or D14)
Measure: Gain or loss of functional phenotypic markers between between acute and mild infections Time: Day 14Description: Qualitative identification of immune subpopulations showing a significant variation between acute stage and recovery (at 4 months) and quantification of this variation
Measure: Gain or loss of functional phenotypic markers between D1 and month 4 Time: Month 4Description: Blood sample
Measure: Evaluation of V, D, J gene usage alterations in the immunoglobulin and T cell receptor (TCR) repertoires during ARDS linked to COVID-19 Time: Day 14Description: Blood sample
Measure: Identification of the Ig classes and of V, D, J sequences of anti-CoV-2 antibodies Time: Month 4Description: Blood sample
Measure: Characterization of a new set of human antibodies from patients who have recovered of COVID-19 Time: Month 4Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.
Description: Time from randomisation to clinical improvement by two points on a seven-category ordinal scale: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both Death
Measure: Time to improvement by two points on a seven-category ordinal scale Time: Up to 28 days from randomisationDescription: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 7) Time: Day 7 from randomisationDescription: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 14) Time: Day 14 from randomisationDescription: Survival of patients to end of study
Measure: Overall survival Time: 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS score Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for temperature Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for heartrate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for respiratory rate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for oxygen saturation. Time: Up to 28 days from randomisationDescription: Frequency of admission of patients to intensive care
Measure: Admission to intensive care Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer mechanical ventilation to patients
Measure: Requirement for mechanical ventilation Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients
Measure: Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen Time: Up to 28 days from randomisationDescription: Frequency of culture-confirmed bacterial or fungal infection in patients
Measure: Incidence of bacterial or fungal infection Time: Up to 28 days from randomisationDescription: Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.
Measure: Incidence of adverse events not directly caused by COVID-19 infection. Time: Up to 28 days from randomisation.Description: Frequency of readmission to inpatient care of patients discharged from hospital.
Measure: Readmission to inpatient care Time: Up to 28 days from randomisationThe primary objective of this multi-center study is to clarify the value of a CRP measurement for triage of patients initially presenting with light symptoms of the COVID-19 infection. Current recommendations of management of COVID-19 include large-scale tests for virus. Such tests reveal whether an individual is infected with the virus, however, the demonstration of virus per se has no prognostic value for the ensuing course of the COVID-19 disease. Publications of possible treatments strategies increase exponentially, while evidence of triage of the affected individuals is mainly based on the level of pulmonary affection as measured by the Oxygen saturation. To inform decision making for which patients are to be hospitalized due to risk of developing more severe affection, this study addresses the question, whether triage may be performed with the aid of a simple CRP measurement.
Description: Admission to a hospital. Reason for admission is recorded.
Measure: Hospitalisation Time: within 28 daysPlasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
Description: Number of exitus at 28 days after plasma exchange in patients with COVID-19 disease and invasive mechanical ventilation.
Measure: Impact of plasma exchange Time: 28 daysThis is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.
Description: Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.
Measure: Transfer to ICU Time: Days 0 - 60Description: Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.
Measure: 28 day mortality Time: Days 0 - 60Description: Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.
Measure: Cumulative incidence of serious adverse events Time: Days 0 - 60Description: Will be done by collecting respiratory tract swabs and testing for SARS-CoV-2 positivity.
Measure: Rates and duration of SARS-CoV-2 Time: Days 0, 7, 14, and 21Description: Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.
Measure: Serum of plasma antibody titer to SARS-CoV-2 Time: Days 0, 7, 14, and 28Description: Blood will be collected and analyzed for cellular and humoral response.
Measure: Cellular and humoral immune response Time: Days 0, 7, 14, 28Description: All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.
Measure: Supplemental oxygen free days Time: Days 0-28Description: All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.
Measure: Ventilator free days Time: Days 0 - 28Description: All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.
Measure: ICU free days Time: Days 0 - 28Description: The patient will be evaluated throughout their enrollment in the study. The score will be evaluated to see if the score improved or worsened throughout their admission.
Measure: Sequential organ failure assessment score Time: days 0, 1, 4, 7, 14, 21, 28Description: Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.
Measure: Need for vasopressors Time: Days 0 - 60Description: Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.
Measure: Need for renal replacement therapy Time: Days 0 - 60Description: Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.
Measure: Need for extracorporeal membrane oxygenation (ECMO) Time: Days 0 - 60Description: Will be calculated from the date the patient entered the hospital until they were discharged.
Measure: Hospital length of stay (LOS) Time: Days 0-60Description: Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.
Measure: ICU LOS Time: days 0 - 60Description: All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.
Measure: Grade 3 or 4 Adverse Events (AEs) Time: days 0 - 60Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.
Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"
Measure: Venous thromboembolisms Time: 7 daysDescription: Deaths from all causes during the follow-up
Measure: Deaths Time: 7 daysOn 11 March 2020, the World Health Organization declared SARS-CoV-2 (commonly called COVID-19) a global pandemic. As in any pandemic, maintaining the health and safety of the healthcare workforce is of great importance as health care workers (HCW) remain a critical line of defence against the spread of COVID-19 and play a vital role in the recovery of those already infected. Frontline HCW, such as those in the emergency department (ED), are at high risk of contracting COVID-19 due to their close proximity to patients who may have the virus. The impact of frontline HCW becoming ill and thus unable to go to work is equally high, and of grave risk to the function of the healthcare system and the ability to minimize the impact of the current pandemic. This study aims to evaluate whether hydroxychloroquine (HCQ), a well-tolerated drug typically used in the prevention of malaria transmission and rheumatic disease, taken before and during exposure to patients with COVID-19, is effective at reducing COVID-19 infections among ED health care workers.
Description: This is a composite endpoint which includes any positive result from a validated SARS-CoV-2 diagnostic assay including detection of viral RNA, or seroconversion by day 104 (14 days after end of the randomization period).
Measure: Microbiologically confirmed COVID-19 (SARS-CoV-2 infection) Time: Samples collected at day 0, 30, 60, 90 and 120Description: Assessed using the DAIDS Table for Grading the Severity of Adverse Events
Measure: Adverse events Time: Assessed at day 30, 60, 90, and day 120Description: Collected weekly from participants via self-report, sent by email
Measure: Symptom duration of COVID-19 Time: Collected every 7 days from day 7 to day 120Description: The number of days (or partial days) spent admitted to an acute care hospital during the study period
Measure: Days of hospitalization attributable to COVID-19 Time: Collected every 7 days from day 7 to day 120Description: the number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation during the study period
Measure: Respiratory failure requiring ventilatory support attributable to COVID-19 Time: Collected every 7 days from day 7 to day 120Description: Mortality attributable to COVID-19 and all-cause mortality during the study period
Measure: Mortality Time: Collected every 7 days from day 7 to day 120Description: Number of days ineligible/unable to work due to COVID-19
Measure: Impact on work eligibility Time: Collected every 7 days from day 7 to day 120Description: COVID-19 reactive serology
Measure: Seropositivity Time: Blood collected at day 0, 30, 60, 90, 120Description: Short-term psychological impact of exposure to COVID-19 measured using the K10, a validated measure of non-specific psychological distress, with a standard cutoff score of ≥16
Measure: Short-term psychological impact Time: Measured at day 1, 60, 120Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.
Description: Days
Measure: Median duration of fever Time: 1 yearDescription: Days
Measure: Median duration of mechanical ventilation Time: 1 year follow upDescription: Days
Measure: Median length of ICU stay Time: 1 year follow upDescription: Days
Measure: Median length of admission Time: 1 year follow upDescription: days
Measure: Median length of viral clearance Time: 1 year follow upSARS-CoV-2 belong to beta-coronavirus family and its transmission route and symptoms follow those of all community-acquired coronaviruses. The main difference of the novel Coronavirus is the higher mortality rate, that is around 3%. Death rate is over 1% only for patients over 50 years old, whereas until 40 years old is under 0,4%. No fatalities are declared among children under 10 years old to date. Death rate is almost double for male rather than female. This distribution of mortality rate according to age of infected patients could be only partially ascribed to other comorbidities in addition to great age. In fact, patients with no pre-existing conditions have however a case fatality rate of 0,9%. The almost null rate of severe illness in children and generally in patients younger than 40 years old is quite un-explicable. Infant, children and young people could be infected but infection is rapidly self-limited or without symptoms. Older patients undergo severe lung injury as consequence of an immune response that is late in coming. Possible explanation of these phenomena could be something, which assure ability to prompt response to SARS-CoV-2 in younger people independently from the novelty of the virus itself. It would seem to be that younger people are already sensitized to the antigens of the virus without a previous contact. This immunity is not really specific, but "partially specific" for many antigens of the virus, however able to limit the infection in the organism. Something stimulated the immune system and it scattered immunity against more and more antigens present. Children are the age group mostly exposed to all community-circulating viruses. This immunity is not persistent but progressively fade out. It protects from the age of two, when the hypothetical stimulation occurs, to the fifth decade because of its slow decrease. The only external stimulation, which healthy people receive are vaccines. All vaccinations and especially tetanic, diphtheria toxoids and inactivated bacteria as pertussis could stimulate immune system. They develop the specific immunity but generate also a sprouting immunity against antigens in transit, as coronaviruses and other community-circulating viruses. The developed immunity gives some protection against multiple viral infection for years until the natural fade out. After the fifth decade, that immunity is slower to be recall and reactivated. Additionally, transplant recipients and HIV infected patients, which have an immune system inhibited, unexpectedly, do not seem to suffer the worst complications of SARS-CoV-2 infection. An immune system imbalance could be play a pivotal role during the reaction to the virus, limiting destructive consequences of excessive inflammation. According to the medical hypothesis on which the protocol is based on, young people could benefit from a functional adaptation of innate immune cells induced through epigenetic reprogramming and, especially, a pre-existing "partially specific" immunity to the community viruses caused by "bystander effect" of preceding vaccinations. In this study, we will explore the main differences existing among patients infected by SARS-CoV-2 who experience the illness at different degree of severity. We suppose to recognize different populations of patients, each one with a specific immunological pattern. It could differ in terms of cytokines, soluble factors serum level and immune cells activity both of the innate compartment and of the acquired one. The proof of a role of these immunological phenomena in the pathogenesis of Covid-19 are bases for implementation of therapeutic immunomodulatory treatments. In addition, the definition of an immunological risk profile could tailor established therapies to each kind of patient.
Description: Scientists' hypothesis is that monocytes, NK, CD4 AND CD8 T cells, in patients with severe infection to SARS-CoV-2, show an impairment in their function: cells reveal an overpowering hyperactivity that provokes a pathologic inflammatory response with a massive production of proinflammatory cytokine, edema and pulmonary fibrosis.
Measure: Immune cells activity Time: 6 monthsDescription: The secondary objectives are to correlate clinical data and vaccination history with laboratory immune pattern to identify protective factors for Covid 19 and open paths for new therapeutic strategies.
Measure: Protective factors and new therapeutic strategies Time: 6 monthsCoronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection. Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States. Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.
Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Measure: Percentage of Participants Alive and Without Respiratory Failure Time: Day 28Description: WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).
Measure: Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline Time: Day 14Description: Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.
Measure: Median Reduction in Days Spent on Supplemental Oxygen Time: Up to Day 28Description: Percentage of participants with mortality from any cause.
Measure: All-Cause Mortality Time: Up to Day 28Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Measure: Percentage of Participants Experiencing Respiratory Failure or Death Time: Up to Day 28Description: Percentage of participants alive and not requiring mechanical ventilation.
Measure: Mechanical Ventilation-Free Survival Time: Up to Day 56Description: Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.
Measure: Days on Mechanical Ventilation Time: Up to Day 56Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.
Measure: Duration of hospitalization Time: Up to Day 56Description: Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.
Measure: Time to Discharge Time: Up to Day 56Description: PaO2:FiO2 ratio is an index of respiratory distress.
Measure: Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio Time: Up to Day 56Description: Oxygenation Index is a parameter of pulmonary function of participants.
Measure: Oxygenation Index Time: Up to Day 56Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measure: Number of Participants With Adverse Events Time: Up to Day 56Description: Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measure: Number of Participants With Abnormal Laboratory Findings Time: Up to Day 56This study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions. It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.
Description: Self-managed questionnaire on functional status, anxiety, pain and independence in daily living; The EuroQoL includes a five item scale and a visual analog scale from 0-100 in order to quantify perception of current health. The five item scale includes ordinary scores from 0-5. Lower numbers equal less problems and better quality of life. For the visual analog scale a higher number represents a better health status perceived.
Measure: Health-related quality of life; EuroQoL (EQ-5D-5L) Time: 01.04.2020 - 30.05.2021Description: 6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.
Measure: 6-minute walk test Time: 01.04.2020 - 30.05.2021Description: Measures the handgrip strength and is associated with sarcopenia, mortality and independence in life (e.g. for older individuals and patients after or with critical illness)
Measure: Jamar dynamometer Time: 01.04.2020 - 30.05.2021Description: Self-administered questionnaire on anxiety and depression after hospitalization; bot, anxiety and depression is quantified by an ordinal scale from 0-3, respectively. The lower the number the less signs of depression or anxiety are present.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: 01.04.2020 - 30.05.2021Description: Questionnaire on avoidance, intrusion and arousal (or overreaction) in order to identify potential risk for post-traumatic stress. The Scale includes 22 questions ordinally scored from "not at all" to " very frequent" with four scores. The scores are transformed into numbers (0,1,3,5). The values are put in a formula resulting in a single value.A value below zero indicates no risk of post-traumatic stress disorder (PTSD) is present. Values equal or higher than zero indicate the risk of a PTSD
Measure: revised Impact of Event Scale (IES-R) Time: 01.04.2020 - 30.05.2020Description: Questionnaire on the nutritional condition of the patient. It includes 16 questions and 2 measures. Points range from 0-30; A score <17 indicates malnutirtion, a score from 17-23.5 indicates a risk of malnutrition and scores between 24-30 indicate normal nutritional behaviour.
Measure: Mini-Nutritional Assessment (MNA) Time: 01.04.2020 - 30.05.2021Description: Measures the lung function (bedside screening)
Measure: Spirometry (bed-side) Time: 01.04.2020 - 30.05.2021Description: This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.
Measure: Post-Covid Functional Scale (PCFS) Time: 01.04.2020 - 30.05.2021Description: Quantifies and stratifies the perception of dyspnoea with a score ranging from 0-4. The higher the value the more frequent and more severe is the perception of dyspnoea during daily life activities.
Measure: modified Medical Research Council Dyspnoea Scale (mMRC Dyspnoea) Time: 01.04.2020 - 30.05.2021The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death. The purpose of this study is to: - Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents - Determine the prevalence of antibody development over time in children and parents - Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions - Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants
Description: Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts. Calculated at the end of surveillance/study follow-up or fate, defined as follows: Time from entry until the first of the following events: Tests positive for SARS-CoV-2 RNA in nasal samples Is lost to follow-up or withdraws from the study End of study (Week 24) Fate at the end of follow-up: 1 (positive): If the participant tests positive for SARS-CoV-2 0 (censored): If the participant has no evidence of having had disease by the end of follow-up
Measure: Cumulative Incidence of SARS-CoV-2 RNA Detection in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period Time: Up to Week 24Description: Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts. Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
Measure: Percent of Index Participants and Their Household Contacts with Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Testing method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.
Measure: Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants with Asthma and Other Atopic Disease Compared to Index Participants without Atopic Disease Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
Measure: Percent of Index Participants with Asthma and Other Atopic Disease with Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants without Atopic Disease Over the Study/Surveillance Period Time: Through study completion, an average of 24 WeeksDescription: Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis. Total RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.
Measure: Changes in the Nasal Transcriptome Associated with Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period Time: Up to Week 24Description: Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed. Definition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.
Measure: Changes in the Nasal Transcriptome Associated with Detection of SARS-CoV-2 in Nasal Samples Among Index Participants with Asthma and Other Atopic Disease Compared to Index Participants without Atopic Disease Over the Study/Surveillance Period Time: Up to Week 24Description: An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted. Included in analysis: Index participants and their household contacts.
Measure: Symptoms Associated with Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Tests:Positive for SARS-CoV-2 RNA in nasal samples
Measure: Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants using Topical Steroids Compared to Index Participants that are Not Using Topical Steroids Over the Study/Surveillance Period Time: Up to Week 24Description: Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Tests: Positive for SARS-CoV-2 RNA in nasal samples.
Measure: Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants Using Topical, Oral, or Inhaled Steroids Compared to Index Participants that are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period Time: Up to Week 24Description: An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.
Measure: Analysis of Factors, Baseline and Prior History, for Possible Association with the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period Time: Baseline, Week 24This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
Description: Time it takes to identify eligible donors whom are willing to donate
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time from consent to infusion
Measure: Plasma Recipient Time: Measured evey 24 hours up to 30 daysDescription: Survival
Measure: Plasma Recipient Time: Measured in days with 30 day from discharge follow-upDescription: Time until plasma is donated
Measure: Plasma Donor Time: Measured every 24 hours up to 1 yearDescription: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Morbidity reduction
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Reduced Length of Stay in hospital
Measure: Plasma Recipient Time: Measured every 24 hours until patient discharged from hospital up to 1 yearDescription: Reduced Length of Stay on Advance Respiratory Support
Measure: Plasma Recipient Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 yearThe new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
Description: Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.
Measure: Initial biological profile of children and adults with COVID-19 infection Time: Day 0Description: measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.
Measure: Initial immunological profile of children and adults with COVID-19 infection Time: Day 0Description: Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection
Measure: Clinical worsening Time: Within 21 days following inclusionDescription: measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening
Measure: Evolution of the immunological profile of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation
Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 Time: Day 0Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 Time: Day 0Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measure: titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19 Time: Day 0Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.
Measure: Genetic profile of adults with COVID-19 infection Time: Day 0Description: Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening
Measure: Genetic profile of adults with COVID-19 infection Time: Within 21 days following inclusionThe present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton & Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised. Four sets of variables (1-demographic characteristics, 2-pre-morbid state of health, 3-characteristics of acute illness, and 4- specific Covid-19 treatments received) will be assessed as potential risk factors for health-related quality of life and secondary outcomes.
Description: The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Measure: One-year utility score of health-related quality of life Time: The outcome will be assessed 12 months after enrollment.Description: Incidence of all-cause mortality.
Measure: Incidence of all-cause mortality Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: Incidence of all-cause rehospitalizations.
Measure: Incidence of rehospitalizations Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: Percentage of return to work or study among patients that were working or studying at the moment of hospitalization.
Measure: Percentage of return to work or study Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence).
Measure: Score of Instrumental Activities of Daily Living Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms.
Measure: Score of dyspnea Time: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.Description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
Measure: Percentage of long-term ventilatory support need Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
Measure: Symptoms of anxiety and depression Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
Measure: Symptoms of posttraumatic stress disorder Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.Description: The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Measure: Utility score of health-related quality of life at 3, 6, and 9 months Time: The outcome will be assessed 3, 6, and 9 months after enrollment.Description: The outcome will be assessed using the visual analogue scale of the Brazilian version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).
Measure: Score of self-rated health Time: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of participants with severe COVID-19 related pulmonary disease. The study population will consist of hospitalized participants with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.
Description: Participants are alive and free of respiratory failure if they are in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.
Measure: Proportion of participants alive and free of respiratory failure at Day 28 Time: Day 28Description: Number of deaths due to all causes will be assessed.
Measure: Number of deaths due to all causes at Day 60 Time: Day 60Description: Time to death due to all causes will be assessed.
Measure: Time to number of deaths due to all causes up to Day 60 Time: Up to Day 60Description: Participants alive and free of respiratory failure if they are in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.
Measure: Proportion of participants alive and free of respiratory failure at Days 7, 14, 42 and 60 Time: Days 7, 14, 42, and 60Description: Time will be recorded from dosing to recovery from respiratory failure. Participants are in respiratory failure if they are in category 5 or above from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.
Measure: Time to recovery from respiratory failure Time: Up to Day 28Description: Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.
Measure: Proportion of participants alive and independent of supplementary oxygen at Days 7, 14, 28, 42, and 60 Time: Days 7, 14, 28, 42, and 60Description: Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.
Measure: Time to last dependence on supplementary oxygen Time: Up to Day 28Description: For participants not in ICU at time of dosing, the proportion of participants admitted to the ICU prior to Day 28.
Measure: Proportion of participants admitted to Intensive Care Unit (ICU) Time: Up to Day 28Description: Defined as the time from dosing to when the participant is discharged from the ICU.
Measure: Time to final ICU discharge Time: Up to Day 28Description: Time from dosing to when a participant is discharged from the hospital.
Measure: Time to final hospital discharge Time: Up to Day 28Description: AEs and SAEs will be collected.
Measure: Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) Time: Up to Day 60This is a multicentered, open-label, randomized controlled Phase 2 trial to evaluate the safety and efficacy of providing human coronavirus-immune convalescent plasma as treatment for COVID-19 disease in hospitalized children in the context of the COVID-19 pandemic.
Description: defined in the last 24 hours as normal respiratory and heart rate (or return to baseline, absence of fever, absence of low blood pressure, oxygen saturation greater than 94% or room air (or return to baseline), no need for intravenous fluids (or return to baseline)
Measure: Clinical recovery Time: at day 30Description: Proportion of patients experiencing death in hospital (Yes/No) 30 days
Measure: Combined mortality/intubation Time: at 30 dayDescription: Proportion of patients experiencing Intubation (Yes/No)
Measure: Respiratory status-1 Time: at 30 daysDescription: time to intubation
Measure: Respiratory status-2 Time: time from admission to intubationDescription: Mean number of ventilator-free days in 30 days
Measure: Respiratory status-3 Time: from admission to day 30 of hospitalizationDescription: Mean number of ventilator days in 30 days
Measure: respiratory status -4 Time: from admission to day 30 of hospitalizationDescription: The number of oxygen free days in the first 30 days or the incidence and duration of new oxygen use during the trial, defined as oxygen use that was not present at time of randomization but occurs subsequently
Measure: respiratory status -5 Time: from admission to day 30 of hospitalizationDescription: The proportion of patients needing ECMO in 30 days
Measure: respiratory status-6 Time: at 30 daysDescription: Time to in-hospital death censored
Measure: Mortality 1a Time: at 30 daysDescription: Time to in-hospital death censored
Measure: Mortality 1b Time: at 90 daysDescription: Proportion of patients with Survival status
Measure: Mortality 2a Time: at 30 daysDescription: Proportion of patients with Survival status
Measure: Mortality 2b Time: at 90 daysDescription: Length of hospitalization and stay in the ICU
Measure: Care and Critical Care Time: at 30 daysDescription: The proportion of patients needing renal replacement therapy
Measure: organ systems: renal Time: up to 365 daysDescription: The proportion of patients developing myocarditis
Measure: organ systems: cardiac Time: up to 365 daysDescription: The proportion of patients developing adverse events to the treatment arm, C19-CP as assessed by Proposed Standard definitions for surveillance of non-infectious adverse transfusion reactions.
Measure: Transfusion-associated adverse events (AE) Time: up to 365 daysDescription: cumulative incidence of severe and life-threatening AEs and severe AEs
Measure: Safety of the intervention Time: up to 365 daysDescription: The proportion of patients developing multi-system inflammatory disease
Measure: organ systems: multi-system inflammatory disease Time: up to 365 daysDescription: Proportion of patients with negative virology
Measure: Virological measures 1 Time: at day 3Description: Proportion of patients with negative virology
Measure: Virological measures 3 Time: at day 10Description: Proportion of patients with negative virology
Measure: Virological measures 4 Time: at day 15Description: Exploratory analysis of biomarker differences between groups
Measure: Modulation of biomarkers Time: up to 365 daysDescription: Time to fever resolution (no longer requiring fever management)
Measure: Resolution of fever Time: hoursDescription: Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP group on the primary outcome and other outcomes.
Measure: Presence and titres levels Time: at day 30Description: efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales
Measure: Functional measure 1 Time: up to 365 daysDescription: Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)
Measure: Functional measure 2 Time: up to 365 daysDescription: Evaluate the efficacy of C19-CP on rehospitalization after discharge
Measure: Functional measure 3 Time: up to 365 daysEffective communication is a critical component of managing pandemic outbreaks like COVID-19. This study explores COVID-19 related public knowledge, perceptions, belief in public health recommendations, intent to comply with public health recommendations, trust in information sources and preferred information sources. Participants are invited to include detailed free-text answers to make sure their COVID-19 experiences are heard.
Description: Binary knowledge measures (true/false questions pertaining to COVID-19) each have a corresponding 5-point confidence score, the inverse of which generates a weighting variable. Weighted knowledge scores will be analyzed via a generalized linear mixed-methods effects model with a logistic link function and a random effect for the participant, generating a probability of correct response from 0 to 1.0.
Measure: Knowledge and Confidence in Knowledge of COVID-19 Time: Through study completion, an average of 3 months.Description: Participants are asked, "Do you think that following these CDC recommendations will decrease the spread of COVID-19 in your community?" and select from a 5-point scale, Minimum: 1=certainly not; Maximum: 5 = most certainly.
Measure: Beliefs about the effectiveness of public health recommendations Time: Through study completion, an average of 3 months.Description: Participants are asked, "Will you follow these recommendations?" and select from a 5-point scale, Minimum: 1=certainly not; Maximum: 5 = most certainly.
Measure: Intent to comply with public health recommendations Time: Through study completion, an average of 3 months.Description: Participants are asked, "How likely is it that you will be diagnosed with any of the following diseases over the next year?" and rate their perceived likelihood of diagnosis for Measles, Flu, Lung Cancer, Ebola and COVID-19 on a 5 point scale. Minimum: 1, very unlikely; Maximum: 5, very likely. Participants are asked, "How serious do you think infection with any of the following diseases would be (or is) to your own personal health?" and rate their perceived seriousness of diagnosis for Measles, Flu, Lung Cancer, Ebola and COVID-19 on a 5 point scale. Minimum: 1, Not at all Serious; Maximum: 5, Very Serious
Measure: Perception of Risk of COVID-19 and other health threats Time: Through study completion, an average of 3 months.Description: Participants are asked the extent to which they trust common information sources: The World Health Organization, The U.S. Centers for Disease Control and Prevention, the European Commission, the participant's national government, the participant's local government, and the participant's personal healthcare provider. Participants rate on a 5 point scale. Minimum: 1, Not at all; Maximum: 2, Completely. (As these sources are not recognized in all places, participants may select "Not Applicable" in lieu of ranking.
Measure: Perceptions of trust in common health information sources Time: Through study completion, an average of 3 months.Description: Participants are asked to identify their single most trusted source of news through selection from a pre-generated list or via free-text.
Measure: Single most trusted news source Time: Through study completion, an average of 3 months.Description: Participants are asked if COVID-19 will change how they consume news (y/n)
Measure: Intention to change consumption of news because of COVID-19 (yes/no) Time: Through study completion, an average of 3 months.Description: Participants who answer, "Yes" to Outcome 7 are asked to provide a free-text response to describe how their consumption of news will change.
Measure: For participants who will change their news consumption, in what way will they change? Time: Through study completion, an average of 3 months.Description: Participants are asked to identify all other sources of information via selection from pre-generated menu or free-text.
Measure: Secondary information sources Time: Through study completion, an average of 3 months.Description: Free-text response invited to describe their concerns regarding COVID-19.
Measure: Concerns about COVID-19 Time: Through study completion, an average of 3 months.A rapid oxygen desaturation has observed in patients with COVID-19 which have seriously respiratory failure and most of them have intubated and connected to the mechanical ventilator. Finally, many of them have died during the process. ORF8 and superficial glycoproteins of a novel coronavirus bind to porphyrin on haemoglobin molecules and inhibit heme metabolism in an erythrocyte. However, it is not clarify the effects of the novel coronavirus on mean corpuscular volume (MCV), mean corpuscular of haemoglobin (MCH) and mean corpuscular haemoglobin concentration (MCHC).
Description: The severity of disease can decrease haemoglobin concentration and destroy oxygen transport.
Measure: Relationship between severity of disease and values of erythrocyte indices Time: 5 daysDescription: Detecting of cut-off value of haemoglobine indices can predict severity of the disease
Measure: Sensitivity of haemoglobin concentration on severity of the disease Time: 5 daysThe purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.
Description: Proportion of subjects with grade 3 and 4 adverse events during the study period
Measure: Safety of treatment with high-titer anti-SARS-CoV-2 plasma as assessed by adverse events Time: 28 daysDescription: Descriptive analysis of these outcomes, e.g. disease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death
Measure: Proportion of subjects with disease worsening event Time: 28 daysDescription: Anti-SARS-CoV-2 antibody titer changes
Measure: Pharmacokinetics of anti-SARS-CoV-2 antibodies as defined by changes in antibody titers Time: Up to 28 daysDescription: This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers. Antibody titer will be collected one time between 60-120 days.
Measure: Proportion of subjects with a natural antibody response to SARS-CoV-2 infection Time: 60-120 daysThe Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children
Description: measure by two rt-PCR COVID-19 tests regardless the serological status of the child
Measure: evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice Time: at 42 daysDescription: measure by two serological COVID-19 test (IgG and/or IgM)
Measure: evaluation of the serological prevalence of the Covid-19 infection Time: at inclusion and at 42 daysDescription: measure by two serological COVID-19 test (IgG and/or IgM)
Measure: evaluation of the COVID-19 reinfection among seropositive children at the inclusion time Time: at inclusion and at 42 daysDescription: positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)
Measure: evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus) Time: at 42 daysDescription: measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)
Measure: comparison of inflammatory response level between different coronavirus strains Time: at 42 daysDescription: measure of the medico-social relative risk associated with rt-PCR COVID-19 test positivity among : school level, gender, school type, day care facilities before 11th May, number of siblings, housing type, number of bedrooms, precariousness level, by score EPICES ( (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'examens de santé, means Assessment of precariousness and health inequalities in health examination centers). Questionnaire of EPICES counts 11 items, the answer to each question is assigned a coefficient, the sum of the 11 answers gives the score EPICES. The score is continuous, it varies from 0 (lack of precariousness) to 100 (maximum precariousness).
Measure: Estimation of medico-social risk factors associated with COVID-19 infection Time: at 42 daysThis is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively. The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.
Description: the proportion of patients who survive to ICU discharge or for 28 days in the ICU
Measure: ICU survival at 28 days Time: 28 daysDescription: the proportion of patients who survive to hospital discharge or for 60 days in the hospital
Measure: Hospital survival at 60 days Time: 60 daysDescription: Number of days under invasive ventilatory support
Measure: Duration of mechanical ventilation Time: 28 daysDescription: Proportion of patients who received renal replacement therapy during the ICU stay
Measure: Need for renal replacement therapy Time: 28 daysDescription: percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications
Measure: Complications during the ICU stay Time: 28 daysAccording to the data of February 2020, in Turkey with a population of 83.9 million, internet and social media usage percentage to population are 74% and 64% respectively. Although previous researches have investigated the effect of social media on different medical situations, there is no study focused role of social media on patients' behavior and information source during the COVID-19 pandemic. In the present study, it is aimed to reveal the impact of social media on patients' attitudes and information sources during the COVID-19 pandemic.
Description: applying a custom made survey to examine the role of social media and which type of research module is more effective
Measure: the role of social media Time: 1 weekThis surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.
Description: The incidence of mortality in the first 28 days.
Measure: Mortality Rate Among COVID-19 Patients Time: Day 1 to Day 28Description: As a measure of disease acuity and severity.
Measure: Proportion of Patients with COVID-19 who Require Intensive Care Unit (ICU)-Level Care, Mechanical Ventilatory Support (MV), and/or Extracorporeal Membrane Oxygenation (ECMO) Over Time to Day 28 Time: Day 1 to Day 28Description: As a measure of disease acuity and severity.
Measure: Proportion of Patients with COVID-19 who Develop Shock, Secondary Organ Failure, or Secondary Infection Over Time to Day 28 Time: Day 1 to Day 28Description: Ribonucleic acid (RNA) from the nasal swab will be used to assess SARS-CoV-2 viral load.
Measure: Mechanistic: Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 28 Time: Day 1 to Day 28Description: Focus on the immune response to SARS-CoV-2, seroconversion and immunoglobulin and transitions. Antibody isotypes present in a patient specimen(s) provide information about the timing of initial exposure and may provide insight on the progression of the disease and prognosis.
Measure: Mechanistic: Antibody Isotype/Subclass Classification and Functionality Over Time through Day 28 and at follow-up through month 12 Time: Up to 12 MonthsDescription: Collected as part of clinical care.
Measure: Mechanistic: Longitudinal Assessment of Inflammatory Mediators as Collected Over Time to Day 28 Time: Day 1 to Day 28Description: Collected as part of clinical care.
Measure: Mechanistic: Longitudinal Assessment of Markers of Myocardial Injury Over Time to Day 28 Time: Day 1 to Day 28Description: A measure of disease morbidity.
Measure: Duration of Mechanical Ventilation in Patients with COVID-19 Over Time to Day 28 Time: Day 1 to Day 28Description: A measure of disease morbidity.
Measure: Proportion of Patients with COVID-19 with Requirement for New (Or Increased from Baseline if on Home Oxygen) Supplemental Oxygen Over Time to Day 28 Time: Day 1 to Day 28Description: A measure of disease morbidity.
Measure: Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients with COVID-19 Over Time to Day 28 Time: Day 1 to Day 28Description: Method of immune profiling and quantitating the response to COVID-19 over time.
Measure: Mechanistic: Immune Cell Frequencies and Activation Status (CyTOF) in Blood and Endotracheal Aspirate over time Through Day 28 and In blood at Select Study Visits Through Month 12 Time: Up to 12 MonthsDescription: To identify and quantitate differences in immune response associated with disease outcome.
Measure: Mechanistic: Gene Expression (Transcriptomics) in Blood Time: Up to 12 MonthsDescription: To identify and quantitate differences in immune response associated with disease outcome.
Measure: Mechanistic: Gene Expression (Transcriptomics) in Respiratory Epithelium Time: Up to 12 MonthsDescription: To identify and quantitate differences in immune response associated with disease outcome.
Measure: Mechanistic: Gene Expression (Transcriptomics) in Plasma Protein Time: Up to 12 MonthsDescription: To identify and quantitate differences in immune response associated with disease outcome.
Measure: Mechanistic: Gene expression (Transcriptomics) in Metabolic Profiling Time: Up to 12 MonthsDescription: Circulating immune biomarkers will be explored by use of the OLINK® (name of brand), a multiplex protein biomarker discovery panel.
Measure: Mechanistic: Circulating Immune Mediators Assessed by OLINK Methodology Time: Up to 12 MonthsThis trial is designed to determine if the inflammation modulating effect of vagus nerve stimulation can improve pulmonary function and limit progression to ARDS in hospitalized COVID-19 hospitalized patients.
Description: Survival
Measure: Survival without need of mechanical ventilation Time: Day 14 since symptom onsetDescription: WHO Progression Scale
Measure: WHO progression scale ≤ 5 at day 4 since admission. Time: Score on day 4 since admissionDescription: Successful tracheal extubation
Measure: Cumulative incidence of successful tracheal extubation at day 14 since symptom onset. Time: Day 14 since symptom onsetDescription: WHO Progression Scale
Measure: WHO progression scale ≤ 7 at day 4 since admission. Time: Score on day 7 since admissionDescription: Survival
Measure: Survival at day 14 of hospitalization Time: Day 14Description: Duration of hospitalization
Measure: Duration of hospitalization Time: Day 28Description: Time to hospital discharge
Measure: Time to hospital discharge Time: Day 28At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor's choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood. Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies.
Description: Clinical
Measure: Proportion of patients without any need* for INV until end-of-study (EoS) Time: Throughout the Study (Day 0 to Day 28)Description: Key Secondary
Measure: Duration of ICU treatment until EoS Time: Throughout the Study (Day 0 to Day 28 )Description: Key Secondary
Measure: 28-day all-cause mortality Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy: defined as the time from first dose of investigational medicinal product (IMP) to an improvement of at least 2 points on the WHO 9 category ordinal scale , or live discharge from hospital without oxygen supplementation, whichever comes first
Measure: Time to clinical improvement Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy: Duration of hospitalization (for US sites only: or treatment in special outpatient setting in lieu of hospitalization due to resource restraints)
Measure: Duration of hospitalization Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients both for all patients and surviving patients free of renal-replacement therapy (RRT)* until EoS Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients both for all patients and surviving patients free from extracorporeal membrane oxygenation (ECMO)* until EoS Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients free of INV until Days 6 and 14* Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients free of RRT until Days 6 and 14* Time: Day 0 to Days 6 and 14Description: Efficacy
Measure: Proportion of patients free ECMO until Days 6 and 14* Time: Day 0 to Days 6 and 14Description: Efficacy
Measure: Proportion of patients with improvement of at least 2 points (from randomization) on the 9-category WHO ordinal scale1 on Days 6, 14, and 28 Time: on Days 6, 14, and 28Description: Efficacy
Measure: Proportion of patients with auxiliary oxygen therapy (including all types of oxygen therapy) on Days 6, 14, and 28 Time: on Days 6, 14, and 28Description: Efficacy
Measure: Proportion of patients with clinical recovery: Axillary temperature ≤36.6 ℃, or oral temperature ≤37.2 ℃, or rectal or tympanic temperature ≤37.8 ℃; Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients with clinical recovery: Respiratory frequency ≤24 times/min without oxygen inhalation; and Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients with clinical recovery: Oxygen saturation ≥98% without oxygen inhalation Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Proportion of patients with clinical improvement, defined as the time from first dose of IMP to an improvement of at least 2 points on the WHO 9 category ordinal scale, or live discharge from hospital without oxygen supplementation, whichever comes first Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Clinical patient status on the 9-category WHO ordinal scale1 on Days 6, 14, and 28 Time: on Days 6, 14, and 28Description: Efficacy
Measure: Duration of INV Time: Throughout the Study (Day 0 to Day 28 )Description: Efficacy
Measure: Duration of ECMO Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Duration of RRT Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Duration of auxiliary oxygen therapy (including all types of oxygen therapy) Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Duration of hospitalization for survivors Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: The rate of ICU* admission on Days 6, 14, and 28 Time: on Days 6, 14, and 28Description: Efficacy
Measure: Hospital-free days Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Time from IMP treatment initiation to death Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Time to first prescription of INV Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Time to first prescription of RRT Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Time to first prescription of ECMO Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Time to first prescription of INV, RRT, and ECMO Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Time to ICU admission Time: Throughout the Study (Day 0 to Day 28)Description: Efficacy
Measure: Cumulative dose of vasoactive therapies and days with vasoactive therapies (daily until Day 14) Time: Day 0 to day 14Description: Efficacy
Measure: Time to clinical recovery Time: Throughout the Study (Day 0 to Day 28)Description: Pharmacokinetics
Measure: Morning trough plasma levels of IMU-838 on Days 0, 1, 2, 3, 6, 14, and 28 Time: on Days 0, 1, 2, 3, 6, 14, and 28Description: Pharmacokinetics
Measure: Correlation of trough levels (quartiles) to selected clinical outcomes (Clinical improvement accoding to WHO criteria) Time: on Days 0, 1, 2, 3, 6, 14, and 28Description: Safety
Measure: Adverse events (AEs) and serious AEs Time: Throughout the Study (Day 0 to Day 28)Description: Safety Height in centimeters will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.
Measure: Vital signs: height Time: only at ScreeningDescription: Safety Weight in kilograms will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.
Measure: Vital signs: weight Time: Throughout the Study (Day 0 to Day 28)Description: Safety Body temperature can be measured axillary, oral, rectal or tympanic, but should be always measured by the same method for a patient. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.
Measure: Vital signs: body temperature (ºC) Time: Throughout the Study (Day 0 to Day 28)Description: Safety Pulse must be measured with the patient in a seated position (if possible), after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.
Measure: Vital signs: pulse rates, Time: Throughout the Study (Day 0 to Day 28)Description: Safety Blood pressure (systolic and diastolic) must be measured with the patient in a seated position (if possible), after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.
Measure: Vital signs: systolic and diastolic blood pressures Time: Throughout the Study (Day 0 to Day 28)Description: Safety
Measure: Clinical laboratory parameters: blood chemistry Time: Throughout the Study (Day 0 to Day 28)Description: Safety
Measure: Clinical laboratory parameters: hematology Time: Throughout the Study (Day 0 to Day 28)Description: Safety
Measure: Clinical laboratory parameters: urinalysis Time: Throughout the Study (Day 0 to Day 28)Description: Safety
Measure: 12-lead electrocardiogram: heart rate Time: Day 0 to Day 6 and Day 28Description: Safety
Measure: 12-lead electrocardiogram: PQ-interval Time: Day 0 to Day 6 and Day 28Description: Safety
Measure: 12-lead electrocardiogram: QRS-interval Time: Day 0 to Day 6 and Day 28Description: Safety
Measure: 12-lead electrocardiogram: QT interval Time: Day 0 to Day 6 and Day 28Description: Safety
Measure: 12-lead electrocardiogram: the heart rate-corrected QTc interval (according to Bazett's formula) Time: Day 0 to Day 6 and Day 28Description: Safety
Measure: Temperature Time: Throughout the Study (Day 0 to Day 28)Description: Disease markers
Measure: D-dimer Time: Throughout the Study (Day 0 to Day 28)Description: Disease markers
Measure: Lactate dehydrogenase (LDH) Time: Throughout the Study (Day 0 to Day 28)Description: Disease markers
Measure: C-reactive protein Time: Throughout the Study (Day 0 to Day 28)Description: Disease markers
Measure: Troponin I Time: Throughout the Study (Day 0 to Day 28)Description: Disease markers
Measure: Procalcitonin Time: Throughout the Study (Day 0 to Day 28)Description: Disease markers
Measure: Correlation of disease markers to selected clinical outcomes (Clinical improvement accoding to WHO criteria) Time: Throughout the Study (Day 0 to Day 28)Description: Virologic markers
Measure: Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Decrease of SARS-CoV-2 viral load Time: Throughout the Study (Day 0 to Day 28)Description: Virologic markers
Measure: Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Time course of SARS-CoV-2 viral load Time: Throughout the Study (Day 0 to Day 28)Description: Virologic markers
Measure: Qualitative virologic clearance in spontaneous sputum and nasopharyngeal swab samples (= 2 consecutive negative SARS-CoV-2 reverse transcriptase polymerase chain reaction tests at least 24 hours apart) Time: Throughout the Study (Day 0 to Day 28)Description: Virologic markers
Measure: Rate of conversion to a negative SARS-CoV-2 (qualitative) test on Days 6, 14 and 28 Time: on Days 6, 14 and 28Description: Virologic markers
Measure: Time to conversion to a negative SARS-CoV-2 (qualitative) test Time: Throughout the Study (Day 0 to Day 28)Description: Biomarkers
Measure: Interleukin (IL)-17 Time: Day 0, 6, 14 and Day 28Description: Biomarkers
Measure: Interleukin (IL)-1ß Time: Day 0, 6, 14 and Day 28Description: Biomarkers
Measure: Interleukin (IL)-6 Time: Day 0, 6, 14 and 28Description: Biomarkers
Measure: interferon gamma (IFNγ) Time: Day 0, 6, 14 and 28Description: Biomarkers
Measure: tumor necrosis factor alpha Time: Day 0, 6, 14 and 28Description: Serologic markers
Measure: Immunoglobulin (Ig)A and IgG antibodies against SARS-CoV-2: • Time to appearance of IgA and/or IgG antibodies Time: Day 0, 6, 14 and 28Description: Serologic markers
Measure: Immunoglobulin (Ig)A and IgG antibodies against SARS-CoV-2: • Proportion of patients with IgA and/or IgG antibodies on Days 6, 14, and 28 Time: Day 0, 6, 14 and 28Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled in the study. Each patient will have 2 studies (routine chest CT and low-dose chest CT) sequentially during one visit to the computed tomography room.
Description: A standardized scale CT1-CT4 will be used. The expected correlation percentage is 90%.
Measure: Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia. Time: Upon completion, up to 1 yearDescription: Expected threshold - 10 mm.
Measure: Threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan. Time: Upon completion, up to 1 yearDescription: Expected number - more than two zones.
Measure: Number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan. Time: Upon completion, up to 1 yearThe primary objective of the study is to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study
Description: Proportion of patients, responded to the study therapy, in each of the treatment groups. The patient can be considered as the therapy responder, in case tocilizumab or sarilumab were not administered and there is an improvement of a clinical status at least by 1 point on a 6-points COVID-19 scale, where 1 point means most favorable outcome, 6 points means most undesirable outcome.
Measure: Proportion of patients, responded to the study therapy, in each of the treatment groups Time: Day 15Description: Changes of patients' clinical status on a 6 points ordinal scale over time
Measure: Changes of patients' clinical status on a 6 points ordinal scale over time Time: from Day 2 until Day 15, Day 29Description: Mortality rate over the follow-up period
Measure: Mortality rate over the follow-up period Time: from Day 1 until Day 29Description: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.
Measure: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration. Time: on screening and then from Day 1 until Day 29Description: Proportion of patients received tocilizumab or sarilumab due to COVID-19
Measure: Proportion of patients received tocilizumab or sarilumab due to COVID-19 Time: from Day 1 until the Day 29Description: Proportion of patients having National Early Warning Score 2 (NEWS2) of ≤ 4 maintained for 2 consecutive days
Measure: Proportion of patients having National Early Warning Score 2 of ≤ 4 maintained for 2 consecutive days Time: from day 3 until day 15Description: Time to a NEWS2 of ≤ 2 maintained for two consecutive days
Measure: Time to a NEWS2 of ≤ 2 maintained for two consecutive days Time: from day 1 until day 15Description: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, CRP, ferritin (if applicable), D-dimer (if applicable)
Measure: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, C-Reactive protein (CRP), ferritin (if applicable), D-dimer (if applicable) Time: Day 2, Day 3, Day5, Day 7, Day 15Description: Mortality during an ICU stay, on days 7, 15, 29 of the study
Measure: Mortality during an ICU stay, on days 7, 15, 29 of the study Time: On Day 7, Day 15, Day 29Description: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days
Measure: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days Time: from Day 2 until Day 15Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period
Measure: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period Time: On Day 1 and from Day 2 until Day 15Description: Duration of ICU stay measured in days
Measure: Duration of ICU stay measured in days Time: from Day 2 until Day 15Description: Changes from baseline (if applicable) in severity of ARDS according to WHO criteria
Measure: Changes from baseline (if applicable) in severity of Acute Respiratory Distress Syndrome (ARDS) according to World Health Organization (WHO) criteria Time: from Day 1 until Day 15Description: Duration of mechanical ventilation and EMO (if applicable) measured in days
Measure: Duration of mechanical ventilation and Extracorporeal Membrane Oxygenation (EMO) (if applicable) measured in days Time: from Day 2 until Day 15Description: Duration of oxygen support (if applicable) measured in days
Measure: Duration of oxygen support (if applicable) measured in days Time: from Day 1 until Day 15Description: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days
Measure: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days Time: from day 3 until day 15Description: Time to a NEWS2 of ≤ 4 maintained for two consecutive days
Measure: Time to a NEWS2 of ≤ 4 maintained for two consecutive days Time: from day 1 until day 15Description: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)
Measure: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable) Time: On Day 1 and from Day 2 until Day 15Description: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)
Measure: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable) Time: from day 1 until day 15Description: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale
Measure: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale Time: from day 1 until day 29Description: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale
Measure: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale Time: from day 1 until day 29Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study
Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study Time: from Day 1 until Day 29Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable
Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable Time: from Day 1 until Day 29Description: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)
Measure: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable) Time: from Day 1 until Day 29The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.
Description: Patient reported change
Measure: Patient reported main complaint Time: 24 hoursDescription: Patient reported change
Measure: Patient reported main complaint Time: 48 hoursDescription: Patient reported change
Measure: Patient reported main complaint Time: 3 monthsDescription: Patient reported change
Measure: Patient reported main complaint Time: 12 monthsDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 24 hoursDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 48 hoursDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 3 monthsDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 12 monthsAs part of the ROCO project, the University of Bern is investigating an online self-help program for people who are psychologically distressed due to the situation surrounding Covid-19. The ROCO program offers support in overcoming this psychological distress. ROCO stands for a 3-week online self-help program comprising 6 modules. The aim of the study is to investigate the efficacy of an online self-help intervention for people with psychological distress due to the situation surrounding Covid-19. All participants will be randomized to one of two groups: The first group receives direct access to the online self-help intervention and the second group is a waiting control group that receives access to the program 3 weeks later. In both conditions additional care or treatment is allowed. There are 4 assessments, which all take place online: baseline, post assessment (after 3 weeks) and two follow-up assessments (after 6 and 18 weeks). All participants from both groups are asked to fill out all assessments.
Description: 9-item questionnaire assessing depressive symptoms
Measure: Patient Health Questionnaire (Löwe et al., 2002) Time: up to 18 weeksDescription: 4-item questionnaire assessing suicidal ideation
Measure: Suicide Behavior Questionnaire Revised (Glaesmer et al., 2018) Time: up to 18 weeksDescription: 21-item questionnaire assessing depression, anxiety and stress symptoms
Measure: DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995) Time: up to 18 weeksDescription: 12-item questionnaire assessing various aspects of well-being
Measure: SF-12: Short Form Health Survey (Ware et al., 1996) Time: up to 18 weeksDescription: 10-item questionnaire assessing optimism and pessimism
Measure: LOT-R: Revised Life Orientation Test (Herzberg et al., 2006) Time: up to 18 weeksDescription: 6-item questionnaire assessing embitterment
Measure: Berner Verbitterungsinventar Kurzversion (Znoj, 2008) Time: up to 18 weeksDescription: 27-item questionnaire assessing emotion regulation skills
Measure: Emotion regulation skills SEK-27 (Berking & Znoj, 2008) Time: up to 18 weeksDescription: 10-item questionnaire assessing general self-efficacy
Measure: SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003) Time: up to 18 weeksDescription: 9-item questionnaire assessing loneliness
Measure: UCLA Loneliness Scale (Döring & Bortz, 1993) Time: up to 18 weeksDescription: 10-item questionnaire assessing resilience
Measure: Connor-Davidson Resilience Scale (Sarubin et al., 2015) Time: up to 18 weeksDescription: 8-item questionnaire assessing content with an online-program
Measure: ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982) Time: at 3 weeks for experimental group and at 6 weeks for waiting control groupDescription: 10-item questionnaire assessing usability of an online-program
Measure: SUS: System Usability Scale (Brooke, 1996) Time: at 3 weeks for experimental group and at 6 weeks for waiting control groupThe purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.
Description: Time to improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale. The 6-point ordinal clinical recovery scale provides 6 mutually exclusive conditions ordered from best to worst, and the score reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are : not hospitalized (category 1); Hospitalization; not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO (category 5); death (category 6).
Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale Time: Up to Day 28Description: Percentage of participants with an improvement of at Least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.
Measure: Percentage of Participants with an Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28 Time: Day 28Description: Percentage of participants with all-cause mortality will be reported.
Measure: Percentage of Participants with All-cause Mortality Time: Up to Day 28Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.
Measure: Percentage of Participants with Serious Adverse Events (SAEs) Time: Up to Day 28Description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measure: Percentage of Participants with Related Adverse Events Time: Up to Day 28Description: Percentage of participants with severe or life-threatening, bacterial, invasive fungal, viral or opportunistic infections (other than severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) will be reported.
Measure: Percentage of Participants with Severe or Life Threatening Bacterial, Invasive Fungal, Viral or Opportunistic Infections Time: Up to Day 28Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) neutropenia will be reported.
Measure: Percentage of Participants with Grade 3 and 4 Neutropenia Time: Up to Day 28Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) lymphocytopenia will be reported.
Measure: Percentage of Participants with Grade 3 and 4 Lymphocytopenia Time: Up to Day 28Description: Percentage of participants with increased ALT >=3 times ULN combined with increased bilirubin >2 times ULN (up to Day 28) will be reported.
Measure: Percentage of Participants with Increased Alanine Aminotransferase (ALT) Greater than or equal to 3 Times Upper Limit of Normal (ULN) Combined with Increased Bilirubin > 2 Times ULN Time: Up to Day 28Description: Time to improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale will be reported.
Measure: Time to Improvement of at least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale Time: Up to Day 28Description: Percentage of participants with an improvement of at Least 1 category relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.
Measure: Percentage of Participants with an Improvement of at Least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28 Time: Day 28Description: Time from study intervention to end of oxygen supplementation is defined as achieving category 1 or 2 on the 6-point ordinal clinical recovery scale.
Measure: Time from Study Intervention to end of Oxygen Supplementation Time: Up to Day 28Description: Time from study intervention to hospital discharge among the surviving participants will be reported.
Measure: Time from Study Intervention to Hospital Discharge Among the Surviving Participants Time: Up to Day 28Description: Total length of hospitalization (days from admission to hospital discharge) among the surviving participants will be reported.
Measure: Total Length of Hospitalization Time: Up to Day 28Description: Number of Ventilation free Days will be reported.
Measure: Number of Ventilation Free Days Time: Up to Day 28Description: Participant's clinical status at Day 7, 14, 21, 28 will be assessed by 6-point ordinal clinical recovery scale.
Measure: Participant's Clinical Status at Day 7, 14, 21, 28 as Assessed by 6-Point Ordinal Clinical Recovery Scale Time: Day 7, 14, 21, 28Description: Total time on invasive mechanical ventilation will be reported.
Measure: Total Time on Invasive Mechanical Ventilation Time: Up to Day 28Description: Percentage of participants with a worsening of at least 1 category on the 6-point ordinal clinical recovery scale over time (between Day 5 and Day 28) will be reported.
Measure: Percentage of Participants with a Worse Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale over Time Time: From Day 5 up to Day 28Description: Percentage participants on ECMO over time will be reported.
Measure: Percentage of Participants on Extracorporeal Membrane Oxygenation (ECMO) Over Time Time: Up to Day 28Description: Total time on ECMO will be reported.
Measure: Total Time on ECMO Time: Up to Day 28Description: Percentage of alive participants at Day 28, Week 8 and Week 16 will be reported.
Measure: Percentage of Alive Participants at Day 28, Week 8 and Week 16 Time: Day 28, Week 8 and Week 16Description: Percentage of alive participants that required readmission (if previously discharged) at Week 8 and Week 16 will be reported.
Measure: Percentage of Alive Participants that Required Readmission at Week 8 and Week 16 Time: Week 8 and Week 16Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.
Measure: Percentage of Participants with Serious Adverse Events (SAEs) Time: Up to Week 16COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Description: days of ICU stay
Measure: Length of ICU stay Time: up to 60 daysDescription: days of hospital stay
Measure: Length of hospital stay Time: up to 90 daysThe purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.
Description: The primary efficacy outcome will be defined based on the blinded analysis of data of the first 100 patients in the 1st part of the study. There is uncertainty about the clinical course and potential different trajectories according to baseline disease severity, so the day of the primary endpoint may be modified based on a blinded evaluation of the primary efficacy outcome in various days.
Measure: Clinical status of the patient (according to 7-point ordinal scale) Time: Day 15Description: Time to improvement by one category from admission on the ordinal scale. Clinical status of the patient. Average change in the ordinal scale from baseline.
Measure: Clinical status of the patient (according to 7-point ordinal scale) Time: Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29.Description: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Change in NEWS from baseline.
Measure: NEWS Time: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.Description: Oxygenation free days. Incidence and duration of new oxygen use.
Measure: Oxygenation Time: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.Description: Ventilator free days. Incidence and duration of new mechanical ventilation use.
Measure: Mechanical Ventilation Time: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).
Description: Fatal outcome from COVID-19
Measure: Death Time: From date of randomization until the date of death from any cause assessed up to 3 months.Description: Resolved infection
Measure: Recovery from COVID-19 Time: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.Description: Percentage of patients requiring intensive care admission or ventilation
Measure: Progression to ICU care or ventilation Time: 30 daysDescription: The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days
Measure: Clearance of SARS-CoV-2 from respiratory specimen Time: The number of calendar days from date of PCR positive test (counted as 1 day) in respiratory specimen until date of such test first become negative in the respiratory specimen assessed up to 3 monthsDescription: Cell-mediated and humoral immunity
Measure: Immune response to COVID-19 Time: From date of randomization until the date of clinical follow-up assessed up to 3 months.The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.
Description: VFD is the number of days alive and free of mechanical ventilation in the first 28 days after study enrollment. Death before 28 days will be assigned a VFD equal to 0 to penalize non-survival. In cases of repeated intubation and extubation, periods free from invasive ventilation and lasting at least 24 consecutive hours will be calculated and summed. Timing of intubation and extubation will be captured in hours, and the number of hours a patient received invasive ventilation will be used to calculate duration of ventilation.
Measure: Ventilator-Free Days (VFD) Time: 28 daysDescription: Days spent in the ICU and hospital after time of enrollment
Measure: ICU and Hospital Length of Stay Time: 28 daysDescription: Incidence and time to intubation in days after the time of enrollment
Measure: Intubation Time: 28 daysDescription: Incidence of RRT after the time of enrollment
Measure: Renal Replacement Therapy (RRT) Time: 28 daysDescription: Death from any cause during after the time of enrollment
Measure: Mortality Time: 28 days, 90 daysRECOVERY is a randomised trial investigating whether treatment with Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Synthetic neutralizing antibodies (REGN-COV2), Tocilizumab or Aspirin prevents death in patients with COVID-19.
Description: For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.
Measure: All-cause mortality Time: Within 28 days after randomisationDescription: To assess the effects of study treatment on number of days stay in hospital
Measure: Duration of hospital stay Time: Within 28 days and up to 6 months after the main randomisationDescription: Among patients not on invasive mechanical ventilation at baseline, the number of patients with a composite endpoint of death or need for invasive mechanical ventilation or ECMO.
Measure: Composite endpoint of death or need for mechanical ventilation or ECMO Time: Within 28 days and up to 6 months after the main randomisationDescription: To assess the effects of study treatment on number of patients who needed ventilation and the number of days it was required
Measure: Need for (and duration of) ventilation Time: Within 28 days and up to 6 months after the main randomisationDescription: To assess the effects of study treatment on number of patients who needed renal replacement therapy
Measure: Need for renal replacement Time: Within 28 days and up to 6 months after the main randomisationDescription: To assess the effects of study treatment on number of patients who develop new major cardiac arrythmias
Measure: Development of new major cardiac arrythmias Time: Within 28 days and up to 6 months after the main randomisationAgent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2. Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events. Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy. Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2. Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities. Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19. Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19. Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.
Description: patient will be assessed using a scoring table for changes in clinical signs
Measure: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of Time: 24 hoursDescription: Adverse events caused by the study drug will be assessed
Measure: Percentage of participants with definite or probable drug related adverse events Time: 14 daysThe study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The active and control groups will be diseased and severity matched. The primary objective is to reduce initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Secondary objectives are to evaluate cytokine trends/prevent cytokine storms, evaluate supplemental oxygen requirements, decrease mortality of CoViD-19 patients and to delay the onset of mechanical ventilation.
Description: measure the change (in hours) between the control group and treatment group
Measure: change in initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first, assessed up to 3 monthsDescription: measure the changes in the serum/plasma concentrations of TH1 and TH2-type cytokines
Measure: evaluate cytokine trends Time: From the time of initial blood draw until the time of final blood draw, assessed up to date of mechanical ventilation, death, or discharge from hospital, whichever occurs first,assessed up to 3 monthsDescription: compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19.
Measure: evaluate supplemental oxygen requirements Time: From the time of randomization, assessed up to time of mechanical ventilation, day of discharge or death, whichever occurs first,assessed up to 3 monthsDescription: measure the change (in hours) to death between control group and treatment group
Measure: decrease mortality of CoViD-19 patients Time: From the time or randomization until the date of death from any cause, assessed up to day of discharge or death,assessed up to 3 monthsDescription: measure the change (in hours) to time of mechanical ventilation between control group and treatment group
Measure: delay onset of ventilation Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first,assessed up to 3 monthsBackground: Corona virus disease 2019 (COVID-19) is a highly infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Purpose: To give initial experience about COVID-19 in Alexandria-Egypt describing radiological patterns of lung involvement, also surveying prevalence of co-morbid lung diseases and their effect on COVID-19 presentation. Methods: Retrospective study including 48 patients with positive polymerase chain reaction (PCR) test for COVID-19 during the period from February 2020 till May 2020 in Alexandria/Egypt. Full clinical and laboratory data are obtained. High resolution computed tomography (HRCT) findings are described. Serial follow up studies are done. Surveying co-morbid lung diseases done including tuberculosis (TB), interstitial lung diseases (ILDs), chronic obstructive lung disease (COPD), immune and vascular-related diseases. Prevalence rate is the predominant analysis.
Description: HRCT findings
Measure: Radiological pattern of initial presentation, disease progress, healing and recovery Time: "through study completion, an average of 1 month"Description: prevalence
Measure: Survey of co-morbid lung diseases Time: "through study completion, an average of 1 month"A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.
Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year
Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting Time: 1 yearDescription: Patient/parent reported positive tests for COVID19
Measure: Number of children/adults tested positive for COVID19 Time: 1 yearDescription: Patient/parent reported admissions in hospital because of COVID19
Measure: Number of children/adults admitted in hospital because of COVID19 Time: 1 yearDescription: Patient/parent reported effect of COVID19 on daily activities
Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children Time: 1 yearThe study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.
Description: Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale
Measure: Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen. Time: 7, 14 and 28 daysDescription: Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen. Time: 7, 14 and 28 daysDescription: NEWS2 score 20 points is the maximum and indicates that the patient needs emergent assessment by a clinical team or critical care team and usually transfer to higher level of care.
Measure: Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28. Time: 1, 7, 14 and 28Description: qSOFA, score for sepsis, a maximum value of 3 indicates high risk qSOFA Scores 2-3 are associated with a 3- to 14-fold increase in in-hospital mortality. Assess for evidence of organ dysfunction with blood testing including serum lactate and calculation of the full SOFA Score. Patients meeting these qSOFA criteria should have infection considered even if it was previously not.
Measure: Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28. Time: 1, 7, 14 and 28 daysNitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.
Description: the number of patients with virological cure
Measure: Number of patients with virological cure Time: 6 monthsThe vital signs are critical in assessing the severity and prognosis of infections, such as Covid-19. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). This project aims to evaluate a new camera-based system for contactless measurement of vital signs as well as an artificial intelligence (AI) predicting hospitalization or death within 30 days. This particular study will evaluate the new system's ability without interfering with standard care of the patient.
Description: Body temperature will be measured with the new camera based method as well as with a conventional ear thermometer. Both measurements will estimate the body temperature in degrees Celsius. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.
Measure: Agreement between the new camera based method and reference standard to estimate body temperature Time: Two minutes between measurementsDescription: Heart rate will be measured with the new camera based method as well as with a conventional apparatus for measuring pulse rate. Both measurements will estimate the heart rate in beats per minute. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.
Measure: Agreement between the new camera based method and reference standard to estimate heart rate Time: Two minutes between measurementsDescription: Blood oxygen saturation will be measured with the new camera based method as well as with a conventional apparatus for measuring blood oxygen saturation. Both measurements will estimate the blood oxygen saturation in percent (ranging from 0-100%). The agreement between blood oxygen saturation estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.
Measure: Agreement between the new camera based method and reference standard to estimate blood oxygen saturation Time: Two minutes between measurementsDescription: Systolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring systolic blood pressure. Both measurements will estimate the systolic blood pressure in mm Hg. The agreement between systolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.
Measure: Agreement between the new camera based method and reference standard to estimate systolic blood pressure Time: Two minutes between measurementsDescription: Diastolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring diastolic blood pressure. Both measurements will estimate the diastolic blood pressure in mm Hg. The agreement between diastolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.
Measure: Agreement between the new camera based method and reference standard to estimate diastolic blood pressure Time: Two minutes between measurementsDescription: Respiratory rate will be measured with the new camera based method as well as manually using a stethoscope. Both measurements will estimate the respiratory rate in breath per minute. The agreement between respiratory rate estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.
Measure: Agreement between the new camera based method and reference standard to estimate respiratory rate Time: Two minutes between measurementsDescription: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.
Measure: Prediction of hospital admission using vital signs estimated using reference standard methods Time: Hospital admission for any cause up until 30 days after inclusionDescription: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for death within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.
Measure: Prediction of death using vital signs estimated using reference standard methods Time: Death for any cause up until 30 days after inclusionDescription: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.
Measure: Prediction of hospital admission using vital signs estimated using the new camera based method Time: Hospital admission for any cause up until 30 days after inclusionDescription: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for hospitalization within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.
Measure: Prediction of death using vital signs estimated using the new camera based method Time: Death for any cause up until 30 days after inclusionDescription: An artificial intelligence (AI) algorithm will use 75% of patient observations of raw camera data for training and raw data from the remaining 25% of patients will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.
Measure: Prediction of hospital admission using raw camera data Time: Hospital admission for any cause up until 30 days after inclusionDescription: An artificial intelligence (AI) algorithm will use 75% of patient observations of raw camera data for training and raw data from the remaining 25% of patients will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for death within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.
Measure: Prediction of death using raw camera data Time: Death for any cause up until 30 days after inclusionIn the course of COVID disease, some patients need intensive care treatment. We aim to find an answer to the question of whether the patient's CRP, ferritin, D-dimer, Oxygen Saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with COVID to the intensive see unit.
Description: With this scoring, identifying patients who may need intensive care early and following them closely will have a positive effect on patient prognosis.
Measure: COVICU score Time: 1 weekDescription: Minimum and maximum values will be determined at the end of the study. Higher scores mean a worse outcome
Measure: Values Time: 1 weekThe objectives of this study are to characterise immune responses in people with CoV-SARS-2 infection and use this knowledge to advance vaccine design, treatment options, and diagnostic reagents. Eligible participants will include people diagnosed with SARS-CoV-2 infection, and may include recently returned travellers and non-travellers in the community presenting to tertiary hospital healthcare facilities. Recruitment will be opportunistic, and sampling intensity may vary depending on the phase of the outbreak. Participants can be enrolled at any timepoint (up to 6 months) following diagnosis of SARS-CoV-2 infection (COVID-19). Blood samples and clinical data will be collected.
Description: The viruses will be sequenced to to help understand epitope specificity
Measure: Coronavirus sequencing Time: 4 months post COVID-19 diagnosis.Description: The viruses will then be either cultured to study the immune response against them in culture.
Measure: Coronavirus culturing Time: 4 months post COVID-19 diagnosis.It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities. This was attributed to: 1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells, 2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression, 3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival. However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection. Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms. Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction. EMA remains prudent about this assertion In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations. It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection.
Description: Describe medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions on existing pathology, drugs administrated symptom onset and when, hospitalisation. Each questions have a multiple choice.
Measure: Describe medications used prior to admission associated with worse infection in COVID-19 patients in France. Time: At inclusion dayDescription: Quantify medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions: existing pathology, drugs administrated symptoms onset and when, hospitalisation. Each questions have a multiple choice.
Measure: Quantify medications used prior to admission associated with worse infection in COVID-19 patients in France. Time: At inclusion dayDescription: Describe patient characteristics thanks to the same questionnaire.
Measure: Describe other patient characteristics with worse infection in COVID-19 patients in France. Time: At inclusion dayDescription: Quantify patient characteristics thanks to the same questionnaire.
Measure: Quantify other patient characteristics with worse infection in COVID-19 patients in France. Time: At inclusion dayThe Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The case-control study is described here (the cross-sectional study is described in a separate ClinicalTrials.gov record).
Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances
Measure: Presence or absence of olfactory and taste disturbances in study participants Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infectionDescription: The relationship between case & control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.
Measure: Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19/within the past 2 weeks of answering the questionnaire (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)
Measure: Clinical manifestations of study participants Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)
Measure: Other pre-existing health conditions Time: BaselineDescription: PPV reflects the probability that the presence of olfactory and taste disturbances will have a positive diagnosis of COVID-19. This is derived from dividing the number of patients with olfactory & taste disturbances with COVID-19 infection over the total number of patients with olfactory and taste disturbances, and multiplying by 100%
Measure: Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection Time: BaselineDescription: NPV reflects the probability that the absence of olfactory and taste disturbances will have a negative diagnosis of COVID-19. This is derived from dividing the number of patients without olfactory & taste disturbances and without COVID-19 infection over the total number of patients with no olfactory and taste disturbances, and multiplying by 100%
Measure: Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection Time: BaselineDescription: The percentage of true positives, i.e. the proportion of patients with olfactory and taste disorders with COVID-19 infection. This can be calculated by dividing the number of subjects with olfactory & taste disturbances who have COVID-19 infection with the number of patients with olfactory & taste disturbances, and multiplying by 100%
Measure: Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection Time: BaselineDescription: The percentage of true negatives, i.e. the proportion of patients without olfactory and taste disorders who do not have COVID-19 infection. This can be calculated by dividing the number of subjects without olfactory & taste disturbances who do not have COVID-19 infection with the number of patients without olfactory & taste disturbances, and multiplying by 100%
Measure: Specificity of olfactory and taste disturbances in predicting COVID-19 infection Time: BaselineThe effective medical treatment against COVID-19 infection is still unknown. Chloroquine phosphate is a well-known antimalarial drug which has been on the market for many years. Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also an immune-modifier and could distribute to the whole body including lung. Also, chloroquine is cheap and safe, and could be a promising agent against COVID-19 infection. However, only hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore, hydroxychloroquine instead become the best choice for the treatment candidate, since it shows higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the original effect which compared with chloroquine.
Description: To evaluate the efficacy of HCQ, with respect to the time to negatively RT-PCR assessments in COVID-19 patients.
Measure: Time to negatively RT-PCR Time: 14 daysDescription: To evaluate the efficacy of HCQ in the aspect of virologic assessments in COVID-19 patients
Measure: Virologic assessment Time: 14 daysDescription: To evaluate the safety and tolerability of HCQ
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: 28 daysThe purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.
Description: Safety will be defined by the incidence of any infusion associated adverse events as assessed by treating physician
Measure: Incidence of any infusion associated adverse events Time: 60 DaysDescription: Safety will be defined by the incidence of severe adverse events as assessed by treating physician
Measure: Incidence of Severe Adverse Events Time: 60 DaysDescription: Measured at day 60 or at hospital discharge, whichever comes first.
Measure: All Cause Mortality Time: 60 DaysDescription: Number of participants that are alive at 60 days post first infusion follow up
Measure: Survival Rate Time: 60 DaysDescription: Measure IL-6, TNF-alpha from serum of blood samples
Measure: Cytokine Levels Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28Description: D-dimer from serum of blood samples methodology using blood samples or nose / throat swab
Measure: D-dimer Levels Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28Description: CRP from serum of blood samples
Measure: C-reactive protein Levels Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28Description: Viral load by real time RT methodology using blood samples or nose / throat swab
Measure: Quantification of the COVID-19 Time: Day 0, Day 4, Day 8Description: Improved organ failure within 30 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs using Sequential Organ Failure Assessment (SOFA) score.
Measure: Improved Organ Failure Time: Day 30Description: Chest imaging changes for 30 days compare to placebo: 1) Ground-glass opacity, - 2) Local patchy shadowing, 3) Bilateral patchy shadowing, and 4) Interstitial abnormalities.
Measure: Chest Imaging Changes Time: Day o, Day 30We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of COVID-19?
Description: Proportion of participants in whom there was a a positivity for SARS-CoV-2 through specific examination (RT-PCR) or by serology for antibodies specific (IgM and IgG), corroborated or not with clinical finding of COVID-19, defined as the occurrence of signs and symptoms suggestive of this disease.
Measure: Proportion of participants in whom there was a positivity for SARS-CoV-2. Time: Post-intervention at day 52Description: Proportion of participants who developed mild, moderate, or severe forms of COVID-19.
Measure: Participants who developed mild, moderate, or severe forms of COVID-19. Time: Post-intervention at day 52.Description: Measurement of the QT interval through electrocardiogram evaluation.
Measure: Measurement of the QT interval. Time: Baseline, 3, 15 and 45 days post-intervention.Description: Proportion of participants who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.
Measure: Widening of the corrected QT interval or with changes in heart rate on the ECG. Time: Day 52.Description: Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.
Measure: Comparison of hematological and biochemical parameters. Time: Day 52.Description: Proportion of occurrence of adverse events reported by participants or verified by the attending physician, or even observed in laboratory tests.
Measure: Occurrence of adverse events. Time: Post-intervention at day 52.Description: Severity of symptoms of COVID-19 measured by a visual analog scale (VAS), with scores ranging from zero to 10, where zero represents the absence of the symptom and 10 corresponds to the most intense manifestation of symptoms (severe dyspnoea).
Measure: Assessment of COVID-19 symptom severity. Time: Post-intervention at day 52.Description: Proportion of participants who discontinue study intervention,
Measure: Proportion of participants who discontinue study intervention. Time: Post-intervention at day 52.Description: Proportion of participants who required hospital care.
Measure: Proportion of participants who required hospital care. Time: Post-intervention at day 52.Description: Proportion of participants who required mechanical ventilation.
Measure: Proportion of participants who required mechanical ventilation. Time: Post-intervention at day 52.Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world. The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.
Description: lipid profile
Measure: Change of lipid profile during exposure to SARS-Cov-2 Time: at the end of the study, maximum 1 yearDescription: HDL-cholesterol size
Measure: HDL-cholesterol size Time: at the end of the study, maximum 1 yearDescription: circulating plasma cytokine levels
Measure: circulating plasma cytokine levels Time: at the end of the study, maximum 1 yearDescription: ACE2 gene polymorphisms
Measure: ACE2 gene polymorphisms Time: at the end of the study, maximum 1 yearCovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic. Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of: - Colorectal cancer - Oesophagogastric cancer As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.
Description: Frequency of COVID-19 infection within 30 days
Measure: 30-day postoperative COVID-19 infection rate Time: 30 daysDescription: Number of deaths at 30-days post surgery
Measure: 30-day postoperative mortality rate Time: 30-daysDescription: Critical care utilisation in high-risk cancer surgery patients
Measure: Postoperative critical care utilisation rate in high-risk cancer surgery patients. Time: 30-daysDescription: Number of patients with a delay of more than 4 weeks from the decision taken for surgery to the date of surgery
Measure: Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery Time: More than 4 weeks from decision dateDescription: Number of non-operated patients with progression to incurable disease by 3-months after decision for surgery
Measure: Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery Time: Up to 3-monthsConvalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.
Description: To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital
Measure: Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment Time: Over a period of 28 daysDescription: Number of Participants with resolution of fever (<38ºC temperature)
Measure: Clinical evolution Time: Over a period of 28 daysDescription: The clinical improvement will be established with a two-point improvement within this seven categories (recommended by World Organization Health-WHO): 1) Not hospitalized, with resumption of normal activities 2) Not hospitalized, but unable to resume normal activities 3) Hospitalized that does not require supplemental oxygen 4) Hospitalized requiring supplemental oxygen 5) Hospitalized requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both 6) Hospitalized requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both 7) death
Measure: Clinical evolution by seven-parameter ordinal scale Time: 3, 7, 14 and 28 daysDescription: Evolution by SOFA (Sequential Organ Failure Assessment), The range is between 0 and 24 points, with the highest scores being indicators of a more serious illness
Measure: Multi-organ failure progression Time: 3, 7, 14 and 28 daysDescription: Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment
Measure: Change in hemoglobin concentration Time: 3, 7, 14 and 28 daysDescription: Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment
Measure: Change in blood cell count Time: 3, 7, 14 and 28 daysDescription: Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment
Measure: Change in serum creatinine level Time: 3, 7, 14 and 28 daysDescription: Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment
Measure: Change in aspartate aminotransferase level Time: 3, 7, 14 and 28 daysDescription: Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment
Measure: Change in alanin aminotransferase level Time: 3, 7, 14 and 28 daysDescription: Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment
Measure: Change in bilirubin level Time: 3, 7, 14 and 28 daysDescription: Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment
Measure: Change in lactate dehydrogenase level Time: 3, 7, 14 and 28 daysDescription: Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment
Measure: Change in creatine kinase level Time: 3, 7, 14 and 28 daysDescription: Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment
Measure: Change in creatine kinase MB level Time: 3, 7, 14 and 28 daysDescription: Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L
Measure: Change in C reactive protein concentration Time: 3, 7, 14 and 28 daysDescription: Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment
Measure: Change in D Dimer concentration Time: 3, 7, 14 and 28 daysDescription: Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment
Measure: Change in Procalcitonin concentration Time: 3, 7, 14 and 28 daysDescription: Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment
Measure: Change in IL6 level Time: 3, 7, 14 and 28 daysDescription: Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)
Measure: Radiography imaging Time: Over a period of 60 daysDescription: Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Measure: Tomography imaging Time: Over a period of 60 daysDescription: Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
Measure: Assessment of oxygenation Time: 3, 7, 14 and 28 daysDescription: Viral Load Quantification
Measure: Viral Load Time: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes firstDescription: Neutralizing antibody anti SARS-CoV-2 titer evolution
Measure: Antibody titer Time: Day 0, Day 3 and Day 7Description: Number of days without use of Oxygen
Measure: Oxygen-free days through Day 60 Time: Until hospital discharge or a maximum of 60 days whichever comes firstDescription: Number of days without use of mechanical ventilation
Measure: Mechanical ventilation-free days through Day 28 Time: Until hospital discharge or a maximum of 28 days whichever comes firstDescription: Time outside of ICU, in days
Measure: Intensive Care Unit (ICU)-free days through Day 28 Time: Until hospital discharge or a maximum of 28 days whichever comes firstDescription: Time outside of the hospital, in days
Measure: Hospital-free days through Day 60 Time: Until hospital discharge or a maximum of 60 days whichever comes firstDescription: Occurrence of adverse events during inactivated convalescent plasma transfusion, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
Measure: Incidence of adverse events Time: Up to 28 daysPilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Description: For intubated patients improvement in PaO2/FiO2
Measure: Improvement in respiratory disease Time: day 1 post transfusionDescription: For intubated patients improvement in PaO2/FiO2
Measure: Improvement in respiratory disease Time: day 3 post transfusionDescription: For intubated patients improvement in PaO2/FiO2
Measure: Improvement in respiratory disease Time: day 5 post transfusionDescription: For intubated patients improvement in PaO2/FiO2
Measure: Improvement in respiratory disease Time: day 7 post transfusionDescription: For intubated patients improvement in PaO2/FiO2
Measure: Improvement in respiratory disease Time: day 14 post transfusionDescription: For intubated patients improvement in PaO2/FiO2
Measure: Improvement in respiratory disease Time: day 28 post transfusionDescription: For non intubated patients time to intubation post transfusion
Measure: Improvement in respiratory disease Time: 7 daysDescription: ICU length of stay
Measure: ICU Length of Stay Time: 28 daysDescription: Hospital length of stay
Measure: Length of Stay Time: 28 daysDescription: Duration of time on ventilator
Measure: Ventilator days Time: 28Description: Adverse transfusion events
Measure: Tolerability of convalescent plasma Time: During transfusion, 1 day post-transfusionDescription: Improvement in Chest X Ray
Measure: Radiographic improvement Time: 3 days post transfusionDescription: Improvement in Chest X Ray
Measure: Radiographic improvement Time: 28 days post transfusionIn December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.
Description: We measure functional score of comorbidities
Measure: To evaluate the relative contributions of comorbidities on intra-hospitalized death Time: 1 monthDescription: We measure Functional Independence Measure scale
Measure: To evaluate the relative contributions of functional characteristics on intra-hospitalized death Time: 1 monthDescription: We describe the role fo geriatric syndrome such as delirium, falls
Measure: To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes Time: 1 monthIn December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.
Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)
Measure: IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement Time: 72 hoursDescription: time to successful ECMO-explantation within 30 days after randomization
Measure: time to successful ECMO-explantation Time: 30 daysDescription: Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization
Measure: Ventilator free days (VFD) Time: 30 daysDescription: Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last visit for surviving patients under ventilation and/or ECMO.
Measure: Time to extubation from ventilation and explantation from ECMO Time: 30 daysDescription: Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients.
Measure: Overall survival time Time: 30 daysDescription: Days on intensive care unit (ICU)
Measure: Days on intensive care unit (ICU) Time: 30 daysDescription: Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h
Measure: Vasopressor dosage Time: 24, 48, 72 hoursDescription: Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h
Measure: Fluid substitution and fluid balance Time: 24, 48, 72 hoursDescription: Serum lactate at 24, 48, 72 h
Measure: Serum lactate Time: 24, 48, 72 hoursDescription: Urine output at 24, 48, 72 h
Measure: Urine output Time: 24, 48, 72 hoursDescription: Willebrand factor at 24, 48, 72 h
Measure: Willebrand factor Time: 24, 48, 72 hoursDescription: d-dimers at 24, 48, 72 h
Measure: d-dimers Time: 24, 48, 72 hoursDescription: interleukin-6 levels at 24, 48, 72 h
Measure: interleukin-6 levels Time: 24, 48, 72 hoursDescription: Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Measure: SOFA-Score Time: 24, 48, 72 hoursDescription: serious complications or malfunctions related to the CytoSorb device
Measure: serious adverse device effects Time: 30 daysDescription: unintended air in the ECMO system during operation of the device
Measure: adverse event of special interest: air in the ECMO system Time: 30 daysDescription: unintended blood-clotting in the ECMO system during operation of the device
Measure: adverse event of special interest: blood-clotting in the ECMO system Time: 30 daysDescription: major bleeding events
Measure: adverse event of special interest: bleeding complications Time: 30 daysNasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.
Description: values of ROX index during ICU stay
Measure: Changes in ROX index Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: percentage of patients requiring intubation
Measure: NHF failure Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: level of flow used with NHF
Measure: NHF flow Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: level of inspired fraction in oxygen used with NHF
Measure: NHF inspired fraction in oxygen Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: level of pulse oxymetry during NHF therapy
Measure: oxygenation Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: respiratory rate during NHF therapy
Measure: respiratory status Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: defining the values of ROX index associated with intubation
Measure: prediction of intubation Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsDescription: defining the values of ROX index associated with NHF success (no intubation required)
Measure: prediction of NHF success Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 monthsIt is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin
Description: Time to clinical improvement, from the point of randomization to two-point improvement on a seven-point ordinal scale or discharged alive from hospital, whichever comes first. Ordinal Scale - 1, Ambulatory with normal activities; 2, Ambulatory with limitation of normal activities; 3, not requiring supplemental oxygen; 4, requiring supplemental oxygen by mask or nasal prongs; 5, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, requiring ECMO, invasive mechanical ventilation, or both; and 7, death
Measure: clinical improvement Time: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.Demographics of pregnant COVID persons under investigation and those who were positive from March-May 2020. Looking at demographics including age, socio-economic status and pregnancy outcomes in these groups.
Description: increased risk of preterm birth, preeclampsia, etc.
Measure: Pregnancy Outcome Time: through study completion, approximately 1 yearThe aim of this study is to reduce COVID-19 related pulmonary complications in adult patients undergoing all types of elective or emergency surgery in a COVID-19 exposed environment. A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)
Description: The primary outcome is any one of the following COVID-19 specific, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death
Measure: Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death Time: From randomisation until discharge from hospital, average less than 30 daysDescription: Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.
Measure: Rate of Pneumonia Time: From randomisation until discharge from hospital, average less than 30 daysDescription: ARDs will be presented and analysed separately as a secondary outcome measure
Measure: Rate of ARDs Time: From randomisation until discharge from hospital, average less than 30 daysDescription: Death will be presented and analysed separately as a secondary outcome measure
Measure: Death rate Time: From randomisation until discharge from hospital, average less than 30 daysDescription: Unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation by 30 days after surgery
Measure: Rate of unexpected ventilation Time: From operation until 30 days post operationDescription: Postoperative diagnosis of proven COVID-19 pulmonary complications
Measure: COVID-19 pulmonary complications Time: 30 days post-surgeryDescription: Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic)
Measure: Overall SARS-CoV-2 infected rate Time: 30 days post-surgeryDescription: Duration of hospital stay (including time spent in intensive care, time ventilated)
Measure: Duration of hospital stay Time: 30 days post-surgeryDescription: Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale
Measure: Pulmonary function Time: 30 days post-surgeryThis study will determine the neurological profile and predictors of outcomes in patients with COVID-19 disease in the Philippines. It will also evaluate if there is significant difference between COVID-19 patients with neurological manifestations compared to those COVID-19 patients without neurological manifestations in terms of various prespecified clinical outcomes. Furthermore, the likelihood of these outcomes in COVID-19 patients with neurological manifestations compared to those without neurological manifestation will be determined in this study.
Description: Defined as patients with confirmed COVID-19 who died
Measure: Mortality (binary outcome) Time: from admission until occurrence of mortality, assessed up to 6 monthsDescription: Defined as the patient with confirmed COVID-19 who experienced clinical symptoms and signs of respiratory insufficiency. Clinically, this condition may manifest as tachypnea, abnormal blood gases (hypoxemia or hypercapnia), signs of increased work of breathing, and requires oxygen supplementation
Measure: Respiratory failure (binary outcome) Time: from admission until occurrence of respiratory failure, assessed up to 6 monthsDescription: Defined as the number of days from initiation of assisted ventilation to extubation
Measure: Duration of ventilator dependence (continuous outcome) Time: day of intubation to day of extubation, assessed up to 6 monthsDescription: Defined as the patients with confirmed COVID-19 who are admitted to an ICU or ICU-comparable setting
Measure: Intensive care unit (ICU) admission (binary outcome) Time: admission to ICU admission, assessed up to 6 monthsDescription: Defined as the number of days admitted in the ICU or ICU-comparable setting
Measure: Length of ICU stay (continuous outcome) Time: ICU admission to ICU discharge, assessed up to 6 monthsDescription: Defined as the number of days from admission to discharge
Measure: Length of hospital stay (continuous outcome) Time: admission to hospital discharge, assessed up to 6 monthsThere is an evidence gap in relation to the incidence, impact and severity of COVID-19 in newborn babies. International data are very limited, we have no robust estimates of incidence and no UK-based data with which to inform policy, clinical care, service delivery or advice to pregnant women. The research aims are to investigate the three mains ways in which COVID-19 might affect newborns and babies that need neonatal care: 1. Newborn babies might catch COVID-19 before, during or soon after birth and this may lead to problems with breathing or feeding that need support in hospital. 2. COVID-19 could affect babies that are already on neonatal units with other medical conditions (like being very premature) that place them at greater risk of severe COVID-19. 3. COVID-19 might affect that way that pregnant women are looked after in pregnancy, labour or bith which could lead to problems for some babies, even if they do not themselves become infected with COVID-19.
Description: Number of neonatal participants with COVID-19 divided by the total number of live births in the population
Measure: Incidence of neonatal COVID-19 Time: April 2020 to March 2021Description: Number of neonatal participants with COVID-19 following vertically transmission of the Coronavirus divided by the total number of live births in the population
Measure: Incidence of vertically transmitted COVID-19 Time: April 2020 to March 2021Description: Questionnaire data
Measure: Presentation and natural history of neonatal COVID-19 Time: April 2020 to March 2021Description: Questionnaire data
Measure: Presentation of neonates with COVID-19 positive mothers Time: April 2020 to March 2021Description: Proportion of neonate participants who died and the proportion who were discharged home alive.
Measure: Outcomes for neonates with COVID-19 Time: April 2020 to March 2021Description: Questionnaire data
Measure: Clinical treatment of neonatal COVID-19 Time: April 2020 to March 2021Description: Questionnaire data
Measure: Neonatal secondary impacts of maternal COVID-19 Time: April 2020 to March 2021Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis
Description: Proportion of cases who during 14 days exhibit one of the following conditions (the most severe): respiratory failure that requires mechanical ventilation organ failure that requires intensive care monitoring and treatment death
Measure: Proportion of cases who during 14 exhibit one of the following conditions Time: 14 daysDescription: Mortality 28 days after randomization
Measure: Mortality 28 days after randomization Time: 28 daysCoronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections. In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,
Description: absence of the virus shedding evidenced by negative swabs
Measure: length of stay in hospital Time: within the first 6 days interventionDescription: reduction of morbidity and mortality
Measure: number of ICU admission Time: 14 daysDescription: finding the time that the symptoms disappear
Measure: resolution of symptoms Time: 6 days - 10 dayMolecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases. Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal. Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies. In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.
Description: assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.
Measure: Serology Time: 3 weeksDescription: to find if the combination of CT scan and serology could help us in the identification of those patients who were initially negative at laboratory testing alone.
Measure: Efficacy of CT scan and Serology Time: 3 weeksDescription: the efficacy of different pharmaceutical treatments against Covid-19
Measure: Efficacy of different pharmaceutical treatments Time: 3 weeksThe "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community
Description: Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures
Measure: Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city Time: 15 minutesDescription: Search for a correlation of covid-19 immunity based on the officer's position, if he is in contact with the public.
Measure: Determine if there is a relationship between the profession carried out by the agents of the territorial community of Orleans metropolitan city, the Loire Valley Region, the CCTVL and contamination by covid-19 Time: 6 monthsProspective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.
Description: Determine the prevalence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
Measure: Prevalence of SARS-CoV-2 infection throughout pregnancy in women Time: Up to 9 monthsDescription: Determine the incidence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.
Measure: Incidence of SARS-CoV-2 infection throughout pregnancy in women Time: Up to 9 monthsDescription: Determine risk ratios of adverse obstetric outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.
Measure: Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women Time: Up to 9 monthsDescription: Determine risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.
Measure: Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women Time: Up to 1.5 yearsDescription: Identify clinical, behavioral and sociodemographic determinants that predict risk of (a) maternal infection during pregnancy and (b) severe infection symptomatology (hospitalization, ICU admission). Deliverable: The investigators will provide novel findings that identify high-risk groups warranting more aggressive social avoidance measures during pregnancy.
Measure: Clinical, behavioral, and sociodemographic determinants Time: Up to 27 monthsCOVID-19 has adversely affected the healthcare system across the world. The world was not prepared for global outbreak of infectious diseases. The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is enabling researchers worldwide to acquire a large amount of clinical data regarding coronavirus disease (COVID-19). The COVID-19 infection severely affects the respiratory system in the critical cases and results in mortalities. The affected people experience a dry cough, fever, breathing problems, diarrhea, muscle pain, and sore throat. Besides that, some of the evidence from Italy, South Korea, China, and Spain suggest that the COVID-19 cases also lose their senses of smell and taste resulting in alterations in those patients. The objective of this proposed study is to determine whether COVID-19 cases have Olfactory and gustatory dysfunctions as a hallmark indicator and can be used as diagnostic tools for the isolation of suspected people. Investigators are presenting a prospective proportional case-control study that is conducted to investigate the COVID-19 cases with anosmia and /or Ageusia in a university hospital in Riyadh, Saudi Arabia. The sample size of this case series would be 250 cases of suspected COVID-19 patients. The cases included in the study are analyzed prospectively to determine if the cases had a history of anosmia and /or Ageusia, and then tested for the alteration of these senses through a panel of standardized odors/taste strips. That is looked at statistically allowing us to confirm the proposed effectiveness of these tests as a diagnostic tool.
Description: to how extent alteration of smell and taste senses is related to covid19 status
Measure: correlation of anosmia and ageusia to covid19 positive patients Time: from 1/06/2020 to 31/12/2020Description: to determine the range of sense affection ranging from total loss to mild form
Measure: objective assessment of severity of smell and taste senses alterations in covid19 patients Time: from 1/06/2020 to 31/12/2020This study will evaluate the changes in sexual function, reproductive function and mental health of male patients discharged from the hospital with COVID-19, and the impact of SARS-CoV-2 on male reproductive health and mental health compared with healthy people during the same period. In addition, men's semen examination reports before and after the new coronavirus pneumonia event will be collected and compared to assess the impact of the event on the quality of men's semen. Also, This study will test the SARS-CoV-2 nucleic acid of the urogenital system of male patients discharged with COVID-19 to provide evidence for the effect of the new coronavirus on the male reproductive system.
Description: Sperm density will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measure: Sperm density Time: 3 monthsDescription: Sperm activity will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measure: Sperm activity Time: 3 monthsDescription: Erection hardness and duration will be evaluated during sleep by RigiscanHealth Organization (WHO) normal values based on the WHO 2010 reference limits.
Measure: Erection hardness and duration Time: 3 monthsDescription: IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit.
Measure: IIEF-5/QEQ questionnaire score Time: 3 monthsDescription: Detection rate of SARS-CoV-2 in male genitourinary system will be evaluated by real time-polymerase chain reaction (RT-PCR).
Measure: Detection rate of SARS-CoV-2 in male genitourinary system Time: 1 monthDescription: Sperm volume will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measure: Semen volume Time: 3 monthsDescription: Sperm survival rate will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Measure: Sperm survival rate Time: 3 monthsDescription: The serum testosterone/LH/FSH levels will be tested in every visit.
Measure: Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level Time: 3 monthsDescription: SCL-90 questionnaire score will be obtained using SCL-90 questionnaire.
Measure: SCL-90 questionnaire score Time: 3 monthsDescription: Height will be measured at every visit
Measure: Height Time: 3 monthsDescription: Weight will be measured at every visit
Measure: Weight Time: 3 monthsDescription: Clinical classification of COVID-19 will be determined according to the New Coronavirus Pneumonia Prevention and Control Program (7th edition) published by the National Health Commission of China
Measure: Clinical classification of COVID-19 Time: 1 monththe retrospective observation study, the first line to care CAVID-19
Description: The isolated person and first-line care person who taking JGF
Measure: the number confirmed COVID-19 cases Time: 8 weeksDescription: The isolated person and first-line care person who taking JGF
Measure: The person with COVID-19 like symptoms Time: 8 weeksDescription: The isolated person and first-line care person who taking JGF
Measure: The improving rate of COVID-19 like symptoms Time: 8 weeksDescription: The isolated person and first-line care person who taking JGF
Measure: The satisfaction% to taking JGF Time: 8 weeksTo demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).
Description: To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 29. Respiratory failure is defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation
Measure: Proportion of subjects that are alive without respiratory failure at Day 29. Time: Day 29Description: Improvement on the WHO Ordinal Scale for Clinical Improvement (8-point ordinal scale)
Measure: WHO clinical Improvement Time: Day15 Day 22 and Day 29Description: Proportion of subjects with normalization of fever and oxygen saturation through
Measure: Normalization of Fever and Oxygen Time: Day 15, Day 22, and Day 29Description: Percentage of subjects discharged from hospital
Measure: Discharge from Hospital Time: Day 15 and Day 22Description: Proportion of patients alive and free of respiratory failure
Measure: Patients alive and free of respiratory failure Time: Day 15, and Day 22Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused mass mortality in the last 3 months that necessitates urgent development of new therapeutical agents. So far there is no effective anti-viral drug to reduce viral load that has critical importance to prevent progress into severe viral pneumonia and systemic hyper inflammation state. This project is to offer a biologic agent based on T cell derived exosomes. This is a novel approach using our proprietary protocols for drug development. This clinical trial is to test the safety and efficacy of this new agent following targeted delivery by metered dose inhaler. The project have received proper approvals from the Turkish Ministry of Health and Erciyes University, Kayseri Turkey. Turk-Patent Application Number: PCT/TR2020/050302
Description: Safety Assessment
Measure: Adverse reaction (AE) and severe AE (SAE) Time: 28 daysDescription: Time to Clinical Recovery (TTCR)
Measure: Efficacy Assessment Time: 28 daysDescription: Efficacy Assessment
Measure: The Rate of Recovery Without Mechanical Ventilator Time: 28 daysCombination Therapy with Isotretinoin and Tamoxifen expected to provide Complete Protection against Severe Acute Respiratory Syndrome Coronavirus Abstract: The COVID-19 pandemic caused by SARS-COV-2 has infected over 2,000,000 people causing over 150,000 deaths.Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 and for which there are currently no approved treatments.The principal investigator reported according to previous research data that combination therapy with Isotretinoin and tamoxifen expected to provide Complete Protection against Severe Acute Respiratory Syndrome Coronavirus, ACE2-expressing cells can act as home cells and are prone to SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry and replication. A study demonestrated that patients with hypertension and diabetes mellitus may be at higher risk of SARS-CoV-2 infection, as these patients are often treated with ACE inhibitors (ACEIs) or angiotensin II type-I receptor blockers (ARBs), which have been previously suggested to increase ACE2 expression, In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are currently being investigated in clinical trials for treating COVID-19 (chloroquine, thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov), none of which was found to significantly alter ACE2 expression (P>0.1) Moreover, another study demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment by performing target-based virtual ligand screening. As Investigators discussed before in their previous clinical trial (NCT04353180) that Isotretinoin is the strongest down-regulator of ACE2. and the principal investigator expects that Isotretinoin can inhibit or downrgulat ACE2 by direct interaction and binding with the transmembrane ACE2, Suggesting its therapeutic potential in preventing the entry of COVID 2019 to the host cell. The second combined drug is tamoxifen, A study demonstrated that tamoxifen causes redistribution of weak base chemotherapeutics from acidic organelles to the nucleus in drug-resistant cells. Agents that disrupt organelle acidification (e.g., monensin, bafilomycin A1) cause a similar redistribution. Measurement of cellular pH in several cell lines reveals that tamoxifen inhibits acidification of endosomes and lysosomes without affecting cytoplasmic pH, Tamoxifen decreased the rate of vesicular transport though the recycling and secretory pathways. Organellar acidification is required for many cellular functions, and its disruption could account for many of the side effects of tamoxifen. A sudy demonstrated that the phagocytosis is inhabited by tamoxifen and chloroquine in retinal epithelial cells and Also, a study demonstrated that Tamoxifen have weak base property and increase endolysosomal pH and alter endosomal dynamics. Importantly, TAM treatment enhanced survival of mice injected with a lethal dose of STx1 or STx2,The protective effect was independent of estrogen receptors but dependent on the weak base property of TAM, which allowed TAM to increase endolysosomal pH and alter endosomal dynamics. A study demonstrated that Tamoxifen have antimalarial effect via treating mice infected with P. berghei, which show lower levels of parasitaemia and do not develop signs of cerebral malaria, Tamoxifen is found to prevent lung fibrosis and reduce serum TGFβ-1 levels. A study Reported that Tamoxifen have endosomal and lysosomal cysteine proteases inhibitory effect better than chloroquine , Cathepsins are endosomal and lysosomal cysteine proteases that play important roles in protein degradation in various cellular processes including both the endocytic pathway and autophagy. The role of cathepsins in viral infection was first identified by Huang et al and they found that one cysteine proteases inhibitor E64d and a specific cathepsin L inhibitor Z-FY(t-Bu)-DMK are able to block the SARS-CoV infection. A study demonestrated that Cathepsin D was more sensitive to tamoxifen than to chloroquine. Tamoxifen exposures decreased the cathepsin D activity at less than 10 pM concentrations. The effect of chloroquine started at concentration of 15 pM, Finally, the principal investigator expects strong inhibition of COVID-19 by this combination therapy. Keywords: COVID 2019 , Isotretinoin , Tamoxofin, ACE2,.Endosomal and Lysosomal pH.
Description: Proportion of lung injury score decreased or increased after treatment
Measure: lung injury score Time: at 7 daysDescription: lymphocyte counts
Measure: Absolute lymphocyte counts Time: at day 7 and 14Description: Serum levels of CRP, ESR ,IL-1,IL-6,TNF and Type I interferon
Measure: Serum levels of CRP, ESR ,IL-1,IL-6,TNF and Type I interferon Time: at day 7 and 14Description: Serum level of COVID19 RNA
Measure: Serum level of COVID19 RNA Time: at day 7 and 14Description: less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample
Measure: d-dimers Time: at 3-5 daysDescription: (if pos. at baseline)
Measure: Time to first negative SARS-CoV-2 PCR in NP swap Time: 14 daysThis project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
Description: Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection
Measure: Serious adverse events in convalescent plasma treated patients Time: From baseline (enrolment) to 24 hours follow-upDescription: Change in SARS-CoV2 quantitative in nasopharyngeal swab
Measure: Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28Description: Transfer to ICU
Measure: Transfer to ICU Time: at Baseline (admission to Covid-ward) until day 28Description: in-hospital death
Measure: in-hospital death Time: at Baseline (admission to Covid-ward) until day 28Description: Change in SARS-CoV2 quantitative in plasma
Measure: Virologic clearance in plasma of convalescent plasma treated patients Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28Description: Duration of hospitalisation
Measure: Time to discharge from hospital after enrolment Time: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)Description: Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)
Measure: Humoral immune response Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. PCRs were performed using two target genes (E and N).
Measure: Proportion of Patients With a Positive SARS-CoV-2 PCR Time: 7 days post-treatmentDescription: Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).
Measure: Median Viral Load Time: Baseline and on days 4, 7, 14 and 21Description: Proportion of patients with fever and cough
Measure: Fever and Cough Progression Time: Days 4, 7, 14 and 21Description: Proportion of participants with positive IgG at day 21
Measure: Seroconversion at Day 21 Time: Up to and including day 21Description: Proportion of drug-related adverse events
Measure: Proportion of Drug-related Adverse Events Time: 7 days post treatmentDescription: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay. [Results not yet available]
Measure: Levels of IgG, IgM and IgA Time: Up to and including day 28Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry. [Results not yet available]
Measure: Frequency of Innate Immune Cells Time: Up to and including day 7Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry. [Results not yet available]
Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells Time: Up to and including day 7Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher). [Results not yet available]
Measure: Results From Cytokine Human Magnetic 30-Plex Panel Time: Up to and including day 28The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).
Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances
Measure: Presence or absence of olfactory and taste disturbances in COVID-19 patients Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)
Measure: Prevalence of olfactory disturbances in COVID-19 patients Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: Percentage of COVID-19 patients experiencing taste disturbances
Measure: Prevalence of taste disturbances in COVID-19 patients Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19 (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)
Measure: Clinical manifestations of study participants Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)
Measure: Other pre-existing health conditions Time: Prior to diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste before their diagnosis of COVID-19 infection
Measure: Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection Time: Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of diagnosis of COVID-19 infection
Measure: Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of answering questionnaire survey
Measure: Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey Time: Up to 6 monthsThere is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness. Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.
Description: Decrease in progression to requiring non-invasive or invasive ventilation
Measure: Disease progression Time: 28 daysDescription: Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
Measure: Adverse events (AE) Time: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.Description: Measured daily until discharged from the hospital.
Measure: Time ro resolution of fever and symptoms Time: Until discharged from the hospital, up to 2 monthsDescription: SARS-CoV-2 RNA detection by polymerase chain reaction (PCR) in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measure: Clearance of viraemia Time: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.Description: Time to normalization of inflammatory parameters. The markers that will be monitored are the following: C-reactive protein (CRP), white blood cell count (WBC), haemoglobin (Hb), Pro-calcitonin, and Creatine Kinase. Blood samples for these markers will be taken daily until normalized or discharged from hospital.
Measure: Inflammatory parameters Time: Until discharged from the hospital, up to 2 monthsDescription: Change in the antibody response to SARS-CoV-2 as measured in serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measure: Antibody response to SARS-CoV-2 Time: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.There is surge in COVID infected patients in New York City with a shortage of hospital beds, ICU beds and ventilators. Strategies to reduce the need for all of the above are immediately needed. Further, few interventions are targeted in COVID infected patients early in the course of their disease and especially in the community/home settings. Respiratory decompensation appears to occur later in the disease process (i.e. 7-10 days after becoming symptomatic) therefore many patients are sent home from the Emergency Room and they subsequently decompensate later at home. Some patients die at home and others are returning to the Emergency Room with hypoxemic respiratory failure. There is no treatment offered to this population of patients, i.e. COVID suspected or confirmed and with respiratory symptoms or abnormal chest x-ray at the time of presentation. Based on experience across the globe, these patients are likely to worsen at home. The study team therefore proposes a prospective, single-center, parallel group, open-label, randomized clinical trial to assess the efficacy of fixed low continuous positive airway pressure therapy (CPAP) (FDA approved and often used for treatment of sleep apnea) in COVID confirmed or suspected patients with abnormal chest x-ray or respiratory symptoms who do not require hospital admission and are discharged home from the emergency room.
Description: Non-weighted composite score comprised of the following components: All-cause mortality within 14 days of randomization, hospital Admission (including ED visit) within 14 days of randomization, oxygen saturation less than 90 during the 72-hour observation period from randomization, absolute reduction in oxygen saturation of more than 4% during the 72-hour observation period from randomization.
Measure: Efficacy Endpoint composite score Time: 14 daysDescription: The time from randomization to an admission to the intensive care unit within 14 days from randomization
Measure: Time to ICU admission Time: 14 days from randomizationDescription: The time from randomization to the patient needing to be intubated and needing mechanical ventilation within 14 days from randomization
Measure: Time to Intubation and mechanical ventilation Time: 14 days from randomizationDescription: The time from randomization to death within 14 and 28 days from randomization
Measure: 14 day and 28 day mortality Time: 14-28 days from randomizationDescription: The conversation rate of household members from being COVID negative to COVID positive in the CPAP arm vs the control arm within 14 days from randomization
Measure: Conversion rate of COVID household members in CPAP vs control Time: 14 days from randomizationDescription: If there is any improvement in respiratory symptoms of cough or shortness of breath etc. assessed via a respiratory symptom questionnaire within 14 days from randomization. The CCQ is a 10-item instrument, full scale from 0 to 6, with higher score indicating lower health status.
Measure: Clinical COPD Questionnaire (CCQ) Time: 14 days from randomizationDescription: Percentage of the patients in the CPAP arm elect to continue using the CPAP after the initial 72 hour period.
Measure: Percentage of patients electing to continue CPAP for greater than 72 hours Time: 7 days from randomizationDescription: The degree of improvement in oxygen saturation within 14 days of randomization.
Measure: Degree of improvement in oxygen saturation Time: 14 days from randomizationDescription: Time to hospital admission or ED within 14 days of randomization
Measure: Time to hospital admission or ED Time: 14 days from randomizationModerate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.
Description: O2 saturation
Measure: Change from baseline blood oxygenation Time: 28 daysDescription: Total days the patient is admitted to hospital
Measure: Number of Hospital stay days Time: 28 daysDescription: Total days the patient is admitted to ICU
Measure: Number of ICU stay days Time: 28 daysDescription: Total number of intubations performed after the treatment
Measure: Number of intubation events Time: 28 daysDescription: Changes in WBC count if base-line is abnormal
Measure: WBC Time: 28 daysDescription: Changes in Platelets count if base-line is abnormal
Measure: Platelets Time: 28 daysDescription: Changes in CRP serum level
Measure: CRP Time: Day 1Description: Changes in CRP serum level
Measure: CRP Time: Day 2Description: Changes in CRP serum level
Measure: CRP Time: Day 3Description: Changes in CRP serum level
Measure: CRP Time: Day 4Description: Changes in CRP serum level
Measure: CRP Time: Day 5Description: Changes in IL-6 serum level
Measure: IL-6 Time: Day 1Description: Changes in IL-6 serum level
Measure: IL-6 Time: Day 2Description: Changes in IL-6 serum level
Measure: IL-6 Time: Day 3Description: Changes in IL-6 serum level
Measure: IL-6 Time: Day 4Description: Changes in IL-6 serum level
Measure: IL-6 Time: Day 5A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.
Description: Percentage of patients with discharge to ICU.
Measure: Cases with discharge to ICU. Time: 30-daysDescription: Percentage of patients with home discharge.
Measure: Patients with home discharge. Time: 30-daysDescription: Percentage of deaths.
Measure: Mortality. Time: 30-daysDescription: Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
Measure: Treatment safety assessed by number of adverse events. Time: 30-daysDescription: Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
Measure: New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients. Time: 30-daysDescription: Percentage of patients with negative PCR for SARS-CoV-2.
Measure: Patients with negative PCR result for SARS-CoV-2 infection. Time: 30-daysThe purpose of this study is to prospectively evaluate a machine learning algorithm for the prediction of outcomes in COVID-19 patients.
Description: Ventilated or not ventilated within 24 hours
Measure: Mechanically ventilated patient outcome Time: Through study completion, an average of 2 monthsDescription: Death or ventilated, or no death or not ventilated within 24 hours
Measure: Mortality or mechanically ventilated patient outcome Time: Through study completion, an average of 2 monthsProne position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation. Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation. Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care. Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
Description: Therapeutic failure: death or intubation
Measure: Therapeutic failure death or intubation Time: 28 days within randomizationDescription: Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions)
Measure: Feasibility and safety of prone position in HFNC patients Time: 28 days within randomizationDescription: Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortality
Measure: Efficacy of prone position in HFNC patients Time: 28 days within randomizationPrompted by the current COVID-19 pandemic, the American Academy of Ophthalmology has recommended the use of telemedicine to continue ophthalmic care while maintaining patient and provider social distancing. As part of remote examinations, patients may be expected to perform home eye testing for visual acuity and the use of various home visual acuity charts have been proposed to provide clinicians with this vital data. However, the use of home visual acuity exams has not been validated in our patient population. This project aims to determine the efficacy and validity of measuring visual acuity at home with a printed-out ETDRS chart.
Description: Best Visual Acuity per eye
Measure: Best Corrected Visual Acuity (BCVA) Per Eye Time: From the time they sign the consent until we take their BCVA in clinic. Approximately 1-2 weeks.The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.
Description: Increase in plasma D-dimer level compared with baseline at enrollment.
Measure: Change in D-dimer Time: baseline, up to approximately 28 days after last study drug administrationDescription: Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.
Measure: Global composite rank score Time: up to approximately 28 days after last study drug administrationCompare the resting energy expenditure of COVID-19 patients (obese or non-obese) in intensive care unit with mechanical ventilation to a control group of non-COVID-19 intensive care patients.
The objectives of the study, are to describe detection of SARS-CoV-2 in the semen of COVID-19 positive patients, the duration of positive semen and to investigate the impact on semen quality, thereby providing insights into the early impact on male reproductive function.
Description: detection of SARS-CoV-2 in the semen of men positive for SARS-CoV-2 on nasopharyngeal swab
Measure: detection of SARS-CoV-2 in the semen Time: within 7 days after positive testing for SARS-CoV-2Description: in case of a positive SARS-CoV-2 semen sample, for how long stays the virus present in semen
Measure: duration of SARS-CoV-2 presence in semen Time: from first positive semen testing until first negative semen testing, upto 15 weeksDescription: viscosity of semen will be assessed macroscopically
Measure: semen viscosity Time: from first until last semen analysis, upto 15 weeksDescription: semen volume
Measure: semen volume Time: from first until last semen analysis, upto 15 weeksDescription: semen pH
Measure: semen pH Time: from first until last semen analysis, upto 15 weeksDescription: Sperm motility assesment, according to the WHO guidelines of 2010
Measure: Sperm motility Time: from first until last semen analysis, upto 15 weeksDescription: Sperm morphology assesment, according to the WHO guidelines of 2010
Measure: Sperm morphology Time: from first until last semen analysis, upto 15 weeksDescription: Sperm density assesment, according to the WHO guidelines of 2010
Measure: Sperm density Time: from first until last semen analysis, upto 15 weeksThis is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.
Description: Number and severity of treatment emergent adverse events
Measure: Safety and Tolerability of Single Ascending Dose (SAD) of EIDD-2801 (Part 1): Adverse Events Time: From screening through study completion, up to 15 daysDescription: Number and severity of treatment emergent adverse events
Measure: Safety and Tolerability of Multiple Ascending Dose (MAD) of EIDD-2801 (Part 3): Adverse Events Time: From screening through study completion, up to 20 daysDescription: Multiple pharmacokinetic variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax
Measure: Pharmacokinetics (PK) of EIDD-2801 when given as Single Doses (Part 2): Maximum observed concentration Cmax Time: Day 1 through Day 18Description: Multiple PK variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax
Measure: Pharmacokinetics (PK) of EIDD-2801 when given as Single Ascending Dose (SAD) (Part 1): Maximum observed concentration Cmax Time: Day 1 up to Day 4Description: Multiple PK variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax
Measure: Pharmacokinetics (PK) of EIDD-2801 when given as Multiple Ascending Dose (MAD) (Part 3): Maximum observed concentration Cmax Time: Day 1 up to Day 14Description: Number and severity of treatment emergent adverse events
Measure: Safety and Tolerability of Single Doses of EIDD-2801 (Part 2): Adverse Events Time: From screening through study completion, up to 30 daysPurpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.
Description: % patients who survived
Measure: Survival Rate Time: At 28 DaysThis study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery.
Description: Improvement of clinical symptoms related to Covid-19 infection (fever, pneumonia, shortness of breath)
Measure: Clinical improvement Time: 3 monthsDescription: Improvement of lungs assessed by CT Scan
Measure: Lung damage improvement Time: 3 monthsDescription: Negative, measured by RT-PCR laboratory tests for the virus
Measure: Sars-Cov-2 viral infection laboratory test Time: 3 monthsDescription: Cell types and numbers
Measure: Blood test Time: 3 monthsSARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed.
Description: Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with Polymerase Chain Reaction for detected SARS-CoV-2 .
Measure: Identify antibodies Time: 1 dayDescription: Determine the sensitivity of IgM and IgG antibody detection by ELISA in direct eastern contacts of patients with PCR for detected SARS-CoV-2.
Measure: Determine antibody sensitivity Time: 1 dayDescription: Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
Measure: IgM determination Time: 1 dayDescription: Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
Measure: IgG determination Time: 1 dayCOVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.
Description: viral load as measured by real time polymerase chain reaction (PCR)
Measure: Change in viral load in the oral and nasopharyngeal cavity Time: Day 0, 2, 3, 7, 14Description: Visual analogue score 1-5 per symptom via a smartphone app
Measure: Symptom severity in primary participants and co-residents Time: Days 0 to 14Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA reviewed) can be conducted effectively at home to detect COVID-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from COVID-19 and recovered. The study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.
Description: Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test
Measure: Does Participant Accurately Read Result Time: Day 0Description: Mesure of participant self report on ease of test administration via a custom survey assessment
Measure: Acceptability and Usability of Tests Time: Day 0Description: Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.
Measure: Social Distancing Behavior Change Time: Week 8Description: Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale.
Measure: COVID-19 Related Anxiety Time: Week 8Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.
Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer. Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation
Description: The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner.
Measure: Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days. Time: In 30 daysDescription: It will be considered the main safety endpoint
Measure: Incidence of Major bleeding and clinically relevant non-major bleeding by the ISTH criteria Time: In 30 daysProne positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
Description: Total time spent in prone position, as recorded by nursing or respiratory therapists
Measure: Time in prone position Time: Up to 28 days post randomizationDescription: Daily evolution of oxygenation
Measure: Oxygenation (SpO2/FiO2 ratio) Time: Until HFNC weaning, or up to 14 days after randomization, whichever is firstA randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.
Description: Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.
Measure: Admission to ICU and/or mechanical ventilation Time: One yearDescription: Time in the hospital from admission to discharge or death.
Measure: Length of hospital stay Time: One yearDescription: Neutralizing antibody (IgG) titers against COVID-19
Measure: Neutralizing antibody (IgG) titers against COVID-19 Time: One yearDescription: Non-serious adverse events (NSAEs) and serious adverse events (SAEs)
Measure: Safety - Adverse events Time: One yearDescription: Overall mortality
Measure: Death Time: One yearThis is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using ResCure™ Time: 12 WeeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or progression of symptomatic days Time: 12 WeeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of ResCure™ via pulse Time: 12 WeeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of ResCure™ via oxygen saturation Time: 12 WeeksDescription: EKG from baseline to 12 weeks
Measure: Assess the safety of ResCure™ via EKG Time: 12 WeeksDescription: Assess Adverse Events and Serious Adverse Events due to ResCure™
Measure: Assess Tolerability of ResCure™ Time: 12 WeeksThis is observational study to assess the prognosis of patients hospitalized with COVID-19 confirmed by RT-PCR and exposed to trimethylxanthine (TMX). Trimethylxanthine is the active molecule present in coffee. Due to the lack of etiologic treatments and considering interest about old treatments as an avenue for research, we conducted a comparative study aiming to evaluate the effect of 1,3,7-trimethylxanthine on COVID-19 infected patients. This is actually a study about methodology. The objective of this study is therefore not to demonstrate the effect of the substance on the disease but the importance of a rigorous methodology in scientific research. This project is called "Method and Teaching of Scientific Studies".
Description: the patient clinical status at day 6 after hospital admission, defined as alive, or dead.
Measure: Comparison of vital status Time: 6 daysDescription: Evaluated by National Early Warning Score from 0 to 20, 20 being the worst score, with a high risk of death.
Measure: Comparaison of severity Time: 6 daysDescription: with
Measure: Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee). Time: 6 daysThe present study aims to assess the impact of exercise training, physical activity, and sedentary lifestyle on clinical outcomes in surviving patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, this study will evaluate cross-sectionally and through a questionnaire in Portuguese and English on the internet, whether physically active patients have better outcomes for the disease such as shorter hospital stay, lesser symptoms, lesser need for mechanical ventilation, and medications.
Description: Number of hospitalizations required due to COVID-19
Measure: Number of hospitalizations Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)Description: Symptoms such as fever, cough, shortness of breathe, and muscle pain due to COVID-19
Measure: Percentage of symptoms of the disease Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)Description: Length of hospital stay required due to COVID-19
Measure: Length of hospital stay Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)Description: Need for mechanical ventilation during hospitalization due to COVID-19
Measure: Percentage of mechanical ventilation Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements. The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.
Description: Short Form (36) Health Survey (SF-36)
Measure: Short Form (36) Health Survey (SF-36) Time: 3 monthsDescription: Mortality
Measure: Mortality Time: 90 daysDescription: Modified Rankin Scale (mRS); (0=no Symptoms at all, 6=dead)
Measure: Modified Rankin Scale (mRS) Time: 90 daysDescription: Duration of mechanical ventilation in days
Measure: Duration of mechanical ventilation in days Time: 3 monthsDescription: Barthel Index (80-100= patient should be able to live independently, <20=total dependence)
Measure: Barthel Index Time: 3 monthsDescription: Beck's Depression Inventory II (BDI-II)
Measure: Beck's Depression Inventory II (BDI-II) Time: 3 monthsDescription: Essener Questionnaire for Coping with a Disease (EFK); (0=no burden of disease, 180-strong burden of disease)
Measure: Essener Questionnaire for Coping with a Disease (EFK) Time: 3 monthsDescription: Number of patients with Critical Illness Myopathy
Measure: Number of patients with Critical Illness Myopathy Time: day 10The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.
Description: Hospital mortality
Measure: Hospital mortality Time: up to 90 daysDescription: Mortality Day 28
Measure: Mortality Day 28 Time: Day 28Description: Mortality Day 90
Measure: Mortality Day 90 Time: Day 90Description: Ventilator-free days
Measure: Ventilator-free days Time: Day 28Description: ICU-free days
Measure: Intensive care unit-free days Time: Day 28Description: Hospital-free days
Measure: Hospital-free days Time: Day 28the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients
Description: to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis
Measure: the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis Time: 3 monthsThe purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 DaysDescription: Time to non-invasive ventilation
Measure: Time to NIV Time: 14 DaysDescription: Time to high flow nasal cannula
Measure: Time to HFNC Time: 14 DaysDescription: Time to intubation
Measure: Time to intubation Time: 14 daysDescription: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93% Time: 14 daysDescription: Need for supplemental oxygen
Measure: Need for supplemental oxygen Time: 14 daysDescription: Change in viral load
Measure: Change in viral load Time: 30 daysDescription: Duration of the Hospital Length of Stay (LOS)
Measure: Duration of the Hospital Length of Stay (LOS) Time: 14 daysDescription: Mortality rate at Day 30
Measure: Mortality rate at Day 30 Time: 30 daysRecent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
Description: This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) Time: Day 1 to Day 8Description: This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline Time: Day 1 to Day 8Description: Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4 Time: Day 4Description: This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline on day 4 Time: Day 4Description: Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following pO2/FiO2 less than 150 Need for mechanical or non-mechanical ventilation (CPAP)
Measure: Range of development of severe respiratory failure Time: Day 1 to Day 14Description: Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.
Measure: Range of hospital readmission until day 14 Time: Day 1 to Day 14Description: Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8
Measure: Change of viral load in respiratory secretions from baseline on day 8 Time: Day 1 to Day 8Description: Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of function of monocytes at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th1 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th2 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum human beta defensin-2 (hBD-2) between days 1 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of the IL-10/TNFα ratio between days 1 and 8 Time: Day 1 to Day 8In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.
Description: Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission
Measure: Asymptomatic COVID-19 positive pregnant women Time: Through completion of the study, an average of 1 yearDescription: Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission
Measure: Asymptomatic Hispanic COVID-19 positive pregnant women Time: Through completion of the study, an average of 1 yearDescription: Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms
Measure: Follow up of asymptomatic COVID-19 positive pregnant women Time: Through completion of the study, an average of 1 yearDescription: Prevalence of COVID-19 positive newborns from infected mothers
Measure: COVID-19 positive newborns Time: Through completion of the study, an average of 1 yearDescription: Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19
Measure: Severe COVID-19 disease in pregnant women Time: Through completion of the study, an average of 1 yearThe objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.
Description: A patient is consider responder in the absence of either moderate to severe oxygenation impairment according to Berlin criteria - measured as Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)
Measure: Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria) Time: 8 daysDescription: Absence of death within 8 days from enrollment
Measure: Response to treatment: survival Time: 8 daysDescription: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days Time: 8 daysDescription: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days Time: 15 daysDescription: To quantify mortality within 8 and 15 days
Measure: Mortality Time: 8 days and 15 daysDescription: SpO2 will be assessed with the median and 25th-75th percentiles
Measure: Peripheral capillary oxygen saturation (SpO2) Time: 8 days; 15 daysDescription: PaO2/FiO2 will be assessed with the median and 25th-75th percentiles
Measure: Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2) Time: 8 days; 15 daysDescription: Number of patients over the number of patients enrolled
Measure: To assess the rate of patients admitted to the intensive care unit Time: 8 days; 15 daysDescription: Median number of days and 25th-75th percentiles
Measure: To measure the length of hospital stay Time: 8 days; 15 daysDescription: To quantify 28-day mortality
Measure: 28-day mortality Time: 28 daysDescription: Number of patients readmitted over the number patients enrolled
Measure: To quantify the rate of re-admission within 28 days Time: 28 daysDescription: Number, type, and severity of adverse events
Measure: To quantify the cumulative incidence and severity of adverse events Time: 28 daysDescription: Serial serum assessments from baseline up to 15 days
Measure: Interleukin (IL)-1; IL-2; IL-10; IL-6; IL-8; IL-17; IL-2 receptor levels; Time: 15 daysDescription: Serial serum assessments from baseline up to 15 days
Measure: TNFalpha; vascular endothelial growth factor (VEGF); interferon gamma (IFNgamma) levels Time: 15 daysDescription: Serial assessments from baseline up to 15 days for viral load persistence
Measure: Viral load analyses Time: 15 daysThis is a 30 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. IND 19968 to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The key secondary endpoints are 28 day survival, an increase in PaO2/FiO2 ratio by 50% at 96 hours, days to hospital discharge to home or rehab, and number of days requiring mechanical ventilation. Patients will be eligible for treatment with 3 daily consecutive doses of hCT-MSC at 1 million cells/kg (max dose 100 million cells), 18-30 hours apart, if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS. Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 20 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.
Description: Incidence of infusion reactions measured by any one of the following: fever, anaphlyaxis, rash, hypertension, hypotension, tachycardia, nausea, vomiting, or any other new or worsening symptoms associated with the infusion.
Measure: Safety of the Investigational Product Time: 24 hoursDescription: Incidence of later reactions attributed to the investigational product as measured by any one of the following: rash, infection, allergic reaction, or any other symptoms associated with infusion of the investigational product.
Measure: Safety of the Investigational Product Time: 28 daysDescription: Formation of new anti-PRA antibodies as measured by an antibody screen test at 28 days post first infusion of the investigational product.
Measure: Safety of the Investigational Product Time: 28 daysDescription: Survival after 28 days after the first dose of MSCs
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 28 daysDescription: Increase in PaO2/FiO2 ratio by 50%
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 3 days after MSCsDescription: The number of days from hospitalization to discharge to home
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 90 daysDescription: The number of ventilator free days
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 90 daysDescription: A 50% decrease in opacities by CT chest one week post initiation of MSC therapy
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 7 daysDescription: The number of days requiring oxygen support
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 90 daysDescription: Changes in viral load after MSCs measured by routine PCR testing from baseline to 4 days, 7 days and 28 days after MSCs
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: baseline, day 4, day 7, and day 28Description: Number of patients able to be on the randomized portion of this study
Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs Time: 90 daysCoronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection. In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.
Description: It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection
Measure: The survey that was taken by telephone calls Time: Day 0Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.
Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Measure: Number of secondary cases of SARS-CoV2 infection among residents at six days Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Measure: Number of secondary cases of SARS-CoV2 infection among residents at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Measure: Number of secondary cases of SARS-CoV2 infection among residents at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable
Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at six days Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable
Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable
Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous qualitative variable (1: Death 0: Survival)
Measure: Mortality Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period
Measure: Compliance with treatment Time: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administeredDescription: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.
Measure: Symptoms of SARS-CoV-2 infection at six days Time: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.
Measure: Symptoms of SARS-CoV-2 infection at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.
Measure: Symptoms of SARS-CoV-2 infection at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection
Measure: Hospitalization Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors
Measure: Adverse events at six days Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors
Measure: Adverse events at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors
Measure: Adverse events at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineA phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.
Description: Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Measure: Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older. Time: Study duration (12 months from last vaccination)Description: Occurrence of serious adverse events (SAEs) throughout the study duration.
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults Time: Study duration (12 months from last vaccination)Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following Time: 7 days post vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following Time: 7 days post vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination Time: 28 days post vaccinationDescription: Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 & 10)
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests) Time: 6 monthsDescription: Occurrence of disease enhancement episodes
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes Time: Study duration (12 months from last vaccination)Description: Number of hospital admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions Time: Study duration (12 months from last vaccination)Description: Number of intensive care unit (ICU) admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Number of deaths associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths Time: 6 monthsDescription: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates Time: 6 monthsDescription: Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19 Time: Study duration (12 months from last vaccination)Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification Time: 28 days post vaccinationDescription: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion Time: 28 days post vaccinationDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only) Time: 6 monthsDescription: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity Time: 7 days post vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity Time: 7 days post vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) Time: 28 days post vaccinationDescription: Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests) Time: 6 monthsDescription: Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion Time: 56 days post vaccinationDescription: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) Time: 56 days post vaccinationDescription: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Measure: Exploratory Immunology by virus neutralising antibody assays Time: 6 monthsDescription: Cell analysis by flow cytometry assays
Measure: Exploratory Immunology by flow cytometry Time: 6 monthsDescription: Functional antibody assays
Measure: Exploratory Immunology by functional antibody assays Time: 6 monthsDescription: Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19
Measure: Exploratory Immunology: anti-vector immunity Time: 6 monthsDescription: Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures
Measure: Measure exposure to COVID-19 Time: 6 monthsDescription: Number of PCR or NAAT positive cases of COVID-19 infection
Measure: Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection by PCR or NAAT Time: 6 monthsDescription: Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections
Measure: Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection Time: 6 monthsDescription: Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
Measure: Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002 Time: 6 monthsDescription: Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B, C and D respectively (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
Measure: Compare safety, reactogenicity and immunogenicity between different methods for measuring doses Time: 6 monthsDescription: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
Measure: Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals Time: 6 monthsDescription: Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 PCR or NAAT positivity
Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive individuals Time: 6 monthsDescription: Differences in antibody titres (ELISA and Neutralising antibodies) in participants who received 1 or 2 doses of ChAdOx1 nCoV-19 (groups 1, 2, 7 and 8)
Measure: Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: differences in antibody titres Time: 6 monthsDescription: Longevity of immune responses in participants who received 1 or 2 doses of ChAdOx1 nCoV-19
Measure: Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: longevity of immune responses Time: 6 monthsDescription: Differences reactogenicity profile, antibody titres and T-cell responses between groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.
Measure: Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines on safety and immune responses to ChAdOx1 nCoV-19 Time: 6 monthsDescription: Cell-mediated and humoral responses against SARS-Cov-2 These will be measured by the following: Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike protein measured by ELISA. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike protein responses Further exploratory immunology
Measure: Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults Time: 6 monthsDescription: Relationship between nadir CD4 count vs vaccine immune responses
Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: CD4 count-vaccine immune responses Time: 6 monthsDescription: Relationship between age at enrolment and vaccine immune response
Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: age vs vaccine immune responses Time: 6 monthsDescription: Immune responses to ChAdOx1 nCoV-19 (assessed as described above)
Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults Time: 6 monthsDescription: Measured by the following: Occurrence of serious adverse events (SAEs) throughout the study duration Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination Occurrence of solicited systemic signs and symptoms for 7 days following each vaccination Occurrence of unsolicited AEs for 28 days following each vaccination
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults Time: Study duration (12 months from last vaccination)Description: Change in Total HIV DNA copies per million CD4 T cells
Measure: To assess Impact of vaccination on HIV reservoirs Time: Study duration (12 months from last vaccination)The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing endoscopic procedure in a third level hospital with CoronaVirus Disease (COVID-19) hospitalization plants and patients who make a telephonic visit (do not go to the hospital) in the digestive system service.
Description: Proportion of patients who develop SARS-CoV-2 infection in 3 groups: patients undergoing an abdominal ultrasound examination in a Specialty Center, patients undergoing an endoscopic examination in a third-level hospital with hospitalization facilities COVID-19 and patients who make a non-face-to-face consultation (do not go to the hospital) in the digestive system service
Measure: SARS-CoV-2 infection in patients Time: may-june 2020Description: Number of Health Care Workers (HCW) who develop SARS-CoV-2 infection in endoscopy service in this period
Measure: SARS-CoV-2 infection in HCW Time: may-june 2020Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.
Description: level of agreement between novel test and standard test
Measure: kappa value Time: 6 monthsDescription: test of accuracy for the result versus a validated sample set
Measure: sensitivity and specificity Time: unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 yearDescription: timeliness of results
Measure: clinical utility of test Time: 3 monthsThe purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation. It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs. Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9 plus standard of care. Part 2 of the study is double-blind, randomized; participants will receive either APL-9 or the vehicle-control plus standard of care.
Description: The minimum value is 0 and maximum value is 24. The higher a score the worse the outcome.
Measure: Sequential Organ Failure Assessment Time: Day 1 through day 21The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
Description: In-hospital mortality or discharge to hospice at Day 60.
Measure: Hospital mortality or discharge to hospice Time: 60 daysDescription: An Adverse Event (AE) is any unfavourable or other finding (including clinically significant laboratory tests), symptom or disease occurring during the during of the study, whether or not it is considered to be related to the medicinal (investigational) product, not explicitly classified elsewhere in this protocol, and whether or not it is expected. A Serious Adverse Event (AE) is any unfavourable medical finding (including clinically significant laboratory tests) at any dose that: Results in death (primary outcome) Is life threatening Results in persistent of significant disability or incapacity Requires in in-patient hospitalisation or prolongation of Hospitalisation
Measure: Adverse Events and Serious Adverse Events Time: 60 daysDescription: Change in SpO2 during each PP session (SpO2 in prone position - SpO2 prior to prone positioning). Clinicians will be asked to record this change for the first proning session per shift (for 12 hour shifts this will result in 2 proning sessions being documented per 24 hour period, and for 8 hour shifts this will result in 3 proning sessions being documented per 24 hour period).
Measure: Change in SpO2 Time: 60 daysDescription: Number of hospital free days in the 60 days after enrolment.
Measure: Hospital free days Time: 60 daysDescription: Admission to the Intensive Care Unit.
Measure: Admission to ICU Time: 60 daysDescription: Patient is intubated and requires mechanical ventilation.
Measure: Intubation and mechanical ventilation Time: 60 daysDescription: Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Measure: Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO). Time: 60 daysDescription: The number of oxygen-free days at Day 60 (censored at discharge).
Measure: Oxygen-free days Time: 60 daysDescription: Time from admission to all-cause in-hospital death.
Measure: In-hospital death (time) Time: 60 daysDescription: Death at 90 days.
Measure: Death at 90 days Time: 90 daysCOVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world. If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date). However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms. Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc. Given the novelty of this infection, several questions remain: - What are all the symptoms that can be contracted by a COVID-19 patient? - Are there clinical forms not described? - What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis? - What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?
Description: measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30
Measure: COVID-PSL Cohort Time: 3 monthsTo evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.
Description: To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.
Measure: Development of Acute Respiratory Distress Syndrome (ARDS) and Other Organ Injuries Time: 28 daysDescription: High-frequency oscillatory ventilation, with its rapid delivery of low tidal volumes and a respiratory rate in the range of 60 to 900 breaths/minute, has also been utilized in ARDS patients.
Measure: Ventilation-free days Time: 28 daysDescription: Oxygen therapy provided as non-invasive therapy for ARDS patients.
Measure: Time on nasal cannula or oxygen masks Time: 28 daysDescription: 28 day mortality - all cause and attributable
Measure: 28 day mortality - all cause and attributable Time: 28 daysDescription: ICU and hospitalization length of stay (days)
Measure: ICU and hospitalization length of stay (days) Time: 28 daysDescription: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rate
Measure: SARS-CoV2 testing Time: 28 daysDescription: Extracorporeal membrane oxygenation (ECMO) is often used for severe ARDS to allow lung healing/repair and reverse respiratory failure.
Measure: Need and duration for extracorporeal membrane oxygenation (ECMO) Time: 28 daysDescription: Vasopressor free days
Measure: Vasopressor free days Time: 28 daysDescription: Chest X-rays performed at Baseline, Day 3, at clinical improvement, and end-of-treatment (EOT) and study (EOS) to determine presence of bilateral opacities.
Measure: Radiographic pulmonary assessments Time: 28 daysDescription: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcome
Measure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores Time: 28 daysDescription: Incidence of other organ (non-lung) disorders
Measure: Incidence of non-lung disorders Time: 28 daysDescription: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline
Measure: Measures of liver dysfunction Time: 28 daysDescription: Change in SCr and eGFR from baseline
Measure: Measures of kidney dysfunction Time: 28 daysDescription: Change in highly-sensitive troponin (hs-troponin) from baseline
Measure: Measures of cardiac dysfunction Time: 28 daysDescription: Change from baseline ACT, aPTT, and/or PT/INR levels
Measure: Measures of coagulopathies Time: 28 daysDescription: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.
Measure: Changes in immunogenic responses Time: 28 daysDescription: Changes in total healthcare costs from admission to discharge between treatment groups.
Measure: Healthcare outcomes Time: 28 daysDescription: Change in serum cytokines including IL-1α, IL-1ß, IL-1ra, IL-5, IL-6, IL-8, IL-12, TNFα, CXCL10/IP10, MCP-3, and ferritin drawn at the same time as LSALT peptide levels
Measure: Molecular changes in pro-inflammatory pathways Time: 28 daysDescription: Pharmacokinetics of LSALT peptide over the study period.
Measure: Pharmacokinetics of LSALT peptide Time: 28 daysTo investigate the difference of the difference between the nonfatal Coronavirus Disease 2019 (COVID-19) Patients and the fatal Patients .The cross sectional study was undertaken to compare the clinical information (laboratory and radiologic characteristics)of nonfatal participants and fatal cases. The investigators wish figure out the clinical character of the fatal participants. The result may help the physician to find the fatal patients with COVID-19 more easily. The fatal patients with COVID-19 could be treated early.
Description: the counting of Lymphocyte(counts/L)
Measure: Lymphocyte cell Time: 2 monthDescription: d-dimer（mg/L）
Measure: d-dimer Time: 2 monthDescription: the counting of Platelets（(counts/L)）
Measure: PLT Time: 2 monthDescription: the level of C-reactive protein (mg/uL)
Measure: CRP Time: 2 monthDescription: lactate dehydrogenase ( U/L)
Measure: LDH Time: 2 monthDescription: creatine kinase (U/L)
Measure: CK Time: 2 monthDescription: prothrombin time(second)
Measure: PT Time: 2 monthDescription: alanine aminotransferase(U/L)
Measure: ALT Time: 2 monthDescription: aspartate aminotransferase(U/L)
Measure: AST Time: 2 monthDescription: natural killer cell(counts/L)
Measure: NK cell Time: 2 monthDescription: procalcitonin（ng/ml）
Measure: PCT Time: 2 monthDescription: interleukin-6(mg/L)
Measure: IL-6 Time: 2 monthDescription: CT scan feature
Measure: the clinical difference of radiologic characteristics between the fatal patients with COVID -19 and the non fatal cases Time: 2 monthsDescription: oxygen Saturation
Measure: SPO2 Time: 2 monthThe COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)
Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease Time: Measuring during 28-day period since randomization (Intention to treat analysis)Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)
Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization Time: Measuring during 14-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.
Measure: Time to clinical improvement Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;
Measure: Time to clinical failure Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with hospitalization for any cause
Measure: Hospitalization for any cause Time: Measuring during 28-day period since randomizationDescription: Evaluation of adverse events evaluated as associated to any of study arms
Measure: Proportion of participants who presented with adverse events Time: Measuring during 28-day period since randomizationDescription: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.
Measure: Time to improvement on respiratory scale symptoms Time: Measuring during 28-day period since randomizationThere is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.
Description: defined as the time from first dose of polyphenol extract to hospital discharge
Measure: Time to hospital discharge Time: Throughout the Study (Day 0 to Day 28)Description: proportion
Measure: 28-day all-cause mortality Time: Throughout the Study (Day 0 to Day 28)Description: proportion
Measure: invasive ventilation on day 28 Time: Throughout the Study (Day 0 to Day 28)Description: mean difference
Measure: Difference in Pro and antiinflammatory citoquine levels Time: day 1-14Description: proportion
Measure: Negativization of COVID-PCR at day 14 Time: day 14This study is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation and holds a European CE marking for in vitro diagnostic devices. These tests have been made available to South West Pathology Services as a donation in kind by iPP (Integrated Pathology Partnership). They have been widely used in South Korea. This study will test the practical delivery of the test in terms of time constraints and error rates. We will also compare the objective performance to the current standard diagnostic test for COVID-19 and against a proven serological antibody test when a suitable reference testing becomes available. We will recruit patients having a SARS CoV-2 PCR swab test and ask for consent to test them with the PCL antigen test in parallel. We aim to study 200 patients split across three sites; Musgrove Park Hospital, Basildon University Hospital and Southend University Hospital. The results will not be used to guide clinical decision making. Patients having a COVID PCR test will be asked to read the patient information sheet and asked if they would like to participate. The patients will be asked to have a second nasal/throat swab taken shortly after their swab for the PCR test. Written informed consent will be taken for whole blood or plasma left over from any routine clinical sample to be stored as anonymised samples for future testing once a reference test becomes available. We will report results of the onsite clinical diagnostic test and the PCL antigen test with the number of the kit used, and test date. Anonymised information about year of birth, gender and place of testing will be collected alongside date of onset, symptoms and immunodeficiency status or significant conditions.
Description: Compare the sensitivity and specificity of the rapid antigen testing to current PCR test and any future developed reference test
Measure: To compare the result of SARS-COV2 PCR test to PCL rapid antigen test Time: within 24 hoursDescription: Number of PCL antigen tests that are invalid (no control testing line)
Measure: Number of technically failed samples due to test issues. Time: At time of testing (within 30 minutes)Description: Time from swab being taken to result being read by point of care analyser, manufacturer anticipates 10-15 minutes
Measure: Time taken for PCL Antigen test result Time: within 30 minutesIn this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019
Description: death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula
Measure: severe COVID-19 Time: 17/04/2020 to 01/06/2020This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.
Description: Measure the incidence of COVID-19 infection among children with cancer
Measure: Incidence of COVID-19 among children with cancer Time: 12 monthsDescription: Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission
Measure: Families training Time: 12 monthsHospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.
Description: Incidence rate of IPC-defined HOCIs, measured as incidence rate of recorded cases per week per 100 inpatients, during each phase of the study based on case report forms.
Measure: Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs) Time: 6 monthsDescription: Identification of nosocomial transmission using sequencing data in potential HOCIs in whom this was not identified by pre-sequencing IPC evaluation, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
Measure: Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing Time: 6 monthsDescription: Incidence rate of IPC-defined hospital outbreaks, defined as cases of hospital transmission linked by location and with intervals between diagnoses of no greater than 2 weeks (relevant data extracted from case report forms), measured as incidence rate of outbreak events per week per 100 inpatients during each phase of the study.
Measure: Incidence rates of IPC-defined hospital outbreaks Time: 6 monthsDescription: Incidence rate of IPC+sequencing-defined hospital outbreaks, defined by retrospective review of all available sequencing and epidemiological data for identification of transmission clusters and measured as outbreak events per week per 100 inpatients during each phase of the study.
Measure: Incidence rates of IPC+sequencing-defined hospital outbreaks Time: 6 monthsDescription: Changes to IPC actions implemented following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
Measure: Changes to IPC actions following viral sequence reports Time: 6 monthsDescription: Changes to IPC actions that would ideally have been implemented (given unlimited resources) following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
Measure: Recommended changes to IPC actions following viral sequence report - not implemented Time: 6 monthsDescription: Health economic benefit of standard and rapid sequencing reports to IPC measured using bespoke health economic case report data comparison between baseline, standard and rapid sequencing phases.
Measure: Health economic benefit to IPC of standard vs rapid sequencing reports Time: 6 monthsDescription: Number of HCW days off work measured from sampling these data points on case report forms at all study phases.
Measure: Impact of both standard and rapid sequencing reports on number of HCW days off work Time: 6 monthsThe new coronavirus outbreak has led to a public health emergency of international concern, putting all health organizations on high alert. As part of the hygienic measures, isolation and reinforcement cleaning strategies have been followed. It is known that special attention and efforts should be applied to protect or reduce transmission in susceptible populations, including the elderly or those with comorbidities.It has also been proposed a semaforization to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough, headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis, chest pain, diarrhea, anosmia, ageusia. Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA, including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory Syndrome (MERS). Facing the lack of options against COVID-19 outbreaks for example in health workers, nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus reducing at the same time the Hospital saturation of patients positive to this virus.
Description: The percentage of health workers that require hospitalization after beginning an early treatment with nitazoxanide in case of referring symptoms of COVID-19.
Measure: Health workers that require hospitalization Time: Two weeks since the begining of symptomsConsidering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.
Description: skin laser Doppler perfusion monitoring before and after local thermal hyperemia
Measure: To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19. Time: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.Observational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.
Description: Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.
Measure: Description of the characteristics of patients Time: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeksScientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.
Description: PNRT50
Measure: Plaque reduction neutralization test (PNRT) Time: day 7 after first transfusionDescription: Change of D-dimer compared between pre and post transfusion
Measure: D-dimer Time: day 1,4,7,14 after first transfusionDescription: Change of CRP compared between pre and post transfusion
Measure: C-Reactive Protein (CRP) Time: day 1,4,7,14 after first transfusionDescription: Change of INR compared between pre and post transfusion
Measure: International Normalized Ratio (INR) Time: day 1,4,7,14 after first transfusionDescription: Change of OI compared between pre and post transfusion
Measure: Oxygenation Index Time: day 1,4,7,14 after first transfusionDescription: Change of CXR with CXR covid score compared between pre and post transfusion
Measure: Chest X-ray Time: day 1,4,7,28 after first transfusionDescription: every adverse event that cause patient to die, prolonged hospitalization or worsening clinical stage of illness
Measure: severe adverse event Time: from day 0 to 14 days after plasma transfusionThe United Kingdom and wider world is in the midst of the 2019 novel coronavirus (SARS-CoV-2) pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance to our response. Widespread population testing has proven difficult in western countries and has been limited by test availability, human resources and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients and early treatment for those most at risk. The life sciences industry has responded to the pandemic by developing multiple new in vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests we require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation in this global pandemic, we will conduct a platform adaptive diagnostic study on a national level, utilising a national network of expertise in the evaluation of diagnostic technology. This study will enable the evaluation of multiple assays in three priority areas: 1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2 2. Evaluation of assays monitoring the immune response to SARS-CoV-2 infection 3. Evaluation of the prognostic value of commercially available tests for predicting prognosis in patients with suspected or confirmed SARS-CoV-2 infection. (This arm will not be active immediately but may be activated after initiation).
Description: This will be determined using the point-of-care test and the laboratory test results
Measure: If the participant has an active SARS-CoV-2 infection during admission Time: BaselineDescription: This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results
Measure: The participant has had a past SARS-CoV-2 infection Time: Day 90The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.
Description: SpO2 was measured by peripheral pulse oximetry.
Measure: Change in SpO2 Time: Before proning and 1 hour after initiation of the prone positionDescription: The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. <95% 1 hour after initiation of the prone position was assessed.
Measure: Mean Risk Difference in Intubation Rates Time: Duration of hospitalization or up to 1 month from admissionMorbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for detecting the progress of Covid-19 pneumonia or not.
Description: İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.
Measure: estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio Time: March-May 2020This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (COVID 19)
This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers, assessment of clinical presentation and severity of COVID 19 infection among healthcare workers and discover relation between the time of COVID 19 viral clearance resolution of symptoms
Description: different relations between different symptoms, investigation results and time of viral clearness
Measure: the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms. Time: baslineDescription: good and bad knowledge or practice
Measure: knowledge and practice of infection control measures Time: baselineIn this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 30 seconds, for 4 weeks.
Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load
Measure: Change in SARS-Cov-2 viral load Time: Baseline to 4 weeksDescription: Change in self-reported (questionnaire) clinical symptom onset. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Measure: Change in self-reported clinical symptom onset Time: Baseline to 4 weeksDescription: Change in healthcare utilization and hospitalization
Measure: Change in healthcare utilization and hospitalization Time: Baseline to 4 weeksDescription: Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers
Measure: Change in SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksDescription: Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Measure: Change in self-reported clinical symptom onset in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksDescription: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers
Measure: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksThis study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others. The evaluation procedure includes symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored.
Description: PaO2/FiO2
Measure: Oxygenation index Time: one day after the last sessionDescription: Room air saturation
Measure: SpO2 Time: 6 hours after a sessionDescription: Room air saturation
Measure: SpO2 Time: one week after the last sessionDescription: COVID19 symptoms
Measure: Symptoms level Time: one week after the last sessionDescription: Radiologic
Measure: Chest Xray Time: one week after the last sessionIn light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global population and health care systems are facing unprecedented challenges through the combination of transmission and the potential for severe disease. Acute respiratory distress syndrome (ARDS) has been found with unusual clinical features dominated by substantial alveolar fluid load. It is unknown whether this is primarily caused by endothelial dysfunction leading to capillary leakage or direct virus induced damage. This knowledge gap is significant because the initial balance between fluid management and circulatory support appear to be decisive. On progression of the disease, bacterial superinfection facilitated by inflammation and virus related damage, has been identified as the main factor for patient outcome, but the role of the host versus the environment microbiome remains unclear. The overarching aim of the present research proposal is to improve therapeutic strategies in critically ill patients with ARDS due to SARS-CoV-2 infection by advancing the pathophysiological understanding of this novel disease. This research thus focuses on inflammation, microcirculatory dysfunction and superinfection, aiming to elucidate risk factors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients and contribute to the rationale for therapeutic strategies. The hypotheses are that (I) the primary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggerated pro-inflammatory response causing primary endothelial dysfunction, and subsequently acting two-fold on the degradation of the lung parenchyma - through the primary cytokine response, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophil axis. The pronounced inflammation and primary damage to the lung disrupts the pulmonary microbiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterial superinfections are a significant cause of morbidity and mortality in COVID-19 patients. Pathogen colonization main Risk Factor for lower respiratory tract infections. To establish colonization, pathogens have to interact with the local microbiota (a.k.a. microbiome) and certain microbiome profiles will be more resistant to pathogen invasion. Finally, (III) Handheld devices used in clinical routine are a potential reservoir and carrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.
Description: Daily recorded Vitals and Inflammatory Response will be analyzed by means of multivariable mixed effect models analysis and generalized linear models, with corrections for time and randomness. To account for the different units of measure we will standardize all values to an absolute measure by means of the z-score. The following variables will be considered: Respiratory values, Vital signs, Haemodynamic monitoring, Microcirculation, Inflammatory values, Hematology: T-cells CD3, 4 and 6 Chemistry: Inflammatory Cytokines and Biomarkers:CRP, PCT, MR-ProADM, IFN-1, IFN-γ, TNF-α/β, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, MIG, RANTES, MCP-1, IP-10, PD1, PD-L1 Lipid-pannel3: LDL, HDL, Cholesterol, Triglyceride Other: HLA DR/DQ TBS, Swabs, sublingual nonnvasive microscopy
Measure: Change of pro-inflammatory response over the ICU stay as a causative for primary endothelial dysfunction Time: Admission, on day 0, day 1, day 2 , day 3, day 5, every 5 days up to 1 yearDescription: COX proportional hazards model and generalized mixed effect models assessing the effect of positive bacterial infection on mortality. Correction for time and randomness (multiple sampling). Super infection will be defined as a positive bacterial/ fungal sample (Bood cultures, BAL, TBS, Swabs, Urine)
Measure: Time-to-event "pulmonary bacterial superinfection or death" Time: Through study completion, an average of 30 daysDescription: Mobile devices will be swabed for bacterial and viral contamination, simultaneously adherence of the user to disinfection protocols will be assessed.
Measure: Positive bacteria and/ or SARS-CoV-2 cultures on handheld devices used in clinical routine and correlation to the adherence to disinfection protocols Time: Through study completion, an average of 30 daysDescription: SF 36 questionnaire
Measure: Life Quality after COVID-19 Infection Time: follow up 30 + 90 days and 1 year after dischargeTo find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease
Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.
Description: Proportion of patients who reduce the time in the hospital
Measure: Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19 Time: 30 daysDescription: Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19
Measure: Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19 Time: 30 daysDescription: Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment
Measure: Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment Time: 30 daysDescription: Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment
Measure: Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment Time: 30 daysDescription: Assess the efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.
Measure: Efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms. Time: 30 daysDescription: Evaluate the efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.
Measure: Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease. Time: 30 daysDescription: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19
Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19 Time: 30 daysThe aim of this study is to measure current affective symptoms and psychological distress in individuals with severe mental illness during the COVID-19 pandemic using an online questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep quality, attitudes concerning the virus, the adherence to the measures, believing processes, and coping strategies/resilience patterns referring to COVID-19 in different study centers.
Description: Brief Symptom Inventory-18 with higher scores meaning a worse outcome (more depression, anxiety and somatization); Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 72)
Measure: Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index) Time: 1 yearDescription: Beck Depression Inventory-II with higher scores mean a worse Outcome (more depressive Symptoms; each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
Measure: Depressive symptoms Time: 1 yearDescription: Pittsburgh Sleep Quality Index (PSQI) with higher scores mean a worse Outcome (more sleeping disturbances; Each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
Measure: Sleep disorders and Sleep Quality Time: 1 yearDescription: Lifestyle Questions including physical activity, eating behavior, substance use, smoking
Measure: Life style changes Time: 1 yearDescription: Food Craving Inventory (FCI) with higher scores mean a worse Outcome (more Food craving; Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 112)
Measure: Food Craving Time: 1 yearDescription: COVID-19 questionnaire with higher scores meaning a worse Outcome (more fears and negative emotions; each item is weighted on a 0-10 interval scale)
Measure: COVID-19 associated fears and emotional responses to the pandemic Time: 1 yearBeyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.
Description: Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma
Measure: Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure. Time: Track patient progress for 28 days post initial convalescent dose.Description: Measure reduction in ventilator use and/or changes in mechanical ventilator parameters
Measure: Ventilatory free days Time: Track patient progress for 28 days post initial convalescent dose.Description: Measure length of stay from the time of admission to the hospital and subsequent admission to the ICU. Document resolution of COVID-19 infection or alternatively patient death.
Measure: Patient mortality (including death from any cause) Time: Track patient progress for 28 days post initial convalescent dose.Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days) vs late (after at least 10 days) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality will be evaluated and compared.
Description: Number of days without mechanical ventilation
Measure: Mechanical ventilation Time: 28 daysDescription: Number of days at ICU
Measure: ICU stay Time: 28 daysDescription: Number of days with need of additional oxygen support
Measure: Oxygen support Time: 28 daysDescription: Number of days with the need of sedation
Measure: Sedation Time: 28 daysDescription: Various adverse events associated with the tracheotomy/tracheostomy
Measure: Adverse events Time: 28 daysDescription: Mortality
Measure: Mortality Time: 90 daysThe aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
Description: Comparing the influence of the intervention on the Survival rate.
Measure: Survival rate. Time: up to 8 weeks.Description: For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.
Measure: Rate of disease remission. Time: up to 4 weeks.Description: Comparing the influence of the intervention on the PCR negative results.
Measure: The number of patients with PCR negative results. Time: up to 4 weeks.Description: Recording the changes from severe to moderate or mild and the time taken.
Measure: Mean change in the disease severity (clinical assessment). Time: up to 4 weeks.Description: Recording the changes in blood pressure mmHg.
Measure: Mean change in blood pressure. Time: up to 4 weeks.Description: Recording the changes in heart rate in beat/second.
Measure: Mean change in heart beats. Time: up to 4 weeks.Description: Recording the changes in body temperature in Celsius.
Measure: Mean change in body temperature. Time: up to 4 weeks.Description: Recording the changes in the respiratory rate in breath/minute.
Measure: Mean change in body respiratory rate. Time: up to 4 weeks.Description: Recording the changes in arterial oxygen saturation in mmHg.
Measure: Mean change in oxygen saturation. Time: up to 4 weeks.Description: Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).
Measure: Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio). Time: up to 4 weeks.Description: Recording the changes in complete blood picture (CBC) in cells per liter.
Measure: Mean change in complete blood picture (CBC). Time: up to 4 weeks.Description: Recording the changes in C reactive protein (CRP) in mg/L.
Measure: Mean change in C reactive protein (CRP). Time: up to 4 weeks.Description: Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.
Measure: Mean change in erythrocyte sedimentation rate (ESR). Time: up to 4 weeks.Description: Recording the changes in D-dimer in ng/mL.
Measure: Mean change in D-dimer. Time: up to 4 weeks.Description: Recording the changes in ferritin in ng/mL.
Measure: Mean change in ferritin. Time: up to 4 weeks.Description: Recording the changes in liver Albumin in g/L.
Measure: Mean change in liver Albumin. Time: up to 4 weeks.Description: Recording the changes in total and direct Bilirubin in mg/dL.
Measure: Mean change in total and direct Bilirubin. Time: up to 4 weeks.Description: Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).
Measure: Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ). Time: up to 4 weeks.Description: Recording the changes in aspartate aminotransferase (AST) in IU/L.
Measure: Mean change in aspartate aminotransferase (AST). Time: up to 4 weeks.Description: Recording the changes in Alanine Aminotransferase (ALT) in IU/L.
Measure: Mean change in Alanine Aminotransferase (ALT). Time: up to 4 weeks.Description: Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.
Measure: Mean change in Blood Urea Nitrogen (BUN). Time: up to 4 weeks.Description: Recording the changes in Serum Creatinine in mg/dL.
Measure: Mean change in Serum Creatinine. Time: up to 4 weeks.Description: Recording the changes in Serum Creatinine in ml/min.
Measure: Mean change in Serum Creatinine clearance. Time: up to 4 weeks.Description: Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.
Measure: Mean change in Glomerular filtration rate (GFR ). Time: up to 4 weeks.Description: Recording the changes in interleukin-1 (IL-1) in pg/ml.
Measure: The mean change in serum interleukin-1 (IL-1). Time: up to 4 weeks.Description: Recording the changes in interleukin-6 (IL-6) in pg/ml.
Measure: The mean change in serum interleukin-6 (IL-6). Time: up to 4 weeks.Description: Recording the changes in interleukin-10 (IL-10) in pg/ml.
Measure: The mean change in serum interleukin-10 (IL-10). Time: up to 4 weeks.Description: Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.
Measure: The mean change in serum tumor necrosis factor-alpha (TNF alpha). Time: up to 4 weeks.Description: Recording the changes in immunoglobulin G (IgG) in ng/ml.
Measure: Mean changes in immunoglobulin G (IgG). Time: up to 4 weeks.Description: Recording the changes in immunoglobulin M (IgM) in ng/ml.
Measure: Mean changes in immunoglobulin M (IgM). Time: up to 4 weeks.Description: Recording the changes in PCR viral load in copies/mL.
Measure: The mean change in PCR viral load. Time: up to 4 weeks.Description: Recording the changes in lung CT.
Measure: Mean change in lung CT manifestation. Time: up to 4 weeks.Description: Recording any unexpected Adverse Events of the intervention.
Measure: Nature and severity of Adverse Events. Time: up to 4 weeks.Description: Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.
Measure: Time for lung recovery. Time: up to 8 weeks.Description: Recording the changes the event of missed drug doses.
Measure: The number of missed drug doses among each treatment group. Time: up to 4 weeks.This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
Measure: Identification of requirement of mechanical ventilation Time: 3 weeksDescription: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Measure: Prediction of requirement of mechanical ventilation Time: 3 weeksDescription: Descriptive assessment of clinical parameters and LUS-score over time
Measure: Association of LUS to clinical parameters Time: 3 weeksDescription: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
Measure: Description of findings on LUS Time: 3 weeksBy Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China. It is known that some predisposing conditions lead to a worse outcome with coronavirus. In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36). The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms. In the future, this study will provide answers for two main questions 1. Why diabetics are more at risk of developing Covid-19 infection? 2. Why diabetics are at high risk of developing severe forms?
Description: Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen
Measure: Prevalence of diabetes among all hospitalized COVID-19 Time: 3 monthsDescription: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19
Measure: Diabetes-related factors risk Time: 3 monthsThe study will analyze the prevalence of cardiac involvement of health care workers from the University Hospital of Salamanca (HUSA) who have overcome SARS-CoV-2 infection. Participants will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR) and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.
Description: Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
Measure: Myocarditis Time: up to 3 monthsDescription: Prevalence of pericarditis assessed by clinical criteria
Measure: Pericarditis Time: up to 3 monthsDescription: Prevalence of atrial fibrillation on EKG
Measure: Atrial fibrillation Time: up to 3 monthsDescription: Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
Measure: Ischemic heart disease Time: up to 3 monthsDescription: Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
Measure: Dilatation of right heart chambers Time: up to 3 monthsDescription: Prevalence of valvular heart disease assessed by cardiac magnetic resonance
Measure: Valvular hear disease Time: up to 3 monthsDescription: Prevalence of prolonged QT interval on EKG
Measure: Rhythm disorders Time: up to 3 monthsCritically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Hence, it may be need a new scoring system for contagious critically ill patients.
Description: To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.
Measure: Polymerase Chain Reaction (PCR) test Time: 5 daysDescription: To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.
Measure: A scoring system for patients to be admitted to the intensive care unit Time: 5 daysCOronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.
Description: COVID-19's Patients mortality all cause: incidence proportion.
Measure: Mortality Time: 12 months.Description: COVID-19's Patients suicide: incidence proportion.
Measure: Mortality-suicide Time: 12 months.Description: In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -
Measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients- Time: 1 months.Description: Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
Measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder. Time: 12 months.Description: Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.
Measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II). Time: 12 months.Description: Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.
Measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI). Time: 12 months.According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.
Description: Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).
Measure: Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period Time: Day of intervention (1 day)Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2
Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3. Time: Visit 3 (90 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Time: Visit 4 (135 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Time: Visit 5 (180 +/- 5 days)Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled
Measure: Prevalence of IgG/IgM against SARS-CoV-2 Time: Screening Visit and Visit 3 (90 +/- 5 days)Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit
Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19. Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.
Measure: The impact of new cardiovascular events between the two study groups Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.
Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed
Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. 20 patients will receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive matching placebo in addition to standard of care unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
Description: To compare the total oxygen requirement (area under the curve) for each arm using daily supplemental oxygen flow (L/min) over 14 days
Measure: Measurement of the oxygen requirement Time: 14 daysDescription: To comparing the time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min
Measure: Measurement of the reduction in oxygen requirement. Time: 14 daysDescription: To comparing the proportion of patients in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14
Measure: Eliminating supplemental oxygen Time: 14 daysDescription: To compare the proportion of afebrile patients in each arm at Day 14 via measurement of temperature.
Measure: Elimination of fever Time: 14 daysDescription: To compare the time in each arm to negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab for SARS-CoV-2
Measure: Time to negative swabs for SARS-CoV-2 by PCR post treatment Time: 6 weeksDescription: To comparing the time in each arm to achieve negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab for SARS-CoV-2 during treatment
Measure: Time to negative swabs for SARS-CoV-2 by PCR at Day 14 Time: 14 daysDescription: To compare the percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
Measure: Intubation and mechanical ventilation requirements Time: From screening phase and every day from day 1 to day 14 of treatmentDescription: To compare the time in each arm for the patient to require mechanical ventilation.
Measure: Evaluation of the time to mechanical ventilation Time: From screening phase and every day from day 1 to day 14 of treatmentDescription: To compare the proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14
Measure: Evaluation the proportion of patients, with at least one measurement of fever at baseline who are afebrile at Day 14 Time: From screening phase and every day from day 1 to day 14 of treatmentDescription: To compare the mortality in each arm 30 days post-baseline.
Measure: Evaluation of mortality 30 days post-baseline Time: 30 days after day 1 of treatmentDescription: To compare the number of all treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measure: Safety Time: 6 weeksThe aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
Description: Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.
Measure: Disease severity Time: on day 7Description: Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)
Measure: Time to clinical improvement Time: within 14 days after enrolmentDescription: Proportion of participants alive and not having required invasive or non-invasive ventilation
Measure: Proportion of participants alive and not having required invasive or non-invasive ventilation Time: at 14 days after enrolmentDescription: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)
Measure: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg) Time: within 14 days after enrolmentDescription: Changes in the ordinal WHO scale
Measure: Changes in the ordinal WHO scale Time: from baseline over 14 daysDescription: Length of hospital stay in survivors
Measure: Length of hospital stay in survivors Time: until day 28Description: Proportion of participants progressing to mechanical ventilation
Measure: Proportion of participants progressing to mechanical ventilation Time: on day 7 and day 14Description: Proportion of participants requiring ICU treatment
Measure: Proportion of participants requiring ICU treatment Time: on day 7 and 14Description: Length of ICU stay
Measure: Length of ICU stay Time: until day 28Description: 28 Ventilator-free days
Measure: 28 Ventilator-free days Time: until day 28Description: All-cause mortality
Measure: All-cause mortality Time: time from randomisation to death within four weeksDescription: Changes in biomarker level CRP
Measure: Changes in biomarker level CRP (mg/l) Time: until day 14Description: Changes in biomarker level LDH
Measure: Changes in biomarker level LDH (U/l) Time: until day 14Description: Changes in biomarker level D-Dimer
Measure: Changes in biomarker level D- Dimer (yg/ml) Time: until day 14Description: Changes in biomarker level Ferritin
Measure: Changes in biomarker level Ferritin (ng/ml) Time: until day 14Description: Changes in biomarker level IL-6
Measure: Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml) Time: until day 14Description: Changes in lymphocyte count
Measure: Changes in lymphocyte count (cells per microliter of blood) Time: until day 14Description: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples
Measure: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples Time: time from enrolment to first of 2 negative assays at least 12 hours apartDescription: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins
Measure: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins Time: within 14 daysDescription: Time to defervescence (temperature <38.0°C)
Measure: Time to defervescence (temperature <38.0°C) Time: sustained for at least 48 hoursDescription: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)
Measure: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28 Time: until day 28Description: Duration of supplemental oxygen
Measure: Duration of supplemental oxygen Time: until day 28Description: Peak serum concentration of conestat alfa will be measured
Measure: Change in pharmacokinetics of conestat alfa Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge dateDescription: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)
Measure: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration) Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge dateThis is a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care, compared with placebo plus standard of care, in patients with respiratory signs and symptoms secondary to novel coronavirus disease (COVID-19).
Description: Respiratory failure as defined by need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation >6L oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation
Measure: Proportion of subjects alive and free of respiratory failure Time: 29 DaysDescription: Proportion of subjects achieving a ≥ 2 category improvement on 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29
Measure: Secondary clinical improvement outcomes Time: 29 DaysDescription: National early warning score (NEWS) of ≤2 maintained for 24 hours
Measure: Time to clinical improvement (TTCI) Time: 29 DaysDescription: Change from baseline to Day 29 or hospital discharge or death, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2)
Measure: To evaluate improvement in oxygenation in hospitalized adults with respiratory signs and symptoms secondary to COVID 19 treated with axatilimab Time: 29 DaysDescription: Serum concentrations of IL 6 and c-reactive protein (CRP) change from baseline to Day 15 or hospital discharge or death
Measure: To evaluate changes in biomarkers following treatment with axatilimab Time: 15 DaysDescription: Frequency and severity of AEs and SAEs
Measure: To evaluate the safety and tolerability of axatilimab in the same population Time: 29 DaysDescription: Proportion of subjects who require initiation of mechanical ventilation after study entry
Measure: Ventilation outcomes Time: 29 DaysDescription: Proportion of subjects who are SARS CoV-2 virus free by Day 15 or hospital discharge, whichever is sooner
Measure: To evaluate antiviral effect of axatilimab in hospitalized adults with recently diagnosed SARS CoV-2 infection Time: Day 15Description: Serum concentration of axatilimab and presence of anti-drug antibody
Measure: To characterize exposure to axatilimab Time: 29 DayAccording to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.
Description: Changes of three measurements of extracellular water in both lungs
Measure: ECW Time: three measurements with half an hour intervalsSince the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.
Description: Rate of presence
Measure: rate of presence of anti-SARS-CoV-2 antibodies (Ig G _ Ig M) among employees working in a GHT Haute Bretagne health establishment. Time: at inclusion visitDescription: Sensitivity
Measure: a) Validation of the Biotech NG test: Time: at inclusion visitDescription: Specificity
Measure: a) Validation of the Biotech NG test: Time: at inclusion visitDescription: agreement between observers (kappa coefficient)
Measure: a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgG Time: at inclusion visitDescription: agreement between observers (kappa coefficient)
Measure: a) Validation of the Biotech NG test: Agreement between observers (kappa coefficient) for IgM. Time: at inclusion visitDescription: Demographic characteristics (age, sex)
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - Professional characteristics (establishment, profession, service).
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - Management of confirmed or probable COVID-19 patients
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - From contact with confirmed or probable COVID-19 professionals.
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - From contact in his personal circle with COVID-19 confirmed or probable persons.
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - Episodes of symptoms suggestive of COVID-19
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - The existence of a chronic immunomodulatory pathology
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - The existence of smoking
Measure: b) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - The use of materials adapted to good hygiene practices
Measure: c) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: - Service organization
Measure: c) Risk of presence of anti SARS-CoV-2 antibodies in function: Time: At inclusion visitDescription: depending on the work sector (COVID dedicated or not) and depending on the profession: - Rate of employees who changed their tobacco consumption
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of the reasons for modifying tobacco consumption
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: depending on the work sector (COVID dedicated or not) and depending on the profession: - Rate of employees who changed their alcohol consumption
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of the reasons for modification of alcohol consumption
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: depending on the work sector (COVID dedicated or not) and depending on the profession: - Rate of employees who have changed their eating habits
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of sleep changes
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: depending on the work sector (COVID dedicated or not) and depending on the profession: - Description of lived experience and perceived stress
Measure: d) Description of the experience and behavioral changes related to the epidemic, Time: at Day 0Description: For employees identified as COVID "certain or probable" * Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.
Measure: e) Evolution of seroprevalence over time: Time: At Day30Description: For employees identified as COVID "certain or probable" * Evolution of the kinetics of antibodies (IgG and IgM) against SARS CoV-2 on D30 and D90.
Measure: e) Evolution of seroprevalence over time: Time: At Day 90Description: For the random sample of employees with follow-up on D90: Percentage of employees with antibodies (IgG and IgM) against SARS CoV-2
Measure: e) Evolution of seroprevalence over time: Time: At Day 90This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
Measure: SARS-CoV-2 Neonatal Infection Time: 7 daysDescription: stillbirths and deaths in the first week of life
Measure: Perinatal mortality Time: 35 weeksDescription: maternal ICU admission due to COVID-19
Measure: ICU maternal admission Time: 35 weeksDescription: Newborn 5 minute Apgar Score < 7
Measure: 5 minute Apgar Score < 7 Time: 1 dayDescription: Delivery between 24 and 36 weeks
Measure: Preterm labour Time: 35 weeksDescription: Preterm premature rupture of the membranes between 24 and 36 weeks
Measure: PPROM Time: 35 weeksDescription: spontaneous pregnancy loss before 24 weeks
Measure: Miscarriage Time: 14 weeksAt the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus. Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells. Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible. The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.
Description: Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19
Measure: Emergency department attendance of hospitalisation related to COVID-19 Time: Day 1 to day 28Description: Evaluate the effect of intervention on body temperature
Measure: Body temperature Time: Day 1 to day 14Description: Evaluate the effect of intervention on blood oxygen level
Measure: Blood oxygen saturation level Time: Day 1 to day 14Description: Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.
Measure: Symptoms as assessed by common cold questionnaire Time: Day 1 to day 14Description: Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.
Measure: Symptoms as assessed by FluPro questionnaire Time: Day 1 to day 14Description: Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load
Measure: Nasal/throat swab SARS-CoV-2 viral load Time: Day 1, 7 and 14Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.
Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Measure: Health-related quality of life. Time: One-year (12 months) after ICU discharge.Description: Length of stay at the ICU.
Measure: Length of stay at the ICU. Time: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).Description: Incidence of all-cause mortality.
Measure: Incidence of all-cause mortality Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Rehospitalization.
Measure: Rehospitalization. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
Measure: Percentage of long-term ventilatory support need. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Percentage of patients requiring any kind of renal replacement therapy.
Measure: Percentage of renal replacement therapy need. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
Measure: Symptoms of anxiety and depression. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).
Measure: Score of functional independence. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.
Measure: Score of cognitive function. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Percentage of major cardiac events.
Measure: Percentage of major cardiac events. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.
Measure: Score of Chronic obstructive pulmonary disease (COPD) Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
Measure: Symptoms of posttraumatic stress disorder Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Measure: Utility score of health-related quality of life at 3, 6, and 9 months. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).
Measure: Score of self-rated health. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System
Description: Conduct a quantitative fit test and calculate the percentage of participants who pass the test.
Measure: Success Percentage Time: 15 minutesDescription: Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask
Measure: End-tidal CO2 Variation. Description: mmHg. Time: at 0 and 15 minutesDescription: Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask
Measure: Oxygen Pulse Oximetry Variation. Description: mmHg. Time: at 0 and 15 minutes.Description: Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes
Measure: Mask Visibility. Description: Likert Scale. Time: 15 minutesDescription: When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.
Measure: Willingness of usage. Description: Likert Scale. Time: after 15 minutesIn-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19. This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.
Description: Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status. * Seven-category ordinal scale of clinical status not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalization, not requiring supplemental oxygen; hospitalization, requiring supplemental oxygen; hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; death.
Measure: Proportion of patients with clinical improvement Time: Day 14 & Day 28Description: Time to clinical improvement (TTCI) was defined as time from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first.
Measure: Time to clinical improvement (TTCI) Time: up to 28 daysDescription: * Seven-category ordinal scale of clinical status not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalization, not requiring supplemental oxygen; hospitalization, requiring supplemental oxygen; hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; death. Higher scores of Seven-category ordinal scale mean serious clinical status.
Measure: Clinical status assessed by 7-category ordinal scale Time: days 7, 14, and 28Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The range of NEW score is from zero to 23. Higher scores of NEWS mean the higher risk of poor outcomes. The NEW Score is being used as an efficacy measure.
Measure: Change in National Early Warning Score (NEWS) Time: Day 1 trough Day 28To date no treatment has proven its effectiveness in the caring of patients infected with type 2 Coronavirus. The Centre Hospitalier Princesse Grace (CHPG) has decided to only propose randomized double-blind placebo-controlled clinical trials to patients at the early and symptomatic stages of the disease. Data from the literature show in vitro results on the potential clinical benefit of some treatments such as chloroquine or hydroxychloroquine (HXCQ). Observational data suggest a potential benefit of this treatment alone or in combination with azithromycin (HXCQ + AZ). These data were advertised or led to a request from ambulatory medicine and patients to have access to these treatments despite their poor level of evidence. This leads to a decrease in the number of patients recruitable for clinical trials because they refuse the concept of control arms or they wish active treatment (CQ, HXCQ or HXCQ + AZ) from the start. In this context, we propose to conduct in parallel with randomized trials, a so-called "patient preference" protocol which, after patients information, gives them the choice, either to participate in the trial or to choose between treatment with HXCQ, treatment with HXCQ + AZ or standard of care without medication. The patients follow-up and the main endpoint will be the same under the patient preference protocol as for the randomized trial. The advantage of this approach is to offer a common follow-up to all patients, to take into account patients who refuse to participate in the clinical trial, to obtain external validity data, to reduce selection bias and to increase the heterogeneity of patients exposed to treatment options. The expected objective is to see if the patient preference protocol leads to observe the same effects as in the randomized trial.
Description: Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.
Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment. Time: day 14Description: Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.
Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment. Time: day 28Description: Clinical evolution on the World Health Organisation (WHO) Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 between day 0 and day 14. Score is between 0 and 8, 8 being the worst.
Measure: Clinical evolution on the World Health Organisation (WHO) Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 between day 0 and day 14 Time: day 14Description: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28. Score is between 0 and 8, 8 being the worst.
Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28. Time: day 28Description: Number of all-cause mortality at day 14
Measure: Number of all-cause mortality at day 14 Time: day 14Description: Number of all-cause mortality at day 28
Measure: Number of all-cause mortality at day 28 Time: day 28Description: Rate of positive severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) Reverse Transcriptase (RT) - Polymerase Chain Reaction (PCR) on nasopharyngeal samples at day 5
Measure: Rate of positive severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) Reverse Transcriptase (RT) - Polymerase Chain Reaction (PCR) on nasopharyngeal samples at day 5 Time: day 5Description: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10
Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10 Time: day 10Description: The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.
Measure: The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee. Time: day 28Description: Number of all-cause mortality at day 28 in patients aged 75 and older
Measure: Number of all-cause mortality at day 28 in patients aged 75 and older Time: day 28Description: Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older. Score is between 0 and 8, 8 being the worst.
Measure: Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older Time: day 28Description: Rate of severe adverse events at day 28
Measure: Rate of severe adverse events at day 28 Time: day 28Description: Number of all-cause mortality at day 14 in patients aged 75 and older
Measure: Number of all-cause mortality at day 14 in patients aged 75 and older Time: day 14The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Moreover, plasma-exchange is expensive and requires large volumes of substitution fluid With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The use of plasma as a substitution fluid further increases treatment costs and is associated with risk of infections, allergic reactions and citrate-induced hypocalcemia. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. The aforementioned limitations of plasma therapy can be in part overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP)3. During DFPP, plasma is separated from cellular components by a plasma filter, and is then allowed to pass through a fractionator filter. Depending on the membrane cut-off, the fractionator filter retains larger molecules and returns fluid along with smaller molecules to the circulation. Thus, the selection of a membrane with an appropriate sieving coefficient for IgG allows to efficiently clear autoantibodies in patients with antibody-mediated diseases (e.g., macroglobulinemia, myasthenia gravis and rheumatoid arthritis) with negligible fluid losses and limited removal of albumin and coagulation factors1. In patients with severe membranous nephropathy and high titer of autoreactive, nephritogenic antibodies against the podocyte-expressed M type phospholipase A2 receptor (PLA2R), DFPP accelerated anti PLA2R depletion4. Measurement of the antibody titer in treated patient and recovered fluid showed that antibody removal was extremely effective and that large part of antibodies was removed during the first DFPP procedure. This therapeutic regimen was safe and well tolerated and easy to apply4. In an ongoing pilot study we found that the same methodological approach can be used to remove circulating antibodies from patients who recovered from COVID 19 and to infuse these antibodies in patients with active viral infection. Treatment was well tolerated and preliminary findings are encouraging. Thus, in this novel pilot study we aim to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for patients with earlier stages of coronavirus (COVID-19) pneumonia requiring oxygen supply without mechanical ventilation.
Description: Marker of complement activation in plasma.
Measure: C5a concentration Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: C3a concentration Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum C5b-9 concentration Marker of complement activation Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum IL-6 levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum IL-1b levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum IFNγ levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum MCP-1 levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum TNFα levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum IL-10 levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum IL-2 levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.Description: Marker of complement activation in plasma.
Measure: Serum IL-7 levels Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease
Description: Decrease in dyspnea measured by respiratory rate (RR)
Measure: Decrease in Respiratory Rate Time: First hour after first dose of NACDescription: Hospital LOS for admitted patients
Measure: Hospital length of stay (LOS) Time: Through study completion, average 9 monthsDescription: Whether a patient needed mechanical ventilation (intubation)
Measure: Need for mechanical ventilation Time: Through study completion, average 9 monthsDescription: If intubated, how long needing mechanical ventilation
Measure: Length of time intubated Time: Through study completion, average 9 monthsDescription: Outpatients on NAC needing admission to the hospital
Measure: Need for hospitalization Time: Through study completion, average 9 monthsDescription: Whether outpatients continued to recover as outpatients; whether admitted patients were managed on medical floors or level of care increased to ICU level of care; whether patients expired
Measure: Recovery disposition Time: Through study completion, average 9 monthsFacing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.
Description: Evaluation of the clinical status of patients on the 14th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.
Measure: World Health Organization (WHO) 9-levels ordinal scale (from 0-8) Time: 14 days after randomizationDescription: Evaluation of the clinical status of patients on the 5th, 7th, 10th and 28th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.
Measure: World Health Organization (WHO) 9-levels ordinal scale (from 0-8) Time: 5, 7, 10 and 28 days after randomizationDescription: All-cause mortality at 28 days after randomization
Measure: Mortality Time: 28 days after randomizationDescription: Number of days without need of Mechanical Ventilation at 28 days after randomization
Measure: Ventilation free days Time: 28 days after randomizationDescription: ICU Lenght of Stay on survivors at 28 days after randomization
Measure: ICU Lenght of Stay Time: 28 days after randomizationDescription: Hospital Lenght of Stay on survivors at 28 days after randomization
Measure: Hospital Lenght of Stay Time: 28 days after randomizationDescription: Acute Kidney Disease incidence measured by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 sometime until the 28th day after randomization.
Measure: Acute Kidney Disease incidence Time: 28 days after randomizationDescription: Percentage of patients needing dialysis sometime until the 28th day.
Measure: Percentage of patients needing dialysis Time: 28 days after randomizationDescription: Presence of coagulopathy sometime until the 28th day (platelets < 150000 and/or INR >1.5 and/or KPTT > 35 seconds).
Measure: Coagulopathy incidence Time: 28 days after randomizationDescription: Mean of C Reactive Protein Levels on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization
Measure: Mean of C Reactive Protein Levels Time: 5, 7, 10, 14 and 28 days after randomizationDescription: Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: 5, 7, 10, 14 and 28 days after randomizationDescription: Neutrophils/lymphocytes ratio on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.
Measure: Neutrophils/lymphocytes ratio Time: 5, 7, 10, 14 and 28 days after randomizationDescription: Safety outcome: Any kind of arrhythmia identified by the attending physician at the time of the intercurrence, confirmed by an electrocardiogram (ECG), sometime until the 28th day
Measure: Arrhythmia Time: 28 days after randomizationFor preventing the overwhelming of ICU beds capacity during COVID-19 pandemic in France, national and regional Health-Care institutions decided to optimize the Intensive Care Unit beds availability by opening new ICU beds in institutions with and without prior ICU. The Present study was design to retrospectively describe the origin of the ICU beds and human resources created during the COVID-19 outbreak in France.
Description: Describe the origin of the ICU beds created during the COVID-19 outbreak in France.
Measure: origin of the ICU beds created during the COVID-19 outbreak in France. Time: DAY 0Description: Describe the human resources (medical and non-medical) mobilized to ensure that all acute patients could be managed (physicians according to their initial specialty, nurses and nursing auxiliaries).
Measure: Human Resources Time: DAY 0This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. The current clinical trial aims to assess in a 500 volunteer trial the efficacy of QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.
Description: Prevention of COVID-19 symptoms as recorded in a daily diary
Measure: Prevention of COVID-19 Time: 12 WeeksDescription: Assessment of adverse events and serious adverse events will be performed.
Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events Time: 12 WeeksThe purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.
Description: Progression to mechanical ventilation or death within the first 14 days of enrollment.
Measure: Mechanical Ventilation or Death Endpoint Time: Day 14Description: Progression to mechanical ventilation or death within the first 28 days of enrollment.
Measure: Mechanical Ventilation or Death Endpoint Time: Day 28Description: Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale. Death; Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
Measure: 8-Point Ordinal Scale Endpoint Time: Day 29A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.
Description: The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: Clinical status using National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale Time: Day 7, 14, 28 and day of dischargeStudy Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Measure: Ordinal Scale of COVID19 Disease Severity at 14 days Time: 14 daysDescription: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Measure: Incidence of Hospitalization Time: 14 daysDescription: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
Measure: Incidence of COVID-19 related Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who expire due to all causes.
Measure: Incidence of all-cause Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal Time: 14 daysDescription: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall symptom severity at 5 and 14 days Time: 5 and 14 daysDescription: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline Time: 14 daysThis is an observational prospective cohort study to evaluate the clinical course and outcomes of COVID-19 and the underlying disease in patients with hematologic disease (malignant or non-malignant).
Description: Rate of death from any cause
Measure: 30-day all-cause mortality Time: 30 dayDescription: Rate of COVID-19 complications
Measure: COVID-19 complications Time: 30 dayDescription: Rate of ICU admission
Measure: ICU admission Time: 30 dayDescription: Rate of mechanical ventilation / O2 requirement
Measure: Mechanical ventilation / O2 requirement Time: 30 dayDescription: Rate of relapse or progression of hematologic disease
Measure: Relapse or progression of hematologic disease Time: 30 day, 90 day and 180 dayDescription: Number of patients alive
Measure: Overall survival Time: 30 day, 90 day and 180 dayDescription: Putative risk factors for the severity and lethality of COVID-19
Measure: Risk factors Time: 30 day, 90 day and 180 dayThe present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.
Description: The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.
Measure: Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection Time: through study completion, an average of 1 yearDescription: To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.
Measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval Time: through study completion, an average of 1 yearThis is a cohort study of COVID-19 patients with hyperinflammation. It aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death when untreated is estimated to be 50-80%.
Description: Mortality status of participants
Measure: All-cause mortality Time: Assessed at 30 days post treatmentDescription: Uninfected, ambulatory, hospitalized: mild disease, hospitalized: severe disease, death
Measure: Ordinal Scale for evaluating subject clinical status at days 3, 8, 15, 30, 60 post treatment. Time: Assessed at days 3, 8, 15, 30, 60 post treatmentCovid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. In this study, the association between thrombosis risk and clinical presentation of Covid-19 is investigated.
Description: from admission to discharge expressed in days
Measure: length of hospital stay Time: 2 monthsAs dentists begin reopening their practices during a global pandemic, the risk of COVID-19 infection that dentists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. The goal of the proposed study is to understand U.S.-based dentists' health and dental-practice reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These findings could be used to describe the prevalence and incidence of COVID-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
Description: COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen
Measure: COVID-19 probable or confirmed case Time: 18 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.
Measure: Anxiety Time: 12 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.
Measure: Depression Time: 12 monthsDescription: Self-reports of infection control efforts in the respondents' primary dental practices
Measure: Dental practice infection control efforts Time: 12 monthsDescription: Self-reports of personal protective equipment use
Measure: Dentists' use of personal protective equipment Time: 12 monthsThe purpose of this study was to assess the performance of a machine learning algorithm which identifies patients for whom hydroxychloroquine treatment is associated with predicted survival.
Description: Time to in-hospital death
Measure: Mortality outcome Time: Through study completion, an average of 3 monthsThe medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.
Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.
Description: change in CAS COVID 19 between baseline and 12th +/- 2 days CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4). Minimal number of points - 0; max - 20.Lower the score-better health
Measure: Change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Time: baseline, day 12Description: time to death or mechanical ventilation
Measure: - Combine endpoint - Time: 12 days, 45 daysDescription: - Change from baseline in C-reactive protein
Measure: C-reactive protein Time: 12 days, 45 daysDescription: - Change from baseline in D-dimer
Measure: D-dimer Time: 12 days, 45 daysDescription: Change from baseline in EQ-5D. The EQ-5D descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measure: EuroQol Group. EQ-5D™ Time: 12 days, 45 daysDescription: Change from baseline in EQ VAS EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
Measure: EuroQol Group. EQ VAS Time: 12 days, 45 daysDescription: - Change from baseline Hospital Anxiety and Depression Scale/The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case
Measure: HADS Time: 14 days, 45 daysDescription: Time from admission to the hospital to discharge form the hospital
Measure: Hospital length of stay Time: up to 45 daysThe study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group. Participants will be recruited in Sweden with a nationwide recruitment.
Description: Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.
Measure: Becks Depression Inventory-II Time: Change between baseline and end of treatment after seven weeks.Description: Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
Measure: Brunnsviken Brief Quality of Life Scale Time: Change between baseline and end of treatment after seven weeks.Description: Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Measure: Patient Health Questionnaire Time: Change between baseline and end of treatment after seven weeks.Description: The Alcohol Use Disorders Identification Test is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. 10 items and scores ranging from 0-40.
Measure: Alcohol Use Disorder Identification Test Time: Change between baseline and end of treatment after seven weeks.Description: Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia). Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).
Measure: Insomnia Severity Index Time: Change between baseline and end of treatment after seven weeks.Description: Screening for health impact and exposure of the coronavirus pandemic.
Measure: The CoRonavIruS Health Impact Survey Time: At baselineDescription: Assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The Impact of Event Scale-Revised yields a total score (ranging from 0 to 88).
Measure: Impact of Event Scale-Revised Time: Change between baseline and end of treatment after seven weeks.Description: It is a measure of the degree to which situations in one's life are appraised as stressful. It contains 10 items that are scored on a range between 0 (never) to 4 (very often).
Measure: Perceived Stress Scale Time: Change between baseline and end of treatment after seven weeks.Description: Same as during the treatment phase.
Measure: Becks Depression Inventory-II Time: Change between posttreatment and 12-month follow-up.Description: Same as during the treatment phase.
Measure: Brunnsviken Brief Quality of Life Scale Time: Change between posttreatment and 12-month follow-up.Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in detecting signs of viral pneumonia has become clear from the literature. However, the increased patient flow creates an additional pressure on CT centers. We believe, the use of chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is not available. Lung MRI may be useful in routing a patient in a difficult epidemiological situation.
Description: Expected number - more than two zones
Measure: Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan Time: Upon completion, up to 1 yearcoronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.
Description: the mortality rate of patients
Measure: short term mortality Time: in 28 days.Description: means the stay day of patients in intensive care unit
Measure: icu stay Time: up to 28 daysDescription: partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg
Measure: blood gases Time: at the admission time and 24th hourDisproportionate impact of COVID-19 in patients with obesity is now well established. Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19. The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.
Description: number of fatal cases
Measure: ICU mortality Time: through study completion, an average of 14 daysDescription: number of patients with invasive mechanical ventilation
Measure: Invasive mechanical ventilation Time: through study completion, an average of 14 daysDescription: number of fatal cases
Measure: In-hospital mortality Time: through study completion, an average of 21 daysThis will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for treatment of hospitalized patients with COVID-19 infection. In addition to SOC, the brequinar group will receive 5 daily doses of brequinar 100 mg.
Description: Adverse events are new onset medical conditions.
Measure: Safety/tolerability measured by rates of post randomization adverse events and hematology/chemistry safety labs. Time: Beginning at signing consent through Day 15.Description: In-patient hospitalization, hospitalized in ICU-level care, or discharged
Measure: Hospitalization status Time: Through Day 15Description: Duration in days from admission to discharge
Measure: Duration of hospitalization Time: Through Day 15Description: National Early Warning Score (NEWS) 2. Composite score of respiration rate, oxygen saturation, systolic blood pressure, pulse, consciousness, and temperature.
Measure: NEWS2 Score Time: Through Day 15Description: Subject mortality status
Measure: Mortality Time: Day 29Description: Nasopharyngeal viral load by RT-PCR at days 1, 3, 5, 7, and 15
Measure: SARS-CoV-2 nasopharyngeal viral load Time: Through Day 15Description: Pro-inflammatory cytokines including TNFalpha, INFgamma, IL13, IL12p70, IL10, IL8, IL6, IL4 IL2, IL1-beta and erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), D-dimer, serum ferritin, and fibrinogen
Measure: Inflammatory markers Time: Through Day 15Description: Plasma concentration of dihydroorotate
Measure: DHO Concentration Time: Through Day 15Description: Plasma concentration of brequinar
Measure: Brequinar Concentration Time: Through Day 15We hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.
Description: Time to improvement in oxygenation
Measure: Time to improvement in oxygenation Time: 28 DaysDescription: 28-day mortality
Measure: 28-day mortality Time: 28 DaysDescription: Assessment of cytokine and inflammatory profile at baseline and at 48 hours after therapy
Measure: Assessment of cytokine and inflammatory profile at baseline and at 48 hours after therapy Time: 28 DaysDescription: Qualitative and quantitative toxicity
Measure: Qualitative and quantitative toxicity Time: 28 DaysDescription: incidence and duration of supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device
Measure: incidence and duration of supplemental oxygen administration Time: 28 DaysDescription: Incidence and duration of non-invasive ventilation or by non-rebreather mask or high-flow nasal cannula
Measure: Incidence and duration of non-invasive ventilation or by non-rebreather mask or high-flow nasal cannula Time: 28 DaysDescription: Incidence and duration of mechanical ventilation
Measure: Incidence and duration of mechanical ventilation Time: 28 DaysDescription: Incidence and duration of vasopressor support
Measure: Incidence and duration of vasopressor support Time: 28 DaysDescription: Incidence and duration of extracorporeal membrane oxygenation
Measure: Incidence and duration of extracorporeal membrane oxygenation Time: 28 DaysDescription: Duration of fever
Measure: Duration of fever Time: 28 DaysDescription: Correlation of cytokine profile to clinical outcomes specified in primary and secondary objectives
Measure: Correlation of cytokine profile to clinical outcomes specified in primary and secondary objectives Time: 28 DaysDescription: Duration of hospitalization
Measure: Duration of hospitalization Time: 28 DaysDescription: Secondary infections
Measure: Secondary infections Time: 28 DaysObservational and prospective study with one year of follow-up of the cohort of workers of the CSdM, including workers of subcontracted companies working in the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months. All CSdM workers will be invited to participate by e-mail and by announcements in the corporate website. A space will be set up on the corporate intranet where workers will be informed about the study, will be able to give their informed consent and will be able to answer an electronic questionnaire regarding socio-demographic, clinical and labour personal characteristics. Once the questionnaire answered, participants will be authorized to schedule a blood extraction. Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG). PCR will be also performed for IgM and IgA positive subjects.
Description: Screening for the entire population with total IgA, IgM, IgG to screen the negatives ELISA for positives with differentiated IgM+IgA vs IgG specific for SARS-Cov-2 seroprevalence of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk of infection in CSdM professionals; c) contribute to the improvement of knowledge about the infection and the social and occupational factors that affect its spread; and d) allow in the future to identify the duration of immunity against SARS-CoV-2.
Measure: Antibodies to SARS-CoV2: IgA, IgM, IgG Time: 1 yearDescription: To detect symptomatic or asymptomatic carriers New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears
Measure: PCR of nasopharyngeal smears on all IgM + Time: 1 yearThe associated use of Ivermectin, aspirin, dexamethasone, and enoxaparin (in different combinations and doses) will reduce the impact of COVID infection 19, the need of admission to the intensive care unit, and mortality.
Description: Number of patients who did not go to a more severe stage of disease or die (i.e. they neither go from mild to moderate or severe, nor go from moderate to severe or die, if they had been already enrolled in a severe condition)
Measure: Patients Who Improved Their Condition or Did Not Worsen it Time: 7 daysDescription: Number of patients needing ICU-treatment including mechanical ventilation after 2-week treatment
Measure: ICU-treated Patients After 2-week Treatment Time: 14 daysDescription: Patients who died within 30 days after enrollment
Measure: Mortality Time: 30 daysDescription: Patients who needed dose adjustment of any of the drugs involved in the treatment protocol
Measure: Patients Needing Drug Dose Adjustment Time: 14 daysDescription: Patient presenting serious adverse events
Measure: Adverse Events Time: 14 daysThe study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study. At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing. Following the interim analysis, based on the results, another 800 people are planned to involve.
Description: Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants
Measure: Identification of genetic factors determining the course of the disease in case of COVID-19 Time: 2020. DecemberPeople with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.
Description: Duration of clinical symptoms
Measure: Clinical course of SARS-CoV-2 infection in cancer patients. Time: 56 daysDescription: Severity of clinical symptoms
Measure: Clinical course of SARS-CoV-2 infection in cancer patients. Time: 56 daysDescription: Number of patients whose cancer treatment has been impacted by SARS-CoV-2
Measure: Clinical course of SARS-CoV-2 infection in cancer patients. Time: 56 daysDescription: Proportion of samples successfully processed and result obtained, with 95% confidence interval Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)
Measure: Feasibility of SARS-CoV-2 testing with a lateral flow assay. Time: 56 daysThe emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic. To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
Description: To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the maximum concentration (Cmax) of TY027 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the time to maximum concentration (Tmax) of TY027 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the area under the curve extrapolated to infinity (AUC0-∞) of TY027.
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the AUC calculated from time of administration to the last measurable concentration (AUC0-last) of TY027.
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the half-life (t1/2) of TY027 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the volume of distribution (Vd) of TY027 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate clearance [CL] of TY027 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 84 DaysThis is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.
Description: number of positive serologies
Measure: positive serologies Time: 12 monthsIn December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
Description: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab after Intervention Initiation.
Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 days following interventionDescription: Viral load variation in the nasopharyngeal swab during treatment.
Measure: Viral load variation in the nasopharyngeal swab. Time: 7 days following intervention.Description: Variation of serum lymphocyte counts during treatment.
Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 days following intervention.Description: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab at the end of follow-up.
Measure: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 after intervention.Description: Proportion of patients with clinical improvement, defined as the time to normalize fever, respiratory rate and oxygen saturation and cough relief at the end of follow-up.
Measure: Proportion of patients with clinical improvement. Time: 7 after intervention.The goal of this study is to evaluate the safety and effectiveness of COVID-19 convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. - Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator - Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against SARS-CoV-2 and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.
Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated
Measure: Avoidance of intubation at 28 days (group A) Time: 28 daysDescription: Count of group B participants (participants who are intubated at study entry) who die
Measure: Mortality (group B) Time: 28 daysDescription: Count of participants who experienced cardio-circulatory arrest
Measure: Cardio-circulatory arrest Time: 28 daysDescription: Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome
Measure: Patient Outcome at 28 days Time: 28 daysDescription: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
Measure: Renal failure Time: 28 daysDescription: Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%
Measure: Liver failure Time: 28 daysDescription: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
Measure: Cytokine Storm Time: 28 daysDescription: Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation .
Measure: Respiratory support Time: 28 daysDescription: Count of participants who received pressor drugs, as ordered by treating physicians
Measure: Vasopressor medication support Time: 28 daysDescription: Length of ICU stay in days, for participants who entered ICU
Measure: Length of ICU length of stay Time: 28 daysDescription: Count of patients admitted to the ICU who die in ICU
Measure: Intensive Care Unit (ICU) mortality Time: 28 daysDescription: Length of hospital stay in days
Measure: Hospital length of stay Time: 28 daysDescription: Number of ventilator-free hospitalized days
Measure: Ventilator free days Time: 28 daysDescription: Length of intubation, measured in days
Measure: Intubation duration Time: 28 daysDescription: Count of participants readmitted to hospital following index procedure hospital discharge
Measure: Readmission Time: 90 daysDescription: Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.
Measure: Serum anti-SARS-CoV-2 IgG Time: During hospitalization, a maximum of 28 daysDescription: Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.
Measure: SARS-CoV-2 RNA Time: During hospitalization, a maximum of 28 daysDescription: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die
Measure: Mortality (group A) Time: 28 daysDescription: Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)
Measure: Time from Transfusion to end of ventilator support (group B) Time: During hospitalization, a maximum of 28 daysThe purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.
This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.
Description: Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.
Measure: Time to clinical recovery Time: Up to follow-up day 14 after study startDescription: The rates from both cohort will be reported.
Measure: Freedom from ICU admission Time: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.Description: Temperature in degrees (F)
Measure: Temperature Time: Up to follow-up day 14 after study startDescription: Heart rate in beats per minutes
Measure: Heart rate Time: Up to follow-up day 14 after study startDescription: Systolic blood pressure in mm Hg
Measure: Systolic Blood pressure Time: Up to follow-up day 14 after study startDescription: Oxygen saturation in percentage
Measure: Oxygen saturation Time: Up to follow-up day 14 after study startDescription: Oxygen saturation in percentage
Measure: Supplemental oxygenation need Time: Up to follow-up day 14 after study startDescription: Respiratory rate in breaths per minute.
Measure: Respiratory rate Time: Up to follow-up day 14 after study startDescription: Pre and post intervention; Minimum of 3 (poor) to best (15)
Measure: Glasgow Comma Scale from minimum of 3 to maximum of 15. Time: Up to follow-up day 14 after study startDescription: Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;
Measure: Performance status Time: Up to follow-up day 14 after study startDescription: Survival in percentage
Measure: Survival Time: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.Description: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.
Measure: Serial chest x-rays severe acute respiratory syndrome (SARS) scoring Time: Up to follow-up day 14 after study start;Description: CT scans with volume of consolidation measured in cubic centimeters.
Measure: Changes on computed tomography (CT) scans pre and post RT Time: Baseline up to follow-up day 14 after study startDescription: C-Reactive Protein in mg/L
Measure: CRP Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Serum chemistry + complete blood cell (CBC) with differential Time: Up to follow-up day 14 after study startDescription: pH (no unit)
Measure: Blood gases pH(when available) Time: Up to follow-up day 14 after study startDescription: Albumin in gm/dL
Measure: Albumin Time: Up to follow-up day 14 after study startDescription: Procalcitonin in ng/mL
Measure: Procalcitonin Time: Up to follow-up day 14 after study startDescription: Asparatate Aminotransferase in units/L
Measure: Aspartate aminotransferase (AST) Time: Up to follow-up day 14 after study startDescription: Creatinine in mg/dL
Measure: Creatine kinase Time: Up to follow-up day 14 after study startDescription: Coagulation pathway time in seconds
Measure: Prothrombin time (PT)/partial thromboplastin time (PTT) Time: Up to follow-up day 14 after study startDescription: Troponin-I in ng/mL
Measure: Troponin Time: Up to follow-up day 14 after study startDescription: Lactic Acid in mmol/L
Measure: Lactate Time: Up to follow-up day 14 after study startDescription: B-Natriuretic Peptid in pg/mL
Measure: NT-pBNP (cardiac injury) Time: Up to follow-up day 14 after study startDescription: Gamma-glutamyl transferase in units/L
Measure: Gamma-glutamyl transferase (GGT) Time: Up to follow-up day 14 after study startDescription: Trygliciericdes in mg/dL
Measure: Triglycerides Time: Up to follow-up day 14 after study startDescription: Fibrinogen in mg/dL
Measure: Fibrinogen Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Changes in CD8 T cells Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Changes in CD4 T cells Time: Up to follow-up day 14 after study startDescription: Will be summarized descriptively.
Measure: Changes in serum antibodies against COVID-19 epitope Time: Up to follow-up day 14 after study startDescription: Lactate Dehydrogenase in units/L
Measure: LDH Time: Up to follow-up day 14 after study startDescription: D-Dimer in ng/mL
Measure: D-Dimer Time: Up to follow-up day 14 after study startDescription: Interleukin-6 in pg/mL
Measure: IL-6 Time: Up to follow-up day 14 after study startDescription: Myoglobin in ng/mL
Measure: Myoglobin Time: Up to follow-up day 14 after study startDescription: Potassium in mmol/L
Measure: Potassium Time: Up to follow-up day 14 after study startDescription: Ferritin in ng/mL
Measure: Ferritin Time: Up to follow-up day 14 after study startDescription: Alanine Aminotransferase in units/L
Measure: ALT Time: Up to follow-up day 14 after study startShaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.
First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological observational data are necessary for better understanding the links between vitamin D supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of hypovitaminosis D is very high). The investigators had the opportunity to use information collected in a French middle-sized nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3 supplementation was associated with the prognosis of COVID-19 in residents infected with SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on residents). The main objective of this study is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in improving survival among frail elderly nursing-home residents infected with COVID-19 compared to those having received supplementation longer ago. The secondary objective is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in limiting the clinical severity of the infection according to the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 compared to those having received supplementation longer ago.
Description: Clinical severity score of COVID19 is assessed with Ordinal Scale for Clinical Improvement (OSCI). OSCI ranges from 0 to 8, higher score meaning poorer outcome.
Measure: Clinical severity score of COVID19 in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19 Time: From March 2020 to 15 May 2020At the end of December of 2019, a series of patients in Wuhan, China were struck with a mysterious respiratory infection. These isolated events have rapidly grown into a deadly, global pandemic. This pandemic is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which results in the Coronavirus Disease 2019 (COVID-19). For individuals infected with COVID-19, approximately 30% of the hospitalized cases are associated with cardiovascular complications. Data are emerging that individuals with pre-exiting conditions (like hypertension, diabetes, cancer, or medical issues related to the immune system) are most susceptible to complications related to COVID-19. Furthermore, individuals of certain racial and ethnic backgrounds (e.g. African American and Hispanic) are at a higher risk of death from COVID-19. Despite these emerging observations, it remains unclear who will develop the cardiovascular complications (acute myocardial injury with evidence of a myocarditis-like picture and cardiogenic shock) and what the long term sequelae of this disease will be for survivors of this infection after hospitalization. Thus, the goals of this project are to better understand the epidemiology of cardiac injury in acutely ill COVID-19 patients through deep cardiac phenotyping and identify the molecular profile of individuals most susceptible to cardiac injury from COVID-19.
Description: Patterns of late gadolinium enhancement and T1 and T2 mapping consistent with myocarditis on a post-hospitalization cardiac magnetic resonance imaging examination
Measure: Prevalence of Myocarditis Time: Up to 4 weeksDescription: This includes categorically abnormal structural, mechanical functional, vascular, and metabolic using cardiac magnetic resonance imaging
Measure: Prevalence of cardiac abnormalities by cardiac magnetic resonance imaging Time: Up to 4 weeksDescription: Presence of cardiac autoantibodies and defects within the immune system as detected by Whole Exome Sequencing making an individual susceptible to subacute cardiac injury during COVID-19 infection
Measure: Prevalence of molecular and genetic immune system abnormalities Time: Up to 4 weeksStem cell therapy has emerged as a revolutionary treatment for diseases that were considered untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have been shown to repair damaged liver, kidney, heart, pancreas, skin, cartilage, and cornea in animal models and several human trials. In addition to cellular replacement through regeneration, UCMSCs mediate through paracrine signaling pathways resulting in immune modulation. Clinical manifestations of coronavirus disease 2019 (COVID-19), are believed to arise from septic shock and cytokine storm that cause acute respiratory dysfunction and acute cardiac injury. There is presently no cure for the COVID-19 viral disease; however, multi-treatment strategies are being examined. During the past two months, four reports were published that suggest, mesenchymal stem cells (MSCs), owing to their powerful immunomodulatory ability, may prevent the cytokine storm and thus reduce the COVID-19 related morbidity. All studies reported that COVID-19 patients responded favorably to MSCs therapy. These reports, taken together with the previous successes of stem cell therapy in animal models, the investigators, a seven-institution consortium, propose to explore the efficacy of UCMSC treatment in COVID-19 patients at Jinnah hospital, Lahore. The investigators propose to administer UCMSCs in patients with acute pulmonary inflammation due to COVID-19 infection with moderate to severe symptoms. In the first cohort of 15 patients, UCMSCs will be administered with three intravenous infusions of 500,000 UCMSCs per Kg body weight each on days 1, 3, and 5. The second group of five patients serving as control will only receive standard treatment. During the 30-day post-infusion period, a battery of tests will be performed to evaluate the safety and efficacy of the UCMSCs treatment. In parallel, the investigators propose a comparative study to determine COVID-19 viral count by quantitative real-time PCR and through viral coat protein ELISA, developed in the investigator advisor lab (Dr. Tauseef Butt, Progenra Inc. Philadelphia, USA) with the ultimate objective to locally developing a rapid diagnostic assay.
Description: Number of participants with significant side effects in stem cell treated group
Measure: Safety and efficacy assessment of infusion associated adverse events Time: Day 01 to Day 30Description: Assessment of Pneumonia improvement as a result of stem cell infusions
Measure: Chest Radiograph or Chest CT Scan Time: Day 01 to Day 30Description: Quantitative real-time PCR analysis for the evaluation of negative corona virus test results following stem cell treatment
Measure: COVID-19 Quantitative Real Time PCR Time: Day 01 to Day 30Description: Evaluation of organ function (Each organ system is assigned a value for 0 (normal) to 4 (highest degree of dysfunction))
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: Day 01 to Day 30Description: Number of all mortalities within 30 days post first infusion
Measure: Rate of mortality Time: Day 01 to Day 30Description: Examination of improvement in the physiology of lungs after treatment
Measure: Clinical Respiratory Changes Time: Day 01 to Day 30Background: The rapid spread and high infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important. One of the important target populations for such intervention who are at high risk of exposure are health care workers (HCWs) who may develop disease and/or expose patients and other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus replication and immunomodulation, an important role in the inhibition of pre-entry step of the virus to host cells. Such activity in the early stage of infection may play a role in prevention of disease progression. Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of viral shedding among HCWs following exposure to confirmed COVID-19 patients. Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a confirmed case of COVID-19 without full adherence to droplet precautions. Participants will be eligible in a period no longer than 72 hours after exposure. Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days. Participants in the control group will receive no treatment. Treatment will be started no longer than 72 hours following exposure. Outcomes: The primary outcome will be the number of participants who develop clinical signs compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary outcomes will include virologically-confirmed COVID 19, disease severity (need for hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration (time between first positive PCR to last of two consecutive negative tests) for confirmed COVID 19 cases. Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a power of 80% (alpha 0.05) is 291 participants per each group.
Description: Number of patients developing clinical symptoms and signs compatible with COVID-19 following exposure
Measure: Clinical COVID-19 Time: 14 days following exposure.Description: PCR- proven COVID-19 (confirmed cases)
Measure: Confirmed COVID-19 Time: 14 days following exposure.Description: Time to virological recovery for participants who develop confirmed COVID-19
Measure: Time to virological recovery Time: 30 daysDescription: Time to symptoms onset defined as days until start of fever, cough or shortness of breath.
Measure: Time to symptoms onset Time: 14 daysDescription: Development of pneumonia- clinical and radiological (chest X ray or CT).
Measure: Development of pneumonia Time: 14 daysDescription: Development of severe disease- respiratory failure, mechanical ventilation, severe sepsis, multi-organ failure or acute myocarditis)
Measure: Development of severe disease Time: 14 daysDescription: Need for hospitalization, need for ICU admission
Measure: Need for hospitalization or ICU Time: 14 daysDescription: Number of adverse events - prolonged QT, arrhythmias, nausea, vomiting
Measure: Adverse events Time: 14 daysDescription: All-cause mortality at the end of follow up
Measure: Mortality Time: 30 daysDescription: Number of days between exposure to de-isolation
Measure: Time to de-isolation Time: 30 daysAn observational study of consecutive patients testing positive for COVID-19 who require admission to hospital to determine the degree of myocardial injury through biomarkers and echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and CARdiac Events study (COVICARE).
Description: The primary objective of this study is to characterise the prevalence of myocardial injury and cardiac dysfunction in patients hospitalised with COVID-19 disease.
Measure: Cardiac abnormalities in COVID-19 disease in-patients Time: 6 monthsDescription: To compare levels of biomarkers (hsTnT, NT-proBNP, ferritin, cytokines, stored plasma for future analyses) between patients who experience an adverse event and those who do not.
Measure: Biomarkers Time: 30 daysThis is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.
Description: Respiratory improvement is defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air.
Measure: Time from Randomization to Respiratory Improvement Time: up to Day 28Description: Cough will be rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate.
Measure: Time from Randomization to Cough Reported as Mild or Absent Time: up to Day 28Description: Dyspnea will be rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate.
Measure: Time from Randomization to Dyspnea Reported as Mild or Absent Time: up to Day 28Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation). The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.
Description: Estimated number of deaths avoided by the various population protection strategies, estimated by applying these strategies to the realistic virtual population.
Measure: Establishment of a reliable prediction model for the effectiveness of virus control Time: 18 monthsThe purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.
Description: Decrease from baseline in mean resting SpO2
Measure: Proportion of patients with clinical worsening Time: Day 1 to Day 14Description: Proportion of patients requiring hospitalization
Measure: Maximal severity of COVID-19 after treatment Time: Day 1 to Day 42This study will explore whether a daily supplement of glycine, a substance that has antiinflammatory, cytoprotective, and endothelium-protecting effects, can improve mortality, as well as clinical and biochemical parameters, in patients with severe COVID-19 who initiate mechanical ventilatory support.
Description: Number of participants who die divided by number of subjects enrolled in the that study group.
Measure: Mortality Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of days spent under mechanical ventilation.
Measure: Days under mechanical ventilation Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Arterial pressure of oxygen divided by inspired fraction of oxygen.
Measure: PaO2/FiO2 ratio Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Plasma concentration of lactate in arterial blood.
Measure: Arterial plasma lactate Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 1β.
Measure: Serum IL-1β Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 2.
Measure: Serum IL-2 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 4.
Measure: Serum IL-4 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 5.
Measure: Serum IL-5 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 6.
Measure: Serum IL-6 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 7.
Measure: Serum IL-7 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 8.
Measure: Serum IL-8 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 10.
Measure: Serum IL-10 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 12 (p70).
Measure: Serum IL-12 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 13.
Measure: Serum IL-13 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interleukin 17A.
Measure: Serum IL-17 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of granulocyte colony stimulating factor.
Measure: Serum G-CSF Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of granulocyte monocyte colony stimulating factor.
Measure: Serum GM-CSF Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of interferon gamma.
Measure: Serum IFN-γ Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of monocyte chemoattractant protein 1 (MCAF).
Measure: Serum MCP-1 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of macrophage inflammatory protein 1β
Measure: Serum MIP-1β Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of tumor necrosis factor alpha.
Measure: Serum TNF-α Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of creatinine.
Measure: Serum creatinine Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of alanine aminotransferase. .
Measure: Serum alanine aminotransferase Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of aspartate aminotransferase. .
Measure: Serum aspartate aminotransferase Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of alkaline phosphatase.
Measure: Serum alkaline phosphatase Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of total bilirubin.
Measure: Serum total bilirubin Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of unconjugated bilirubin.
Measure: Serum unconjugated bilirubin Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of conjugated bilirubin
Measure: Serum conjugated bilirubin Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of C reactive protein.
Measure: Serum C reactive protein Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Blood concentration of hemoglobin.
Measure: Hemoglobin Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of white blood cells per µl blood.
Measure: Total leukocytes Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of neutrophils per µl blood.
Measure: Neutrophils Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of lymphocytes per µl blood.
Measure: Lymphocytes Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of monocytes per µl blood.
Measure: Monocytes Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of eosinophils per µl blood.
Measure: Eosinophils Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of basophils per µl blood.
Measure: Basophils Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Number of platelets per µl blood.
Measure: Platelets Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Time that blood takes to clot.
Measure: Prothrombin time Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Serum concentration of plasminogen activator inhibitor 1 (PAI-1).
Measure: Serum PAI-1 Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Sequence Organ Failure Assessment (SOFA) score, composed by assessment of PaO2/FiO2 ratio, Glasgow coma scale, mean arterial pressure, bilirubin, and platelets.
Measure: SOFA score Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.Description: Acute Physiology And Chronic Health Evaluation II (APACHE II) score, composed by assessment of AaDO2 or PaO2, temperature, mean arterial pressure, pH arterial, heart rate, respiratory rate, sodium, potassium, creatinine, hematocrit, white blood cell count, Glasgow coma scale.
Measure: APACHE II score Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.The objective of this study is to screen the patients seeking hospitalization in Ain Shams university hospitals and identify a cost effective tool for continuing screening the patients all through the epidemic period
Description: To measure the incidence of the new SARS-COV-2 (COVID19) among patients seeking hospitalization to Ain-Shams University Hospitals
Measure: The incidence of the new COVID19 among hospitalized patients Time: 12 monthsDescription: To determine the cost of screening hospitalized patients
Measure: Cost of screening hospitalized patients Time: 12 monthsThis is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.
Description: Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
Measure: To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity Time: 6 DaysDescription: Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control
Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection Time: 2, 4 and 6 daysDescription: Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.
Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection Time: 2, 4 and 6 daysDescription: Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms
Measure: To Measure the efficacy of NONI in prevention of progression of COVID-19 Time: 28 daysDescription: Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 & max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.
Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19 Time: 6 daysDescription: Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.
Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19 Time: 2, 4, 6, 14 and 28 daysDescription: Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.
Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19 Time: 2, 4, 6, 14 and 28 daysDescription: Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance
Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection Time: 14 daysDescription: Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.
Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection Time: 14 daysA Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.
Description: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination
Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety) Time: Up to 12 months post enrollmentDescription: Virologically-confirmed COVID-19 clinical disease will be defined as an acute respiratory illness that is clinically consistent with COVID-19 disease, AND SARS-CoV-2 RT-PCR positivity.
Measure: Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy) Time: Up to 12 months post enrollmentDescription: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination
Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety) Time: Up to 12 months post enrollmentDescription: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination
Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity) Time: Up to 12 months post enrollmentDescription: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV Time: Up to 12 months post enrollmentDescription: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus
Measure: Assess humoral Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity) Time: Up to 12 months post enrollmentDescription: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination
Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity) Time: Up to 12 months post enrollmentDescription: Cellular Fc effector functionality assays to measure the ability of vaccine elicited antibodies to mediate cellular cytotoxicity, complement deposition, and phagocytosis.
Measure: Assess Fc effector functionality in participants who receive ChAdOx1 nCoV-19 vaccine or placebo Time: Up to 12 months post enrollmentDescription: Flow cytometric sorting of plasmablasts and memory B cells to using spike and receptor binding domain "baits" to isolate SARS-CoV-2 specific B cells, sequence their immunoglobulin genes and define their epitope specificity.
Measure: Assess B cell responses to SARS-CoV-2 spike trimer and/or the receptor binding domain in participants who receive ChAdOx1 nCoV-19 vaccine or placebo Time: Up to 12 months post enrollmentPublished papers evaluating coagulopathy on COVID-19 patients indicate a higher incidence of thromboembolic events, sometimes, as high as 20%. Such events increase ICU admissions and are associated with death. Considering the importance of thromboembolic events concurring to deteriorate clinical state, we propose to conduct a parallel pragmatic open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and with low oxygen saturation.
Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Measure: Composite main outcome Time: up to 28 daysDescription: All-cause death
Measure: All-cause death Time: 28 daysDescription: Composite outcome of ICU admission or all-cause death
Measure: Composite outcome of ICU admission or all-cause death Time: 28 daysDescription: Major bleeding
Measure: Major bleeding Time: 28 daysDescription: Red Blood Cell transfusion (greater than or equal to 1 unit)
Measure: Number of participants who received red blood cell transfusion Time: 28 daysDescription: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate
Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate. Time: 28 daysDescription: Hospital-free days alive up to day 28
Measure: Number of hospital-free days alive up to day 28 Time: 28 daysDescription: ICU-free days alive up to day 28
Measure: Number of ICU-free days alive up to day 28 Time: 28 daysDescription: Ventilator-free days alive up to day 28
Measure: Number of ventilator-free days alive up to day 28 Time: 28 daysDescription: Venous thromboembolism
Measure: Number of participants with venous thromboembolism Time: 28 daysDescription: Arterial thromboembolism
Measure: Number of participants with arterial thromboembolism Time: 28 daysDescription: Heparin induced thrombocytopenia
Measure: Number of participants with heparin induced thrombocytopenia Time: 28 daysThe purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.
Description: The impact of the treatment on virological clearance (viral load) post-treatment
Measure: Clearance of viral load Time: 14 daysDescription: This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters
Measure: Safety of the treatment Time: 14 daysThe overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
Description: To assess the infusional toxicity
Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.
Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation
Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)
Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: To assess the clinical status (on a 7-point WHO ordinal scale)
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the duration of oxygen therapy and/or mechanical ventilation
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the length of stay at the intensive care unit and of hospitalization
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To assess the number of organ failures
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the intensity of the inflammatory response
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the evolution of coagulation parameter
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the presence of Biomarker of lung lesion, repair and scarring
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To assess the pulmonary function
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations
Measure: To investigate immune modulation Time: Day 28Description: To assess the cytotoxic activity by MLR
Measure: To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro Time: Day 28This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Description: Percentage of subjects hospitalized due to COVID-19
Measure: COVID-19 hospitalization Time: 30 daysIvermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Description: Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
Measure: Incidence of severe complications due COVID-19 infection Time: 28 daysDescription: Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%
Measure: Incidence of Severe Acute Respiratory Syndrome Time: 28 daysDescription: Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute
Measure: Incidence of Severe Acute Respiratory Syndrome Time: 28 daysDescription: Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)
Measure: Adverse events Time: 28 daysDescription: Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)
Measure: Adverse events Time: 28 daysDescription: Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)
Measure: Adverse events Time: 28 daysDescription: Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of > 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.
Measure: Adverse events Time: 28 daysDescription: Death of any cause since protocol enrollment
Measure: Overall survival Time: 28 daysThis study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. We will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.
Description: Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection.
Measure: Validate iAMP testing kit Time: 1 monthThis is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Description: Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity] Incidence of adverse events among participants during the study period [Safety and Tolerability] Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability] Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]
Measure: Primary Outcome Measures Time: Baseline up to Week 52The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 250 people who had COVID-19 based on lab testing to participate. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 8 times over 6 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in the convalescent phase of COVID-19 infection.
Description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR naso/oropharyngeal test, as determined by the established cycle threshold cut-off on a validated real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
Measure: Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples Time: Up to 24 weeksDescription: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR stool or rectal swab samples, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.
Measure: Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples Time: Up to 24 weeksDescription: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR semen sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.
Measure: Duration of SARS-CoV-2 viral persistence in semen samples Time: Up to 24 weeksDescription: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR breast milk sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.
Measure: Duration of SARS-CoV-2 viral persistence in breast milk samples Time: Up to 24 weeksDescription: Prevalence defined as the number of participants with B cell, cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer (NK), and natural killer T (NKT) cell immune responses. Plasma will be used for evaluation of neutralizing and binding antibody titers to SARS-CoV-2.
Measure: Prevalence of cell immune responses Time: Up to 24 WeeksDescription: The duration, in weeks, of COVID-19 symptoms as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.
Measure: Duration of COVID-19 Symptoms Time: Up to 24 weeksDescription: Prevalence defined as the number of participants that develop post-viral sequelae as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.
Measure: Prevalence of post-viral sequelae Time: Up to 24 weeksDescription: Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.
Measure: Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures Time: Up to 24 weeksDuring the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all categories of subjects in order to minimize unnecessary movements of people while maintaining an adequate level of assistance. This is also true for transgender people, who are periodically requested to come into the clinic for hormonal therapy monitoring and continuation. In our center telemedicine programs dedicated to users have been activated for the remote management of hormone therapy. We use a web-based survey to assess the impact of COVID-19 outbreak on trans-population health and to assess the specific needs of this population in this particular moment.
Description: Evaluation of the specific health care needs of this population
Measure: Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy Time: through study completion, an average of 6 monthsDescription: Evaluation of socioeconomical and working condition of this population
Measure: Assessment of risk factors for COVID-19 infection in the traspopulation Time: through study completion, an average of 6 monthsDescription: Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)
Measure: Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring Time: through study completion, an average of 6 monthsDescription: Use of web based validated questionnaire: Impact of Event Scale-Revised (in Italian) to investigate perception of the COVID-19 event and subjects' mood. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. Minimum score=0, maximum score=60, higher scores correspond to a worse outcome.
Measure: Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy Time: through study completion, an average of 6 monthsDescription: Use of web based validated questionnaire: Beck Depression Inventory to investigate mood. The 21 symptoms and attitudes contained in the questionnaire reflect the severity of the depression; the final score ranges from 0 to 63, with worse outcome with higher values.
Measure: Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy Time: through study completion, an average of 6 monthsDescription: Use of web based validated questionnaire: Short Form 2, to assess the impact of health on an individual's everyday life. The SF-12 is made of an eight-scale profile of scores as well as physical and mental health summary measures. Total scores range from 16 to 47 with worse outcomes for lower scores.
Measure: Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy Time: through study completion, an average of 6 monthsThe study will evaluate the safety and efficacy of orally-administered M5049 in COVID-19 pneumonia participants who are hospitalized but not on mechanical ventilation.
Description: A nine point ordinal scale - 0: Uninfected No limitation of activities Limitation of activities Hospitalized, mild disease on, no oxygen therapy Hospitalized, with oxygen by mask or nasal prongs Hospitalized, severe disease: noninvasive ventilation or high flow oxygen Hospitalized, severe disease: intubation and mechanical ventilation Hospitalized, severe disease: ventilation plus additional organ support - example, vasopressors, Extracorporeal membrane oxygenation (ECMO) Death.
Measure: Clinical Status of Participants on a 9-Point Ordinal Scale Time: Day 1 through Day 60Description: Normal oxygen exchange in room air.
Measure: Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours on Room Air Time: Day 1 through Day 28Description: Percentage of Participants who die for any reason.
Measure: Percentage of Participants With All-Cause Mortality Time: Day 1 through Day 28Description: Clinical Deterioration
Measure: Clinical Deterioration: Time to Intensive Care Unit (ICU) Admission Time: Day 1 through Day 28Description: Clinical Deterioration
Measure: Clinical Deterioration: Time to Invasive Mechanical Ventilation Time: Day 1 through Day 28Description: Clinical Deterioration
Measure: Clinical Deterioration: Time to Non-Invasive Mechanical Ventilation Time: Day 1 through Day 28Description: Relapse refers to rehospitalization due to worsening oxygenation, with either a positive result of any respiratory pathogenic nucleic acid test, or worsening lesions on chest imaging.
Measure: Percentage of Participants With Relapse Time: Day 5 through Day 60Description: Percentage or participants who are re-hospitalized for any reason.
Measure: Percentage of Participants who are Re-Hospitalized Time: Day 5 through Day 60Description: Only the first 15 participants will be evaluated for Pharmacokinetic parameters.
Measure: Maximum Observed Concentration (Cmax) of M5049 Time: Day 1 Day 3 and Day 7In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area. A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted. The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study
Description: Anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area
Measure: Anti-SARS-CoV-2 IgT (IgM/IgA/IgG) seropositivity Time: through study completion, an average of 4 hoursDescription: To estimate the proportion of occurrence of an episode of clinical symptoms since the beginning of the epidemic among seropositive people using self report questionnaires.
Measure: Proportion of asymptomatic, symptomatic cases among seropositive people Time: through study completion, an average of 4 hoursDescription: To estimate the proportion of asymptomatic cases (asymptomatic fraction) by the proportion of seropositive individuals who did not show any sign or symptom of COVID-19 since the beginning of the epidemic in France (mid-February).
Measure: Proportion of asymptomatic cases among seropositive people Time: through study completion, an average of 4 hoursDescription: To understand susceptibility factors to infection by comparing infected and uninfected persons on the basis of age, sex, weight status, smoking status, occupation and education.
Measure: Identification of risk groups - Anti-SARS-CoV-2 IgT seropositivity by age, sex and as a function of weight status, smoking status, work activity and social status. Time: through study completion, an average of 4 hoursDescription: Determining the prevalence of seropositive people according to the level of social disadvantage
Measure: Proportion of seropositive subjects according to the level of social disadvantage measured by the EPICES score Time: through study completion, an average of 4 hoursDescription: To estimate the prevalence of infected households
Measure: Proportion of infected households Time: through study completion, an average of 4 hoursDescription: To provide knowledge on intra-household dissemination
Measure: Anti-SARS-CoV-2 IgT seropositivity in the household Time: through study completion, an average of 4 hoursDescription: To develop symptom association profiles in seropositive subjects
Measure: Clinical expression patterns of infection by symptom/antibody association Time: through study completion, an average of 4 hoursDescription: To study the serum distribution of seropositive people, particularly in each symptom typology group.
Measure: Serological Response to Infection Time: through study completion, an average of 4 hoursDescription: To use the results of the SARS-CoV-2 seroprevalence testing campaign and questionnaires to refine our knowledge of the current and future situation and make better projections with better calibrated mathematical models of SIR infectious diseases.
Measure: Anti-SARS-CoV-2 IgT seropositivity Time: through study completion, an average of 4 hoursDescription: 10. To evaluate the in vitro neutralisation capacity of the viral infectivity of the antibodies detected.
Measure: • Evaluation of serum neutralisation of persons positive for anti-SARS-CoV-2 antibodies, of the infectivity of viral strains in cell culture: percentage neutralisation compared to a viral strain not exposed to seropositive serum. Time: through study completion, an average of 4 hoursCoronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The disease is highly infectious, and its main clinical symptoms include fever, dry cough, fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to the severe stage, which is characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction. After China, COVID-19 spread across the world and many governments implemented unprecedented measures like suspension of public transportation, the closing of public spaces, close management of communities, and isolation and care for infected people and suspected cases. The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May 2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle against COVID-19 is still continuing in Malaysia and all over the world. Due to the CMO and CMCO in the country, public and private universities have activated the e-learning mode for classes and as the government ordered, universities are closed and no face-to-face activities allowed. This has forced students of all disciplines including dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning mode. To guarantee the final success for fight against COVID-19, regardless of their education status, students' adherence to these control measures are essential, which is largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP theory. Once the restrictions are eased students have to come back and resume their clinical work in the campus. Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19 and the students preference for online learning.
Description: KAP towards COVID-19 was assessed using validated questionnnaire
Measure: Knowledge, Attitude, Practice of dental students towards COVID-19 Time: 4 monthsDescription: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire
Measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics Time: 4 monthsDescription: Preference towards online learning. was assessed using a standard questionnaire
Measure: Preference towards online learning. Time: 4 monthsThis study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
Description: This data will be collected for decisions on subsequent vaccination of an additional open-label sentinel group with the same dose level.
Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination Time: Up to 24 hours after vaccination on Day 1Description: This data will be collected for decisions on dose escalation as well as continuation of enrollment at the same dose level in the observer-blind placebo-controlled part of the trial.
Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination Time: Up to 60 hours after vaccination on Day 1Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies. At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.
Description: Percentage, intensity, and relationship to vaccination of immediate adverse events (AEs)
Measure: Immediate adverse event (AEs) Time: 30 minutesDescription: Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following each vaccination
Measure: Solicited local and systemic adverse events (AEs) Time: 7 daysDescription: Percentage, intensity, and relationship of unsolicited adverse events (AEs) following each vaccine administration
Measure: Unsolicited adverse events (AEs) Time: 21 daysDescription: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths following each vaccine administration
Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: 21 daysDescription: Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and 3 days following each vaccination.
Measure: Safety labs Time: 3 daysDescription: Nab response induced by the vaccine against the SARS-CoV-2 virus
Measure: Neutralizing antibody (Nab assay) response Time: 21 daysDescription: Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot)
Measure: Specific Th1 cell-mediated immunity (CMI) response Time: 21 daysDescription: Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interleukin-4 (IL-4) ELISpot
Measure: Specific Th2 cell-mediated immunity (CMI) response Time: 21 daysDescription: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths from 22 days after the last vaccination up to the end of the study
Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: Day 42 to 386Description: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus, as measured by total IgG and/or IgM levels
Measure: Specific antibody response induced by the vaccine against the SARS-CoV-2 virus measured by total IgG and/or IgM levels Time: Day 21, 42, 201 and 386Description: Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus
Measure: Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus Time: Day 201 and 386Description: Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IFN- γ ELISpot
Measure: Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus Time: Day 201 and 386Description: Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IL-4 ELISpot.
Measure: Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus Time: Days 201 and 386Description: Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by the percentage of CD4+ T cells expressing functional markers
Measure: Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus Time: Day 21, 201 and 386Description: Specific antibody response induced by the vaccine against plant glycans as measured by serum IgE levels directed against Cross-reactive Carbohydrate Determinants (CCD) MUXF3 using bromelain glycoprotein
Measure: Specific antibody response induced by the vaccine against plant glycans Time: Day 21, 201 and 386Description: If deemed necessary, further characterization of the immune response and the safety profile of the Coronavirus-Like Particle COVID-19 Vaccine
Measure: Further characterization of the immune response and the safety profile of the Coronavirus-Like Particle COVID-19 Vaccine Time: Day 21, 42, 201, 386Description: Occurrence(s) of laboratory-confirmed (virologic or serologic methods) SARS-CoV-2 infection (with or without symptoms
Measure: Laboratory-confirmed SARS-CoV-2 infection Time: Day 0 to 386Description: • If deemed necessary, further characterization of the immune response of the Coronavirus-Like Particle COVID-19 Vaccine.
Measure: Characterization of the immune response of the Coronavirus-Like Particle COVID-19 Vaccine Time: Up to day 386Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity. An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments
Description: weight
Measure: nutritional evaluation Time: before Covid, at hospital discharge and between 7 and 45 days after dischargeDescription: BMI
Measure: nutritional evaluation Time: before Covid, at at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after dischargeDescription: hand grip
Measure: muscle strenght Time: at the time of hospital admission and at the time of hospital dischargeDescription: Caloric account
Measure: food intake Time: at the time of hospital admission, at the time of hospital dischargeDescription: self evaluation of food intake
Measure: food intake Time: between 7 and 45 days after dischargeDescription: self evaluation of muscle strenght
Measure: muscle strenght Time: between 7 and 45 days after dischargeDescription: albuminemia transthyretinemia electrolytes dosage inflammation status
Measure: biological nutritional status Time: at the time of hospital admission, at the time of hospital dischargeDescription: anosmia and agueusia evolution
Measure: anosmia Time: at the time of hospital admission, at the time of hospital discharge and between 7 and 45 days after dischargeThe primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64 mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 29.
Description: Difference between OKZ and placebo groups in the percentage of subjects with an improvement of at least 2 categories of the 5-points clinical status scale relative to baseline or in the "Not hospitalized" category. The points of the scale are: 1. Not hospitalized; 2.Hospitalized, not requiring supplemental oxygen; 3.Hospitalized, supplemental oxygen, spontaneous breathing;4. Hospitalized, mechanical ventilation (invasive/non-invasive) or extracorporeal membrane oxygenation (ECMO); 5. Death
Measure: Percentage of subjects achieving a change in their clinical status defined as improvement for at least 2 categories of the 5-points clinical status scale relative to baseline or in the "Not hospitalized" category Time: at Day 29Description: Subjects' clinical status distribution based on 5-point clinical status scale during the study
Measure: Subjects' clinical status distribution based on 5-point clinical status scale during the study Time: from Day 2 tо Day 15, Day 29, Day 60Description: 28-day case fatality rates
Measure: 28-day case fatality rates Time: from Day 1 to Day 29Description: Case fatality rates during the intensive care unit (ICU) stay at Days 7, 15, and 60
Measure: Case fatality rates during the intensive care unit (ICU) stay, at Days 7, 15, and 60 Time: from Day 1 to Day 60Description: Duration of oxygen support (if applicable)
Measure: Duration of oxygen support Time: From Day 1 to Day 60Description: The time period until SpO2 ≥ 94% at ambient air during 2 consequence days is reached
Measure: The time period until SpO2 ≥ 94% at ambient air during 2 consequence days is reached Time: from Day 2 to Day 60Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable)
Measure: Changes of oxygenation index PaO2/FiO2 from baseline Time: from Day 2 to Day 60Description: Duration of oxygen support (if applicable), in days
Measure: Duration of oxygen support (if applicable) Time: from Day 1 to Day 60Description: Duration of mechanical ventilation and/or ECMO (if applicable), in days
Measure: Duration of mechanical ventilation and/or ECMO (if applicable) Time: from Day 1 to Day 60Description: Duration of ICU stay (if applicable)
Measure: Duration of ICU stay (if applicable) Time: from Day 1 to Day 60Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte counts
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte count Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP)
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP) Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides
Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides Time: from Day 2 and until the end of hospitalization, Day 29 as a maximumDescription: The time period until National Early Warning Score 2 (NEWS2) ≤ 2 during 2 consequent days is reached
Measure: The time period until National Early Warning Score 2 (NEWS2) ≤ 2 during 2 consequent days is reached Time: from Day 1 and until the end of hospitalization, Day 29 as a maximumDescription: The time period until National Early Warning Score 2 (NEWS2) ≤ 4 during 2 consequent days is reached
Measure: The time period until National Early Warning Score 2 (NEWS2) ≤ 4 during 2 consequent days is reached Time: from Day 1 and until the end of hospitalization, Day 29 as a maximumThis Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir with or without Dexamethasone.
Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
Measure: 1. Time (Hours) to recovery Time: [ Time Frame: 36 days ]Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications
Measure: Time fever resolution Time: [ Time Frame: 36 days ]SARS-CoV-2 or COVID-19 is representing the major global burden that implicated more than 10 million infected cases and 500 thousand deaths worldwide. The prevalence of this pandemic disease is expected to rise every day. The challenge is to control its rapid spread meanwhile looking for a specific treatment to improve patient outcomes. Hesperidin is a classical herbal medicine used worldwide for a long time with an excellent safety profile. Hesperidin is a well-known herbal medication used as an antioxidant and anti-inflammatory agent. Available shreds of evidence support the promising use of hesperidin in prophylaxis and treatment of COVID 19. Herein, we discuss the possible prophylactic and treatment mechanisms of hesperidin based on previous and recent findings. Hesperidin can block coronavirus from entering host cells through ACE2 receptors which can prevent the infection. Anti-viral activity of hesperidin might constitute a treatment option for COVID-19 through improving host cellular immunity against infection and its good anti-inflammatory activity may help in controlling cytokine storm. Hesperidin mixture with diosmin co-administrated with heparin protect against venous thromboembolism which may prevent disease progression. Based on that, hesperidin might be used as a meaningful prophylactic agent and a promising adjuvant treatment option against SARS-CoV-2 infection.
Description: PCR negative
Measure: PCR test Time: 14 daysDescription: Changes in respiratory rate
Measure: respiratory rate Time: 14 daysDescription: Change in patients PaO2
Measure: patients PaO2 Time: 14 daysDescription: change in serum IL1β
Measure: serum IL1β Time: 14 daysDescription: changes in serum TNF-α
Measure: serum TNF-α Time: 14 daysDescription: decrease in Mortality rate
Measure: Mortality rate Time: 14 daysThis study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the dynamic changes in eicosanoid mediators with available patient clinical status, including measures of severity of illness, routine laboratory tests, and outcomes.
Description: Temporal changes on eicosanoid lipid mediators over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization
Measure: Changes on eicosanoid lipid mediators Time: 10 daysDescription: Temporal changes on the levels of 40 human cytokines, chemokines and growth factors included in a commercially available panel (Bio-Rad, Human Chemokine Panel, 40-Plex #171AK99MR2) over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization.
Measure: Changes on plasma levels of a panel of 40 human cytokines and chemokines Time: 10 daysDescription: Severe clinical outcome defined as need for ICU admission and/or need for mechanical ventilation and/or multi-organ failure and/or death during hospitalization
Measure: Severe clinical outcome Time: Through study completion, an average of 10 daysCOVID-19 is a new disease and therefore it is still not clear exactly how the virus affects the body and why people are affected so differently. It causes infection in the lungs and the virus can then attack blood vessels in the lungs and other organs to spark off an inflammatory process that can make a person very ill. It also can cause damage within tiny blood vessels that makes a person's blood thicken up and stop flow in vital organs. The investigators believe complement (which is a chemical in the body which can be harmful in excess) orchestrates the inflammation and thickening of the blood that can make a person sick. The investigators now need to know which of these complement chemicals are elevated in COVID-19 and compare to healthy volunteers, and assess whether the levels are higher in people with severe lung disease. The investigators believe that if levels are increased there are special treatments that can counteract them and potentially be an effective treatment for COVID-19. In this study the investigators will measure different parts of the inflammation process to better understand what may be causing severe disease and to see if there may be benefits from a new treatment to reduce inflammation
Description: C5a, C5, C3, sC5b9, Bb concentration from serum
Measure: Complement Activation Time: 14 days sampling time periodDescription: LTB4 concentration from plasma
Measure: Leukotrienes Measure Time: 14 days sampling time periodDescription: Level of platelets, INR, APTS, D-Dimer, Fibrinogen, thrombin antithrombin complex (TAT), from citrate plasma
Measure: Coagulation Measure Time: 14 days sampling time periodDescription: • CRP, Ferritin, PCT, LDH, Troponin, ALT from plasma
Measure: Hyperinflammation Measure Time: 14 days sampling time periodDescription: Total White Blood Cell count (including lymphocytes, monocytes and neutrophils)
Measure: Cell Count Time: 14 days sampling time periodDescription: Level of • Pro-inflammatory - IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-7, IL-8, IL-17, GCSF, GMCSF, IFN γ, IP10, MCP-1, MIP1α, TNFα and anti inflammatory IL-4, IL-10, IL-13, IL-22, TGF-α from plasma
Measure: Cytokines and Chemokine Measure Time: 14 days sampling time periodDescription: VEGF, tissue factor and PAI-1, from plasma
Measure: Endothelial dysfunction measures: Time: 14 days sampling time periodSAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. As a result, after the acute phase of COVID-19, early complications may be observed, including heart, lungs, brain, muscles and liver. A few papers to date have been reported of myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse prognostic effects. Due to the extent of the pandemic, the severity of the complications and the expected high complications' prevalence in the early post-recovery period, a study was designed to determine the extent of the problem of early complications after COVID-19. Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned, including laboratory, imaging and functional tests. The results obtained, in addition to determining the scale of the problem, will allow the selection of studies that optimally identify patients with early complications. The purpose of this procedure is to enable rapid treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect raised in the project will be the issue of psychiatric disorders (anxiety, depression, post traumatic disorders). The main three purposes of the study include: 1. the assessment of prevalence of particular complications after COVID-19. 2. identification of the demographic and clinical risk factors of COVID-19 complications 3. determining the diagnostic tests which are sufficient to detect early complications of COVID-19
Description: Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19. The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies
Measure: Prevalence of COVID-19 complications Time: 2 monthsDescription: Analysis which demographic and clinical parametrs were associated with particular COVID-19 complication. Statistical analysis of relation between clinical parameters before and during COVID19 and the occurence of COVID19 complications
Measure: Assessment of risk factors of COVID-19 complications Time: 2 monthsThe vast majority of individuals with Covid19 have mild illness that can be managed in the outpatient setting. A small but significant number of these people will deteriorate and require hospitalization. Symptoms are a poor - and possibly late - indicator for deterioration. While people who have died, and/or been cared for in the ICU or hospital have been well characterized, there remains a dearth of information about the clinical course of people in the outpatient setting. Most notably, it is not known when to escalate to hospital care. The consequence of non-escalation when needed is significant patient morbidity and mortality, of escalation when not needed is unnecessarily overwhelmed hospitals. Technologies for clinical management and early diagnostics for severe Covid19 infection will address this challenge. The research goal of this study is to use real-time remote patient monitoring to detect which patients with Covid19 are at risk of deterioration to bring to hospital, while at the same ensuring the worried will receive reassurance so they stay at home. The clinical goal is to help clinicians provide excellent care using ubiquitous mobile phones.
Description: Number of participants with an unplanned emergency department visits leading to hospital admission
Measure: Number of participants with an unplanned hospital admissions Time: 30 daysDescription: Number of participants with planned hospital admissions that are found to be necessary
Measure: Number of participants with planned hospital admissions that are found to be necessary Time: 30 daysDescription: Number of participants with an emergency department visit not resulting in a hospital admission
Measure: Number of participants with an emergency department visits not resulting in hospital admission Time: 30 daysDescription: Number of planned hospital admissions which are found to be unnecessary
Measure: Number of planned hospital admissions which are found to be unnecessary Time: 30 daysThis is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.
Description: Incidence of Adverse Events 1 week post immunisation
Measure: Incidence of Adverse Events Time: 1 weeks post immunisationDescription: COVID19 neutralizing antibody titers post immunisation
Measure: COVID19 neutralizing antibody titers Time: 2 weeks post second immunisationDescription: Frequency of COVID19 spike specific T cells 3 weeks post second immunisation
Measure: COVID19 T cell immunogenicity Time: 3 weeks post second immunisationDescription: COVID19 spike specific antibody titers 6 months post second immunisation
Measure: Durability of antibody response Time: 6 months post immunisationThe purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Description: Time to deterioration as measured by any one of the following: need for non-invasive ventilation need for high flow nasal cannula (HFNC) or need for intubation Death from any cause
Measure: Time to deterioration Time: up to 14 daysDescription: Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air
Measure: Time to stable oxygen saturation Time: up to 14 daysDescription: Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment
Measure: Treatment Emergent Adverse Events and SAEs Time: 30 days after last inhalation treatmentThis observational study aims to collect detailed clinical information on confirmed or suspected patients of COVID-19 treated in hospitals from Meta State, Colombia. The objectives are: 1. To establish the characteristics of patients and healthcare workers treated with COVID-19. 2. To assess previous predisposing morbidity. 3. To detail clinical factors associated with complications. 4. To profile clinical indicators for severity and outcomes.
Description: Death within 30 days of hospital admission
Measure: Mortality Time: 30 daysDescription: Need for intensive care unit admission
Measure: ICU admission Time: 30 daysDescription: Need for intubation and invasive mechanical ventilation
Measure: Mechanical ventilation Time: 30 daysDescription: Duration of stay in the intensive care unit
Measure: ICU length of stay Time: 30 daysDescription: Duration of stay in hospitalization
Measure: Hospital length of stay Time: 30 daysDescription: Duration of mechanical ventilation included with intubation or tracheostomy
Measure: Days of mechanical ventilation Time: 30 daysThe objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® (GENERIUM JSC, Russia) with standard therapy versus standard therapy in patients with COVID-19.
Description: PaO2 / FiO2, FiO2 = fraction of oxygen in inhaled air,% PaO2 = partial pressure of oxygen in arterial blood, mm Hg
Measure: Change in oxygenation index Time: Days 3, 5, 8Description: SpO2 / FiO2, FiO2 = fraction of oxygen in inhaled air,% SpO2 = hemoglobin oxygen saturation, %
Measure: Change in SpO2/FiO2 index Time: Days 1, 2, 3, 4, 5, 6, 7, 8PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.
Description: The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.
Measure: Identification of baseline characteristics which correlate with disease severity Time: Based on clinical need - Up to 1 year follow up.Description: Relationship between changes in markers of inflammation (CRP, D dimer, ferritin, fibrinogen, pro-calcitonin) and pulmonary, renal and cardiac complications post hospitalisation for Covid-19 infection.
Measure: Identification of blood biomarkers which correlate with disease severity Time: Based on clinical need - Up to 1 year follow up.Description: Genomic, proteomic and transcriptomic analysis of blood samples to look for genetic susceptibility to severe disease presentations and to identify new biomarkers that predict disease severity or disease trajectory
Measure: Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations Time: Based on clinical need - Up to 1 year follow up.Description: Incidence of: Interstitial lung disease Pulmonary embolism Pulmonary hypertension as determined by pulmonary artery systolic pressure on echocardiogram or mean pulmonary artery pressure on right heart catheterisation if performed Renal dysfunction (as defined by new persistent impairment of egfr or new sustained protenuria measured using urinary protein-creatinine ratio) Cardiac dysfunction (new LV or RV systolic dysfunction on echocardiogram) Psychological distress as measured using Hospital anxiety and depression scale
Measure: Incidence Time: Based on clinical need - Up to 1 year follow up.Description: Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21
Measure: Change in respiratory symptom scores Time: Based on clinical need - Up to 1 year follow up.Description: Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.
Measure: Change in respiratory symptom scores Time: Based on clinical need - Up to 1 year follow up.Description: Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.
Measure: Change in frailty and quality of life scores Time: Based on clinical need - Up to 1 year follow up.Description: Assessed through the Clinical Frailty Scale: Scores range from 1-9.
Measure: Change in frailty and quality of life scores Time: Based on clinical need - Up to 1 year follow up.Description: D dimer/ fibrinogen and new pulmonary embolism
Measure: Relationship between serum markers and clinical outcomes Time: Based on clinical need - Up to 1 year follow up.Description: Troponin/ BNP and cardiac disease
Measure: Relationship between serum markers and clinical outcomes Time: Based on clinical need - Up to 1 year follow up.Description: Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities
Measure: Relationship between serum markers and clinical outcomes Time: Based on clinical need - Up to 1 year follow up.Description: Changes in health behaviours such as alcohol consumption and tobacco use Mental health and psychological wellbeing Factors affecting compliance with Public Health England guidelines The impact of cultural and religious beliefs on behaviours during the pandemic
Measure: Thematic analysis of semi-structured interviews exploring the following areas: Time: Up to 1 year follow up.This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied
Description: The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.
Measure: Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire Time: 3 monthsDescription: prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied
Measure: Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection Time: 3 monthsThis study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores Time: 6 monthsDescription: Time to non-infectivity as measured by PCR testing
Measure: Efficacy of Treatment by Time to Non-Infectivity Time: 10 daysDescription: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores Time: 6 monthsDescription: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. Time: 6 monthsDescription: Changes in blood parameters measured in a Complete Blood Count (CBC).
Measure: Safety of Dual Therapy as Measured by Complete Blood Count Time: 6 monthsDescription: Changes in blood parameters measured in a Complete Metabolic Panel.
Measure: Safety of Quadruple Therapy as Measured by Complete Blood Count Time: 6 monthsDescription: Changes in serum albumin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin Time: 6 monthsDescription: Changes in serum albumin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin Time: 6 monthsDescription: Changes in serum albumin/globulin ratio
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio Time: 6 monthsDescription: Changes in serum albumin/globulin ratio
Measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio Time: 6 monthsDescription: Changes in serum alkaline phosphatase levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase Time: 6 monthsDescription: Changes in serum alkaline phosphatase levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase Time: 6 monthsDescription: Changes in serum AST levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST Time: 6 monthsDescription: Changes in serum AST levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST Time: 6 monthsDescription: Changes in serum ALT levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT Time: 6 monthsDescription: Changes in serum ALT levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT Time: 6 monthsDescription: Changes in serum BUN/Creatinine Ratio
Measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio Time: 6 monthsDescription: Changes in serum BUN/Creatinine Ratio
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio Time: 6 monthsDescription: Changes in serum Blood Urea Nitrogen levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN Time: 6 monthsDescription: Changes in serum Blood Urea Nitrogen levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN Time: 6 monthsDescription: Changes in serum calcium levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium Time: 6 monthsDescription: Changes in serum calcium levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium Time: 6 monthsDescription: Changes in serum carbon dioxide levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide Time: 6 monthsDescription: Changes in serum carbon dioxide levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide Time: 6 monthsDescription: Changes in serum chloride levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride Time: 6 monthsDescription: Changes in serum chloride levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride Time: 6 monthsDescription: Changes in serum creatinine levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine Time: 6 monthsDescription: Changes in serum creatinine levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine Time: 6 monthsDescription: Changes in serum globulin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin Time: 6 monthsDescription: Changes in serum globulin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin Time: 6 monthsDescription: Changes in blood glucose levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose Time: 6 monthsDescription: Changes in blood glucose levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose Time: 6 monthsDescription: Changes in blood potassium levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium Time: 6 monthsDescription: Changes in blood potassium levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium Time: 6 monthsDescription: Changes in serum total bilirubin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin Time: 6 monthsDescription: Changes in serum total bilirubin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin Time: 6 monthsDescription: Changes in serum total protein levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein Time: 6 monthsDescription: Changes in serum total protein levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein Time: 6 monthsDescription: Presence or absence of treatment related serious adverse events Grade III or higher
Measure: Safety of Dual Therapy as Measured by Treatment Related SAE Time: 6 monthsDescription: Presence or absence of treatment related serious adverse events Grade III or higher
Measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE Time: 6 monthsThis study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: - To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. - To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
Description: TEAEs (defined as AEs with onset after study drug administration or existing AEs that worsen in severity after study drug administration)
Measure: Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0 Time: after treatment (Day 1) through to Day 30Description: Blood sample collected for CBC with differential will be assessed from baseline (at screening)
Measure: Change from baseline in clinical laboratory test results for CBC with differential Time: Screening and Day 8Description: Screening blood sample collected for CBC with differential, counting the number of abnormal clinical tests
Measure: Incidence of abnormal laboratory test results for CBC with differential at Screening Time: ScreeningDescription: Day 8 blood sample collected for CBC with differential
Measure: Incidence of abnormal laboratory test results for CBC with differential - Day 8 Time: Day 8Description: Blood sample collected for blood glucose and measured with a glucometer
Measure: Changes from baseline for blood glucose Time: Screening and Day 1Description: Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Measure: Incidence of abnormal laboratory test results for chemistry -Screening Time: ScreeningDescription: Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)
Measure: Incidence of abnormal laboratory tests results for chemistry - Day 8 Time: Day 8Description: Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Measure: Incidence of abnormal laboratory tests results for urinalysis - Screening Time: ScreeningDescription: Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood
Measure: Incidence of abnormal laboratory tests results for urinalysis- Day 8 Time: Day 8Description: The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (September 2007) (TGSHAAV) will be used as the primary criteria for assessment of clinical abnormalities. Mild (17-20 breaths per minute) to Potentially Life Threatening (intubation)
Measure: Changes in vital signs from baseline (pre-dose) - respiratory rate Time: Screening, Day 1, Day 2 and Day 8Description: Oral temperature
Measure: Changes in vital signs from baseline (pre-dose)- temperature Time: Screening, Day 1, Day 2 and Day 8Description: Systolic and diastolic blood pressure
Measure: Changes in vital signs from baseline (pre-dose) - seated blood pressure Time: Screening, Day 1, Day 2 and Day 8Description: Heart rate measure by radial pulse rate (beats/min)
Measure: Changes in vital signs from baseline (pre-dose) - pulse Time: Screening, Day 1, Day 2 and Day 8Description: O2 saturation (%), measured by pulse oximeter. Graded as per TGSHAAV (September 2007) from Moderate (pulse oximeter <92%) to Potentially Life Threatening (Life-threatening airway compromise; urgent intervention indicated)
Measure: Changes in vital signs from baseline (pre-dose) - O2 saturation Time: Screening, Day 1, Day 2 and Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- general appearance Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - general appearance Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- general appearance Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- general appearance Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- neurological Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1- neurological Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- neurological Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- neurological Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular Time: Day 1 (pre-dose, within 3 hours of dose)Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening - lungs Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - lungs Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - lungs Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8 - lungs Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- abdomen Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - abdomen Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- abdomen Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- abdomen Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during screening- endocrine Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - endocrine Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- endocrine Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- endocrine Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- extremities Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1- extremities Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2- extremities Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- extremities Time: Day 8Description: Physical exam by clinician. A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during Screening- lymphatic Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1- lymphatic Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - lymphatic Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8- lymphatic Time: Day 8Description: A directed physical examination will be conducted
Measure: Incidence of abnormal and physical examinations findings during screening - skin Time: ScreeningDescription: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 1 - skin Time: Day 1Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 2 - skin Time: Day 2Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted
Measure: Incidence of abnormal and physical examinations findings on Day 8 - skin Time: Day 8Description: Pulmonary function testing and recording of FEV1, both actual and percent predicted
Measure: Changes from baseline for pulmonary function tests (PFTs) - FEV1 Time: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.Description: Pulmonary function testing and recording of FVC, , both actual and percent predicted
Measure: Changes from baseline for pulmonary function tests (PFTs) - FVC Time: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.Description: Pulmonary function testing and recording of FEV1/FVC
Measure: Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC Time: creening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - QT interval Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QTcB interval (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - QTcB Interval Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QRS duration (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - QRS duration Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG PR interval (msec) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - PR interval Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG heart rate (beats/min) will be the assessment parameter.
Measure: Changes from baseline for ECG readings - heart rate Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG - Screening Time: ScreeningDescription: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG- Day 1 Time: Day 1 pre-dose (within 3 hours of dose) and +2 and +6 hoursDescription: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG - Day 2 Time: Days 2Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.
Measure: Incidence of abnormal ECG - Day 8 Time: Days 8.Description: Blood samples for PK analysis will be collected via indwelling catheter or via direct venipuncture.
Measure: HCQ concentration in whole blood versus time profiles Time: Day 1 pre-dose (time 0) and +2, +3, +5, and +15 minutes after dose, and also +1, +2, +4 and +6 hours post-dose completion. Day 2 (+24±4 hours post dose) and Day 8.In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability to contain the disease. There is currently no vaccine to prevent the disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant mortality has been reported, not related only to tuberculosis. BCG vaccine has been hypothesized to have a non-specific role towards other unrelated pathogens such as viruses that cause airway disease, with reduced morbidity and mortality. In murine as well as in human models it has been shown to decrease the incidence of acute respiratory influenza infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it increases the epigenetic response, causing an increase in the transcription of genes important in the antimicrobial response, as well as an improvement in cellular function. This is the first national clinical trial to evaluate prospectively the effect that the BCG vaccine offers towards the prevention and reduction of severity in cases of COVID-19.
Description: Cumulative incidence of infection in 6 months: disease defined as positive SARS-Cov-2 test (serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
Measure: Demonstrate COVID- 19 disease incidence among Health care workers: Time: During the 6 months study periodDescription: Cumulative incidence of hospitalization for COVID-19
Measure: Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers: Time: During the 6 months study periodDescription: Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months
Measure: Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers Time: During the 6 months study periodDescription: Number of participants who needed hospitalization
Measure: Hospitalization of severe disease COVID-19 Time: During the 6 months study periodDescription: Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients
Measure: Oxygen supplementation in severe disease COVID-19 Time: During the 6 months study periodDescription: Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients
Measure: Need for intubation or non-invasive ventilation for the patient. Time: During the 6 months study periodDescription: Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients
Measure: Critical care admission with SARS-CoV2 Time: During the 6 months study periodDescription: Mortality associated to progressive pulmonary disease in hospitalized patients
Measure: Mortality associated to progressive pulmonary disease Time: During the 6 months study periodDescription: SOFA score: PaO2/FIO2 (mm Hg), SaO2/FIO2, Platelets (×10³/µL), Bilirubin (mg/dL), Hypotension, Glasgow Coma Score and Creatinine (mg/dL) or urine output (mL/d).
Measure: Determine the scores of the Clinical Prediction Rules associated with mortality using Sequential Organ Failure Assessment (SOFA score) at the patient's hospital admission: Time: During the 6 months study periodDescription: APACHE: History of severe organ failure or immunocompromise Heart Failure Class IV, cirrhosis, chronic lung disease, or dialysis-dependent, Age, Temperature (C°), Mean arterial pressure (mmHg), pH, Sodium (mEq/L), Potassium (mEq/L), Creatinine (mg/dL), Hematocrit (%), WBC (x 109/L)
Measure: Determine the scores of the Clinical Prediction Rules associated with mortality using Acute Physiology and Chronic Health disease Classification System (APACHE) at the patient's hospital admission: Time: During the 6 months study periodDescription: CPR, ESR, Ferritin, D-dimer, LDH,Troponins, Procalcitonin, Interleukin-6, Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, MCV, HCM, MCHC, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Glucose, Urea, Creatinine, BUN, Sodium, Potassium, Chlorine, Calcium, Serum albumin, Direct bilirubin, Indirect bilirubin, Alkaline phosphatase, AST, ALT, bleeding time, Prothrombin Time, Activated partial thromboplastin time, Arterial / Venous Blood Gasometry, pH, pCO2, HCO3, pO2, SaO2%, Lactate.
Measure: Evaluate and determine the alteration profile in laboratory studies at the patient's hospital admission Time: During the 6 months study periodA prospective and retrospective cohort study. The objective will to determine the frequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate clinical and laboratory predictors of COVID-19 progression and to determine the factors associated with adverse maternal and perinatal outcomes in healthcare centers in two states of Northeast Brazil.The study will be conducted including pregnant and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be included. The data will be collected in specific forms. The exams will be carried out by trained professionals within each institution.
Description: Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.
Measure: Near miss maternal: Time: 42 daysDescription: It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.
Measure: Maternal death Time: 42 daysDescription: It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar <7 in the 5th minute, birth weight <1,750 grams or gestational age <33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.
Measure: Near miss neonate Time: 7 daysDescription: Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.
Measure: Neonatal death Time: 27 daysDescription: Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable
Measure: Early neonatal death Time: 7 daysDescription: Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.
Measure: Fetal death Time: 1 hourDescription: Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.
Measure: Perinatal death Time: 7 daysDescription: Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.
Measure: Maternal age Time: 1 hourDescription: maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.
Measure: Maternal pre-pregnancy weight Time: 1 hourDescription: expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.
Measure: Maternal height Time: 1 hourDescription: classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to <16.99), low weight grade I (≥ 17 , 00 to <18.49), ideal weight (≥ 18.50 to <24.99), overweight (≥ 25.00 to <29.99), grade I obesity (≥ 30.00 to <34.99) , grade II obesity (≥35.00 to <39.99) and grade III obesity (≥ 40.00).
Measure: Pre-gestational nutritional classification Time: 1 hourDescription: expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.
Measure: Pre-gestational body mass index (BMI) Time: 1 hourDescription: according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.
Measure: Maternal color Time: 1 hourDescription: defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.
Measure: Number of people living in the household Time: 1 hourDescription: collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.
Measure: Family income per capita Time: 1 hourDescription: as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (> 12 years) ). Numerical and discrete variable.
Measure: Maternal education Time: 1 hourDescription: as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.
Measure: Maternal occupation Time: 1 hourDescription: as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.
Measure: Maternal occupation with financial income Time: 1 hourDescription: declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.
Measure: Maternal marital status Time: 1 hourDescription: as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.
Measure: Maternal origin Time: 1 hourDescription: according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.
Measure: Maternal religion Time: 1 hourDescription: smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.
Measure: Maternal smoking Time: 1 hourDescription: habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.
Measure: Maternal alcoholism Time: 1 hourDescription: use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.
Measure: Maternal use of illicit drugs Time: 1 hourDescription: number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
Measure: Number of pregnancies Time: 1 hourDescription: number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
Measure: Parity Time: 1 hourDescription: number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
Measure: Number of previous cesarean sections Time: 1 hourDescription: number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
Measure: Number of previous vaginal births Time: 1 hourDescription: number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
Measure: Number of previous abortions Time: 1 hourDescription: number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.
Measure: Number of children alive Time: 1 hourDescription: as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.
Measure: Number of prenatal consultations Time: 1 hourDescription: gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.
Measure: Gestational age of the onset of flu-like signs and symptoms Time: 1 hourDescription: number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.
Measure: Number of puerperium days of onset of flu-like signs and symptoms Time: 14 daysDescription: number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.
Measure: Duration of maternal symptoms Time: 1 hourDescription: when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.
Measure: Social isolation during the signs and symptoms of flu-like syndrome Time: 14 daysDescription: it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.
Measure: Social distance before the signs and symptoms of flu-like syndrome Time: 1 hourDescription: when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.
Measure: Quarantine Time: 14 daysDescription: when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.
Measure: Need for hospitalization due to flu-like syndrome and/or complications Time: 1 hourDescription: day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.
Measure: Day of hospitalization due to flu syndrome and/or complications Time: 1 hourDescription: length of stay, in days, as described in the medical record. Numerical and discrete variable.
Measure: Length of hospital stay due to flu-like syndrome and/or complications Time: 14 daysDescription: As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).
Measure: Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months Time: 24 monthsDescription: result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.
Measure: Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months Time: 24 monthsDescription: result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.
Measure: Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel) Time: 10 daysDescription: result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.
Measure: Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months Time: 24 monthsDescription: result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.
Measure: Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months Time: 24 monthsDescription: result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.
Measure: Serial maternal IgM COVID-19 Time: 6 months, 12 months and 24 monthsDescription: result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.
Measure: Serial maternal IgA COVID-19 Time: 6 months, 12 months and 24 monthsDescription: result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.
Measure: Serial maternal IgG COVID-19 Time: 6 months, 12 months and 24 monthsDescription: rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.
Measure: Serial maternal serology day Time: 6 months, 12 months and 24 monthsDescription: after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.
Measure: Maternal reinfection Time: 14 daysDescription: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).
Measure: Cytokines in maternal diagnosis Time: 14 daysDescription: day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first blood count from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.
Measure: Hemoglobin of maternal diagnosis Time: 14 daysDescription: value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.
Measure: Leukocytes from maternal diagnosis Time: 14 daysDescription: when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.
Measure: Deviation to the left of the maternal diagnosis Time: 14 daysDescription: value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.
Measure: Platelets of maternal diagnosis Time: 14 daysDescription: value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.
Measure: Typical lymphocytes of maternal diagnosis Time: 14 daysDescription: value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.
Measure: Atypical lymphocytes of maternal diagnosis Time: 14 daysDescription: day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first coagulogram from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.
Measure: Maternal diagnosis bleeding time (TB) Time: 14 daysDescription: value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
Measure: Maternal diagnosis clotting time (CT) Time: 14 daysDescription: value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.
Measure: Maternal prothrombin time of diagnosis (TD) Time: 14 daysDescription: value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.
Measure: Maternal active partial thromboplastin time of diagnosis (APTT) Time: 14 daysDescription: value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.
Measure: International normalized ratio (INR) Time: 14 daysDescription: day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first urea from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.
Measure: Urea from maternal diagnosis Time: 14 daysDescription: day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first creatinine from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.
Measure: Creatinine of maternal diagnosis Time: 14 daysDescription: defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.
Measure: Transaminases in maternal diagnosis Time: 14 daysDescription: day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19: Time: 14 daysDescription: value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.
Measure: VSH of maternal diagnosis Time: 14 daysDescription: day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.
Measure: CRP of maternal diagnosis Time: 14 daysDescription: day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first D-dimer from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
Measure: D-dimer of maternal diagnosis Time: 14 daysDescription: day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.
Measure: DHL of maternal diagnosis Time: 14 daysDescription: day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.
Measure: Alkaline phosphatase in maternal diagnosis Time: 14 daysDescription: day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first troponin from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.
Measure: Troponin in maternal diagnosis Time: 14 daysDescription: day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first ferritin from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
Measure: Ferritin in maternal diagnosis Time: 14 daysDescription: defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.
Measure: Bilirubins in maternal diagnosis Time: 14 daysDescription: day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first blood culture from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Blood culture of maternal diagnosis Time: 14 daysDescription: name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
Measure: Blood culture microorganism in maternal diagnosis Time: 14 daysDescription: day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the first uroculture from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Uroculture of maternal diagnosis Time: 14 daysDescription: name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
Measure: Uroculture microorganism in maternal diagnosis Time: 14 daysDescription: worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.
Measure: IgM COVID-19 worst maternal result Time: 5 daysDescription: Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.
Measure: IgA COVID-19 worst maternal result Time: 5 daysDescription: worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.
Measure: Maternal IgG COVID-19 - worst serial result Time: 14 daysDescription: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).
Measure: Cytokines worst maternal outcome Time: 14 daysDescription: day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the worst urea result from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.
Measure: Urea worst maternal result Time: 14 daysDescription: day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.
Measure: Creatinine worst maternal result Time: 14 daysDescription: defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.
Measure: Transaminases worst maternal outcome Time: 14 daysDescription: day of the worst VSH result from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
Measure: Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the worst result of VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.
Measure: VSH worst maternal result Time: 14 daysDescription: day of the worst CRP result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the worst CRP result measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.
Measure: CRP worst maternal result Time: 14 daysDescription: day of the worst D-dimer result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the worst D-dimer result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
Measure: D-dimer worst maternal result Time: 14 daysDescription: day of the worst DHL result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
Measure: Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19 Time: 14 daysDescription: value of the worst DHL result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.
Measure: DHL worst maternal result Time: 14 daysDescription: value of the worst result of alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.
Measure: Alkaline phosphatase worst maternal result Time: 14 daysDescription: value of the worst result of troponin dosed in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.
Measure: Troponin worst maternal result Time: 14 daysDescription: value of the worst result of ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
Measure: Ferritin worst maternal result Time: 14 daysDescription: defined as the worst result of total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.
Measure: Bilirubins worst maternal result Time: 14 daysDescription: result of the worst blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Blood culture worst maternal result Time: 14 daysDescription: name of the microorganism, which grew on the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
Measure: Blood culture microorganism worst maternal result Time: 14 daysDescription: result of the worst uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Uroculture worse maternal result Time: 14 daysDescription: name of the microorganism, which grew in the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
Measure: Uroculture microorganism worst maternal result Time: 14 daysDescription: presence of any radiological changes, described in a medical report. Yes / No categorical and dichotomous variable.
Measure: Presence of changes in maternal chest radiography Time: 14 daysDescription: description of any radiological alterations, described in a medical report.
Measure: Result of maternal chest radiography Time: 14 daysDescription: presence of any changes in the tomography described in a medical report. Yes / No categorical and dichotomous variable.
Measure: Presence of changes in the mother's chest tomography Time: 14 daysDescription: day of the normalization of any alteration of the tomography, described in a medical report, as of the appearance. Numerical and discrete variable.
Measure: Day of normalization of the alteration of the tomography of the maternal chest Time: 14 daysDescription: description of any alteration of the tomography described in a medical report.
Measure: Result of maternal chest tomography Time: 14 daysDescription: need for maternal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
Measure: Use of maternal nasal catheter Time: 1 monthDescription: need for Venturi mask to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
Measure: Use of maternal Venturi Mask Time: 1 monthDescription: when the patient was placed in prone position on spontaneous ventilation, face down, which was used to improve oxygenation. Yes / No categorical and dichotomous variable.
Measure: Prone maternal position on spontaneous ventilation Time: 1 monthDescription: need for antibiotic therapy to treat associated bacterial infection. Yes / No categorical and dichotomous variable.
Measure: Use of therapeutic antibiotics Time: 14 daysDescription: need for azithromycin as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of azithromycin Time: 14 daysDescription: need for hydroxychloroquine / chloroquine as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of maternal hydroxychloroquine/chloroquine Time: 14 daysDescription: need for antiparasitic drugs as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of antiparasitic drugs Time: 14 daysDescription: need for anticoagulant as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of anticoagulant Time: 14 daysDescription: need for antiretroviral as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of antiretroviral Time: 14 daysDescription: need for corticosteroid pulse therapy as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of pulse therapy Time: 14 daysDescription: need for patient-cured plasma from COVID-19 (convalescent) as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.
Measure: Use of convalescent plasma Time: 14 daysDescription: need for AMV as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.
Measure: Assisted Mechanical Ventilation (AMV) Time: 1 monthDescription: need for medication for neuromuscular block, such as pancuronium, as assessed by the attending physician and described in the medical record. Yes / No categorical and dichotomous variable.
Measure: Use of neuromuscular blocker Time: 14 daysDescription: need to use ECMO to better oxygenate the lungs and heart. Yes / No categorical and dichotomous variable.
Measure: Use of Extracorporeal Circulation (ECMO) Time: 1 monthDescription: need for dialysis (peritoneal or hemodialysis) as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
Measure: Renal replacement therapy (dialysis) Time: 1 monthDescription: need for blood products as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.
Measure: Blood products Time: 1 monthDescription: need for other complementary treatments of COVID-19. Yes / No categorical and dichotomous variable.
Measure: Other therapeutic modalities Time: 1 monthDescription: defined by the amniotic fluid index (ILA) or the largest pocket, according to the experience of the ultrasonographer. The ILA will be measured in cm, being defined as the sum of the largest pockets of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 8.0 and 18.0cm), decreased (between 7.9 and 5.0cm), moderate oligohydramnios (between 4.9 and 3.0cm), severe oligohydramnios (<3 , 0cm), increased (between 18.1 and 24cm) and polyhydramnios (ILA> 24cm) (81.82). The largest pocket will also be measured in cm, being defined as the measure of the largest pocket of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 3.0 and 8.0cm), decreased (between 2.9 and 2.0cm), moderate oligoamine (between 1.9 and 1.0cm), severe oligoamine (<1.0cm), increased (ILA between 8.1 and 12.0cm) and polyhydramnios (ILA> 12.0cm).
Measure: Amniotic fluid in the last ultrasound examination Time: 14 daysDescription: defined by the Delphi procedure 2016 . Yes / No categorical and dichotomous variable.
Measure: Fetal growth restriction Time: 14 daysDescription: defined when the estimated fetal weight is <10pct for gestational age and does not meet the criteria for IUGR. Yes / No categorical and dichotomous variable.
Measure: Small fetus for gestational age (SGA) Time: 14 daysDescription: presence of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound. Yes / No categorical and dichotomous variable.
Measure: Presence of fetal morphological changes Time: 1 monthDescription: description of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound.
Measure: Fetal morphological changes Time: 1 monthDescription: increased FFT diagnosed by ultrasound or Doppler sonar, with sinus rhythm, when greater than 160bpm. Yes / No categorical and dichotomous variable.
Measure: Frequency of fetal tachycardia (FFT) Time: 1 monthDescription: from the pulsatility index (PI), which is automatically calculated by the ultrasound device, using the formula: systolic peak minus the diastolic peak divided by the average speed.
Measure: Doppler velocimetry parameters in the last ultrasound examination Time: 1 monthDescription: gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound of amniocentesis. Numerical and discrete variable.
Measure: Gestational age of amniocentesis Time: 1 monthDescription: indication for amniocentesis, due to COVID-19 or another cause.
Measure: Amniocentesis indications Time: 1 monthDescription: result of RT-PCR for COVID-19, in amniotic fluid, according to the usual technique, being categorized as positive, negative and indeterminate.
Measure: Result of amniocentesis for COVID19 Time: 1 monthDescription: substances capable of modulating the cellular response of several cells, such as interleukins IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in amniotic fluid, in pg / ml, from the beginning of the flu syndrome or COVID-19 , and in the period of the syndrome. Numeric and continuous variable (for each cytokine).
Measure: Amniocentesis cytokines Time: 1 monthDescription: need for hospitalization due to some comorbidity or obstetric complications. Yes / No categorical and dichotomous variable.
Measure: Need for hospitalization due to obstetric causes Time: 1 monthDescription: total hospital stay for any comorbidity or obstetric complications. Numerical and discrete variable.
Measure: Maternal hospital stay Time: 1 monthDescription: calculated based on the last BMI (weight [kg] / height [m] 2), by gestational age, using the curve by Atalah et al. Yes / No categorical and dichotomous variable.
Measure: Obesity Time: 1 monthDescription: defined as blood pressure (BP) greater than or equal to 140 / 90mmHg, diagnosed before pregnancy, or before the 20th week of pregnancy . Yes / No categorical and dichotomous variable.
Measure: Chronic arterial hypertension (CAH) Time: 1 monthDescription: defined as CAH associated with signs of severity . Yes / No categorical and dichotomous variable.
Measure: Superimposed preeclampsia Time: 1 monthDescription: defined as BP greater than or equal to 140 / 90mmHg, diagnosed above the 20th week of pregnancy, with no signs of severity or proteinuria . Yes / No categorical and dichotomous variable.
Measure: Gestational hypertension Time: 1 monthDescription: defined as BP greater than or equal to 140 / 90mmHg, above the 20th week of pregnancy, associated with proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3 ), or target organ dysfunction, which can be categorized as severe and non-severe . Yes / No categorical and dichotomous variable.
Measure: Pre-eclampsia Time: 1 monthDescription: defined as BP greater than or equal to 140 / 90mmHg above the 20th week of gestation, in the presence of proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3), associated with seizures. Yes / No categorical and dichotomous variable.
Measure: Eclampsia Time: 1 monthDescription: defined by the presence of hemolysis, elevated liver enzymes, decreased platelets (below 100,000 / L), elevated TGO / TGP (above 70UI / L) . Yes / No categorical and dichotomous variable.
Measure: HELLP syndrome Time: 1 monthDescription: defined by the presence of one of the criteria: HbA1C ≥ 6.5% or fasting blood glucose ≥ 126mg / dl - the test should be repeated - or random blood glucose> 200mg / dl, associated with symptoms of diabetes , depending on diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.
Measure: Clinical diabetes Time: 1 monthDescription: defined by the presence of at least one of the criteria after an oral glucose tolerance test (TOTG) performed between the 24th and 28th weeks of gestation: fasting glucose ≥ 92mg / dl, or ≥ 180mg / dl (after one hour), or ≥ 153mg / dl (after two hours) , according to the diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.
Measure: Gestational diabetes Time: 1 monthDescription: spontaneous rupture of the membranes, diagnosed by anamnesis and clinical examination of the pregnant woman, before the start of labor. Yes / No categorical and dichotomous variable.
Measure: Premature rupture of membranes Time: 1 monthDescription: defined as the spontaneous triggering of labor before term (<37 weeks), when there were above three contractions in 30 minutes and cervical alteration, according to clinical and obstetric evaluation. Yes / No categorical and dichotomous variable.
Measure: Premature labor Time: 1 monthDescription: define when the placental insertion is low, close to the cervix, regardless of its classification (total, partial and marginal), according to ultrasound report. Yes / No categorical and dichotomous variable.
Measure: Placenta previa Time: 1 monthDescription: termination of pregnancy before the 22nd week and / or below 500 g, gestational age preferable, provided it is reliable, regardless of whether it is spontaneous or provoked. Yes / No categorical and dichotomous variable.
Measure: Abortion Time: 1 monthDescription: defined as vaginal bleeding and / or uterine hypertonia, leading to emergency delivery, with evidence of retroplacental hematoma in the postpartum period. Yes / No categorical and dichotomous variable.
Measure: Normally inserted placental abruption Time: 1 monthDescription: defined when urine culture is positive for any microorganism, and treatment has been started, regardless of symptoms. Yes / No categorical and dichotomous variable.
Measure: Maternal urinary tract infection Time: 1 monthDescription: presence of any congenital or acquired maternal heart disease, according to the patient's information, or diagnosed during hospitalization. Yes / No categorical and dichotomous variable.
Measure: Maternal heart disease Time: 1 monthDescription: as reported by the patient and / or described in the medical record presenting the diagnosis of asthma. Yes / No categorical and dichotomous variable.
Measure: Bronchial asthma Time: 1 monthDescription: as reported by the patient and / or described in the medical record presenting the diagnosis of COPD. Yes / No categorical and dichotomous variable.
Measure: Chronic obstructive pulmonary disease (COPD) Time: 1 monthDescription: as reported by the patient and / or described in the chart that presents the diagnosis of cerebrovascular disease. Yes / No categorical and dichotomous variable.
Measure: Cerebrovascular disease Time: 1 monthDescription: as reported by the patient and / or described in the chart that presents the diagnosis of CRL. Yes / No categorical and dichotomous variable.
Measure: Chronic kidney injury Time: 1 monthDescription: as reported by the patient and / or described in the chart that presents the diagnosis of immunosuppressive disease or use immunosuppressive medication. Categorical and dichotomous Yes / No type.
Measure: Immunosuppression Time: 1 monthDescription: presence of the flu syndrome associated with laboratory changes, such as leukocytosis or leukopenia, and radiological, such as localized or diffuse interstitial infiltrate, or presence of a condensation area, as diagnosed by the attending physician. Yes / No categorical and dichotomous variable.
Measure: Maternal pneumonia Time: 1 monthDescription: life-threatening organ dysfunction resulting from an unregulated response by the body to an infection. Yes / No categorical and dichotomous variable.
Measure: Maternal sepsis Time: 1 monthDescription: defined as a situation of sepsis, associated with signs of hypoperfusion, with fluid-refractory hypotension and requiring vasopressor therapy (Lactate> 2 mmol / L). Yes / No categorical and dichotomous variable.
Measure: Septic shock Time: 1 monthDescription: flu-like syndrome (fever, cough, dyspnoea and other nonspecific), accompanied by oxygen saturation <95% (SatO2), respiratory distress or tachypnea, hypotension and worsening of the clinical conditions of the underlying disease. Yes / No categorical and dichotomous variable.
Measure: Severe acute respiratory syndrome (SARS) Time: 1 monthDescription: increased postpartum bleeding, according to the assessment of the attending physician, requiring some maneuver or therapy for control. Yes / No categorical and dichotomous variable.
Measure: Postpartum hemorrhage Time: 14 daysDescription: exit of purulent secretion by the surgical scar, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.
Measure: Infection of the operative site Time: 14 daysDescription: characterized by the discharge of purulent secretion from the uterine cervix, remaining dilated, with an unpleasant odor and fever for a minimum of two consecutive days, excluding the first 24 hours, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.
Measure: Endometritis Time: 14 daysDescription: characterized by abdominal pain, with compatible image examination, according to the assessment of the attending physician. Categorical and dichotomous Yes / No type.
Measure: Peritonitis Time: 14 daysDescription: removal of the uterus, for any indication, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.
Measure: Need for postpartum hysterectomy Time: 1 monthDescription: defined as the type of delivery performed, categorized as normal, instrumental (vacuum or forceps) or cesarean delivery.
Measure: Type of delivery Time: 1 hourDescription: if a cesarean section was performed, insert the indication that the attending physicians described, which can be later modified, according to the medical record evaluation by the researchers. The main indications are: dystocias, including cephalopelvic disproportion, macrosomia, impaired fetal vitality, placenta previa, cord prolapse, placental abruption, among others.
Measure: Indication of cesarean section Time: 1 hourDescription: gestational age at birth, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the amniocentesis. Numerical and discrete variable.
Measure: Gestational age at birth Time: 1 hourDescription: use of pharmacological labor analgesia, as indicated by the attending physician and declared in medical records. Yes / No categorical and dichotomous variable.
Measure: Use of labor analgesia Time: 4 hoursDescription: method of anesthesia for performing cesarean section, categorized into spinal anesthesia, epidural and general anesthesia.
Measure: Type of anesthesia for cesarean section Time: 1 hourDescription: as noted in the medical records, referring to the complete course of betamethasone (12mg two doses in a 24h interval) or dexamethasone (6mg 12 / 12h, for two days), incomplete course, not taking corticosteroids or without indication for accelerating fetal lung maturity.
Measure: Antenatal corticosteroid therapy (pulmonary maturity) Time: 14 daysDescription: as noted in the medical record, magnesium sulphate for neuroprotection, before delivery and until the 32nd week of pregnancy, being categorized as complete course (performance of attack and first stage of magnesium sulfate before delivery), incomplete, not performed or without indication.
Measure: Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia) Time: 32 weeksDescription: as noted in the medical records, referring to the use of the prophylactic regimen of crystalline penicillin to prevent neonatal infection with group B Streptococcus, being categorized as complete (completion of at least two phases) crystalline penicillin before delivery), incomplete, not performed or without indication.
Measure: Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis) Time: 14 daysDescription: when the pregnant patient was admitted and discharged while pregnant. Yes / No categorical and dichotomous variable.
Measure: Hospital discharge when pregnant Time: 1 monthDescription: when the pregnant or puerperal patient has been admitted and discharged in the puerperal state. Yes / No categorical and dichotomous variable.
Measure: Hospital discharge when puerperal Time: 1 monthDescription: when maternal death occurs with the pregnant patient. Categorical and dichotomous Yes / No type.
Measure: Maternal death when pregnant Time: 1 monthDescription: when maternal death occurs with the patient in the puerperal state. Categorical and dichotomous Yes / No type.
Measure: Maternal death when puerperal Time: 45 daysDescription: birth of a fetus without vitality. Yes / No categorical and dichotomous variable.
Measure: Fetal death Time: 10 hoursDescription: fetal or neonatal death (up to and including the 27th day of life). Yes / No categorical and dichotomous variable.
Measure: Perinatal death Time: 27 daysDescription: as measured on a standard scale, in the delivery room, in grams, and recorded in medical records. Numerical and discrete variable.
Measure: Birth weight Time: 1 hourDescription: classification of birth weight, according to gestational age, being categorized as: small for gestational age (SGA), when <10th pct; suitable for gestational age (AGA), when between 10º pct and 90º pct; and great for gestational age (GIG), when> 90º pct.
Measure: Adequacy of birth weight Time: 1 hourDescription: as calculated by the classic Apgar score , in the first minute of birth, recorded in medical records, which can be later categorized. Numerical and discrete.
Measure: Apgar scores in the first minute Time: 1 minuteDescription: as calculated by the classic Apgar score, in the fifth minute of birth, recorded in medical records, which can be further categorized. Numerical and discrete variable.
Measure: Apgar scores in the fifth minute Time: 5 minutesDescription: defined as the newborn's stay in the neonatal intensive care unit after delivery, to perform any procedure. Yes / No categorical and dichotomous variable.
Measure: Neonatal ICU admission Time: 1 hourDescription: defined as the need for resuscitation maneuvers, performed on the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.
Measure: Need for neonatal resuscitation Time: 27 daysDescription: defined as the need for assisted mechanical ventilation, provided to the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.
Measure: Need for neonatal mechanical ventilation Time: 27 daysDescription: need for a neonatal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
Measure: Neonatal nasal catheter Time: 27 daysDescription: need for neonatal CPAP to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
Measure: Neonatal Continuous Positive Airway Pressure (CPAP) mask Time: 27 daysDescription: defined when the axillary temperature is less than or equal to 35ºC, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
Measure: Neonatal hypothermia Time: 27 daysDescription: defined as peripheral blood glucose below 40mg / dl, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
Measure: Neonatal hypoglycemia Time: 27 daysDescription: defined as any neonatal infection diagnosed as noted in the medical record by neonatal care. Yes / No categorical and dichotomous variable.
Measure: Neonatal infection Time: 27 daysDescription: defined as the infection of the amniotic cavity, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
Measure: Chorioamnionitis Time: 27 daysDescription: defined as newborn's respiratory distress (RDS), transient tachypnea of the newborn (NRT) or absent respiratory distress, as noted in the medical record for neonatal care.
Measure: Neonatal respiratory distress modality Time: 1 monthDescription: defined as any congenital infection confirmed at birth, based on fetal PCR, neonatal examination or maternal serology, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
Measure: Neonatal congenital infection (TORCHS) Time: 1 monthDescription: defined as any fetal congenital malformation present, as noted in medical records by neonatal care. Yes / No categorical and dichotomous variable.
Measure: Congenital malformation Time: 1 monthDescription: exclusive breastfeeding, during hospitalization, by natural method or pasteurized breast milk. Yes / No categorical and dichotomous variable.
Measure: Breastfeeding Time: 1 monthDescription: can be divided into early, when performed in less than three minutes, and timely, when between three to five minutes. Categorical and dichotomous variable.
Measure: Cord ligation Time: 10 minutesDescription: as early contact was made between the mother and the baby, early, still in the delivery room. Yes / No categorical and dichotomous variable.
Measure: Skin-to-skin contact Time: 1 hourDescription: according to breastfeeding, early, still in the delivery room. Yes / No categorical and dichotomous variable.
Measure: Breastfeeding in the delivery room Time: 1 hourDescription: days of life of the newborn until the newborn's diagnostic suspicion. Numerical and discrete variable.
Measure: Days of life of the newborn's diagnostic suspicion Time: 1 monthDescription: result of RT-PCR in the diagnosis of COVID-19, through the blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.
Measure: Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months Time: 6 months, 12 months and 24 monthsDescription: result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.
Measure: Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel) Time: 6 months, 12 months and 24 monthsDescription: result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.
Measure: Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months Time: 6 months, 12 months and 24 monthsDescription: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine)
Measure: Neonatal cytokines Time: 6 months, 12 months and 24 monthsDescription: result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according with the reference values of each serological kit, performed after the 5th day of signs and symptoms.
Measure: Neonatal IgM COVID-19 Time: 5 daysDescription: result of IgA COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.
Measure: IgA COVID-19 neonatal serial Time: 5 daysDescription: result of IgG COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 14th day of signs and symptoms. Numeric and continuous variable.
Measure: Serial neonatal IgG COVID-19 Time: 14 daysDescription: after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.
Measure: Neonatal reinfection Time: 14 daysDescription: value of the first hemoglobin measured in neonatal blood, in g / dL, from the suspicion of the diagnosis by COVID-19. Numeric and continuous variable.
Measure: Hemoglobin from neonatal diagnosis Time: 14 daysDescription: value of the first BT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Diagnostic neonatal bleeding time (BT) Time: 1 monthDescription: value of the first CT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Diagnostic neonatal clotting time (CT) Time: 1 monthDescription: value of the first urea measured in neonatal blood, in mg / dL, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Urea from neonatal diagnosis Time: 1 monthDescription: value of the first creatinine measured in neonatal blood, in mg / dL, based on the suspected diagnosis by COVID-19. Numerical and discrete variable.
Measure: Creatinine from neonatal diagnosis Time: 1 monthDescription: defined as aspartate aminotransferase or glutamic-oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase, based on the suspicion of the diagnosis by COVID-19.
Measure: Transaminases of the neonatal diagnosis Time: 1 monthDescription: result of the first blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Blood culture of the neonatal diagnosis Time: 1 monthDescription: result of the first urine culture, based on the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Uroculture of neonatal diagnosis Time: 1 monthDescription: worst result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate , according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.
Measure: IgM COVID-19 - worst neonatal result Time: 5 daysDescription: worst result of IgG COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 14th day of signs and symptoms. Numeric and continuous variable.
Measure: Neonatal IgG COVID-19 - worst serial result Time: 14 daysDescription: worst result of cytokines, substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12 , IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from suspected diagnosis. Numeric and continuous variable (for each cytokine).
Measure: Cytokines - worst neonatal result Time: 14 daysDescription: day of the worst blood count result, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19 Time: 1 monthDescription: day of the realization of the worst value of the coagulogram, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19 Time: 1 monthDescription: value of the worst BT result measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Bleeding time - worst neonatal result (BT) Time: 1 monthDescription: value of the worst result of urea measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Urea - worst neonatal result Time: 1 monthDescription: value of the worst result of creatinine measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
Measure: Creatinine - worst neonatal result Time: 1 monthDescription: defined as the worst result of aspartate aminotransferase (AST) or glutamic oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase measurements, from the beginning of suspected COVID-19 diagnosis.
Measure: Transaminases - worst neonatal result Time: 1 monthDescription: result of the worst blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Blood culture - worst neonatal result Time: 1 monthDescription: result of the worst urine culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
Measure: Uroculture - worst neonatal result Time: 1 monthDescription: defined as the worst result of measuring hydrogen potential, excess of bases, bicarbonate, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2) and oxygenation index, in neonatal arterial blood, from the beginning of suspected COVID-19 diagnosis.
Measure: Gasometry - worst neonatal result Time: 1 hourDescription: result of RT-PCR in the diagnosis of COVID-19, through the placenta, according to the usual technique, being categorized as positive, negative and indeterminate.
Measure: Result of RT-PCR of the placenta Time: 1 monthDescription: result of the RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through the placenta, according to the technique and kit used, categorized according to the virus found.
Measure: Placental viral panel Time: 1 monthDescription: result of the histopathological of the placenta, according to the usual technique.
Measure: Histopathological of the placenta Time: 1 monthDescription: result of RT-PCR in the diagnosis of COVID-19, using breast milk, according to the usual technique, being categorized as positive, negative and indeterminate.
Measure: Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge Time: 1 monthDescription: result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through breast milk, according to the technique and kit used, categorized according to the virus found.
Measure: Viral panel in breast milk Time: 1 monthDescription: presence of any radiological alteration, described in a medical report. Yes / No categorical and dichotomous variable.
Measure: Presence of alteration of the neonatal chest radiography Time: 1 dayDescription: description of any radiological changes, according to a medical report.
Measure: Result of neonatal chest radiography Time: 1 dayDescription: presence of any alteration of the tomography, described in a medical report. Yes / No categorical and dichotomous variable.
Measure: Presence of alteration of the neonatal chest tomography Time: 1 dayDescription: description of any alteration of the tomography, according to a medical report.
Measure: Result of neonatal chest tomography Time: 1 dayDescription: measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.
Measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference Time: 6, 12 and 24 monthsDescription: measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.
Measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight Time: 6, 12 and 24 monthsDescription: measured by the assistant pediatrician as noted on the prenatal card, in cm. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.
Measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height Time: 6, 12 and 24 monthsDescription: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as adequate, when all are present, and inappropriate, if any of the situations is absent: the baby is firmer and already sits with support; he turns around and rolls from side to side; grabs toys like rings and rattles, holding tight and resisting if someone tries to take them out of your hand; and when he hears some noise, he turns his head to find where it comes from.
Measure: Development of the newborn up to 6 months Time: 6 monthsDescription: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inappropriate, if any of the situations is absent: the baby can stand up, leaning on furniture or with the help of a person; clap your hands, you can point with your finger what you want to catch and have fun saying goodbye; and you may be speaking a word or two like mom, pope, give.
Measure: Development of the newborn up to 12 months Time: 12 monthsDescription: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inadequate, if any of the situations is absent: start to put two words together and speak simple phrases like "where's the cat?" or "milk not"; he demonstrates his own will, tests limits and speaks the word "no" a lot; climbs on chairs and sofas. Run, go up and down stairs, standing, with the help of an adult; can help to dress; and you can start to learn how to control pee and poop.
Measure: Development of the newborn up to 24 months Time: 24 monthsThis study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Description: A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated. A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.
Measure: Cumulative incidence of Grade 3 and Grade 4 adverse events Time: up to Day 28 post-administration of study plasmaDescription: A serious adverse event is any untoward or unfavorable medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect, or is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Measure: Cumulative incidence of serious adverse events Time: up to Day 28 post-administration of study plasmaDescription: Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.
Measure: Proportion of participants with disease worsening event. Time: up to Day 28 post-administration of study plasmaDescription: Anti-SARS-CoV-2 antibody titer changes over time
Measure: Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies Time: Days 0, 7, 14, and 28Description: This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers to be collected once between 60 and 120 days post study plasma administration
Measure: Percentage of participants with a natural antibody response to SARS-CoV-2 infection Time: once between Day 60 and Day 120The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.
Description: Sustained clinical improvement is defined as a 2-point improvement on the 8-point ordinal scale for clinical improvement, that is at least 2 points increase from the lowest score recorded since randomization and no worsening of the score afterwards by Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measure: Percentage of Participants With Sustained Clinical Improvement or Live Discharge at Day 28 Time: Day 28Description: Sustained clinical recovery is defined as achieving score 6, 7, or 8 based on the ordinal scale and maintained the clinical recovery until Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measure: Percentage of Participants With Sustained Clinical Recovery Time: Up to 28 daysDescription: Sustained remission of respiratory symptoms is defined as independence from supplemental oxygen therapy in order to maintain oxygen saturation (SpO2) greater than 94 percent (%) and is maintained up to Day 28.
Measure: Percentage of Participants With Sustained Remission of Respiratory Symptoms Time: Up to 28 daysDescription: Sustained clinical improvement is defined as a 2-point improvement on the 8-point ordinal scale for clinical improvement, that is at least 2 points increase from the lowest score recorded since randomization and no worsening of the score afterwards by Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measure: Time to Sustained Clinical Improvement or Discharge From Hospital Time: Up to 28 daysDescription: Sustained clinical recovery is defined as achieving score 6, 7, or 8 based on the ordinal scale and maintained the clinical recovery until Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measure: Time to Sustained Clinical Recovery Time: Up to 28 daysDescription: Remission of respiratory symptoms is defined as independence from supplemental oxygen therapy in order to maintain SpO2 greater than 94%.
Measure: Time to Sustained Remission of Respiratory Symptoms Time: Up to 28 daysDescription: The SOFA score is a scale for describing multiple organ failure in the critical care setting. It is calculated using the functional status of several organ systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and renal. Each of these organ systems is rated on a scale of 1 to 4, based on objective, testable criteria, chiefly laboratory values. The ratings of each of these systems (worse observed value during that 24-hour period) are then summed to create the total score. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.
Measure: Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Days 7, 14, and 28 Time: Baseline, Days 7, 14, and 28The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.
Description: Mother
Measure: Seroconversion during pregnancy - DSS1 Time: At DSS1 (Around 11-13 weeks gestation)Description: Mother
Measure: Seroconversion during pregnancy - At delivery Time: At DeliveryDescription: Mother (1st); Mother and abortus/stillborn baby(2nd)
Measure: Pregnancy loss Time: At pregnancy lossDescription: Mother and Baby
Measure: Pregnancy course and perinatal outcome Time: From date of recruited until the date of deliveryDescription: Mother and Baby
Measure: Vertical transmission Time: At Newborn 0 hours of life, mother immediately after deliveryDescription: Mother and Baby
Measure: Vertical transmission Time: At Newborn 7 days of lifeDescription: Mother and Baby
Measure: Vertical transmission Time: At Newborn 14 days of lifeDescription: Mother and Baby
Measure: Vertical transmission Time: At Newborn 6 months of lifeDescription: Mother and Baby
Measure: Vertical transmission Time: At Newborn 18 months of lifeDescription: Mother and Baby
Measure: Potential mechanisms for vertical transmission 1) placental barrier, 2) immune response and 3) fetal damage of vertical transmission and mechanism in SARS-CoV-2 infection. Time: through study completion, up to 2 yearsAlthough arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.
Description: To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.
Measure: To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review. Time: January 1, 2020 - June 30, 2020SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment. The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable. Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.
Description: Detection versus No Detection of the virus and indicate which viral protein antigens are most useful for serological testing.
Measure: Detection Test of COVID-19 Time: through study completion, an average of 1 yearIn January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO has described the global situation of COVID-19 as a pandemic. In Côte d'Ivoire, as in other African countries, the number of cases is increasing exponentially. Coronaviruses are a family of viruses that cause illnesses ranging from the common cold to more severe pathologies. COVID-19 can result in fever or a feeling of fever (chills, hot-cold), cough, headache, aches and pains, unusual tiredness, sudden loss of smell, total disappearance of taste, or diarrhea. In severe forms, respiratory difficulties can lead to hospitalization in intensive care or even death. Numerous studies are currently being conducted around the world to seek effective treatment, but few of them have started specifically in Africa. Moreover, most of these studies are using a single drug to control the infection, whether these are repositioned drugs, i.e. already being used for other diseases, or other newer drugs. Currently in Côte d'Ivoire, the preferred treatment for COVID-19 is an antiviral: lopinavir/ritonavir (LPV/r), usually directed against the Human Immunodeficiency Virus (HIV). Since the number of viruses (viral load) is high in the respiratory tract during COVID-19 infection, we propose in INTENSE-COV (ICOV) clinical trial to study whether the combination of two drugs is more effective than taking a single drug on reducing the viral load in the respiratory tract but also on reducing inflammation. These drugs include the LPV/r already in use in Côte d'Ivoire as well as an antihypertensive drug - telmisartan, and a drug that lowers blood cholesterol - atorvastatin. All three have been known for a long time and have been shown to be effective against other viruses. In addition, they are generic, inexpensive and readily available in all countries. The objectives of the ICOV study are therefore to improve viral eradication from the patient's body and respiratory tract, to reduce inflammation, to improve more rapidly the patient's state of health and to reduce the risk of transmission of the virus to others. To participate in ICOV, patients must be over 18 years of age, have a COVID-19 infection confirmed by a specific test, have clinical manifestations of the infection, and have signed an informed consent. They will then be randomized into 3 treatment groups to ensure the robustness of the study results. The reference group will be treated with LPV/r, according to current recommendations in Côte d'Ivoire. The other 2 groups will be treated with LPV/r + telmisartan and LPV/r + atorvastatin respectively. The treatment will last 10 days and patients will be followed for a total of 28 days.
This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.
Description: Mortality at 30 days of Intensive Care Unit (ICU) admission
Measure: Mortality at ICU at 30 days Time: Mortality at 30 daysDescription: Mortality at 90 days of ICU admission
Measure: Mortality at ICU at 90 days Time: Mortality at 90 daysDescription: Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28
Measure: SOFA score of study days 1, 3, 5, 7, 14 and 28 Time: Study days 1, 3, 5, 7, 14 and 28Description: Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment
Measure: Need for supportive therapy after enrollment Time: Duration of supportive therapy through study completion, an average of 3 monthsDescription: Duration (number of days) of stay in ICU between ICU admission and ICU final discharge
Measure: Lenght of stay in ICU Time: Duration of stay in ICU through study completion, an average of 3 monthsDescription: Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation
Measure: Lenght of mechanical ventilation Time: Duration of mechanical ventilation through study completion, an average of 3 monthsDescription: Duration (number of days) of hospitalization between hospital admission and final hospital discharge
Measure: Lenght of hospitalization Time: Duration of hospitalization through study completion, an average of 3 monthsDescription: Duration (number of days) of hospitalization after ICU discharge
Measure: Lenght of hospitalization after ICU discharge Time: Duration (number of days) of hospitalization through study completion, an average of 3 monthsDescription: Number of days without ventilation after enrollment
Measure: Days without ventilation after enrollment Time: Days without ventilation through study completion, an average of 3 monthsDescription: Number of days without vasopressors after enrollment
Measure: Days without vasopressors after enrollment Time: Days without vasopressors through study completion, an average of 3 monthsDescription: Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment
Measure: Changes in Chest X-ray Time: Changes in Chest X-ray through study completion, an average of 3 monthsThe current coronavirus disease pandemic has posed a problem and a challenge for health systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and monitoring disease outbreaks. In this pandemic, the qPCR technique has become vitally important in virus detection, due to its wide detection and quantification range, and the high levels of sensitivity and specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the prior extraction of viral genetic material, which is carried out using commercial kits created for this purpose. Currently, the high demand for supplies to carry out this technique has generated reagent shortage problems, including commercial kits for the extraction of viral genetic material. This research aims to evaluate a solution called AAA-Safe and its method, developed to optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We hope that this alternative can be implemented in any molecular diagnostic laboratory, in order to speed up the delivery of a fast and safe diagnosis.
Description: Two workflows for the detection of SARS-CoV-2 will be compared: Gold Standard: Obtaining nasopharyngeal sample in validated transport medium, RNA extraction by columns and qPCR. Alternative method: Obtaining nasopharyngeal sample in AAA-Safe proprietary transport medium, alternative method of extraction and qPCR.
Measure: Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples. Time: 3 monthsIn this protocol, we seek the understand the demographics of individuals who have used the TraceTogether mobile application. Little is known about the group of individuals who are more likely to utilise the application. Hence, this study hopes to: (1) Understand the demographics of Singaporeans who use and do not use TraceTogether, (2) Identify other behavioural habits of people who do use TraceTogether, (3) Determine if confidence in government would have any effect on TraceTogether usage
Description: Age, gender, social economic status
Measure: Demographic information Time: Once during initial enrolmentThis is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients. Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
Primary Objective: To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with severe coronavirus disease 2019 (COVID-19) Secondary Objectives: - To evaluate the time to onset of effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by CRP levels - To evaluate the time to onset of effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on total duration of supplemental oxygen requirement - To evaluate the effect of SAR443122 relative to the control arm on length of ventilator support needed - To evaluate the effect of SAR443122 relative to the control arm on laboratory markers of severe COVID-19 - To evaluate the effect of SAR443122 relative to the control arm on mortality - To evaluate the effect of SAR443122 relative to the control arm on need for thrombolytic therapy - To evaluate the effect of SAR443122 relative to the control arm on need for vasopressor treatment - To evaluate the safety of SAR443122 as compared to the control arm up to End of Study - To evaluate the effect of SAR443122 relative to the control arm on total duration without high flow supplemental oxygen requirements
Description: Relative change from baseline in CRP level on Day 7
Measure: Relative change from baseline in CRP level Time: Day 7Description: The time to 50% decrease from baseline in CRP level
Measure: Time to 50% decrease from baseline in CRP level Time: Baseline to Day 28Description: The time to improvement of oxygenation as measured by oxygen saturation >/=92% breathing room air over 48 hrs or until discharge
Measure: Time to improvement of oxygenation Time: Baseline to Day 28Description: Change from baseline in SPO2/FiO2 ratio at Day 7
Measure: Change from baseline in SPO2/FiO2 ratio Time: Day 7Description: Number of Days without need for oxygen support and alive (oxygen saturation >=92% breathing room air) up to Day 28
Measure: Number of Days without need for oxygen support and alive Time: Baseline to Day 28Description: Numbers of Ventilator-free days and alive up to Day 28
Measure: Numbers of Ventilator-free days and alive Time: Baseline to Day 28Description: Change from baseline in white blood cell count and differential blood lymphocytes at Day 7 and End of treatment (EOT)
Measure: Change from baseline in markers of inflammation: white blood cell count and differential blood lymphocytes Time: Day 7 and Day 15Description: Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT
Measure: Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio Time: Day 7 and Day 15Description: Change from baseline in IL-6 at Day 7 and EOT
Measure: Change from baseline in marker of inflammation: interleukin 6 (IL-6) Time: Day 7 and Day 15Description: Change from baseline in D-Dimer at Day 7 and EOT
Measure: Change from baseline in D-Dimer Time: Day 7 and Day 15Description: Incidence of Deaths up to Day 28
Measure: Incidence of Deaths Time: Baseline to Day 28Description: Percentage of participants receiving thrombolytic treatment up to Day 28
Measure: Percentage of participants receiving thrombolytic treatment Time: Baseline to Day 28Description: Percentage of participants receiving vasopressor treatment up to Day 28
Measure: Percentage of participants receiving vasopressor treatment Time: Baseline to Day 28Description: Numbers of Respiratory Failure-Free Days (RFFD) and alive up to Day 28
Measure: Numbers of Respiratory Failure-Free Days (RFFD) and alive Time: Baseline to Day 28To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Description: To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Measure: Change in the proportion of patients alive and free from respiratory failure Time: 28 DaysDescription: To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.
Measure: Change in the proportion of patients alive and free of ventilator use or ECMO Time: 28 DaysDescription: To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 and 56 days as compared to SOC treatment combined with placebo.
Measure: Mortality Rate Time: 28 and 56 DaysDescription: Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.
Measure: Clinical Change Time: 14 and 28 DaysDescription: Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.
Measure: Adverse Events Time: up to 56 daysCoronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.
Description: Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.
Measure: Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women. Time: From the start of the study up until one month prior to study end.Description: Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.
Measure: Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women. Time: From the start of the study up until one month prior to study end.Description: Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Measure: Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women. Time: From the start of the study up until one month prior to study end.The outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that started in late December 2019 in the Hubei province of China caused millions of cases worldwide in just a few months, and evolved into a real pandemic. However, only approximately 20% of SARS-CoV-2 infected patients required intensive on sub-intensice medical care and the remained experience mild or subclinical form of the disease that did not require hospital admission and a relatively high percentage (40 to 45%) remained asymptomatic. Understanding the occurrence of SARS-CoV-2-like infectious in a large non-hospitalized population, when the epidemic peak was occurring in Italy, is of paramount importance but data are scarce. The goal of this research project is to estimate the number of suspected cases of COVID-19 and to investigate the role of the potential factors associated with SARS-CoV-2 infection in a large Italian sample of respondents living in Italy during the lockdown (started in Italy on 9 March 2020). EPICOVID19 is an Italian countrywide self-administered cross-sectional web-based survey on adult volunteers launched on April 13, 2020. The on-line questionnaire has been developed starting from the available literature and implemented using an open source platform focusing on beahvioural and clinical features of participants.
Description: Measured by using answers on the Clinical evaluation section of the questionnaire: Fever > 37.5 °C for at least 3 consecutive days; cough; sore throat/rhinorrea; headache; myalgia; olfactory/taste disorders; shortness of breath; chest pain; tachycardia; gastrointestinal disorders; conjunctivitis. Variables on symptomatology will be created by considering each symtom singularly and by combining them using a priori definition (e.g. WHO) and a posteriori approach (based on EPICOVID19 data). Logistic regression models will be applied to assess the measurements of association between exposures of interest and COVID-19-like symptoms by estimating the aOR and 95%CI.
Measure: Number of participants (%) with COVID-19-like symptoms Time: 3 months (July 2020) after initial data collection (April 2020)Description: Measured by using answers collected thorugh the on-line questionnaire about molecular NPS tests results. Logistic regression models will be applied to assess the measurements of association between exposures of interest and SARS-CoV-2 NPS positivity versus negativity by estimating the odds ratios (aOR) and 95% Confidence Intervals (CI).
Measure: Number of participants (%) with SARS-CoV-2 nasopharyngeal swab (NPS) test positivity Time: 3 months (July 2020) after initial data collection (April 2020)Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv with multiple comorbidities. Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic acid content in the test sample (NA) will be recorded from the virology test results. Their exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes' walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements will be taken at every three days intervals from admission to discharge from hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video platforms will be used for the interactions between the physiotherapists and the participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and Nervous System Disorders research group of the University of Lagos, Nigeria will be used for the E-exercises. The exercise package will be loaded into the phones of the participants at hospital admission. The Physiotherapists will lead in the exercises through video interaction will the participants watches the video programme. Their risks for respiratory complications (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval). Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence for inclusion of Physiotherapy in the acute management of individuals tested positive for CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage to reduce the odds of developing complications expedite discharge and reduce odd of death.
Description: The CT value of a reaction is defined as the cycle number when the fluorescence of a PCR product can be detected above the background signal. The CT value is associated with the amount of PCR product in the reaction. The lower the CT value, the more PCR product that is present. It does not have unit of measurement
Measure: Cycle Threshold (CT) values as recorded from the series of the qRT-PCR Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documentedDescription: This is the inverse of the Cycle Threshold. It does not have unit of measurement.
Measure: Nucleic acid values as calculated from the Cycle Threshold recorded from the series of the qRT-PCR Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documentedDescription: Perceived life experience by the participants in relation to the present situation. It does not have unit of measurement.
Measure: Quality of Life perception Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documentedDescription: The maximum amount of physical exertion that a patient can sustain. It will be tested using the 3-metre walk test. This is the time taken to complete a 3-metre distance. The unit of measurement is in seconds
Measure: Exercise capacity Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documentedDescription: The maximum length a patient can sustain an exercise procedure, It will be tested using the 3-minutes' walk test This is the distance covered within a 3-minute walk. The unit of measurement is in metres
Measure: Exercise endurance Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documentedBackground The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported. Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test
Description: Prevalence of positive IgG for SARS-CoV-2
Measure: to establish the seroprevalence of SARS-CoV-2 Time: up to 20 weeksTo measure the effect of Ivermectin (sub-cutaneous) with or without zinc and Nigella sativa in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Description: time needed to turn positive COVID-19 PCR to negative
Measure: qRT-PCR Time: 14 daysDescription: time needed to make patients clinically better
Measure: Severity of symptoms Time: 14 daysSENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were randomly allocated in a parallel assignment involving two groups of participants: Group A (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19 standard care. Standard care is defined as per the "UAE National Guidelines for Clinical Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell processing and investigational product formulation were completed by Abu Dhabi Stem Cells Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).
Description: Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.
Measure: Adverse reactions incidence. Time: Day 0 - 28Description: Incidence of deaths within 28-days in enrolled patients.
Measure: Rate of mortality within 28-days. Time: Day 0 - 28Description: Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.
Measure: Time to clinical improvement on a seven-category ordinal scale. Time: Day 0 - 28Description: Immune response profile characterized according the biomarkers: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, HLA-DR, IgD, and TCRγδ, for the identification of immune cells and subsets analysis; and the humoral Immune profile: IgG, IgA, IgM levels.
Measure: Assessment of the immune response profile. Time: Days 0, 14, and 28Description: Complete Blood Counts (CBC), Acute phase proteins and Inflammatory markers: CRP, ESR, LDH, Procalcitonin (PCT), Ceruloplasmin, Haptoglobin, alpha 1 antitrypsin, IL-6, ferritin C3, PT, fibrinogen and D-dimer.
Measure: Assessment of acute-phase serum markers. Time: Days 0, 14, and 28The purpose of this epidemiologic study is to estimate the prevalence and incidence of anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also estimate the risk of SARS-CoV-2 exposure in target population.
Description: Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.
Measure: Prevalence of Symptomatic Infection Time: 1 yearDescription: Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.
Measure: Prevalence of Subclinical Infection Time: 1 yearThe objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Description: Time taken for viral load clearance
Measure: qRT-PCR Time: 14 daysDescription: Time taken for symptomatic response in patients
Measure: Severity of Symptoms Time: 14 daysPioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.
Description: Number and type of adverse events
Measure: Adverse events outcomes without attribution Time: Baseline, until 30 days after last doseDescription: Number and type of adverse events
Measure: Adverse events attributable Time: Baseline, until 30 days after last doseDescription: Disease severity as measured by 7 point ordinal scale
Measure: Clinical improvement Time: Baseline, until 30 days after last doseDescription: Type of oxygen support treatment
Measure: Levels of treatment Time: Baseline, until 30 days after last doseDescription: Change from Baseline of d-Dimer
Measure: d-Dimer Time: Baseline, until 30 days after last doseDescription: Change from Baseline of CRP
Measure: C Reactive Protein Time: Baseline, until 30 days after last doseDescription: Change from Baseline of Ferritin
Measure: Ferritin Time: Baseline, until 30 days after last doseDescription: Change from Baseline of Lactate dehydrogenase
Measure: Lactate dehydrogenase Time: Baseline, until 30 days after last doseDescription: Change from Baseline of A1c
Measure: A1c Time: Baseline, until 30 days after last doseThe coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement. In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children. In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.
Description: We plan to assess the psychological status of children during coronavirus outbreak : negative and positive feeling during confinement, worries and expectations about school resumption. We also aim at correlating high stress levels with environmental or/and temperamental factors.
Measure: Proportion of children presenting signs of psychological suffering during confinement. Time: We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis. Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.
Description: Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns.
Measure: COVID 19 positive vs negative Time: 3 monthsCorona Virus Disease (COVID-19), spread worldwide and has become an emergency of major international concern. In March 2020, the WHO declared the COVID-19 outbreak a global pandemic. Accurate and fast diagnosis is crucial in managing the pandemic. Current diagnostic approaches raise several difficulties: they are time-consuming, expensive, invasive, and most important lacking high sensitivity. The gold standard diagnostic test for COVID-19, reverse transcription polymerase chain reaction (RT-PCR), is highly dependent on adequate deep sampling of the swab in the naso- and oropharynx. A new diagnostic test that can correctly and rapidly identify infected patients and asymptomatic carriers is urgently required to prevent further virus transmission and thus reduce mortality rates. Aim: This proof-of-principle study aims to investigate if an electronic nose (Aeonose) can distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs). Methods: between April and July 2020, persons undergoing RT-PCR and a serology test for COVID-19 were recruited at Maastricht UMC+ for breath analysis. All participants had to breathe through the Aeonose for five consecutive minutes. The VOC pattern in their exhaled breath was then linked to the matching RT-PCR and serological test results.
Description: Ability of the electronic nose (Aeonose) to distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).
Measure: COVID-19 antibodies vs COVID-19 negative Time: 3 monthsCOVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.
Description: Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Measure: Time to worsening of disease Time: Up to 30 days after inclusionDescription: Time to discharge from hospital assessed by the 7-point ordinal scale
Measure: Time to improvement of disease Time: Up to 30 days after inclusionDescription: Safety evaluation, as measured by AEs
Measure: Adverse events Time: Up to 6 monthsDescription: Total days of extra oxygen
Measure: Duration of supplemental oxygen (days) Time: Up to 30 daysDescription: Frequence of admission to ICU
Measure: Admission to ICU Time: Up to 30 days and up to 6 monthsDescription: Changes of laboratory parameters: Hb
Measure: Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescription: PCR based SARS-CoV-2 measurement from upper respiratory tract
Measure: Virus load assessment day 0, 2, 4 and 6 Time: UP to 7 daysDescription: Total number of days evaluated at 30 days and 6 months
Measure: Hospital stay (days) Time: Up to30 days and 6 monthsDescription: If admitted to hospital due to COVID-19 disease after discharge from hospital
Measure: Re-admission to hospital due to rebound COVID-19 Time: Evaluated for 30 days and after 6 monthsDescription: Death due to any cause
Measure: Mortality at 6 months Time: up to 30 days and up to 6 months respectivelyDescription: Testosterone and estrogen levels
Measure: Hormonal status at 6 months Time: from baseline to 6 monthsDescription: Identification of serologic immunity based after 6 months from inclusion
Measure: Serological immunity for COVID-19 Time: At 6 monthsDescription: Changes of laboratory parameters: CRP
Measure: Laboratory assessment of CRP concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescription: Changes of laboratory parameters: ALAT, ASTA and/or ALP
Measure: Laboratory assessment of liver function day 0, 2, 4 and 6 Time: Up to 30 daysDescription: Changes of laboratory parameters: Createnin
Measure: Laboratory assessment of creatinine concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescription: Changes of laboratory parameters: D-dimer
Measure: Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescription: Changes of laboratory parameters: TPK
Measure: Laboratory assessment of platelets concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescription: Changes of laboratory parameters: IL-6
Measure: Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescription: Changes of laboratory parameters: Differentiate count of leucocytes
Measure: Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6 Time: Up to 30 daysDescriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features
Description: admission to hospital
Measure: Hospital Admission Time: 30 daysThis study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
Description: asymptomatic seroconversion for SARS-CoV-2
Measure: Seroconversion Time: 24 weeksDescription: asymptomatic seroconversion for SARS-CoV-2
Measure: Interim analysis - seropositivity at 12 weeks Time: 12 weeksDescription: Sensitivity and specificity of dried blood spot assay compared with venous blood serology
Measure: Dried Blood Spot performance Time: 24 weeksDescription: Sensitivity and specificity of salivary IgA compared with venous blood serology
Measure: Salivary IgA performance Time: 24 weeksDescription: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
Measure: Prevalence of SARS-CoV-2 Time: 24 weeksDescription: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time
Measure: Change in seropositivity Time: 24 weeksDescription: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity
Measure: Change in seroconversion rate Time: 24 weeksCoronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.
Description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD
Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) Time: 90-120 days after admission of patient to the ICUDescription: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety
Measure: Symptoms of Anxiety Time: 90-120 days after admission of patient to the ICUDescription: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression
Measure: Symptoms of Depression Time: 90-120 days after admission of patient to the ICUDescription: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication
Measure: Family Satisfaction with Communication and Decision Making Time: 90-120 days after admission of patient to the ICUThe overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.
Measure: Survival without needs of ventilator utilization at day 14 Time: day 14Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at day 7 and 14 Time: day 7 and day 14Description: Overall survival
Measure: Overall survival at 14, 28, 60 and 90 days Time: 14, 28, 60 and 90 daysDescription: Cumulative incidence of discharge alive
Measure: Cumulative incidence of discharge alive at 14 and 28 days Time: 14 and 28 daysDescription: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of mechanical ventilation at day 1 Time: day 1Description: Cumulative incidence of oxygen supply independency
Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days Time: 14 and 28 daysPreliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).
Description: The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.
Measure: Change in Methemoglobin level at 48 hours Time: 48 hoursDescription: The primary outcome will be evaluated with the difference in Methemoglobineamia between the groups at 96 hours after randomization.
Measure: Change in Methemoglobin level at 96 hours Time: 96 hoursDescription: The secondary outcome, "Improve the oxygenation at 48 hours," will be evaluated with the measure of the difference in oxygenation among the groups at 48 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.
Measure: Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours Time: 48 hoursDescription: The secondary outcome, "Improve the oxygenation at 96 hours," will be evaluated with the measure of the difference in oxygenation between the groups at 96 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.
Measure: Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours Time: 96 hoursDescription: The secondary outcome "difference in the rate of negative RT-PCR for SARS CoV-2" will be evaluated as the rate of negativization of the RT-PCR for SARS-CoV-2 at 5 days after randomization, at discharge and at 28 days after randomization.
Measure: Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days Time: 28 daysDescription: The secondary outcome "different time to clinical recovery" will be evaluated as the time between the randomization and the clinical indication to interrupt the administration of oxygen for 24 hours.
Measure: Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge Time: 28 daysDescription: The secondary outcome "Different reduction in inflammatory markers" will be evaluated as improvement in the inflammatory markers (IL-6; Ferritin; White Blood Cells; Leucocyte count; CRP; D-Dimer) observed in blood samples collected at day 1, 2, 3, 4, and 7 compared to the Baseline value.
Measure: Reduction in the inflammatory markers among groups Time: 7 daysDescription: The secondary outcome "rate of AKI between groups" will be evaluated as the presence of a comparable rate of AKI during the hospital stay. The AKI will be defined according to the KDIGO classification.
Measure: Rate of Acute Kidney Disease (AKI) between groups during hospitalization Time: 28 daysDescription: The secondary outcome "Difference in Katz score between groups" will be evaluated as the difference in Katz Activities of Daily Living between Baseline and day 28. This questionnaire will coincide with the 28-day phone call to assess health status and survival.
Measure: Difference in Katz score between groups Time: 28 daysDescription: 1. The exploratory outcome "Effect of nitric oxide on heart function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in heart ultrasound at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in heart ultrasound during the administration of NO comparing pre-treatment, during treatment, and post-treatment.
Measure: Effect of NO gas treatment on cardiovascular hemodynamics assessed using cardiac ultrasound in COVID-19 hypoxemic patients Time: 96 hoursDescription: 2. The secondary outcome "Effect of NO gas on lung function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in spirometry at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in spirometry during the administration of NO comparing pre-treatment, during treatment, and post-treatment.
Measure: Effect of NO gas treatment on lung function evaluated with serial spirometry in COVID-19 hypoxemic patients Time: 96 hoursThe purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.
Description: To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.
Measure: Longitudinal survey Time: 2 yearsThe COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.
Description: ICU admission, mechanical ventilation, death or consent withdrawal
Measure: Time to treatment failure Time: 28 daysThe purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with Coronavirus Disease 2019 (COVID-19).
Description: National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities
Measure: Number of participants who are classified 8 (dead), 7 (hospitalized, on invasive mechanical ventilation or ECMO), or 6 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the NIAID ordinal scale Time: day 14Description: Modified Sequential Organ Failure Assessment (MSOFA) scale: Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (≤ 400); 2 (≤ 315); 3 (≤ 235); 4 (≤ 150) Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine ≤ 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine ≤ 0.1, Norepinephrine ≤ 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1) Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6) Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0)
Measure: Number of participants with a total score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) scale Time: day 14Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed
Description: scale 0-64 points
Measure: number of functional limitations post COVID-19 Time: 3-6 monthDescription: Hamilton scale, points
Measure: number of psychologic changes Time: 3-6 monthsDescription: ESS scale 0-20, points
Measure: Sleep Disturbance and quality Time: 3-6 monthsDescription: Chest HRCT
Measure: Radiologic changes Time: 3-6 monthsDescription: Complete blood count, C - reactive protein, serum ferritin
Measure: Laboratory changes Time: 3-6 mothsIn the ER of National Taiwan University Hospital, the critical patients are treated (including tracheal intubation and cardiopulmonary resuscitation) in either resuscitation area or negative pressure isolation rooms based on the past history and present illness. During COVID-19 epidemic, whether sequential changes in environmental and personal protective equipment would change the difference of treatment efficacy and patient safety remains unclear. Whether treating patients in resuscitation area or negative pressure isolation room would cause different physical and psychological stress of medical staff and environmental contamination is also unknown. This study aims to conduct a prospective sequential allocation clinical trial to investigate the success rate, patient safety, physical and psychological stress of medical staff, and the risk of environmental contamination of tracheal intubation and cardiopulmonary resuscitation between the resuscitation area and negative pressure isolation room. The results of the study may be used to improve the protocol and protective policy in treating critical patients during an epidemic.
Description: Comparison between the duration and number of tries needed to intubate a patient, or achieve ROSC in patients requiring cardiopulmonary resuscitation, in resuscitation area and negative pressure isolation rooms.
Measure: The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms Time: 6 monthsDescription: Comparison between the survival rate of patients who were intubated in the resuscitation area and negative pressure isolation rooms, taking into account the duration of hospital stay, respiratory status (successful extubation, post tracheostomy, etc), and neurological state (using the Glasgow coma score, cerebral performance categories, and overall performance categories) upon discharge from the hospital.
Measure: The patient prognosis between resuscitation area and negative pressure isolation rooms Time: 6 monthsDescription: The medical staff involved in the intubation and/or cardiopulmonary resuscitation procedures will be asked to voluntarily fill up a survey form to determine their level of psychological stress. They will also be followed up within 14 days post exposure for covid-19 symptoms and undergo testing and quarantine if needed.
Measure: The physical and psychological stress of medical staff Time: 14 daysDescription: The facilities in both resuscitation area and negative pressure isolation rooms will be sampled and compared for the presence of the coronavirus after each intubation or cardiopulmonary resuscitation procedure.
Measure: The amount of environmental contamination between resuscitation area and negative pressure isolation rooms Time: 14 daysThis is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection. The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients. A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.
Description: All-cause mortality rates at 60 days
Measure: All-cause mortality Time: 60 DaysDescription: To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days
Measure: Incidence and course of symptoms of COVID-19 infection Time: 60 DaysDescription: Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)
Measure: Hospitalizations Time: 60 DaysDescription: Rate of patients requiring oxygen therapy
Measure: Oxygen supplementation Time: 60 DaysDescription: Rate of patients requiring invasive mechanical ventilation
Measure: Use of invasive mechanical ventilation Time: 60 DaysDescription: ICU length of stay
Measure: Intensive care unit length of stay Time: 60 DaysDescription: Percentual changes in serum proteome of patients with mild or moderate to severe disease
Measure: Serum proteomic Time: 60 DaysDescription: Percentual changes in serum metabolome of patients with mild or moderate to severe disease
Measure: Serum metabolomic Time: 60 DaysDescription: Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease
Measure: Genomic description Time: 60 DaysThe clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.
Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to Day 30 Follow-up AssessmentDescription: This will be assessed at various time points by clinical laboratory tests and vital signs.
Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities Time: First dose date up to Day 30 Follow-up AssessmentDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 7 daysThe purpose of the study is to determine if a high dose of IVIG plus SMT can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this context.
Description: Positivity of specific IgM or IgG
Measure: Seroprevalence of SARS-CoV-2 Time: 3 monthsIn this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Description: Time to negative RT-PRC result indicating that patient is no longer infective
Measure: Time to Non-Infectivity by RT-PCR Time: 6 monthsDescription: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) Time: 6 monthsDescription: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) Time: 6 monthsDescription: Patients will have serum stored for titer testing to compare antibody levels over time
Measure: Efficacy of Treatment as measured by Titer Time: 6 monthsDescription: Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Measure: Efficacy of Treatment as measured by RT-PCR Time: 10 daysDescription: Blood D-Dimer levels
Measure: Safety of Treatment as Measured by D-Dimer Time: 6 MonthsDescription: Blood Pro-Calcitonin levels
Measure: Safety of Treatment as Measured by Pro-Calcitonin Time: 6 MonthsDescription: Blood CRP levels
Measure: Safety of Treatment as Measured by C-Reactive Protein Time: 6 MonthsDescription: Blood ferritin levels
Measure: Safety of Treatment as Measured by Ferritin Time: 6 MonthsDescription: Blood enzyme levels
Measure: Safety of Treatment as Measured by Liver Enzymes Time: 6 MonthsDescription: CBC
Measure: Safety of Treatment as Measured by Complete Blood Count Time: 6 MonthsDescription: Blood electrolytes
Measure: Safety of Treatment as Measured by Electrolyte Levels Time: 6 MonthsDescription: Presence or absence of Grade 3 or high treatment related adverse events
Measure: Safety of Treatment as Measured by Treatment Related Adverse Events Time: 6 monthsThe purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Description: DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
Measure: Dose-limiting toxicity(DLT) Time: 7 daysDescription: MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.
Measure: Maximal Tolerable Dose(MTD) Time: 12 weeksDescription: Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)
Measure: AUC0-t Time: 12 weeksDescription: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)
Measure: AUC0-∞ Time: 12 weeksDescription: Elimination Phase Half-life(t1/2)
Measure: t1/2 Time: 12 weeksDescription: Time to the Maximum Concentration(Tmax)
Measure: Tmax Time: 12 weeksDescription: Positive rate of anti-SCT A01 antibody
Measure: Anti-drug antibody(ADA) Time: 12 weeksDescription: Adverse events as assessed by DAIDS v2.1, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs
Measure: Adverse events Time: 12 weeksThe study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.
Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Measure: WHO Ordinal Scale Time: 30 daysDescription: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Measure: Degree of supplemental oxygen Time: 30 daysDescription: Peripheral oxygen saturation measured by pulse oximetry
Measure: Peripheral Oxygen Saturation (SpO2) Time: 30 daysThe study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.
Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Measure: WHO Ordinal Scale Time: 30 daysDescription: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Measure: Degree of supplemental oxygen Time: 30 daysDescription: Peripheral oxygen saturation measured by pulse oximetry
Measure: Peripheral Oxygen Saturation (SpO2) Time: 30 daysBackground: investigators have seen recently from experience in Western countries with best health care systems that pandemics cannot be managed in hospitals. Investigators have seen ICUs crowded to capacity, healthcare workers being exposed and going to quarantine or dying after exposure to large doses of viral inoculums. Investigators recommend that institutions should register for Clinical trials and consider emergency use of TPE. In Pandemics, time is of essence to avoid mortality by intervening early with available evidence, preferably as part of clinical trial. Scientific rationale: Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19) and related pneumonia, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). However, literature review has shown that most common cause of death in severe SARS-COV-2 is Cytokine release syndrome and Hemophygocytic Lymphohistocytosis (HLH). In this context, Investigators seek to treat patients who are sick enough to warrant hospitalization prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or Acute Respiratory Distress Syndrome (ARDS).
Description: Death or recovery
Measure: Survival Time: 28 daysDescription: Duration of hospitalization in days
Measure: Duration of Hospitalization Time: 28 daysDescription: Time in days to achieve viral clearance
Measure: Timing of PCR negativity Time: 28 daysDescription: Time in days required to settle symptoms and laboratory parameters of CRS
Measure: Time to CRS resolution Time: 28 daysDescription: Complications secondary to use of TPE
Measure: Complications Time: 28 daysThe outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes. The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care. This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.
Description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
Measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdownDescription: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
Measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy Time: 6 weeks period following the end of the lockdownDescription: Use BMI, lipid profile, renal and hepatic function from medical records
Measure: Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdownDescription: Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
Measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation
Measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco
Measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)
Measure: Describe healthcare consumption of patients with diabetes during the lockdown. Time: 6 weeks period following the end of the lockdownDescription: Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
Measure: Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19. Time: 6 weeks period following the end of the lockdownThe cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with COVID-19. Patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. Therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. Immuomedulator such as interleukin-6 (IL-6) antagonist, emerged as an alternative treatment for COVID-19 patients with a risk of cytokine storms recently. In this study, we aimed to evaluate the safety and efficacy of anti-IL6 alone vs anti-IL6 corticosteroid combination in patients with COVID-19 pneumonia
Description: The median ventilator-free days will be calculated as calendar days with no ventilator support to day 28 . Participants who die before day 28 are assigned zero free days.
Measure: Ventilator-Free Days Time: Up to Day 28Description: From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first.
Measure: Median duration of ventilation Time: Up to Day 28Description: Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)
Measure: Median change in the PaO2/FiO2 Time: Up to Day 28Description: The median vasopressor-free days will be calculated as calendar days with no vasopressor support to day 28. Participants who die before day 28 are assigned zero free days.
Measure: Vasopressor-Free days Time: Up to Day 28Description: To compare ICU LOS
Measure: Duration of ICU Stay Time: Up to 28 daysDescription: To compare hospital LOS
Measure: Duration of Hospital Stay Time: Up to 28 daysDescription: Death that occurs during 28 days
Measure: Mortality Rate Time: Up to Day 28Description: adverse events that occurs during 28 days
Measure: Percentage of participants with adverse events [transaminitis, hyperglycemia] Time: Up to 28 daysDescription: Concentration of inflammatory markers
Measure: Concentration of Ferritin, IL6, D dimer, fibrinogen, C-reactive protein (CRP), Lactate dehydrogenase (LDH) and absolute lymphocyte count and their correlation with the effectiveness of the treatment Time: Up to 28 daysIn this study, a total of 80 patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive Duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and at the University of Pennsylvania and will be identified and recruited by their treating physician and research team.
Description: This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.
Measure: Number of Participants Requiring Mechanical Ventilation or Dying Time: Up to Day 29Description: Time to recovery (in days) is defined as a score of greater than 5 from the following eight categories from the NIAID ordinal scale. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities.
Measure: Days to Recovery Time: Up to Day 29Description: The number of days spent hospitalized will be compared between study arms.
Measure: Duration of Hospitalization Time: Up to Day 29Description: The incidence of death within 29 days of randomization will be compared between study arms.
Measure: Incidence of Death Time: Up to Day 29Description: Comparing the proportion of subjects in each group requiring ICU transfer within 29 days of randomization
Measure: Proportion of Participants Transferred to ICU Time: Up to Day 29Description: The ECOG Performance Status instrument includes a single item assessing overall physical status. Health status is rated on a scale of 0 to 5 where 0 = fully active and 5 = dead. Median ECOG performance will be compared between study arms.
Measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score Time: Day 15, Day 29Description: The incidence of grade III-V adverse events or Serious Adverse Events (SAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5, will be compared between study arms.
Measure: Incidence of Grade III-V Adverse Events Time: Up to Day 29Description: The incidence of documented secondary bacterial or viral infections among participants will be compared between study arms.
Measure: Incidence of Secondary Bacterial or Viral Infections Time: Up to Day 29Description: The mean frequency of Th1 T cells in blood mononuclear cells will be compared between study arms.
Measure: Change in Th1 T Cell Frequency Time: Weeks 1, 2, and 4Description: The mean frequency of Th17 T cells in blood mononuclear cells will be compared between study arms.
Measure: Change in Th17 T Cell Frequency Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-2 will be compared between study arms.
Measure: Change in Interleukin-2 (IL-2) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-2R will be compared between study arms.
Measure: Change in Interleukin-2 receptor (IL-2R) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-6 will be compared between study arms.
Measure: Change in Interleukin-6 (IL-6) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-7 will be compared between study arms.
Measure: Change in Interleukin-7 (IL-7) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-8 will be compared between study arms.
Measure: Change in Interleukin-8 (IL-8) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-10 will be compared between study arms.
Measure: Change in Interleukin-10 (IL-10) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IP-10 will be compared between study arms.
Measure: Change in Interferon gamma-induced Protein 10 (IP-10) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker MIP-1a will be compared between study arms.
Measure: Change in Macrophage Inflammatory Protein 1alpha (MIP-1a) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker MCP-1 will be compared between study arms.
Measure: Change in Monocyte Chemoattractant Protein-1 (MCP-1) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker G-CSF will be compared between study arms.
Measure: Change in Granulocyte Colony-stimulating Factor (G-CSF) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker TNF-alpha will be compared between study arms.
Measure: Change in Tumor Necrosis Factor (TNF)-alpha Time: Weeks 1, 2, and 4Description: VIP is a peptide hormone with immunosuppressive properties. Mean levels VIP will be compared between study arms.
Measure: Change in Vasoactive Intestinal Peptide (VIP) Time: Weeks 1, 2, and 4Description: Mean levels of the Tregs will be compared between study arms.
Measure: Change in Gene Expression Profile of Regulatory T Cells (Tregs) Time: Weeks 1, 2, and 4Description: Mean levels of CD8+IFNg+GM-CSF+ will be compared between study arms.
Measure: Change in Gene Expression Profile of cluster of differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage colony-stimulating factor (GM-CSF)+ Time: Weeks 1, 2, and 4Description: Mean levels of CD8+Tim3+PD-1+ will be compared between study arms.
Measure: Change in Gene Expression Profile of CD8+ T cell immunoglobulin and mucin domain-containing protein 3 (Tim3)+ Programmed cell death protein 1 (PD-1)+ Time: Weeks 1, 2, and 4Description: Mean levels of CD14+CD16+ monocytes will be compared between study arms.
Measure: Change in Gene Expression Profile of cluster of differentiation 14 (CD14)+ cluster of differentiation (CD16)+ monocytes Time: Weeks 1, 2, and 4Description: Mean levels of SARS-CoV-2 viremia in respiratory specimens will be compared between study arms.
Measure: Change in SARS-CoV-2 Viremia Time: Weeks 1, 2, and 4Description: Median titers of IgG antibodies to SARS-CoV-2 will be compared between study arms.
Measure: Change in Immunoglobulin G (IgG) Antibodies Time: Weeks 1, 2, and 4Description: Median titers of IgM antibodies to SARS-CoV-2 will be compared between study arms.
Measure: Change in Immunoglobulin M (IgM) Antibodies Time: Weeks 1, 2, and 4Description: Overall survival is defined as days from randomization to death and censored at last follow up.
Measure: Overall Survival Time: Up to Day 29Through history, there have been plenty of pandemics however; the social response to corona virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals are living in social segregation during this mother of all pandemics. Initially described in China in December 2019, severe acute respiratory syndrome caused by corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new pandemic is injuring not only health organizations of several countries but also the financial prudence universal. Defining the clinical features and associated outcomes of patients diagnosed with coronavirus disease (COVID-19) is fundamental to improving our understanding and adequate management of this illness. Several articles have recently been published, describing the clinical features and outcomes of retrospective individuals with COVID-19
Description: Determinants of survival in studied covid-19 patients admitted to hospitals
Measure: number of co-morbidities in hospitalized patients with COVID-19 Time: one monthDescription: Determinants of ICU admission in hospitalized patients with COVID-19
Measure: causes of ICU admission Time: one monthTo determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.
Description: Proportion of patients requiring admission to the hospital or experiencing death by Day 15
Measure: Patients requiring admission to the hospital or experiencing death Time: Days 1 to 15The use of nanomaterials in facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with important characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer shows virucidal activity in several types of viruses, including other coronavirus serotypes, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2. The effectiveness of respirators will also be attributed to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Pilot Randomized Clinical Trial with reduced sample and ii) Controlled Randomized Clinical Trial (RCT). This RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The pilot trial will be conducted initially with a group of fifty participants (n = 25 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) of a Hospital. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating centers and will be accompanied by eight consecutive shifts (each shift lasting 6 to 12 hours, followed by approximately 36 hours of rest). Participants will be accompanied during 21 days, and will be assessed at baseline (T0), at the end of the 10th day (T1) and at the end of the 21st day (T2). The respirators will be assessed after the end of the 1st hospital shift for morphological characterization (virus quantity and inactivation).
Description: Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)
Measure: Incidence of laboratory-confirmed COVID-19 Time: 21 daysDescription: Electron microscopy technique will be used, to identify if there is viruses present (through its direct visualization and morphological recognition) and they are inactive. This assessment will occur after the end of the first hospital shift.
Measure: Ability of the filtering element to inactivate the SARS-Cov-2 Time: 24 hoursDescription: 11-point Likert scale ranging from -5 ("extremely unsatisfied"), 0 ("neutral"), to 5 ("completely satisfied")
Measure: Usability and comfort of the respirator Time: Assessments at T1 (day 10) and T2 (day 21)Description: quantified based on the activities and procedures performed by the participants. Adherence will be measured by a self-report recorded in a diary, estimating the percentage of use referring to the total workhours.
Measure: Adherence to the use of the Respirator Time: Assessments at the end of the first and second weeks of interventionDescription: Measured by the Job Stress Scale Questionnaire (17 questions composed by 4-point Likert scales)
Measure: Stress Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by the Maslach Burnout Inventory
Measure: Burnout Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by the Six-dimensional short form quality of life questionnaire (SF-6D), with scores ranging from 0 to 1 (in which 0 is equal to the worst health state and 1 is equal to the best health state).
Measure: Self-reported quality of life Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by the Nordic Musculoskeletal Questionnaire, which assess the self-report of musculoskeletal symptoms in the last 12 months and last 7 days. Identification of areas of the body causing musculoskeletal problems in a body map (possible sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet).
Measure: Musculoskeletal discomfort Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by a VAS-scale ranging from 0 to 10, being 0 the worst work ability and 10 the best work ability, considering the present time.
Measure: Work ability Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.
Description: anxiety increase in SARS-CoV-2 in humans.
Measure: Anxiety in SARS-CoV-2 Time: 4 weeksDescription: The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.
Measure: Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale Time: 4 weeksThe purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms
Description: Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.
Measure: Percent of participants with treatment related Serious Adverse Events (SAE) Time: 12 monthsDescription: Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.
Measure: Change in inflammatory marker levels Time: Baseline, Day 30Description: Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.
Measure: Change in systemic inflammatory marker levels Time: Baseline, Day 30Description: Assessed using blood samples or nose/throat swabs.
Measure: COVID-19 Viral Load Time: Up to 30 DaysDescription: Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.
Measure: Change in SOFA score Time: Baseline, Up to 30 DaysDescription: Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.
Measure: Change in electrolytes levels Time: Baseline, Up to 30 DaysDescription: Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.
Measure: Change in LDH levels Time: Baseline, Up to 30 DaysDescription: ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.
Measure: Number of subjects discharged from the ICU Time: Up to 7 DaysDescription: Percentage of participants requiring less use of vasoactive agents will be reported.
Measure: Percentage of participants with less requirement for vasoactive agents Time: Up to 30 DaysDescription: Percentage of participant deaths throughout the study period.
Measure: Rate of Mortality Time: Up to 30 DaysDescription: The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.
Measure: Percentage of participants with changes in immune marker expression Time: Up to 30 DaysDescription: Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).
Measure: Percentage of participants with changes in radiologic findings Time: Up to 30 DaysDescription: Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.
Measure: Percentage of participants with less pneumonia symptoms Time: Up to 30 DaysSerological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.
Description: The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies
Measure: Measure of the COVID-19 immunity of the population Time: 1 yearDescription: The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population
Measure: Evaluation of the level of asymptomatic and pauci-symptomatic infections Time: 1 yearCollect in an observational study the outcomes of COVID19 infection in MM patients across Europe.
Description: The duration of infection.
Measure: Nature of COVID19 Time: 1 yearsDescription: Costs related to Covid in terms of health resource needs.
Measure: Costs related to COVID-19 Time: 1 yearsDescription: Number of infection recovery for each systemic anti-cancer subgroup.
Measure: Systemic anti-cancer therapy subgroup Time: 1 yearsDescription: Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.
Measure: Laboratory values collected at hospitalization Time: 1 yearsDescription: Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.
Measure: COVID-19 infection in myeloma patient subgroups Time: 1 yearsDescription: Number of frail patients with COVID-19 infection and resolution of it.
Measure: Incidence of COVID-19 infection in frail patients Time: 1 yearsDescription: Number of infection and outcome per country.
Measure: Infection outcome in different countries Time: 1 yearsThis research aims to investigate the incidence, clinical condition, mode of transmission and laboratory data of women and their babies, who were exposed to COVID-19 infection during pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess periodontal condition and quality of life before and after delivery of women with excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence of congenital syndrome in babies associated with the presumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical examination, being a group with congenital malformations and their respective controls and an interview with the mother was carried out.
Description: Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.
Measure: Periodontal status Time: Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.Description: Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.
Measure: Quality of life of pregnants Time: Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).Description: IgM and IgG serology test for COVID19
Measure: Maternal infection Time: Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES.
Description: HYPONATREMIA AND MORTALITY
Measure: MORTALITY Time: 30 DAYSDescription: HYPONATREMIA AND ICU HOSPITALIZATION
Measure: ICU HOSPITALIZATION Time: 30 DAYSULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
Description: Number of subjects with a DLT event during or within 24 hours after ULSC infusion [Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.]
Measure: Incidence of Dose Limiting Toxicity (DLT) Time: 24 hoursDescription: Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion
Measure: Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE) Time: 1 weekDescription: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up
Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE) Time: 1 monthDescription: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up
Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE) Time: 12 monthsDescription: Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Measure: Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS Time: 1 monthDescription: Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator
Measure: Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio Time: 1 monthDescription: Number of ventilator-free days (VFD) in period of 1 month from study treatment
Measure: Number of ventilator-free days (VFD) Time: 1 monthDescription: Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in Complete Blood Count (CBC) with differential from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of blood glucose (mg/dL) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of sodium (mEq/L) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of potassium (mEq/L) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of alanine transaminase (ALT; U/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of alanine transaminase (ALT; U/L) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria
Measure: Change in Urinalysis (UA) from baseline Time: 1 monthThis multi-center, double-blind, placebo-controlled, randomized Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in approximately 400-440 patients hospitalized with confirmed COVID-19. The Phase 2 portion of the trial will include approximately 40 patients and is designed to provide an early interim analysis of safety. The Phase 3 portion of the trial will include approximately 360-400 additional patients, and is designed to determine whether bardoxolone methyl increases the probability of recovery at Day 29 when compared with matching placebo. Patients will be randomized using permuted block randomization in a 1:1 fashion to either once-daily administration of bardoxolone methyl (20 mg) or matching placebo and treatment will be administered for the duration of hospitalization (until recovery), with a maximum treatment duration of 29 days.
Description: Recovery is defined as alive, free of respiratory failure (e.g., need for noninvasive, or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of renal replacement therapy (RRT).
Measure: Proportion of participants who have recovered in Phase 3 Time: Day 29Description: Deterioration is defined by a 1-point worsening scale: 0- Uninfected; no viral RNA detected, 1- Asymptomatic; viral RNA detected, 2- Symptomatic; Independent, 3- Symptomatic; assistance needed, 4- Hospitalized; no oxygen therapy, 5- Hospitalized; oxygen by mask or nasal prongs, 6- Hospitalized; oxygen by NIV or High flow, 7- Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200, 8- Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors, 9- Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO, 10- Death
Measure: Proportion of participants who experienced deterioration from baseline Time: Day 29The registry of COVID-19 patients was designed to collect epidemiolgical, demographic, clinical, anamnestic and outcome information together with serological and microbiological samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted and able to give an informed consent are included, irrespectively of age and gender.
Description: Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.
Measure: Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission
Measure: Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Body temperature (°C)
Measure: Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Blood pressure (mmHg)
Measure: Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Pulse rate (beats per minute)
Measure: Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Pulse rate (beats per minute)
Measure: Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Peripheral oxygen saturation (%)
Measure: Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: CRP (m/gL)
Measure: C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: PCT (ng/mL
Measure: Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: White Blood Count (WBC, cell/mm3)
Measure: White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Neutrophils (cell/mm3)
Measure: Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Lymphocytes (cell/mm3)
Measure: Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Platelets (cell/mm3)
Measure: Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: LDH (mU/ml)
Measure: L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: CK (U/L)
Measure: Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: D-dimer (μg/L)
Measure: D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: fibrinogen (g/L)
Measure: fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: ferritin (mcg/L)
Measure: ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: AST (U/L)
Measure: AST (U/L) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: ALT (U/L)
Measure: ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: Creatinine (mg/dl)
Measure: Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: pH
Measure: Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: pO2 (mmHg)
Measure: Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: pCO2 (mmHg)
Measure: Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: HCO3 (mmol/l)
Measure: Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: SpO2 (%)
Measure: Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona Time: through study completion, an average of 3 monthsDescription: IL-6 (pg/mL)
Measure: Host-related factors associated with the pathogenesis of COVID-19 Time: through study completion, an average of 3 monthsDescription: Nasal and rectal swabs, fecal samples and blood samples
Measure: Virological factors associated with the pathogenesis of COVID-19 Time: through study completion, an average of 3 monthsThis is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.
Description: This score originally ranges from 0 to 4 points based on the average of 4 parameters (PaO2/FiO2, chest X-Ray, PEEP level, and Respiratory compliance). In the modified version, if the patient dies, he or she automatically receives a score of 5 irrespective of the other four parameters. If the patient is extubated, the score is automatically zero. We also substituted FiO2 for PEEP guaranteeing equivalence of the score when either the low or high PEEP-FiO2 table is applied.
Measure: Average daily Modified Lung injury score until day 28 Time: dailyDescription: Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28
Measure: High oxygen dependence free days until day 28 Time: 28 daysDescription: Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28
Measure: Mechanical ventilation free days until day 28 Time: 28 daysDescription: Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma
Measure: Incidence of shock or barotrauma Time: 28 daysDescription: Occurrence of acute renal failure that justifies renal replacement therapy
Measure: Incidence of acute renal failure requiring renal replacement therapy Time: 28 daysDescription: Percentage of patients who died in each arm up to 28 days
Measure: 28-day mortality Time: 28 daysThe primary objective of this early Phase 1 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.
Description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of Participants with at Least 1 Solicited Injection Site Adverse Event Time: Up to ~5 days after vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of Participants with at Least 1 Solicited Systemic Adverse Event Time: Up to ~14 days after vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of Participants with at Least 1 Unsolicited Adverse Event Time: Up to ~28 days after vaccinationDescription: A serious adverse event is "life threatening," requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect.
Measure: Percentage of Participants with at Least 1 Serious Adverse Event Time: Up to ~365 days (±14 days) after vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of Participants who Discontinued Study Treatment due to an Adverse Event Time: Up to ~365 days (±7 days) after vaccinationDescription: A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.
Measure: Percentage of Participants with at Least 1 Medically Attended Adverse Event Time: Up to ~365 days (±14 days) after vaccinationDescription: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.
Measure: Geometric Mean Titers for Serum Neutralizing Antibodies (nAb) as Measured by Plaque Reduction Neutralization Test (PRNT): All Panels Time: Day 29Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.
Measure: Geometric Mean Concentration of Total Anti-Spike Immunoglobulin G (IgG) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA): All Panels Time: Day 29Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.
Measure: Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by PRNT: Panels A,B, I and J Time: Day 85Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.
Measure: Geometric Mean Concentration of Total Anti-Spike IgG Antibodies as Measured by ELISA: Panels A,B, I and J Time: Day 85Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.
Measure: Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by PRNT: Panels K and L Time: Day 197Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.
Measure: Geometric Mean Concentration of Total Anti-Spike IgG Antibodies as Measured by ELISA: Panels K and L Time: Day 197Description: Serum samples will be collected and the presence of serum neutralization antibodies will be assessed using PRNT.
Measure: Geometric Mean Titers for Serum nAb as Measured by PRNT Time: Panels C-E and G-H: Days 1, 15, 29, 57, 85, 115, 211, and 365; Panels A,B, I and J: Days 1, 15, 29, 57, 71, 85, 115, 211, and 422; Panels F, K and L: Days 1, 15, 29, 85, 169, 197, 365 and 534Description: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using ELISA.
Measure: Geometric Mean Concentration of Total Anti-Spike IgG Antibodies as Measured by ELISA Time: Panels C-E and G-H: Days 1, 15, 29, 57, 85, 115, 211, and 365; Panels A,B, I and J: Days 1, 15, 29, 57, 71, 85, 115, 211, and 422; Panels F, K and L: Days 1, 15, 29, 85, 169, 197, 365 and 534In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.
Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Measure: Depression, Anxiety and Stress Scales 21 Score Time: 5 monthsDescription: The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Measure: Insomnia severity index score Time: 5 monthsWe hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
Description: Change is clinical status as captured by 7-point ordinal scale to include Death Hospitalized, requiring mechanical ventilation or ECMO Hospitalized, requiring non-invasive ventilation or high flow oxygen Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). Not Hospitalized
Measure: Change is clinical status Time: Time of plasma infusion (day 0) compared to day 7Description: Presence of any adverse events related to plasma infusion
Measure: Transfusion related events Time: Within 6 hours of infusionDescription: Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 14, 21, and 28
Measure: Change is clinical status Time: Time of plasma infusion (day 0 prior to first infusion) to days 14, 21, and 28Description: Assess change in Sequential Organ Failure Assessment (SOFA) score
Measure: SOFA score at days 0, 7, 14, 21, 28 Time: Days 0, 7, 14, 21, 28Description: Total duration of hospital
Measure: Length of Hospital Stay Time: Days 7, 14, 21, 28Description: Time to discontinuation of supplemental oxygen
Measure: Supplemental oxygen Time: Days 7, 14, 21, 28Description: Need for mechanical ventilation (for those patients not on the ventilator)
Measure: Mechanical Ventilation Time: Days 7, 14, 21, 28Description: Time to liberation from mechanical ventilation (for patients on a ventilator)
Measure: Change in mechanical ventilation status Time: Days 7, 14, 21, 28Description: All-cause Mortality
Measure: Mortality Time: Day 28Description: Change in standard of care inflammatory markers (ferritin, LDH, CRP, D-dimer)
Measure: Change in inflammatory markers Time: Day 0 to days 7, 14, 21, 28Patients who receive intensive care are known to be at high risk for physical, psychological, and cognitive impairments, a constellation known as PICS. COVID-19 patients are expected to have high chances of suffering from PICS (PICS-COV) as they frequently require several weeks of intensive care and traditional PICS preventive measures are virtually impossible due to infection control precautions, prone positioning, and deprivation of social contact. To prevent PICS after ICU discharge in COVID-19 patients, physical therapy is recommended. From recent but limited experience it appears that even patients with COVID-19 who have not been admitted to the ICU can suffer from impairments in the same domains and sometimes to a similar degree of severity. Also for these patient group rehabilitation seems warranted. Yet, the resources needed to provide rehabilitation treatment to COVID-19 patients are inadequate because healthcare systems faced a shortage of high-quality treatment for these impairments already before the COVID-19 crisis emerged. Virtual Reality (VR) provides potential to healthcare practitioners to administer fast, temporary, and tailor-made rehabilitation services at a distance, and offers a solution to address the impending surge of demand for rehabilitation after COVID-19 infection. VR consists of a head mounted display (HMD) that can bring the user by computer-generated visuals into an immersive, realistic multi-sensory environment. Current VR technology is accessible, easy in use for a large audience, and safe in use. There already exist multiple VR applications for providing physical, psychological, and cognitive rehabilitation. These applications have been brought together in a VR suite for rehabilitation after COVID-19. Patients visiting a physiotherapist for rehabilitation from COVID-19 will be asked to participate in this study. They receive a VR HMD for training purposes. This study aims to understand the usability, feasibility, and tolerability of VR for rehabilitation after COVID-19, and to pilot the effectiveness of VR improving the physical ability, mental and cognitive status of patients.
Description: At the end of the study, 15 patients will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the patients. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.
Measure: Semi-structured interview with 15 patients on their experiences of VR for rehabilitation from COVID-19. Time: Day 42Description: By means of digital tracking in the VR goggles, we aim to understand what games are used most often by the participants.
Measure: Use of VR Time: Day 42Description: At the end of the study, 10 physiotherapists will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the physiotherapists. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.
Measure: Semi-structured interviews with physiotherapists on their experiences of VR for rehabilitation from COVID-19. Time: Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress. The baseline performance test consists of several items of which the patient specific complaints is the first. Patient specific complaints refer to complaints the patients aim to improve by means of physiotherapy. Outcomes are qualitative outcomes.
Measure: Change in baseline performance test (guidelines KNGF) - Patient specific complaints. Time: Day 0, day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress. The baseline performance test consists of several items of which the 6 minute walk test is the second. The 6 minute walk test studies the physical capacity of a patient. We measure at day 0 how many meter a patient can walk in 6 minutes and compare this to the meters a patient is able to walk at day 42.
Measure: Change in baseline performance test (guidelines KNGF) - 6 minute walk test Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress. The baseline performance test consists of several items of which hand grip strength is the third. The hand grip strength is measured by the One-repetition maximum test which measures the amount of kg's a patient can grip at his peakforce. Measurements are done at day 0 and day 42 and compared.
Measure: Change in baseline performance test (guidelines KNGF) - one-repetition maximum test Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress. The baseline performance test consists of several items of which the 30 sec sit to stand test for lower extremities is the fourth. The 30 seconds sit to stand test is for testing leg strength and endurance. A patient has to do as many sit to stand exercises in 30 seconds. Measurements are done at day 0 and compared to day 42.
Measure: Change in baseline performance test (guidelines KNGF) - 30 sec sit to stand Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress. The baseline performance test consists of several items of which the Borgscale for fatigue is the final item. The borgscale for fatigue is a numerical scale (1-10) to rate physical exertion and fatigue. Patients fill in the scale at day 0 and day 42. Results are compared.
Measure: Change in baseline performance test (guidelines KNGF) - Borgscale for fatigue Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we will as well measure change in activities of Daily Life. This questionnaire (ADL) measures the ease of participating in activities of daily life (ADL) of the patient. The questionnaire consists of 22 questions ranging from 0 (not at all) to 3 (easily autonomous). Maximum score is 63.
Measure: Change in activities of daily life. Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves psychological rehabilitation, we will measure change in HADS. The HADS (Hospital Anxiety and Depression Scale) is used to measure change in psychological outcomes before and after the intervention period. Questionnaire consists out of 14 questions with answers ranging from 0 (often) to 3 (almost never). All questions are summed up to a total of 42 points.
Measure: Change in HADS. Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves cognitive rehabilitation, we will use the CFQ. The CFQ (Cognitive Failure Questionnaire) is used to measure change in cognitive outcomes before and after the intervention period. Questionnaire consists out 25 questions ranging from 0 to 5. All questions are summed up to a total of 100 points.
Measure: Change in CFQ. Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves quality of life, we will use the SF12. The SF12 questionnaire is used to measure change in quality of life before and after the intervention period. SF12: SF12 measures via different scaled questions eight concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The first four items together form the physical health scale. The latter four items form the mental health scale. The higher the scores, the better the physical and mental health. Highest possible score: 56. Lowest possible score: 12.
Measure: Change in SF12. Time: Day 0, Day 42Description: To investigate whether adding VR to rehabilitation (perceivably) improves quality of life, we will as well use the Positive Health questionnaire. The Positive Health questionnaire is used to measure change in quality of life before and after the intervention period. Positive Health:Positive health consists out of 42 statements separated in 6 categories: bodily functioning, mental functioning, spiritual dimension, quality of life, social participation, daily functioning. Each question should be rated with a 0 (worst) to a 10 (best). The higher the scores, the better the quality of life.
Measure: Change in positive health. Time: Day 0, Day 42Description: Age, gender, education, employment, lifestyle, experience with technology - qualitative measures.
Measure: Patient characteristics related to use of VR Time: Day 0Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited. Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.
Description: evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers
Measure: PSAS (Psychological Stress and Adaptation at work Score) during the crisis Time: during the pandemic (April 9, 2020 to April 19, 2020)Description: evaluate the psychological stress in Spain in healthcare workers
Measure: PSAS (Psychological Stress and Adaptation at work Score) in basal conditions Time: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.The purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic Coronavirus Disease 2019 (COVID-19) Infection.
Description: Time to first occurrence of a composite endpoint of symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, noncentral nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality will be assessed.
Measure: Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, All-cause Hospitalization and All-cause Mortality Time: Up to Day 35Description: Time to first occurrence of a composite endpoint of symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic embolization, and all-cause mortality will be assessed.
Measure: Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, and All-cause Mortality Time: Up to Day 35Description: Time to first occurrence of all-cause hospitalization will be assessed.
Measure: Time to First Occurrence of All-cause Hospitalization Time: Up to Day 35Description: Time to first occurrence of symptomatic VTE which includes DVT or pulmonary embolism (PE) will be assessed.
Measure: Time to First Occurrence of Symptomatic VTE Time: Up to Day 35Description: Time to first occurrence of an ER visit will be assessed.
Measure: Time to First Occurrence of an Emergency Room (ER) Visit Time: Up to Day 35Description: Time to first occurrence of symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic embolization, and all-cause hospitalization will be assessed.
Measure: Time to First Occurrence of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, and All-cause Hospitalization Time: Up to Day 35Description: Percentage of participants who are hospitalized or dead from any cause at Day 35 will be assessed.
Measure: Percentage of Participants who are Hospitalized or Dead From Any Cause Time: Day 35Description: Time to all-cause mortality up to Day 35 will be assessed.
Measure: Time to All-cause Mortality up to Day 35 Time: Up to Day 35Description: Time to first occurrence of ISTH critical site and fatal bleeding will be assessed.
Measure: Time to First Occurrence of International Society on Thrombosis and Hemostasis (ISTH) Critical Site and Fatal Bleeding Time: Up to 37 Days (last dose on Day 35 plus 2 Days)Description: Time to first occurrence of ISTH major bleeding will be assessed. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
Measure: Time to First Occurrence of ISTH Major Bleeding Events Time: Up to 37 Days (last dose on Day 35 plus 2 Days)Description: Time to first occurrence of clinically relevant non-major bleeding will be assessed. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.
Measure: Time to First Occurrence of Clinically Relevant Non-major Bleeding Time: Up to 37 Days (last dose on Day 35 plus 2 Days)The McMaster Multi-Regional Hospital Coronavirus Registry (COREG) is a platform that is collecting detailed case data on laboratory confirmed COVID-19 hospital inpatients and outpatients. The COREG platform will provide rapid high-quality evidence to improve the prevention and clinical management of COVID-19 for older adults in Canada, and internationally. The COREG platform will also provide researchers and partners with complete regional level clinical data on COVID-19 cases to inform rapid decision-making and projections, sub-studies, extensions, and linkage for all affected populations.
Description: Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.
Measure: Serious COVID-19 infection Time: through study completion, an average of 1 yearDescription: Defined as persons admitted with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform. We will also conduct sub analyses of hospital acquired COVID-19 also captured in the COREG platform.
Measure: Severe infection (requiring admission) Time: through study completion, an average of 1 yearDescription: Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.
Measure: COVID-19 related death Time: through study completion, an average of 1 yearDescription: Days from admission to discharge.
Measure: Length of stay Time: through study completion, an average of 1 yearDescription: New or increased severity of conditions and syndromes from pre-morbid state.
Measure: Complications Time: through study completion, an average of 1 yearDescription: Rate of intensive interventions during hospital stay.
Measure: Intensive interventions Time: through study completion, an average of 1 yearThe Investigators plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in SARS-Cov-2 infected individuals. Patients with mild, moderate and severe COVID-19 disease will be enrolled.
Description: Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Measure: Cytokine response to SARS-Cov-2 Time: At enrollmentDescription: Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)
Measure: Cytokine response to SARS-Cov-2 Time: 28 days (+/-7) after enrollmentDescription: Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Measure: Innate immune response to SARS-Cov-2 Time: At enrollmentDescription: Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Measure: Innate immune response to SARS-Cov-2 Time: 3 days after enrollmentDescription: Measurement of HLA-DR expression on CD14+ cells (flowcytometry)
Measure: Innate immune response to SARS-Cov-2 Time: 5 days after enrollmentDescription: Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)
Measure: Humoral immune response Time: At enrollmentDescription: Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Measure: Cell mediated immune response Time: At enrollmentDescription: Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)
Measure: Cell mediated immune response Time: 28 days (+/-7) after enrollmentDescription: Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
Measure: Neurological damage Time: At enrollmentDescription: Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)
Measure: Neurological damage Time: 28 days (+/-7) after enrollmentDescription: Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9
Measure: Complement activation Time: At enrollmentDescription: Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9
Measure: Complement activation Time: 28 days (+/-7) after enrollmentThe C-MORE study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among COVID-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.
Description: Characterise and compare the prevalence and extent of lung, heart, liver, kidney, brain injury on magnetic resonance imaging (MRI) in patients with moderate to severe COVID-19 disease with matched uninfected controls.
Measure: Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI. Time: 6 monthsDescription: Characterise and compare the prevalence and extent of lung, heart, liver and kidney, brain injury on magnetic resonance imaging (MRI) in patients with moderate to severe COVID-19 disease with matched uninfected controls.
Measure: Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI. Time: 3 and 12 monthsDescription: Characterise and compare the prevalence of cardiac, renal and liver injury on blood test in COVID-19 survivors and controls.
Measure: Prevalence of acute/chronic cardiac, renal and liver injury on blood tests. Time: 3, 6,12 monthsDescription: Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.
Measure: VO2 max on cardiopulmonary exercise testing Time: 3, 6,12 monthsDescription: Characterise and compare the prevalence of lung function test abnormalities among survivors and controls.
Measure: Prevalence of abnormal lung function test (any of the following: Forced expiratory volume in 1 second (FEV1)< 80% of predicted FEV1, or forced vital capacity (FVC)<80% predicted, ratio of FEV1/FVC >0.7 or diffusion lung capacity (<80% predicted)) Time: 3, 6,12 monthsDescription: For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).
Measure: Quality of life - Short form-36 SF-36 score Time: 3, 6,12 monthsDescription: Described and compare the prevalence of impaired cognition (MoCA) between COVID-19 survivors and controls. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measure: Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26) Time: 3, 6,12 monthsDescription: Compare 6-minute walk distance between COVID-19 survivors and controls.
Measure: 6-minute walk distance Time: 3, 6,12 monthsDescription: Compare prevalence and severity of anxiety between COVID-19 survivors and controls.
Measure: Severity of anxiety on GAD-7 (Score) Time: 3, 6,12 monthsDescription: Compare prevalence and severity of depression among COVID-19 survivors and controls. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent outpoints for mild, moderate, moderately severe and severe depression, respectively.
Measure: Severity of depression on PHQ-9 (Score) Time: 3, 6,12 monthsDescription: To assess the association of multi organ damage on MRI and inflammatory response.
Measure: Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count). Time: 3,6,12 monthsDescription: To assess the association of ongoing symptomatology and multi-organ injury/inflammation.
Measure: Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury. Time: 3,6,12months.The purpose of this trial is to conduct a Stage 1 Substudy powered to detect a difference in continuous laboratory outcomes: 1. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 can improve laboratory outcomes associated with Covid-19 severity 2. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 infection can prevent emergency department utilization for Covid-19. 3. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 disease can prevent Covid-19 disease progression.
Description: This is one of the primary outcomes for the stage 1 trial. Outcome is reported as the change in serum concentrations of c-reactive protein (mg/L) from baseline to 5 days and baseline to 10 days.
Measure: Change in C-Reactive Protein Time: 10 daysDescription: This is one of the primary outcomes for the stage 1 trial. Outcome is reported as the change in serum concentrations of albumin (g/dL) from baseline to 5 days and baseline to 10 days.
Measure: Change in Albumin Time: 10 daysDescription: This is one of the primary outcomes for the stage 1 trial. Outcome is reported as the change in serum viral load (copies per ml of blood) from baseline to 5 days and baseline to 10 days.
Measure: Change in Viral load Time: 10 daysDescription: For Covid-19 Symptoms (as defined by current CDC definition of Covid-19 symptoms).
Measure: Emergency Department Utilization Time: 14 days, 28 daysDescription: Assessed with Symptom Scale Recommended by FDA for Industry 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: Incidence of Possible COVID-19 Symptoms Time: 14 days, 28 daysDescription: Incidence of hospitalization for Covid-19 Incidence of oxygen therapy needed Incidence of mechanical ventilation Incidence of death
Measure: WHO Disease Progression Scale Time: 14 days, 28 days.Coronavirus Disease 2019 (COVID-19) has been widespread worldwide since December 2019. It is highly contagious, and severe cases can lead to acute respiratory distress or multiple organ failure. On 11 March 2020, the WHO made the assessment that COVID-19 can be characterised as a pandemic. With the development of machine learning, deep learning based artificial intelligence (AI) technology has demonstrated tremendous success in the field of medical data analysis due to its capacity of extracting rich features from imaging and complex clinical datasets. In this study, we aim to use clinical data collected as part of routine clinical care (heart tracings, X-rays and CT scans) to train artificial intelligence and machine learning algorithms, to accurately predict the course of disease in patients with Covid-19 infection, using these datasets.
Description: Accuracy with which computer based analysis (machine learning) can diagnose and/or prognosticate Covid-19 Number of Participants With COVID19 who died or survived following hospital admission
Measure: Accuracy of machine learning to be able to predict outcome of coronavirus (COVID-19) infection Time: At the end of data analyses, approximately 1 yearDescription: Number of participants who required invasive vs non-invasive ventilation vs ward-based care vs died
Measure: Accuracy of machine learning to be able to predict prognosis of coronavirus (COVID-19) infection Time: At the end of data analyses, approximately 1 yearDescription: Number of participants who had COVID19-related heart problems.
Measure: Accuracy of machine learning to be able to predict cardiac involvement of coronavirus (COVID-19) infection Time: At the end of data analyses, approximately 1 yearDescription: Number of participants that can be identified as having COVID19 using machine learning vs human or other clinical test or assessment
Measure: Accuracy of machine learning vs human assessment to diagnose coronavirus (COVID-19) infection Time: At the end of data analyses, approximately 1 yearThe purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).
Description: Treatment and placebo will be compared on the basis of the unmatched win-ratio approach of Pocock. When comparing two patients, the winner will be determined by the first component in which the two patients differ (4 weeks after randomization): longer survival time longer ventilation-free time longer ICU-free time shorter hospitalization time If there is no difference between treatment and Placebo: the win ratio is 1. If there is a difference between treatment and Placebo: the win ratio is not 1.
Measure: unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint) Time: within 4 weeks after treatment with canakinumab or placeboDescription: Time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever comes first. "The seven-category ordinal scale consists of the following categories: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and death"
Measure: Time to clinical improvement Time: From randomization up to 4 weeksDescription: Death rate during the 4-week period after study treatment
Measure: Death rate Time: 4 weeksDescription: Admission to the intensive care unit from the medical ward during the 4-week period after study treatment
Measure: Admission to intensive care unit (ICU) Time: 4 weeksDescription: Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)
Measure: Secondary worsening of disease Time: 4 weeksDescription: Prolonged hospital stay > 3 weeks
Measure: Prolonged hospital stay Time: >3 weeksDescription: Ratio to baseline in the glycated hemoglobin
Measure: Change in ratio to baseline in the glycated hemoglobin Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the fasting glucose
Measure: Change in ratio to baseline in the fasting glucose Time: Baseline, Day 29Description: Ratio to baseline in the fasting insulin
Measure: Change in ratio to baseline in the fasting insulin Time: Baseline, Day 29Description: Ratio to baseline in the fasting c-peptide
Measure: Change in ratio to baseline in the fasting c-peptide Time: Baseline, Day 29Description: Ratio to baseline in the C-reactive protein (CRP)
Measure: Ratio to baseline in the C-reactive protein (CRP) Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the D-dimer
Measure: Change in ratio to baseline in the D-dimer Time: Baseline, Day 29Description: Ratio to baseline in the Natriuretic peptide (NTproBNP)
Measure: Change in ratio to baseline in the Natriuretic peptide (NTproBNP) Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)
Measure: Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR) Time: Baseline, Day 29 and Day 90Description: Type of antidiabetic treatment at Day 29
Measure: Type of antidiabetic treatment at Day 29 Time: Day 29Description: Number of antidiabetic treatment at Day 29
Measure: Number of antidiabetic treatment at Day 29 Time: Day 29Description: Type of antidiabetic treatment at three months
Measure: Type of antidiabetic treatment at three months Time: Month 3Description: Number of antidiabetic treatment at three months
Measure: Number of antidiabetic treatment at three months Time: Month 3The coronavirus (COVID-19) pandemic continues to grow exponentially. Angiotensin II levels are increased in human influenza and are associated with influenza viral load, disease progression and mortality. Preliminary data shows angiotensin II receptor blockers (ARBs) limits lung injury in murine influenza H7N9, as well as viral titre and RNA. ARBs could limit viral titre and organ injury in COVID-19. We will therefore collect clinical chart data and test angiotensin II levels of patients who are admitted to ICU with COVID-19 to determine whether there is a correlation between taking ARBs and clinical outcomes in these patients. Other blood biomarkers and clinical risk factors for COVID-19 have come to light in recent weeks. We include these in our observational analysis to help generate an understanding of COVID-19 presentation and blood biomarker characterization of disease.
Viral respiratory infections are common infectious complications after kidney transplantation, especially in the pediatric age group, and immunosuppressed patients may develop more severe disease. Immunosuppressive medications alter the patient's immune response by acting on humoral, cellular immunity and neutrophil function, increasing the risk of serious viral infections. Little is known about how these patients respond to infection by the new coronavirus (SARS-CoV-2). Experience with SARS caused by the Influenza H1N1 virus suggests that the severity of the disease depends on pre-existing comorbidities and the individual immune response. In more severe cases, an imbalance between the inflammatory system and the immune system is observed, determining direct consequences when pro and anti-inflammatory cytokines reach the systemic circulation in an exacerbated and unbalanced manner. Such fact can generate "cytokine storm syndrome", resulting in multiple organ dysfunction syndrome. March 2020 reports from Papa Giovanni XXIII Hospital in Bergamo, Italy - one of the largest pediatric liver transplant centers - showed that the number of transplant patients infected with Coronavirus disease 2019 (COVID- 19) increased progressively. However, they did not see greater severity and complications in this population. Immunosuppression could act as a protective factor. The present study aims to describe the prevalence of viral infection by SARS-CoV-2 in a sample of immunosuppressed children, from three groups: kidney transplants, liver transplants and oncohematological. The investigators will also look for the epidemiological profile and clinical evolution of these patients, enabling a better understanding of the COVID-19 in this special population. The investigators' hypothesis is that infection with the new coronavirus may be asymptomatic in a large number of children and that immunosuppression, observed in liver and kidney transplant patients and also seen in cancer patients, may act as protection for severe forms of COVID-19. After obtaining written informed consent from the family, the investigators will include patients from 0-18 years of age, on regular outpatient follow-up, symptomatic or not, and will check for the presence of IgM/IgG antibodies against the SARS-CoV-2. For those symptomatic or with a positive IgM result, material (oro/nasopharyngeal swabs) for RT-PCR trial for the new coronavirus will be collected. Demographic and clinical variables will be registered. The outcomes are: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.
Description: percentage of positivity
Measure: Serology (IgM, IgG) for COVID-19. Time: 9 monthsDescription: percentage of patients admitted to hospital
Measure: Hospital admission Time: 9 monthsDescription: percentage of patients admitted to intensive care unit
Measure: Intensive care admission Time: 9 monthsDescription: percentage of patients who died
Measure: Death Time: 9 monthsDescription: percentage of positivity
Measure: Positive PCR for COVID-19 Time: 9 monthsDescription: Percentage of patients with symptoms of COVID-19
Measure: Clinical characteristics of patients with COVID-19 Time: 9 monthsDescription: Percentage of patients with positive PCR in respiratory secretion and feces on days 3, 7, 14, 21 and 30 after confirmation of covid 19.
Measure: Proportion of patients with viral excretion in respiratory secretion and faeces on days 3, 7, 14, 21 and 30 after confirmation of covid 19. Time: 9 monthsThis is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof of concept study to evaluate the safety and efficacy of razuprotafib subcutaneously administered three times daily (TID) in hospitalized subjects with moderate to severe COVID-19. Part 1 of the study is a 2-step dose escalation period conducted in approximately 60 subjects. Part 2 is a safety and efficacy period evaluating razuprotafib doses selected from Part 1 and will be conducted in approximately 120 subjects. Subjects will receive razuprotafib or placebo TID for 7 days or until discharge from the hospital (or death) and will be evaluated for safety and efficacy through Day 28. The effects of razuprotafib on biomarkers of coagulation, inflammation and vascular leakage will also be evaluated.
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus. Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach. As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people. All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved. If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus. The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.
Description: Measure of anti-SARS-CoV-2 antibodies using COVID-PRESTO (AAZ company)
Measure: Measure of the proportion of contact persons who have developed anti-SARS-CoV-2 antibodies (secondary transmission rate) within the same household of a subject who had a COVID-19 disease assessed by a rapid diagnostic-oriented test Time: 4 hoursThe main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine. We will be using a Real Time Polymerase Chain Reaction (RT-PCR) assay collected by a nasopharyngeal (nose) swab. RT-PCR is a real time test that can detect the amount of genetic material of a specific virus.The study is funded by The Miami Center for AIDS Research (CFAR)
Description: SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay
Measure: Number of participants who tested positive with SARS COV-2 Infection Time: month 3Description: SARS COV-2 antibody will be analyzed from blood samples via serological assay
Measure: Number of participants who tested positive with SARS COV-2 antibody Time: month 3To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitation protocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to be conducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging and blood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later (T3). Expected results: a) clinical, image and transcriptome changes; b) clinical-functional improvement after CPRP.
Description: In the supine position, the patient will perform deep inspiration followed by momentary apnea inside the high resolution scanner to capture cross-sectional images of the chest with smaller cuts than 1mm of collimation which helped in the detection of even small lesions.
Measure: Characteristics of lung Time: post treatment in 3 daysDescription: Respiratory muscle strength will be assessed using the digital manovacuometer. The measurement will be performed as follows the patient will be asked to empty the lungs to the residual volume and then perform an inhalation until the total lung capacity.
Measure: Respiratory muscle strength Time: post treatment in 3 daysThe aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.
Description: Prevalence of COVID-19 infection will be estimated on the basis of the replies to the questionnaire
Measure: Prevalence of COVID-19 infection among French military professional aircrew Time: At enrollmentDescription: Predictive factors of COVID-19 infection will be assessed using a top-down logistic regression model taking into account socio-demographic and occupational variables.
Measure: Predictive factors of COVID-19 infection Time: At enrollmentDescription: Techniques used for COVID-19 screening will be estimated on the basis of the replies to the questionnaire (among participants who reported being tested for COVID-19)
Measure: Techniques used for COVID-19 screening Time: At enrollmentDescription: Reasons for COVID-19 screening will be estimated on the basis of the replies to the questionnaire (among participants who reported being tested for COVID-19)
Measure: Reasons for COVID-19 screening Time: At enrollmentDescription: Experienced symptoms of COVID-19 will be estimated on the basis of the replies to the questionnaire (among participants who reported being infected)
Measure: Experienced symptoms of COVID-19 Time: At enrollmentDescription: Medical care of COVID-19 will be estimated on the basis of the replies to the questionnaire (among participants who reported being infected)
Measure: Medical care of COVID-19 Time: At enrollmentDescription: Social consequences of the COVID-19 pandemic will be estimated on the basis of the replies to the questionnaire
Measure: Social consequences of the COVID-19 pandemic Time: At enrollmentDescription: Factors associated with pejorative consequences of the COVID-19 pandemic will be assessed using a top-down logistic regression model taking into account socio-demographic and occupational variables.
Measure: Factors associated with pejorative consequences of the COVID-19 pandemic Time: At enrollmentThis study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Day 29Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Day 43Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: Day 29Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: Day 43Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: Day 29Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: Day 43Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Day 29Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Day 43Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Day 29Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Day 43Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: Day 29Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: Day 43Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Solicited Local Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Duration of Solicited Local Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Solicited Systemic Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Duration of Solicited Systemic Adverse Events Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine Time: 7 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Unsolicited Adverse Events Following the Booster Vaccine Time: 28 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine Time: 28 days after booster vaccinationDescription: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.
Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine Time: 28 days after booster vaccinationDescription: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using an activity assay.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using an activity assay.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Day 57, Day 85, Day 180, Day 208 and Day 393Description: Measured using an activity assay.
Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies Time: Day 57, Day 85, Day 180, Day 208 and Day 393This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.
A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19
Description: Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R&D BOSCI 1) by Day 28 post-randomisation.
Measure: Clinical Improvement Time: Day 28Description: 1. Proportion of participants with adverse events of special interest (Transfusion-Associated Circulatory Overload (TACO); Transfusion-Related Acute Lung Injury (TRALI); allergic transfusion reaction).
Measure: Adverse Events of special interest Time: Day 28Description: 2. Proportion of participants with serious adverse events.
Measure: Serious Adverse Events Time: Day 28Description: 3. Proportion of participants surviving at Day 28 post-randomisation.
Measure: Survival Time: Day 28Description: 4. Proportion of participants requiring invasive mechanical ventilation.
Measure: Invasive mechanical ventilation Time: Day 28Description: 5. Proportion of participants with moderate and severe ARDS.
Measure: Disease severity Time: Day 28Description: 6. Time from randomization to death, clinical improvement, ICU admission, and invasive mechanical ventilation.
Measure: Time to outcomes of interest Time: Day28Description: 7. Duration of hospitalisation, ICU stay, and mechanical ventilation in survivors.
Measure: Length of stay meausures Time: Day28Description: 8. Proportion negative SARS-CoV-2 PCR at Day 28; time to viral clearance (PCR-negativity); change in SARS-CoV-2 PCR Ct value.
Measure: SARS-CoV PCR Time: Day28Description: 9. Proportion with and time to normalisation of inflammatory markers, including CRP, lymphocyte count, D-dimer, ferritin.
Measure: Inflammatory markers Time: Day28Description: 10. Worsening of radiographic abnormalities.
Measure: Radiography Time: Day28Description: 11. Proportion with and time to resolution of fever and hypoxia.
Measure: Fever & Hypoxia Time: Day28Description: 12. Proportion of patients with HIV infection and other comorbidities (obesity, diabetes, hypertension) with primary efficacy outcome.
Measure: patients with HIV infection and other comorbidities Time: Day 28Description: 13. Relationship between timing of transfusion from symptom onset and primary efficacy outcome.
Measure: Timing of IP & Efficacy Outcome Time: Day 28Description: 14. Relationship between convalescent plasma neutralizing antibody titers and primary efficacy outcome
Measure: Neutralising Ab Time: Day28Description: 15. Comparison of anti-SARS-CoV-2 titer dynamics between treatment arms
Measure: SARS CoV Antibody titre Time: Day28Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission is by droplet route, with an R0 of approximately 3. Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions. Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced. During the period of containment, the majority of students from the Lyon-Bron Military Medical Schools were sent as reinforcement in Army Training Hospitals and in the Military Reanimation Unit (Mulhouse). Some students developed symptomatic forms of SARS-Cov-2 infection, documented by positive PCR, during Operation Resilience or on their return from the mission. The Lyon-Bron Military Medical Schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.
Description: The proportion of anti-SARS-CoV2 seropositive participants will be determined. ELISA serology test will be used to detect anti-SARS-CoV2 antibodies (IgG and IgM) at Day 0.
Measure: Proportion of anti-SARS-CoV2 seropositive participants Time: Day 0Description: The proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants) will be determined. COVID-19 symptoms will be measured using a questionnaire.
Measure: Proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants) Time: Day 0Description: Correlation coefficient between medical risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
Measure: Correlation coefficient between medical risk factors and a positive serology Time: Day 0Description: Correlation coefficient between epidemiological risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
Measure: Correlation coefficient between epidemiological risk factors and a positive serology Time: Day 0Description: Correlation coefficient between social risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.
Measure: Correlation coefficient between social risk factors and a positive serology Time: Day 0There is emerging evidence that patients with SARS-CoV-2 are affected by increased coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to the lung but also involving the kidneys, heart and gut. Thrombin plays a central role in mediating clot forming as well as in mediating inflammation. A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the risk of venous and arterial thrombotic complications. Colchicine is an inexpensive (generic drug), orally administered, and a potent anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance. The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR.
Description: To assess the effect of edoxaban versus no active treatment on the composite endpoint of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-CNS systemic embolism or death at day 25 (+/-3) after randomization.
Measure: Edoxaban vs. no active treatment Time: Baseline to day 25Description: To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.
Measure: Colchicine vs no active treatment Time: Baseline to day 14Description: An intraluminal filling defect on CT scan or MR venography in the IVC or iliac veins.
Measure: Number of patients with asymptomatic proximal deep-vein thrombosis Time: Baseline to day 25Description: Typical symptoms of DVT associated with non-compressible vein segment on ultrasonography or an intra-luminal filling defect on venography, CT venography or MRI venography,located in the inferior vena cava (IVC), the iliac vein, the common femoral vein, the femoral or the popliteal vein.
Measure: Number of patients with symptomatic proximal or distal deep-vein thrombosis Time: Baseline to day 25Description: Typical symptoms of PE associated with an intra-luminal filling defect in (sub) segmental or more proximal branches on spiral computed tomography scan (CT) or computerized tomographic pulmonary angiography (CTPA). a considerable perfusion defect (~ 75% of a segment) with a local normal ventilation result (high probability) during perfusion-ventilation lung scan (PLS, VLS or V/Q scan). an intraluminal filling defect or a sudden cut-off of vessels (~more than 2.5 mm in diameter) on a catheter guided pulmonary angiogram. In case of an inconclusive CTPA, inconclusive V/Q scan or inconclusive angiography demonstration of DVT in the lower extremities e.g. by compression ultrasound or venography will be required
Measure: Number of patient with symptomatic pulmonary embolism or thrombosis Time: Baseline to day 25Description: For the primary analysis, MI endpoint will be defined based on the third universal definition of myocardial infarction with the exception of periprocedural MI after PCI, which will be defined according to the SCAI definition.
Measure: Number of patients with myocardial infarction Time: Baseline to day 25Description: Ischemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by CNS infarction
Measure: Number of patients with non-CNS systemic embolism Time: Baseline to day 25Description: Death will be classified in 5 categories with respect to cause. Thromboembolism, cardiovascular, bleeding, Pulmonary other known cause. In general, all deaths will be assumed to be due to thromboembolism or pulmonary in nature unless another cause is obvious
Measure: Number of deaths Time: Baseline to day 25Description: Need for non-invasive or invasive ventilation
Measure: Ventilation need Time: Baseline to day 25Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.
Description: Professional burnout is measured at D21 by the Burnout Measure Short Version (BMS) questionnaire It is a 10-item questionnaire used to assess burnout regardless of the occupational category. Each item is rated from 0 to 6 ("never" to "always"). An average score (sum/10) below 2.4 indicates a very low degree of burnout exposure; a score between 2.5 and 3.4 indicates a low degree of burnout exposure; a score between 3.5 and 4.4 indicates the presence of burnout; a score between 4.5 and 5.4 indicates a high degree of burnout exposure; a score above 5.5 indicates a very high degree of burnout exposure.
Measure: Professional burnout Time: 21 days after enrollment (Day 21)Description: Mindfulness level is assessed at D0 thanks to the Freiburg Mindfulness Inventory. It is a 14 item scale. Each item is rated from 1 to 4 ("almost never" to "almost always"). The total score is between 14 and 56. The mean value in a population of young adults under 36 years of age is 38.5 (+/- 5.1 standard deviation).
Measure: Mindfulness level Time: Day 1Description: Perceived stress level is assessed with the Perceived Stress Scale (PSS). It is a 14 item scale. Each item is rated from 0 to 5 ("never" to "very often"). The total score ranges from 0 to 56 with higher scores indicating greater perceived stress.
Measure: Perceived stress level following the emotional stimulation Time: Day 1Description: Parasympathetic flexibility is assessed through dynamic electro-physiological analysis of cardiac and electrodermal conductance recordings. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall.
Measure: Parasympathetic flexibility evolution during emotional recall Time: Day 1Description: The activity of the sympathetic tone is assessed by the measurement of the resting state salivary Chromogranin A. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall. The activity of the sympathetic tone is assessed by the measurement of the resting salivary Chromogranin A
Measure: Sympathetic tone at rest Time: Day 1Description: Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio
Measure: Corticotropic activation at rest Time: Day 1Description: The Hospital Anxiety and Depression Scale (HAD-s32) is used to assess mood disorders in the general non-psychiatric population. It is used to discriminate between anxiety and depression. Scores greater than 11 are indicative of characterized anxiety/depression.
Measure: Mood disorders (anxiety / depression) Time: Day 1Description: Post-traumatic disorder is assessed with the PTSD Checklist (PCL-5). It is a 20-item self-administered questionnaire representing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Post-traumatic stress disorder (PTSD) diagnosis symptoms rated by the subject on a scale from 0 ("not at all") to 4 ("extremely") during the past month. Scores range from 0 to 80. A score greater than of 33 evokes the presence of post-traumatic stress disorder.
Measure: Post-traumatic stress disorder Time: Day 1Description: Sleep quality is assesses thanks to the Leeds Sleep Evaluation questionnaire (LEEDS). It consists of ten visual analogue scales assessing four aspects of sleep: (i) quality of falling asleep and degree of drowsiness, (ii) quality of sleep, (iii) quality of wakefulness, and (iv) quality of post-wakefulness and performance.
Measure: Sleep quality Time: Day 1Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to progress to moderate or severe COVID and associated advantages such as reduce the risk of death. Adittionnally this RCT is launching to explore the benefits of this combination of strains to modulate fecal microbiome and explore how this correlate with clinical improvement.
Description: Frequency of randomized subjects who progress from mild to moderate or severe COVID-19, as evaluated by WHO Clinical Progression Scale
Measure: Severity progression of COVID-19 Time: 30 daysDescription: Length of stay at Intensive care unit
Measure: Stay at ICU Time: 30 daysDescription: Mortality ratio for all the causes related to COVID-19
Measure: Mortality ratio Time: 30 daysDescription: Frequency of lung abnormalities clasified by severity and measured by x-ray and artificial intelligence
Measure: Lung abnormalities Time: 30 daysDescription: Description of SARS-Cov-2 viral load evaluated by RT-PCR at screening and on days 15 and 30
Measure: Viral load Time: 30 daysDescription: Levels of Immunoglobulin G and Immunoglobulin M evaluated on day 15 and 30
Measure: Levels of immunoglobulins Time: 30 daysDescription: Frequency and severity of gastrointestinal manifestation evaluated by Gastrointestinal Symptom Rating Scale (GSRS)
Measure: Gastrointestinal manifestations, where 0 means good health status and 5 worse status Time: 30 daysDescription: Changes on fecal microbiome evaluated by 16S analysis on day 1st and 30th
Measure: Fecal microbiome Time: 30 daysDescription: Frequency of adverse events reported on dairy report form after randomization and until day 30
Measure: Adverse events Time: 30 daysDescription: Change on C-reactive high sensitivity protein (hsCRP) and D-Dimer
Measure: Change on Serum Biomarkers Time: Days 1st, 15th and 30th after randomizationSevere pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19. This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.
Description: To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia
Measure: Urinary levels of renal biomarkers Time: Seven daysDescription: Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia
Measure: Incidence of AKI Time: One monthDescription: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality
Measure: Urinary levels of renal biomarkers and mortality Time: 30 daysDescription: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.
Measure: Urinary levels of renal biomarkers and severity of the disease. Time: 30 daysDescription: Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.
Measure: Risk factors for AKI in severe COVID-19 Time: 30 daysDescription: Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.
Measure: Evolution renal biomarkers Time: 7 daysDescription: Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.
Measure: Evolution of viral load Time: 7 daysDescription: Analyze the complement pathway in urine and compare its evolution over time in patients with and without acute kidney injury and SARS-CoV-2 infection.
Measure: Evolution of complement pathway Time: seven daysDescription: Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.
Measure: Metabolomic profile Time: 7 daysDescription: Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.
Measure: Respiratory changes Time: 30 daysDescription: Stablish the nosocomial infections in subjects with or without AKI
Measure: Nosocomial Infections Time: 30 daysDrug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. Participants in the study will be treated with either a study drug or with placebo.
Description: Symptoms: Fever or feeling feverish; cough, shortness of breath or difficulty breathing at rest or with activity; sore throat; body pain or muscle pain/aches; fatigue; headache, chills, nasal obstruction or congestion; nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Measure: Duration of COVID-19 symptoms (Phase 2) Time: Up to Day 28Description: Measured as detectable or undetectable, from site-collected NP (nasopharyngeal) swabs
Measure: Post-treatment presence of SARS-CoV-2 RNA at Day 3 (Phase 2) Time: Day 3Description: Measured as detectable or undetectable, from site-collected NP (nasopharyngeal) swabs
Measure: Post-treatment presence of SARS-CoV-2 RNA at Day 7 (Phase 2) Time: Day 7Description: Measured as detectable or undetectable, from site-collected NP (nasopharyngeal) swabs
Measure: Post-treatment presence of SARS-CoV-2 RNA at Day 14 (Phase 2) Time: Day 14Description: Measured as detectable or undetectable, from site-collected NP (nasopharyngeal) swabs
Measure: Post-treatment presence of SARS-CoV-2 RNA at Day 21 (Phase 2) Time: Day 21Description: Measured as detectable or undetectable, from site-collected NP (nasopharyngeal) swabs
Measure: Post-treatment presence of SARS-CoV-2 RNA at Day 28 (Phase 2) Time: Day 28Description: ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted ton address medical needs of those with severe COVID-19
Measure: Cumulative incidence of death from any cause or hospitalization (Phase 3) Time: Thru Day 28Description: ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted ton address medical needs of those with severe COVID-19
Measure: Cumulative incidence of death from any cause or hospitalization (Phase 2) Time: Thru Day 28Description: Symptoms: Fever or feeling feverish; cough, shortness of breath or difficulty breathing at rest or with activity; sore throat; body pain or muscle pain/aches; fatigue; headache, chills, nasal obstruction or congestion; nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Measure: Duration of COVID-19 symptoms (Phase 3) Time: Up to Day 28Description: Measured as detectable or undetectable, from participant-collected nasal swabs
Measure: Presence of SARS-CoV-2 RNA (Phases 2 and 3) Time: Thru Day 28Description: Measured from participant-collected nasal swabs
Measure: Level of SARS-Cov-2 RNA (Phases 2 and 3) Time: Thru Day 28Description: Based on symptom severity scores. Symptoms: Fever or feeling feverish; cough, shortness of breath or difficulty breathing at rest or with activity; sore throat; body pain or muscle pain/aches; fatigue; headache, chills, nasal obstruction or congestion; nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3). For participants who are alive at 28 days and not previously hospitalized, the severity ranking will be based on the area under the curve (AUC) of the symptom score associated with COVID-19 disease over time. Participants hospitalized or who die during follow-up through 28 days will be ranked as worse than those alive and never hospitalized as follows (in worsening rank order): alive and not hospitalized at 28 days; hospitalized but alive at 28 days; and died at or before 28 days.
Measure: COVID-19 severity ranking (Phases 2 and 3) Time: From Day 0 thru Day 28Description: Progression of one or more COVID-19-associated symptoms to a worse status than recorded at study entry, prior to start of investigational product or placebo
Measure: Incidence of ≥1 worsening symptom of COVID-19 (Phases 2 and 3) Time: Thru Day 28Description: Defined as the last day in the participant's study diary on which a temperature ≥ 38°C (100.4°F) was recorded or a potentially antipyretic drug was taken.
Measure: Duration of fever (Phases 2 and 3) Time: Thru Day 28Description: As recorded in participant's study diary
Measure: Time to self-report return to usual (pre-COVID-19) health (Phases 2 and 3) Time: Thru Day 28Description: Measured by pulse oximeter and categorized as <96% versus ≥96%
Measure: Oxygen saturation level (Phase 2) Time: Thru Day 28Description: Measured by AUC and above assay lower limit of quantification
Measure: Level of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2) Time: Days 0, 3, 7, 14, 21 and 28Description: Measured by AUC and above assay lower limit of quantification
Measure: Level of SARS-CoV-2 RNA from saliva (Phase 2) Time: Days 0, 3, 7, 14, 21 and 28Description: Measured by AUC and above assay lower limit of quantification
Measure: Level of SARS-CoV-2 RNA from self-collected nasal swabs (Phase 2) Time: Daily at Days 0-14, plus Days 21 and 28Description: From site-collected NP swabs
Measure: Level of SARS-CoV-2 RNA (Phase 2) Time: Days 3, 7, 14, 21 and 28Description: Measured as detectable or undetectable
Measure: Post-treatment presence of SARS-CoV-2 RNA in saliva (Phase 2) Time: Days 3, 7, 14, 21 and 28Description: Measured from saliva samples
Measure: Post-treatment level of SARS-CoV-2 RNA (Phase 2) Time: Days 3, 7, 14, 21 and 28Description: Analyses of plasma samples collected from placebo-treated participants are not planned
Measure: Concentration of investigational agent (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Description: Analyses of plasma samples collected from placebo-treated participants are not planned
Measure: Level of anti-drug antibodies (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Description: Area under the concentration-time curve. Analyses of plasma samples collected from placebo-treated participants are not planned
Measure: AUC (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Description: Analyses of plasma samples collected from placebo-treated participants are not planned
Measure: Total body clearance (CL) (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Description: T1/2. Analyses of plasma samples collected from placebo-treated participants are not planned
Measure: Elimination half-life (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Description: Maximum plasma concentration of LY3819253. Analyses of samples collected from placebo-treated participants are not planned
Measure: Cmax (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Description: Minimum plasma concentration of LY3819253. Analyses of samples collected from placebo-treated participants are not planned
Measure: Cmin (Phase 2 - LY3819253) Time: Days 0, 14, 28, Week 12, Week 24Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A Randomized Clinical Trial. This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers. The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, which is safe and is used as prophylaxis and treatment for HIV and other viral infections such as Hepatitis. Several laboratory-based studies indicate that this drug has the potential to inhibit SARS-CoV-2 replication. In addition, one study in HIV infected persons found that those taking Tenofovir /Emtricitabine tended to have a lower occurrence of COVID-19. In this study, we will compare the occurrence of infection with SARS-CoV-2/ COVID19 in health care workers between those assigned to an intervention group and those assigned to a control group. The intervention group will receive Tenofovir /Emtricitabine during 60 days in addition to the use of personal protective equipment (PPE), and the control group will receive a placebo during 60 days in addition to the use of personal protective equipment (PPE). The study will recruit 950 health professionals above 18 and less than 70 years, working in the emergency room, COVID wards and intensive care units of seven hospitals in Colombia. To make the comparison groups very similar, the participants will be assigned through a random mechanism to either the intervention (475), or the control (475) groups. In order to prevent biases in the evaluation of the results, neither the participants nor the clinical investigators, data managers, analysts and support personnel will know which intervention the participants are receiving. To determine the occurrence of infection with the virus the study will use both molecular tests that detect the presence of viral genes in respiratory secretions, and serological tests that detect the response of the immune system to the virus. The study will evaluate also the safety of this drug determining the occurrence of adverse events.
Description: Positivity of RT-PCR in nasopharyngeal samples in any of the measurements during follow up, or in symptomatic participants at any time. Positive IgG antibodies against SARS- CoV-2 in any of the measurements during follow up
Measure: SARS-CoV-2 infection Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)Description: Reported Serios and non serious adverse events during follow up
Measure: Serious and non-serious adverse events Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)Description: To discontinue the intervention during follow up
Measure: Discontinuation of using TDF/FTC for any reason Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)Description: number of tablets taken/total number of dispensed tablets
Measure: Adherence to TDF/FTC Time: At any time during the 60 days of interventionDescription: Severity of SARS-CoV-2 infections according to the following categories: Asymptomatic infection Mild symptomatic SARS-CoV-2 infection with no need for hospitalization Moderate symptomatic SARS-CoV-2 infection that requires hospitalization, but no ICU Severe SARS-CoV-2 infection: dyspnea with other SARS-CoV-2 symptoms requiring ICU hospitalization
Measure: Severity of SARS-CoV-2 infection Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)An estimated 22% of the global population is at an increased risk of a severe form of COVID-19, while one in four coronavirus patients admitted to intensive care unit will develop a pulmonary embolism. A major public health question remains to be investigated: why COVID-19 is mild for some, critically severe for others and why only a percentage of COVID-19 patients develop thrombosis, despite the disease's proven hypercoagulable state? Patients' intrinsic characteristics might be responsible for the deep variety of disease forms. Our study aims to assess the validity of the hypothesis according to which underlining genetic variations might be responsible for different degrees of severity and thrombotic events risks in the novel coronavirus disease. Moreover, we suspect that prothrombotic genotypes occuring in the genes that encode angiotensin-converting enzyme (ACE-DEL/INS) and angiotensinogen (AGT M235T) are involved in the unpredictable evolution of COVID-19, both in terms of severity and thrombotic events, due to the strong interactions of SARS-CoV-2 with the renin-angiotensin-aldosterone system (RAAS). Therefore, we also aim to assess the validity of the theory according to which there is a pre-existing atypical modulation of RAAS in COVID-19 patients that develop severe forms and/or thrombosis. Our hypothesis is based on various observations. Firstly, there is a substantial similarity with a reasonably related condition such as sepsis, for which there is a validated theory stating that thrombophilic mutations affect patients' clinical response. Secondly, racial and ethnic genetic differences are responsible for significant dissimilar thrombotic risks among various nations. Thirdly, an increase in stroke incidence has been reported in young patients with COVID-19, without essential thrombosis risk factors, favoring the idea that a genetic predisposition could contribute to increase the thrombotic and thromboembolic risk. Fourthly, the plasminogen activator inhibitor (PAI)-1 4G/5G inherited mutation was found to be responsible for a thrombotic state causing post-SARS osteonecrosis.
Description: The difference of prothrombotic genotypes frequency between the three groups
Measure: Number of patients with thrombophilic profile alterations Time: One yearDescription: The differences of RAAS components levels between the three groups
Measure: Number of patients with RAAS components alterations Time: One yearThis is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with SOC treatment, in subjects with COVID 19. For the purposes of this study, standard of care (SOC) may include any written or established treatment protocol followed at the study site for the treatment of severe COVID-19 or its complications, including off-label use of marketed pharmaceutical products and / or products with emergency use authorization granted for the treatment of COVID-19 (ie, not yet marketed) (eg, remdesivir).
1.5. Why this clinical study? The prevalence of seropositivity following SARS-CoV 2 infection might have its own potential benefits in terms of predicting the end of pandemic and the validity of herd immunity. It is not clear if SARS-CoV 2 infection would have a long-lasting antibody-mediated immunity, and if the antibodies' persistence is dependent on disease severity.depends on the severity of illness. If evidence is provided about the persistence of antibodies that is reflective of the protective immune response, serodiagnosis will be an important tool to identify individuals with various risk for infection, and those who are in need of receiving the forthcoming vaccines. The here proposed prospective clinical study will test the prevalence of seropositivity following SARS-CoV 2 infection in critically ill patients compared to those who do not require intensive care unit (ICU) admission or invasive ventilation with respect to the IgM and IgG levels.
Description: The measurements are dependent on epitope recognitions for synthetic, adsorbed S proteins
Measure: Changes in the levels of S specific antibodies in severely ill patients compared to mild cases. Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: The measurements are dependent on epitope recognitions for synthetic, adsorbed N proteins
Measure: Changes in the levels of N specific antibodies in severely ill patients compared to mild cases. Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Titers of the S specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions
Measure: S specific binding antibodies of SARS-CoV-2 Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Titers of the N specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions
Measure: N specific binding antibodies of SARS-CoV-2 Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Titers of the neutralizing antibodies directed against S protein of SARS-CoV-2 would be assayed as described in the interventions
Measure: Neutralizing antibodies directed against S protein of SARS-CoV-2 Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: The severity category of critically ill patients would be estimated using an APACHI II score. Minimum score = 0; maximum score = 71.
Measure: The severity category of critically ill Time: Day 0, 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Length of ICU stay from the admission day to the ICU
Measure: Length of ICU Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Length of hospital stay from the hospital admission day
Measure: Length of hospital stays Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: If the patients alive or dead through a telephone interview.
Measure: Alive status at 28-days Time: For 28 days after the onset of symptoms of SARS-Cov2 infectionDescription: If the patients alive or dead through a telephone interview.
Measure: Alive status at 90-day Time: For 90 days after the onset of symptoms of SARS-Cov2 infectionDescription: To correlate the levels of S neutralizing antibodies in severely ill patients compared to mild cases.
Measure: Correlation between the levels of S neutralizing antibodies and disease severity Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: To correlate the levels of N neutralizing antibodies in severely ill patients compared to mild cases.
Measure: Correlation between the levels of N neutralizing antibodies and disease severity Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionCoronavirus-2019 disease (COVID-19) and community-acquired pneumonia are significant problems of modern medicine. Pneumonia is the most common severe complication of COVID-19. But at the same time, COVID-19 is not the only cause of community-acquired pneumonia. Moreover, pneumonia is only one of the numerous possible severe complications of COVID-19. Medical centers specialized for the hospital treatment of patients with severe COVID-19 and community-acquired pneumonia were organized in different regions of Russia during coronavirus pandemic-2020. The indications for hospitalization to one of these centers based in the National Medical and Surgical Center (NMSC) are: confirmed or suspected severe COVID-19 or community-acquired pneumonia. A prospective medical registry of such patients hospitalized to NMSC, is intended to analyze and compare their clinical and instrumental data, co-morbidity, treatment, short-term and long-term outcomes in real clinical practice. Stage 1. Hospital treatment in NMSC Duration of this stage: from the date of admission to the hospital up to the date of discharge from the hospital / or up to the date of death during the reference hospitalization. The date of admission to the hospital will be the date of enrollment to the study. Evaluation of electronic health record data using the Medical Information System (MIS). Assessment of the outcomes of the hospital phase (discharge from the hospital, death) and significant events (acute respiratory and pulmonary failure, requiring mechanical ventilation; cardiovascular events - myocardial infarction, cerebral stroke, acute heart failure, paroxysmal heart rhythm disturbances, bleedings, thrombosis of large vessels and thromboembolic complications). A survey of patients to clarify data on risk factors, somatic diseases, and drug therapy before hospitalization. COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was confirmed by Polymerase chain reaction (PCR). Pneumonia was confirmed according to computerized tomography (CT) data. Stage 2. Prospective outpatient follow-up for 24 months Duration of this stage: 24 months after discharge from the hospital This work will be delivered by investigators from the National Medical Research Center for Therapy and Preventive Medicine. Evaluation of long-term outcomes and events among residents of Moscow and the Moscow Region according to a patient survey (contact by phone for 30-60 days, 6 months, 12 and 24 months after discharge from the hospital) and medical records.
Description: Damage area >50% according to the computer tomography data at any time point during hospitalization
Measure: Proportion of patients with severe pneumonia Time: from admission to discharge or death during reference hospitalization, assessed up to 90 daysDescription: SpO2 <90% - at any point during hospitalization
Measure: Proportion of patients with low oxygen saturation value Time: from admission to discharge or death during reference hospitalization, assessed up to 90 daysDescription: In patients with pneumonia during reference hospitalization time to recurrent pneumonia. In patients without pneumonia during reference hospitalization - time to first pneumonia
Measure: Time to pneumonia/recurrent pneumonia Time: from discharge up to two years after reference hospitalizationDescription: In patients without COVID-19 - time to primary diagnosis and in patients with COVID-19 - time to recurrent event
Measure: Time to primary or recurrent coronavirus infection disease (COVID-19) Time: from discharge up to two years after reference hospitalizationDescription: proportion of patients with thromboembolic events
Measure: thromboembolic events Time: from admission to discharge or death during reference hospitalization, assessed up to 90 daysDescription: the sum of the days when the patients required artificial pulmonary ventilation
Measure: Duration of Artificial Pulmonary Ventilation Time: from admission to discharge or death during reference hospitalization, assessed up to 90 daysDescription: proportion of patients with rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV)
Measure: Rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV) Time: from discharge up to two years after reference hospitalizationDescription: proportion of patients with hospitalization due to cardiovascular disease
Measure: Hospitalization due to cardiovascular disease (CVD) Time: from discharge up to two years after reference hospitalizationSafety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
Description: Adverse events which appear in subjects with ADR-001 treatment are evaluated.
Measure: Safety: Adverse Event Time: 12 weeksThe purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
Description: The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.
Measure: Evidenced of active and trained innate immunity Time: Day 61 and 90 (post vaccination)Description: cases ( nasal swab for viral antigen and antibody testing), symptoms (symptom checklist), hospitalizations (MDS 3.0 report/chart reviews) and deaths (MDS 3.0 report/chart reviews) associated with flu, pneumonia, and COVID-19.
Measure: Respiratory Disease Severity (6 month) Time: Days 90 through 180Clinical observation has found that COVID-19 patients often present inconsistency of clinical features, nucleic acid of the SARS-CoV-2 and imaging findings, which brings challenges to the management of patients.The quantitative assessment of patients' pulmonary lesions of chest CT, combined with the basic information, epidemiological history, clinical symptoms, basic diseases and other information of patients, will quickly establish a reliable prediction model for the severe COVID-19. This model will greatly contribute to the effective diagnosis and treatment of COVID-19.
Description: chest CT imaging data of the patient, basic patient information, epidemiological history, clinical symptoms, and underlying diseases
Measure: Chest CT and clinical features Time: 2020-1-1 to 2020-6-1While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.
Description: Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls
Measure: Native myocardial T1 relaxation time Time: 12 weeks post COVID-19 diagnosisDescription: Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging
Measure: FLAIR imaging Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline
Measure: Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline
Measure: Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline
Measure: Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI
Measure: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI Time: 12 weeks post COVID-19 diagnosisDescription: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic
Measure: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic Time: 12-24 weeks post COVID-19 diagnosisThe world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.
Description: Overall duration of the hospitalization from day of admission until the day of discharge or fatality
Measure: Length of hospitalization Time: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Did the patient need a intensive care treatment during the hospitalization (yes/no)
Measure: Need of intensive care Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: Day of admission to ICU until discharge or fatality
Measure: Lenght of the Intensive Care Treatment Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: Percentage of patient died during hospitalization
Measure: Overall mortality Time: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)Description: percentage of patients with 25-hydroxyvitamin D > 50nmol/L (>20ng/mL) at day 7 - The values of calcium, phosphorus, 24-hydroxyvitamin D, 1.25-dihydroxyvitamin D, parathyroid hormone.
Measure: Development of vitamin D levels Time: Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)Description: percentage of patients developing a sepsis
Measure: Development of sepsis Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)Description: We assess every other complications which occurs due to COVID-19
Measure: Complications due to COVID-19 Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)Description: The BP will be assessed daily in mmHg
Measure: Blood pressure (BP) Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: The heart rate will be assessed daily in bpm
Measure: Heart rate Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: The SpO2 will be assessed daily in %
Measure: Peripheral oxygen saturation (SpO2) Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Requirement for oxygen will be assessed daily (yes/no) if yes how many liters per minute
Measure: Percentage of patients who require oxygen Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Breathing frequence will be assessed daily in breaths per minute
Measure: Breathing frequency Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: GCS will be assessed daily 3 to 15 points. It describes the extent of impaired consciousness. 15 points means no impairment, 3 points means severe impairment of consciousness.
Measure: Glasgow Coma Scale (GCS) Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Assessing the history of smoking in pack years (PY). the assessment will be made with the following options for answering Current smoker: Smoking for how many years? Cigarettes per day? Former smoker, how many years smoked? How many cigarettes per day Life-long non-smoker
Measure: Percentage of patients are smokers, former smokers or lifelong non-smokers Time: Assessing of the smoking Status at BasleineDescription: Assessed in No/ Mild/ Moderate /Severe
Measure: Current Symptoms Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Temperature will be assessed daily in degrees celsius
Measure: Temperature Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Purpose: - To determine the presence of SARS-CoV-2 in tears - To determine SARS-CoV-2 receptors in tear production system
Description: Outcome is reported as the percent of tear samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.
Measure: COVID-19 Virus Detection in Tears Time: single time pointDescription: Outcome is reported as the percent of nasopharyngeal swab samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.
Measure: COVID-19 Virus Detection in Nasopharyngeal Swabs Time: single time pointDescription: Pathology slides of lacrimal gland samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of lacrimal gland samples scored in each category (no expression, mild expression, or heavy expression).
Measure: Expression of ACE2 in Lacrimal Gland Samples Time: single time pointDescription: Pathology slides of ocular surface samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of ocular surface samples scored in each category (no expression, mild expression, or heavy expression).
Measure: Expression of ACE2 in Ocular Surface Samples Time: single time pointThe COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans. Currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk. Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection. Therefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period. The study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds. Participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.
Description: evidence of SARS-CoV-2 antibodies
Measure: The number of employees tested who have evidence of SARS-CoV-2 antibodies Time: 12 monthsDescription: Survey to establish Type of healthcare role Ethnicity Age Index of multiple deprivation Previous RT-PCR test status Previous clinical COVID infection Previous period of self isolation Level of COVID-19 related anxiety Presence of one or more high risk factors for COVID 19 Presence or absence of self-reported COVID 19 symptoms
Measure: Factors associated with a positive test Time: 12 monthsDescription: Infection compared to antibody presence
Measure: Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests Time: 12 monthsThis pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection.
Description: Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.
Measure: Proportion of patients with recovery Time: Day 29Description: Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.
Measure: Time to recovery Time: Day 1 to Day 29Description: All-cause mortality
Measure: Mortality rate Time: Days 29 and 60Description: respiratory failure = requiring invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]
Measure: Proportion of patients alive and not in respiratory failure Time: Day 29Description: breaths/minute
Measure: Respiration Rate Time: Day 1 to Day 29Description: beats/minute
Measure: Heart Rate Time: Day 1 to Day 29Description: mmHg
Measure: Blood Pressure Time: Day 1 to Day 29Description: AVPU scale
Measure: Level of Consciousness Time: Day 1 to Day 29Description: SpO2 %
Measure: Oxygen saturation Time: Day 1 to Day 29SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.
Description: All-cause mortality at day 28, defined as the comparison of proportions of patients death for any cause at day 28 from randomization.
Measure: All-cause mortality at day 28 Time: Day 28 from randomizationDescription: All-cause mortality at ICU discharge, defined as the comparison of proportions of patients death for any cause at ICU discharge.
Measure: All-cause mortality at ICU discharge Time: from randomization to ICU discharge, censored at day 30Description: All-cause mortality at Hospital discharge, defined as the comparison of proportions of patients death for any cause at hospital discharge
Measure: All-cause mortality at hospital discharge Time: from randomization to ICU discharge, censored at day 90Description: Occurrence of rescue administration of high-dose steroids or immune-modulatory drugs
Measure: Need of rescue administration of high-dose steroids or immune-modulatory drugs Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of new organ dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score ≥3 for the corresponding organ occurring after randomization.
Measure: New organ dysfunction during ICU stay Time: From randomization to ICU discharge, censored at day 28Description: Grade of organ dysfunction during ICU stay, grade of dysfunction is measured with Sequential Organ Failure Assessment (SOFA) score daily from randomization to day 28 or ICU discharge.
Measure: Grade of organ dysfunction during ICU stay Time: From randomization to ICU discharge, censored at day 28Description: Total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered.
Measure: ICU free days at day 28 Time: From randomization to day 28Description: Occurrence of new infections including bacterial infections, fungal infections by Candida, Aspergillus, and viral reactivations including Adenovirus, Herpes Virus e Cytomegalovirus
Measure: Occurrence of new infections Time: from randomization to day 28Description: Total number of days that patient is alive and free of ventilation between randomisation and day 28. Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.
Measure: Ventilation free days at day 28 Time: From randomization to day 28, censored at hospital dischargeDescription: Total number of days that patient is alive and free of vasopressors between randomisation and day 28.
Measure: Vasopressors free-days at day 28 Time: From randomization to day 28, censored at hospital dischargeDescription: Occurrence of switch from non-invasive to invasive mechanical ventilation
Measure: Switch from non-invasive to invasive mechanical ventilation Time: from randomization to ICU discharge, censored at day 28Description: Total number of hours from start of non-invasive to invasive ventilation to switch to invasive ventilation
Measure: Delay from start of non-invasive ventilation to switch to invasive ventilation Time: from randomization to ICU discharge, censored at day 28Description: Adverse events occurred from randomization to day 28. Events that are part of the natural history of the primary disease process or expected complications of critical illness will not be reported as adverse events.
Measure: Occurrence of protocol related adverse events Time: From randomization to day 28Description: Occurrence of objectively confirmed venous thromboembolism, stroke or myocardial infarction
Measure: Occurrence of venous thromboembolism, stroke or myocardial infarction Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of major bleeding defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death)
Measure: Occurrence of major bleeding (safety end point) Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of clinically relevant non-major bleeding defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm2, or 100 cm2, intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.
Measure: Occurrence of clinically relevant non-major bleeding (safety end point) Time: from randomization to ICU discharge, censored at day 28Description: Mean arterial pressure will be measured in millimeters of mercury
Measure: Mean arterial pressure Time: Daily from inclusion until ICU discharge, censored day 28Description: hearth rate will be measured in beats per minute
Measure: hearth rate Time: Daily from inclusion until ICU discharge, censored day 28Description: respiratory rate will be measured in breaths per minute
Measure: respiratory rate Time: Daily from inclusion until ICU discharge, censored day 28Description: diuresis will be measured daily in milliliters of urine output in the previous 24 hours
Measure: diuresis Time: Daily from inclusion until ICU discharge, censored day 28Description: systemic body temperature will be measured in celsius degrees
Measure: systemic body temperature Time: Daily from inclusion until ICU discharge, censored day 28Description: fluid balance will be measured in milliliters of fluids input and output in the previous 24 hours
Measure: fluid balance Time: Daily from inclusion until ICU discharge, censored day 28Description: Haemoglobin will be measured in mg/dl
Measure: Haemoglobin concentration Time: Daily from inclusion to ICU discharge (censored at day 28)Description: platelets count will be measured in U 10^3/mm^3
Measure: platelets count Time: Daily from inclusion to ICU discharge (censored at day 28)Description: white blood cells count will be measured in U per 10^9/L
Measure: white blood cells count Time: Daily from inclusion to ICU discharge (censored at day 28)Description: troponin will be measured in µg/L
Measure: troponin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: coagulative function will be measured with parameters INR, PT, aPTT
Measure: coagulative function Time: Daily from inclusion to ICU discharge (censored at day 28)Description: D-dimer will be measured in µg/ml
Measure: D-dimer Time: Daily from inclusion to ICU discharge (censored at day 28)Description: anti-thrombin will be measured as a percentage
Measure: anti-thrombin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: liver function will be assessed through measurement of AST, ALT in U/L
Measure: Liver function Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Bilirubin will be measured in mg/dL
Measure: Bilirubin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Creatinine will be measured in mg/dL
Measure: Creatinine Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Blood cells count will be measured in Units per x 10^9/L of blood
Measure: Blood cells count Time: daily from inclusion to ICU discharge (censored at day 28)Description: C-reactive protein (CRP) will be measured in mg/dl
Measure: C-reactive protein (CRP) Time: daily from inclusion to ICU discharge (censored at day 28)Description: procalcitonin(PCT) wiull be measured in ng/ml
Measure: procalcitonin(PCT) Time: daily from inclusion to ICU discharge (censored at day 28)Description: interleukin 6 (IL-6) will be measured in pg/ml
Measure: interleukin 6 (IL-6) Time: daily from inclusion to ICU discharge (censored at day 28)Description: Ventilation mode will be cathegorized in spontaneous breathing, invasive or non invasive ventilation
Measure: Ventilation mode Time: Daily from inclusion to ICU discharge (censored at day 28)Description: inspired oxygen fraction will be measured in percentage of oxygen in inspired air
Measure: inspired oxygen fraction Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Gas exchanges will be assessed by measurement of PaO2, PaCO2 in mmHg by arterial blood gas analysis
Measure: Gas exchanges Time: Daily from inclusion to ICU discharge (censored at day 28)Description: lactates will be measured in mMol/L
Measure: lactates Time: Daily from inclusion to ICU discharge (censored at day 28)Description: pH will be measured in pH scale
Measure: pH Time: Daily from inclusion to ICU discharge (censored at day 28)Description: oxygen saturation in blood will be measured in arterial and venous samples in percentage values
Measure: oxygen saturation in blood Time: Daily from inclusion to ICU discharge (censored at day 28)Description: New blood, respiratory and urinary-tract infections will be recorded
Measure: New infections Time: From randomization to day 28Description: Viral reactivation measured by CMV DNA titres will be recorded.
Measure: Viral reactivation Time: From randomization to day 28Description: Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) will be recorded.
Measure: Need of new renal replacement therapy Time: from randomization to day 28Description: Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded
Measure: Adjunctive treatments Time: from randomization to ICU discharge (censored at day 28);The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.
Description: The primary endpoint will be the disease severity on the 7-point WHO Ordinal Scale on day 7. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19
Measure: Disease Severity on the 7-Point WHO Ordinal Scale Time: Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline valueDescription: at least 2 points Ordinal Scale for Clinical Improvement, clinical severity will be assessed.
Measure: Clinical improvement Time: Daily until day 14Description: Admission to ICU with invasive or non-invasive ventilation or death will be assessed.
Measure: Invasive or non-invasive ventilation Time: Daily until day 14.Description: Patients with ALI within 14 days after enrollment, PaO2/FiO2 will be determined daily. This is only relevant for patients with arterial blood gas sampling performed in the ICU or rarely in the medical unit.
Measure: Acute Lung Injury Time: Daily until day 14.Randomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder
Description: Frequency of adverse reaction in the seven days following each immunization per age group
Measure: Frequency of adverse events up to seven days after immunization Time: Seven days after each immunizationDescription: Frequency of adverse reaction in the 21 days following each immunization per age group
Measure: Frequency of adverse events up to 21 days after immunization Time: 21 days after each immunizationDescription: The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination compared with a placebo.
Measure: The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo Time: at days 0, 21, 27, 42Description: Incidence of serious adverse events during the study.
Measure: Incidence of serious adverse events during the study Time: throughout the study, an average of 42 daysDescription: Cell-mediated immune profile
Measure: Cell-mediated immune profile Time: at days 0, 7, 21, 27, 42Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.
Description: Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.
Measure: pH Time: 10 daysDescription: Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.
Measure: Number of Days Alive Free of Stage 2-3 AKI Time: 28 days post-treatmentDescription: proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).
Measure: Stage 2-3 AKI Time: 28 daysDescription: Ventilator-free days to 28 days
Measure: Vent-Free Time: 28 daysDescription: Hospital-free days to 60 days
Measure: Hospital-Free Time: 60 days post-index hospitalizationAn observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis
Description: Number of patients with positive serological test of SARS Cov2
Measure: Serological Profile Time: InclusionThis is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.
Description: Symptom severity will be tracked electronically
Measure: Symptom Severity Time: 14 daysDescription: Determine symptom course of those with moderate or severe symptoms
Measure: Symptom progression Time: 14 daysTo evaluate the safety and efficacy of the use of inhalational heparin in patients with pulmonary compromise / pneumonia / SARS associated with COVID-19, laboratory with marked inflammation parameters, and prothrombotic state secondary to it (Fibrinogen, Ferritin and / or elevated D-Dimer) , from admission to hospitalization. The combination of inhalation heparin combined with prophylactic doses of LMWH could reduce the progression to severe forms of the disease, and consequently the need for intensive care units and mechanical ventilation.
Description: Blood Gas criteria :PaO2 / FiO2 <200 (or the inability to maintain an SpO2 of at least 92% with a reservoir mask). Acute ventilatory failure (pH less than 7.35 with PaCO2 greater than 45 mmHg)
Measure: Percentage of patients requirement mechanical ventilation Time: 15 daysDescription: Mean every 48 hours PaO2 to FiO2 ratio
Measure: Percentage of patients with PaO2 to Fi02 ratio > 300 Time: 7 daysDescription: To compare the lengths of hospital-stay
Measure: Lengths of hospital-stay Time: Days 60Description: All cause mortality
Measure: Mortality rate Time: 30 daysThis is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.
Description: Describe the clinical features of the illness or syndrome and complications, and determinants of severity. Assessment daily for 14 days, then hospital discharge.
Measure: Clinical characterization of coronavirus disease-2019 (COVID-19) Time: 1 yearThis QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.
Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.
Measure: Change in Testing Throughput After Hexapod Implementation Time: Up to 22 weeksDescription: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.
Measure: Change in Isolation Gowns Utilized After Hexapod Utilization Time: Up to 22 weeksDescription: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.
Measure: Change in Cost per Test After Hexapod Implementation Time: Up to 22 weeksDescription: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.
Measure: Return on Investment Time: Up to 22 weeksDescription: The difference in median shift salaries before and after Hexapod implementation will be calculated.
Measure: Change in Testing Personnel Cost Per Test Time: Up to 22 weeksDescription: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.
Measure: Change in Cost of Isolation Gowns Utilized Time: Up to 22 weeksDescription: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.
Measure: Cost of Additional Consumable Supplies Utilized Time: Up to 22 weeksEvaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study
Description: incidence of taste and smell impairment in critically ill subjects
Measure: taste and smell impairment Time: up to 3 monthsThis is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1 x 10^8cells for the high-dose group after registration. Subjects assigned to the control group were administered with placebo in the same manner as the test drug (DW-MSC). At this time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to standard therapy. This clinical trial is a double-blind trial, in which a randomized method will be used. To maintain the double-blindness of the study, statistician who do not participate in this study independently generate randomization code. Subjects will be randomized to the test groups (low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio. After the completion of the trial, the randomization code will be disclosed after unlocking the database and unblinding procedures. Follow Up period: observed for 28 days after a single administration
Description: Incidence of TEAE* in Treatment group * TEAE: Treatment-Emergent Adverse Event All adverse reactions will be organized according to System Organ Class (SOC) and Preferred Term (PT) using MedDRA (Medical Dictionary for Regulatory Activities), and the incidence of treatment-emergent adverse events will be summarized for the coded adverse reactions.
Measure: Incidence of TEAE* in Treatment group Time: 28 daysDescription: Survival rate is defined as the rate of subjects surviving until Day 14 and Day 28, and the number and rate of surviving subjects for each administration group is given.
Measure: Survival rate Time: until Day 14 and Day 28Description: Duration of hospitalization is defined as the number of days in the hospital until Day 28, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.
Measure: Duration of hospitalization Time: 28 daysDescription: Clinical improvement measured by Ordinal scale change for clinical improvement from baseline to Day 14 and 28
Measure: Clinical improvement Ordinal scale Time: from baseline to Day 14 and Day 28Description: Clinical improvement measured by National EWS (National Early Warning Score) change from baseline to Day 7, 14, 28. EWS Points, Risk and Interpretation as follows: 0~4: Low clinical risk; interpretation= Ward-based response 3~4 : Low~medium clinical risk; interpretation= Urgent ward-based response 5~6: Medium clinical risk; interpretation= Key threshold for urgent response
Measure: Clinical improvement National EWS Time: from baseline to Day 7, 14 and Day 28Description: Clinical improvement measured by Oxygenation index (PaO2/FiO2) change from baseline (Day 1, 3, 7, 10, 14, 28)
Measure: Clinical improvement Oxygenation index Time: Day 1, 3, 7, 10, 14, 28Description: Clinical improvement measured by Lung involvement change by Imaging from baseline (Day 7, 14, 28)
Measure: Clinical improvement Lung involvement change Time: Day 7, 14, 28Description: Inflammation markers change from baseline for WBC
Measure: Clinical improvement Inflammation markers change Time: Day 7, 14, 28Description: Inflammation markers change from baseline for Lymphocytes
Measure: Clinical improvement Inflammation markers change Time: Day 7, 14, 28Description: Inflammation markers change from baseline for ESR
Measure: Clinical improvement Inflammation markers change Time: Day 7, 14, 28Description: Inflammation markers change from baseline for CRP
Measure: Clinical improvement Inflammation markers change Time: Day 7, 14, 28Description: Inflammation markers change from baseline for Fibrinogen
Measure: Clinical improvement Inflammation markers change Time: Day 7, 14, 28Description: Inflammation markers change from baseline for IL-6, TNF-α, IL-1β, IF-γ (Day 7, 14, 28)
Measure: Clinical improvement Inflammation markers change Time: Day 7, 14, 28A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.
Description: COVID-19 virologically confirmed symptomatic cases (PCR positive).
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR Time: 12 months post final vaccinationDescription: Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)
Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination Time: 7 days post vaccinationDescription: Occurrence of serious adverse events
Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events Time: 12 months post final vaccinationDescription: Occurrence of episodes; intensified disease
Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease Time: 12 months post final vaccinationDescription: Hospitalization for COVID-19 disease confirmed by PCR
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR Time: 12 months post final vaccinationDescription: COVID-19 serious disease confirmed by PCR
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR Time: 12 months post final vaccinationDescription: Death associated with COVID-19 disease
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease Time: 6 monthsDescription: Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates) Time: 12 months post final vaccinationDescription: Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)
Measure: Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates) Time: 12 months post final vaccinationDescription: Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus
Measure: Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus Time: 12 months post final vaccinationDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine Time: 12 months post final vaccinationThe world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.
Description: Time to clinical improvement of a decrease of at least two points on a seven-point ordinal scale of clinical status or discharged alive from hospital. The seven-point scale consists of the following categories: not hospitalized; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; hospitalized, intubation and mechanical ventilation; ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); death
Measure: time to clinical improvement Time: Randomization until discharge from hospital but up to maximum 28 daysDescription: Frequency of Patient who need mechanical ventilation during hospital stay
Measure: Frequency of mechanical ventilation Time: Randomization until discharge from hospital up to maximum 28 daysDescription: Frequency of Patient who showed a multi organ dysfunction Syndrome during Hospital stay
Measure: Frequency of Multi organ dysfunction Syndrome (MODS) Time: Randomization until discharge from hospital up to maximum 28 daysDescription: Blood pressure will be assessed daily in mmHg
Measure: Blood pressure Time: Daily until discharge up to maximum 28 daysDescription: Heart rate will be assessed daily in bpm
Measure: Heart rate Time: Daily until discharge up to maximum 28 daysDescription: Respiratory rate will be assessed daily in Counts per minute
Measure: Respiratory rate Time: Daily until discharge up to maximum 28 daysDescription: Body temperature (auricular) will be assessed daily in °C
Measure: Body temperature (auricular) in °C Time: Daily until discharge up to maximum 28 daysDescription: Pulse oximetry will be assessed daily in %
Measure: Pulse oximetry Time: Daily until discharge up to maximum 28 daysDescription: Glasgow Coma Scale will be assessed daily The lowes possible score is 3 = deep coma or death The highest possible score is 15 = Fully awake
Measure: Glasgow Coma Scale Time: Daily until discharge up to maximum 28 daysDescription: Visual analogue scale for dyspnea and cough as patient-related outcome parameter
Measure: Dispnea and caugh Time: Randomization until discharge from hospital up to maximum 28 daysThe purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.
Description: Ordinal Scale for Clinical Improvement (minimum=0 and maximum=8; higher score = worse outcome)
Measure: Change in COVID-19 Severity Time: baseline, Day 2, 7, 10, 14, 17, 30, 90 and 180The aim of this study is to analyze oral disinfection with 1.5% hydrogen peroxide, 0.12% chlorhexidine gluconate or 0.075% cetylpyridinium chloride to 0.28% zinc lactate to reduce the SARS-CoV viral load -2 in the oral and oropharyngeal mucosa and saliva. Patients of both sexes, aged between 18 and 90 years, positive for SARS-CoV-2 by the RT-PCR method and who require oral hygiene care and other preventive and therapeutic dental procedures that are used in the randomized clinical study. The study comprises two arms: Arm 1 - patients hospitalized in the ICU bed with orotracheal intubation - undergo disinfection of the oral mucosa with 1.5% hydrogen peroxide solution, after the 0.12% non-alcoholic chlorhexidine solution ( Peroxide and Chlorhexidine Group) or only disinfection of the oral mucosa with 0.12% non-alcoholic chlorhexidine solution (Chlorhexidine Group - control); Arm 2 - patients hospitalized in the common bed without mechanical ventilation - will undergo oral disinfection or with 1.5% hydrogen peroxide solution (Peroxide Group), or with 0.12% chlorhexidine gluconate (Chlorhexidine Group) or with chloride 0.075% cetylpyridinium with 0.28% zinc lactate (Cetylpyridinium Group) or distilled water (Placebo Group). For the monitoring of viral load, the following procedures are performed: Arm 1 - a scrape with swab on the tongue, deep groove, oral soil, performed before the first oral disinfection (T0), after disinfection with hydrogen peroxide (T1) , after disinfection with chlorhexidine (T2) and 30 minutes after the last disinfection (T3); swab of the fluid adhered to the tube, before disinfecting the tube with hydrogen peroxide and chlorhexidine and immediately after this disinfection. Arm 2 - swab in oropharynx and saliva before application of solutions (T0), 30 min (T1) and 2 hours after application of solutions (T2). The quantification of SARS-CoV-2 will be done through the polymerase chain reaction with reverse-quantitative transcription (RT-qPCR). If some of these solutions are effective in reducing viral load in the oral cavity, this result may contribute to reduce the contamination of the environment caused by aerosols that require dental procedures, contributing to the improvement of biosafety protocols against SARS-CoV-2.
This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days
Description: The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection
Measure: Number of participants who die or require transfer to Intesive care unit Time: In the first 15 days after ramdomizationDescription: The secondary end point is the ocurrence of death in the 15 days after ramdomization
Measure: Number of participants who die Time: 15 days after ramdomizationIn this randomized double blind Phase 3 clinical trial we will study the efficacy and safety of oral polio vaccine with and without NA-831 versus placebo.
Description: Number of participants infected with Covid-19 after second dose
Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831 Time: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)Description: Number of participants with adverse events
Measure: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal Time: Time Frame: Up to Day 365 (1 years after second dose)Description: Clinical signs indicative of severe COVID-19 as predefined for the study.
Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831 Time: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of OPV with or without NA-831 or Placebo regardless of evidence of prior SARS-CoV-2 Infection Time: Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design
Description: Proportion of subjects with four-fold and higher increment of anti-receptor-binding domain antibodies [receptor-binding domain, RBD] of S-protein SARS-CoV-2).
Measure: Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion Time: Day 28 after vaccinationDescription: Geometric mean titer of RBD и S-protein SARS-CoV-2 antibodies.
Measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (titer of SARS-CoV-2 antibodies) Time: Day 14, 28 and after 6 months after vaccination.Description: Level of seroconversion (proportion of persons with four-fold and higher increment of RBD и S-protein SARS-CoV-2 antibodies).
Measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion) Time: Day 14, 28 and after 6 months after vaccination.Description: Geometric mean fold rise of RBD и S-protein SARS-CoV-2 antibodies.
Measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (rise of SARS-CoV-2 antibodies) Time: Day 14, 28 and after 6 months after vaccination.Description: Quantity of T-cells.
Measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response) Time: Day 14, 28 and after 6 months after vaccination.Description: Frequency of confirmed COVID-19 (confirmed case of COVID-19: presence of clinical signs and positive result of laboratory test for RNA of virus SARS-CoV-2) (exploratory analysis).
Measure: Frequency of confirmed COVID-19 Time: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)Description: Frequency of confirmed cases of COVID-19, requiring hospitalization. (confirmed case of COVID-19: presence of clinical signs and positive result of laboratory test for RNA of virus SARS-CoV-2) (exploratory analysis).
Measure: Frequency of confirmed cases of COVID-19, requiring hospitalization Time: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)Description: Frequency of cases with severe course of COVID-19 (confirmed case of COVID-19: presence of clinical signs and positive result of laboratory test for RNA of virus SARS-CoV-2) (exploratory analysis).
Measure: Frequency of cases with severe course of COVID-19 Time: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)Description: Frequency of death due to COVID-19 (exploratory analysis).
Measure: Frequency of death due to COVID-19. Time: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)Description: Frequency and character of general and local postvaccinal reactions.
Measure: Reactogenicity of the vaccine Ad5-nCoV compared with placebo Time: Day 0 (day of vaccination), Day 2, Day 7Description: Frequency and character of adverse events and serious adverse events.
Measure: Frequency and character of adverse events and serious adverse events. Time: Day 0 - Month 6Description: Results of evaluation of vital parameters: Systolic blood pressure Diastolic blood pressure The researcher evaluates each of the vital parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (blood pressure) Time: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6Description: Results of evaluation of vital parameters: • Heart rate. The researcher evaluates each of the vital parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (heart rate) Time: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6Description: Results of evaluation of vital parameters: • Respiratory rate. The researcher evaluates each of the vital parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (respiratory rate) Time: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6Description: Results of physical examination includes examination of organs and systems: General state Ears, nose, throat Skin and examination of the injection site The lymph nodes The cardiovascular system Respiratory system Nervous system Abdominal organs Kidneys and urinary system Musculoskeletal system. During the physical examination, the researcher evaluates each of the systems in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of physical examination Time: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6Description: Results of electrocardiography: • Heart rate (HR) The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography (Heart rate) Time: Day -7-1 (Screening), Day 2Description: Results of electrocardiography: Intervals RR, PQ, QT QRS complex Corrected QT interval (QTcF). The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography Time: Day -7-1 (Screening), Day 2Description: Results of serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH). The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry (enzymes) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of serum chemistry: total bilirubin, creatinine, urea, fasting glucose. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of serum chemistry: total protein, C-reactive protein. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of complete blood count: hemoglobin The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hemoglobin) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of complete blood count: hematocrit. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hematocrit) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of complete blood count: erythrocytes. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocytes) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of complete blood count: platelets, leukocytes and leukocyte formula (neutrophils, lymphocytes, monocytes, eosinophils, basophils (absolute number). The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of complete blood count: erythrocyte sedimentation rate The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocyte sedimentation rate) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of coagulogram: activated partial thromboplastin time, prothrombin time. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of coagulogram: fibrinogen. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram (fibrinogen) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of clinical urinalysis: relative density. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (relative density) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of clinical urinalysis: pH. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (pH) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of clinical urinalysis: leukocytes, erythrocytes, cylinders . The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of clinical urinalysis: protein . The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (protein) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of clinical urinalysis:glucose . The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (glucose) Time: Day -7-1 (Screening), Day 2, Day 28Description: Results of determination of immunoglobulin E serum concentrations.
Measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of determination of immunoglobulin E serum concentrations. Time: Day -7-1 (Screening), Day 28This study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China. These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). This will be a prospective, single-center observational study involving human subjects. IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH). IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection. To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing. Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time. Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study. Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing. For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test. Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive. All testing will be performed in a two-week window. All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment. We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care. The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum. One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020. The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.
Description: The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.
Measure: Physician Prevalence of COVID-19 serum IgG Time: up to 1 yearDescription: The prevalence of COVID-19 serum IgG in household members (as defined above) of physician participants that are positive at the time the associated physician tested positive.
Measure: Household Member Prevalence of COVID-19 serum IgG Time: up to 1 yearDescription: The differences in prevalence of COVID-19 IgG in physician participants that are deemed to be at minimum, moderate or high risk of COVID-19 exposure.
Measure: Physician Risk of Exposure Time: up to 1 yearDescription: The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.
Measure: Physician and Household Member Transmission Time: up to 1 yearDescription: The correlation between IgG prevalence and previous COVID-19 symptoms - a means of quantifying the presence of asymptomatic carriers amongst the medical staff, an important and heretofore poorly described vector of transmission.
Measure: Asymptomatic Infection Time: 1 yearDescription: The correlation between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.
Measure: PPE Use and Positivity Time: up to 1 yearDescription: The development of COVID19 infections in physicians at our hospital over the test period of 12 months, and its correlation to Covid19_IgG positivity. This will allow us to understand the persistence of the antibody and its potential neutralizing power, over time.
Measure: Antibody Persistence Time: up to 1 yearThe study is designed as an open observational non-comparative study of Polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (COVID-19).
Description: Subject clinical status using the 7-point Ordinal Scale, specified as the primary endpoint in the WHO Master Protocol on day 15 as compared to baseline (1 - Not hospitalized, no limitations on activities; 2 - Not hospitalized, limitation on activities; 3 - Hospitalized, not requiring supplemental oxygen; 4 - Hospitalized, requiring supplemental oxygen; 5 - Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 7 - Death).
Measure: Clinical Status of the Patient (According to 7-point Ordinal Scale) Time: Day 1 (Baseline), Day 15Description: Ordinal scale (OS) score status, time to improvement by 1 point for each OS score. Subject clinical status using the 7-point Ordinal Scale: - Not hospitalized, no limitations on activities; - Not hospitalized, limitation on activities; - Hospitalized, not requiring supplemental oxygen; - Hospitalized, requiring supplemental oxygen; - Hospitalized, on non-invasive ventilation or high flow oxygen devices; - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; - Death.
Measure: Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score Time: Days 1 - 29.Description: NEWS scale score status, time to a discharge from a hospital or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS score is based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, temperature. A score of 0, 1, 2, 3 is allocated to each parameter except supplemental oxygen (a score 0 or 1 is allocated) and level of consciousness (a score 0 or 3 is allocated). A higher score means the parameter is further from the normal range. All scores were summed to get an aggregate score. Aggregate score ranges from 0 to 19, with higher scores meaning higher risk. Low risk - aggregate score, 1-4 Low to medium risk - score 3 in any single parameter, Medium risk - aggregate score 5-6, High risk - aggregate score 7-19.
Measure: Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale)) Time: Days 1 - 29.Description: Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29
Measure: Number of Patients Requiring Supplementary Oxygen Time: Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.Description: Duration of hospitalisation
Measure: Hospitalisation Duration Time: Days 1 - 29Description: Number of participants who were dead or alive (Days 1 - 29)
Measure: Mortality Time: Days 1 - 29.Description: The number of participants with serious adverse events (SAE)
Measure: The Number of Participants With Serious Adverse Events Time: Days 1 - 29.Description: The number of participants with adverse events (AE)
Measure: The Number of Participants With Adverse Events Time: Days 1 - 29.Description: Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events
Measure: Number of Participants With Discontinuation of Drug Administration Time: Days 1 - 17.African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.
Description: From pre-intervention to three-month post-intervention, a 30% change is anticipated for chronic physical and mental disease management among African American older adults
Measure: Percentage of Participants Achieving Improvement of Health Conditions Using the Severity of Medical Chronic Conditions Surveys Time: 3 monthsDescription: From pre-intervention to three-month post-intervention, an 80% change is anticipated in knowledge, attitude, and behaviors of COVID-19 risk among African American older adults
Measure: Percentage of Participants Achieving Target Levels of Knowledge, Attitude, and Behaviors with NIH Toolbox Surveys Time: 3 monthsDescription: From pre-intervention to three-month post-intervention, a 40% change is anticipated for COVID-19 testing among the population of African American Older adults.
Measure: Prevalence of COVID-19 testing using Participant COVID-19 Test History Survey Time: 3 monthsDescription: From pre-intervention to three-month post-intervention, a 70% change is anticipated in uptake of pneumococcal and influenza vaccinations among the population of African American Older adults.
Measure: Prevalence of pneumococcal and influenza vaccinations using Participant Immunization History Survey Time: 3 monthsThis proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.
Description: By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in willingness and uptake for testing and vaccination.
Measure: Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report Time: Intervention: 3 months; Follow-up Point: 6 months post-interventionDescription: By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in perceived COVID-19 risk.
Measure: Percentage of Participants Achieving Decreased Levels of COVID-19 Risk Using the NIH Toolbox Surveys on COVID-19 Time: Intervention: 3 months; Follow-up Point: 6 months post-interventionDescription: By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19 testing and vaccination,
Measure: Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19 Time: Intervention: 3 months; Follow-up Point: 6 months post-interventionAs dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
Description: 2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody
Measure: COVID-19 probable or confirmed case Time: 18 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.
Measure: Anxiety Time: 12 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.
Measure: Depression Time: 12 monthsDescription: Self-reports of infection control efforts in the respondents' primary dental practices.
Measure: Dental practice infection control efforts Time: 12 monthsDescription: Availability, frequency of use, and frequency of reuse of personal protective equipment
Measure: Personal protective equipment Time: 12 monthsDescription: Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.
Measure: Employment status Time: 12 monthsAdministration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting
Description: Viral AUCs normalized to peak viral load and housekeeper genes will be calculated, the AUCs on subjects with complete data will be used as dependent measures in t-tests, regressions and repeated measures mixed ANOVAs to compare viral load reduction between groups
Measure: Reduction in SARS-CoV-2 Viral load Time: 1 yearDescription: Review of healthcare resource utilization during study period
Measure: Reduction in Severity of COVID-19 Disease Time: 1 yearIn this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.
Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'. Time: 7 monthsDescription: The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'. Time: 7 monthsDescription: The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'. Time: 7 monthsDescription: The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'. Time: 7 monthsDescription: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/1000 patient days, DDD or DDA of unnecessary AB/1000 patient days, DDD or DDA of inappropriate AB/1000 patient days and DDD or DDA of suboptimal AB/1000 patient days. Used units: g/1000 hospitalized patients days
Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection Time: 7 monthsDescription: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/hospitalization, DDD or DDA of unnecessary AB/hospitalization, DDD or DDA of inappropriate AB/hospitalization and DDD or DDA of suboptimal AB/hospitalization. Used units: g/hospitalization
Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2 Time: 7 monthsDescription: The number of C. Difficile infections in the inpatient setting
Measure: Rate of Clostridioides Difficile infections Time: 7 monthsDescription: median or mean age (number) , comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: median or mean weight (kg), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of comorbidities expressed as mean Charlson Comorbidity Index score, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of chronical pulmonary disease, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in rate of chronical pulmonary disease as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of haematological or solid neoplasia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in rate of haematological or solid neoplasia as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of diabetes mellitus, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in rate of diabetes mellitus as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients with fever (t°>38°c), dyspnea, cough, runny nose, throat pain, thoracic pain, myalgia, fatigue, anosmia, confusion at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: significant difference in rate of patients with presence or not of at least one suggestive symptom of COVID-19 symptomatology, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients rate of patients having received an antibiotic prescription for a suspicion of respiratory tract infection during the 3 weeks before hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics?
Measure: significant difference in rate of patients with recent AB prescription, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients with significant positive respiratory cultures, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the rate of patients having had at least one positive significant respiratory germ culture, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients with oxygen suppletion need, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the rate of patients needing oxygen supletion at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean duration of hospitalization on a COVID-ward, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: significant difference in the mean duration of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: significant difference in the rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean SatO2/FiO2 ratio (number ranging from 50-500), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the mean value of oxygen saturation percentage over fractional oxygen percentage, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean/median qSOFA score at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in qSOFA score level at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: Rate of lymphopenia (<1250/mcl), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the rate of lymphopenia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean CRP values (mg/dl) at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of C-reactive protein measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean WBC count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of white blood cell count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean neutrophil count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of neutrophil count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean lymphocyte count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics
Measure: significant difference in the mean value of lymphocyte count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean creatinine (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of creatinine measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean LDH (U/L) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of LDH measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean bilirubin (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of bilirubin measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean ferritin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of ferritin (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean troponin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of troponins (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean D-dimer (ng/ml) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of D-dimers (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsIn this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric "adult COVID-19" intensive care unit.
Description: Secondary infection will include healthcare associated infections as well as sepsis, and septic shock
Measure: Number of patient with secondary infection Time: 2 weeksDescription: mortality
Measure: Number of patients dying Time: 7-day, 28-day and 60-dayDescription: Description of the variable clinical phenotypes of COVID-19 in adults and children. This include COVID-19 respiratory failure, acute myocarditis and multi system inflammatory syndrome in children (MIS-C)
Measure: Description of clinical phenotypes Time: through study completion, an average of 4 weeksDescription: Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex
Measure: Description of immunological phenotypes Time: through study completion, an average of 4 weeksThe purpose of this study is to identify early signals of efficacy or harm associated with convalescent plasma therapy in a population of Veteran inpatients with coronavirus disease 2019 (COVID-19).
Description: Death at any time after admission recorded in the electronic health record. Specific estimates of risk of death will be produced for 7 days, 14 days, 21 days and 28 days, and total deaths.
Measure: All-cause mortality Time: up to 28 daysDescription: Number of days from index date to first intubation in non-mechanically ventilated patients
Measure: Time to first intubation Time: 28 daysDescription: Number of days from index date to hospital discharge
Measure: Time to hospital discharge Time: 28 daysDescription: Number of days from index date to death from any cause
Measure: Time to all-cause mortality Time: 28 daysDescription: Long-term outcomes will include death at one year following the index date.
Measure: All-cause mortality Time: 1 yearThis protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
Description: The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories.
Measure: Ordinal Outcome Scale - Day 7 Time: 7 daysDescription: Outcome reported as the percent of participants who expire for any reason by day 28 post treatment.
Measure: All-cause mortality through Day 28 Time: 28 daysDescription: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 14, and 28 of follow-up using the primary ordinal outcome. Outcome is reported as the percent of participants in each of 7 categories.
Measure: Ordinal Outcome Scale Time: 3 days, 5 days, 14 days, and 28 daysDescription: The National Early Warning Score (NEWS) is used to determine the degree of illness of a patient and prompt critical care intervention. The score takes into account respiratory rate, oxygen saturation, use of respiratory support, body temperature, blood pressure, and heart rate. These data are entered into a program to calculate a NEW score. Scores range from -3 to +3 with scores closer to zero representing a lower degree of illness. Scores will be collected at baseline and day 7 and the change in score at these 2 time points will be reported.
Measure: Change in National Early Warning Score (NEWS) Time: 7 daysDescription: Time to worsening is defined as the 3 least favorable categories on the primary ordinal scale. Outcome is reported as the percent of participants in each arm who are characterized as categories 5, 6, and 7 on the primary ordinal scale at 7, 14, and 28 days post treatment.
Measure: Time to Worsening Time: 7 days, 14 days, and 28 daysDescription: Outcome is reported as the percent of participants in each arm who are alive and discharged from the hospital to home or rehabilitation at days 7, 14, and 28 post treatment.
Measure: Discharge Status Time: 7 days, 14 days, and 28 daysDescription: Outcome is reported as the mean number of days alive and outside the hospital from study entry to Day 28 for participants in each arm.
Measure: Days Alive Outside the Hospital Time: 28 daysDescription: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 7, 14, and 28 post treatment limited to using the pulmonary elements of the primary ordinal outcome (e.g., requirement for invasive ventilation). Outcome is reported as the percent of participants in each arm who fall into each of the 7 categories of the primary ordinal outcome with regard to their pulmonary dysfunction only.
Measure: Pulmonary-only Components of the Primary Ordinal Outcome Time: 3 days, 5 days, 7 days, 14 days, and 28 daysDescription: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 7, 14, and 28 post treatment limited to using the thrombotic conditions (e.g., arterial thrombosis) in the primary ordinal outcome. Outcome is reported as the percent of participants in each arm who fall in each of the 7 categories of the primary ordinal outcome with regard to thrombotic conditions only.
Measure: Thrombotic Components of the Primary Ordinal Outcome Time: 3 days, 5 days, 7 days, 14 days, and 28 daysDescription: Time to recovery is defined as the 2 most favorable categories on the primary ordinal scale. Outcome is reported as the percent of participants in each arm who are characterized as categories 1 or 2 at 7, 14, and 28 days post treatment.
Measure: Time to recovery Time: 7 days, 14 days, and 28 daysDescription: Clinical organ dysfunction is defined by new onset of any one or more of the following. Outcome is reported as the percent of participants in each arm who meet any 1 of the following criteria by day 28 post treatment. A) Respiratory dysfunction B) Cardiac and vascular dysfunction C) Renal dysfunction D) Hepatic dysfunction E) Neurological dysfunction F) Haematological dysfunction G) Serious infection
Measure: Clinical Organ Dysfunction Time: 28 daysDescription: Outcome is reported as the percent of participants in each arm who experience a new grade 3 or 4 event, a serious adverse event (SAE), or death through day 7 (primary safety endpoint) post treatment.
Measure: Safety and Tolerability - Adverse Events Time: 7 daysDescription: Outcome is reported as the percent of participants in each arm for who had any grade of reaction during the infusion or within 2 hours afterwards, for whom the infusion is interrupted prior to completion, or for whom the infusion is stopped prior to completion.
Measure: Safety and Tolerability - Infusion Reactions, Interruptions, or Cessation Time: approximately 2 hoursDescription: Outcome is reported as the percent of participants in each arm who experience a serious adverse event (SAE) or death through day 28 post treatment.
Measure: Safety and Tolerability - Serious Adverse Events Time: 28 daysDescription: Outcome is reported as the percent of participants in each arm who experience an adverse event (AE) of any grade present (new or continuing) on days 1, 3, 7, and 28 post treatment.
Measure: Safety and Tolerability - Prevalence of Adverse Events Time: 1 day, 3 days, 7 days, and 28 daysDescription: Outcome reported as the change in anti-SARS-CoV-2 IgG antibody level in blood from baseline to 1, 3, 7, and 28 days post treatment. Outcome is reported in units of antibody titer.
Measure: Change in Neutralizing Antibody Level Time: 1 day, 3 days, 7 days, and 28 daysThis is a longitudinal study in which participants that have been confirmed by a National Health Service (NHS) swab test as COVID-19 positive will be asked to provide faecal and saliva samples, and complete short health/lifestyle questionnaires at the time of sampling (referred to as a sample set). The number of sample sets collected from any participant will be dependent on how long the SARS-CoV-2 virus persists within the stool. The investigators aim to collect a minimum of 4 and a maximum of 8 sample sets, and will target all COVID-19-positive subjects, with the exception of those severally ill (e.g. in the intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and up to 200 participants. To obtain the desired numbers, it may be necessary to continue recruitment during any further United Kingdom (UK) COVID-19 infection peaks.
Description: To verify the prevalence and persistence (starting from symptom onset/diagnosis, and up to seven weeks after recovery) of the SARS-CoV-2 virus in the faeces of people diagnosed with COVID-19 infection.
Measure: Prevalence and persistence of the SARS-CoV-2 virus in the faeces, and change in associated health status Time: Weekly for a maximum of 8 weeksDescription: To use whole-genome sequencing (WGS) to type COVID-19 at the strain level to verify whether different viral strains have a different persistence in stool across participants
Measure: Viral strain-specific prevalence, associated with change in health status Time: Weekly for a maximum of 8 weeksDescription: To use whole-genome sequencing (WGS) to type COVID-19 at the strain level to verify whether the viral strain(s) found in the gastrointestinal tract are identical to those found in the respiratory tract of participants
Measure: Biogeographical viral strain identification, associated with change in health status Time: Weekly for a maximum of 8 weeksDescription: To create a repository of material (faeces and saliva) and associated data that will be used to understand the association between gastrointestinal health and SARS-CoV-2 infection in future research.
Measure: Create a SARS-CoV-2 biological sample repository Time: Through study completion, up to two yearsThe purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.
The Paris Fire Brigade staff have been particularly exposed to COVID-19 due to rescue and care activities for victims at risk in Paris area (where the virus was actively circulating). In addition, when the pandemic began in France, they had to take care of patients before procedures to protect caregivers were implemented. The contamination of young military personnel, whose physical capacity was put into strain at work, raises the question of the consequences of COVID-19 on their physical fitness. At the time, the medium- and long-term evolution of this disease and its possible repercussions on physical fitness are unknown. Moreover, like any soldiers who have been confined, they may present at least a cardio-respiratory deconditioning (sometimes independent of the disease making it difficult to distinguish between a sequelae of the infection or rehabilitation). Based on previous coronavirus epidemics (Sars-Cov 1 and Mers-Cov), it appears that long-term sequelae are possible even in mild forms and can result in an alteration of exertion ability. In the current context and in the absence of national or international recommendations on the return to physical activity, the French Armed Forces Health Service has proposed a simple management plan aiming at: i) allowing mass screening for possible exercise intolerance and targeting at-risk personnel, ii) allowing individualized re-training and iii) guaranteeing that military personnel can carry out their mission without jeopardizing their health.
Description: Aerobic performance will be assessed through a test called VAMEVAL. VAMEVAL consists of running around a track marked out every 50 meters to the rhythm of a soundtrack that accelerates at a rate of 0.5 km/h in 2-minute increments until exhaustion or inability to maintain the pace of the race. The result of the test made on return to work will be compared to the last result on the same test performed before COVID-19 infection.
Measure: Magnitude of the decrease in aerobic performance on return to work Time: Up to 18 monthsPopular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells). Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted. Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women. Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Description: The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
Measure: The number of adverse events after intramuscular injection Time: 12 months after full vaccinationDescription: The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month and 6 months after the full vaccination And titer levels and their fold increase before immunity.
Measure: Immunogenic end point Time: Within 6 months after the last dose of vaccinationSince March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.). Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media. In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal. An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.
Description: Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.
Measure: Qualitative result of molecular tests for the SARS-CoV-2 virus. Time: At enrollment (day 1)This study aim is to assess the prevalence of SARS-COV-2 in unselected pregnant women on labour (or a predictable delivery during next 24 hours), their outcome and sociodemographic conditions.
Description: Determine the prevalence of SARS-CoV-2 in pregnant patients on labor (or a predictable delivery during next 24 hours) with PCR form oropharyngeal swab.
Measure: Prevalence of SARS-CoV-2 in pregnant patients on labor Time: Through study completion, an average of 4 monthsDescription: A questionaire was elaborated to quote all of the following symptoms and were checked at the moment of labour by the residents at charge. The questionaire include following symptoms : presence of fever, cough, dyspnea , headache, myalgia, rhinorrhea, odynophagia and anosmia.
Measure: Characterization of clinical features of patients who tested positive for COVID 19. Time: Through study completion, an average of 4 monthsDescription: Number of bedrooms and number of persons that sleep in that bedroom.
Measure: Characterization of living conditions of pregnant women with COVID 19 Time: Through study completion, an average of 4 monthsDescription: Number of days requiring hospitalization in the neonatal unit.
Measure: Neonatal hospitalization Time: Through study completion, an average of 4 monthsDescription: Evaluate the neonatal outcome classifying the newborn in adequate for the gestational age, large for gestational age or growth restriction for Parkin.
Measure: Neonatal weight Time: Through study completion, an average of 4 monthsDescription: Describe the perinatal outcomes of the newborn specifying the Apgar score at delivery.
Measure: Perinatal outcomes Time: Through study completion, an average of 4 monthsThis is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2 via nasopharynx swab and subsequent reverse transcription polymerase chain reaction (RT-PCR).
Description: The FLU- PRO© questionnaire was specifically designed and validated to evaluate in clinical trials the presence, severity and duration of symptoms associated with viral infections. It contains 32 items (eg, felt hot, sweating, headache), grouped into 6 domains, that provide a comprehensive evaluation of such symptoms, using 5-point scales (values ranging from 0 to 4) with higher scores indicating worse symptoms.
Measure: Severity and duration of disease as evidenced by COVID-19 symptoms using the FLU-PRO© questionnaire. Time: 42 daysIn recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Mandatory quarantines have also been applied on index cases and their contacts, as well as an active search for asymptomatic patients. Current strategies to reduce the spread of SARS-CoV-2 do not include measures that could prevent transmission prior to the onset of symptoms. Subjects infected with SARS-CoV-2 have been known to shed virus and be contagious for up to 5 days prior to developing symptoms ('pre-symptomatic transmission'). In fact, nearly 60% of all infected subjects can shed virus pre-symptomatically. Pre- or even asymptomatic shedding occurs across all age groups, contributing to the rapidly expanding pandemic. Post-exposure prophylaxis (PEP) using type 1 interferon (IFN) can potentially eliminate the spread of SARS-CoV-2. IFN could reduce the period of viral shedding by ~1 week. Since pre-symptomatic shedding of virus can start up to 5 days prior to symptom onset, our approach of a PEP intervention to all contacts recently exposed to a case could possibly entirely interrupt the spread of the virus, and with that, the pandemic. The current study focuses on prevention of the disease in addition to its treatment. Thus, the key distinction between these other trials and this study is that this study focuses on containing coronavirus (i.e. cause) in the community, rather than simply its treatment (i.e. consequence) in the individual. Viral spread could be eliminated through interventions effective at abolishing viral transmission. However, such post-exposure prophylaxis interventions, that is initiation of antiviral therapy in pre-infectious contacts to reduce or even eliminate such spread, must be safe since they are given to asymptomatic and possibly uninfected subjects. In none of the previous clinical trials of IFN therapy for SARS-CoV-2 have serious adverse events been recorded. Furthermore, the IFN chosen for this study (pegylated IFN 1b) has been extensively studied in clinical trials, and has been in clinical use for years for multiple sclerosis. Pegylated IFN formulations allow for weekly injections while maintaining serum levels and limiting dose-dependent side effects. Together these data support a sound safety profile for the planned intervention. The aim of this study is to ascertain whether IFN administered to index cases and household contacts of an index case, starting immediately following confirmed exposure (index case confirmed positive for SARS-CoV-2), will reduce duration of SARS-CoV-2 detectable by PCR in the index cases, and incidence of SARS-CoV-2 detectable by PCR in household contacts.
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease. Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.
Description: Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.
Measure: Days with fever Time: Day8Description: Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.
Measure: Days with cough Time: Day8Description: Reduction in the duration of asthenia of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.
Measure: Days with asthenia Time: Day8Description: Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 1; verified using the RT-PCR technique; quantified by the absolute number
Measure: SARS-COV-2 viral load - absolute number Time: Day1Description: Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 8; verified using the RT-PCR technique; quantified by the absolute number.
Measure: SARS-COV-2 viral load - absolute number Time: Day8Description: Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 1; verified using the RT-PCR technique; quantified by the percentage change between the two groups.
Measure: SARS-COV-2 viral load - percentage Time: Day 1Description: Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 8; verified using the RT-PCR technique; quantified by the percentage change between the two groups.
Measure: SARS-COV-2 viral load - percentage Time: Day 8Description: Compare the hospital admission rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 8 days; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Hospital admission rate - absolute number Time: Day8Description: Compare the hospital admission rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 8 days; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Hospital admission rate - percentage Time: Day8Description: Compare the levels of inflammatory mediators: (interleukin [IL] -6 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-6 Time: Day 3Description: Compare the levels of inflammatory mediators: (interleukin [IL] -6 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-6 Time: Day 8Description: Compare the levels of inflammatory mediators: IL-1-beta from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-1-beta Time: Day 3Description: Compare the levels of inflammatory mediators: IL-1-beta from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-1-beta Time: Day 8Description: Compare the levels of inflammatory mediators: IL-8 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-8 Time: Day 3Description: Compare the levels of inflammatory mediators: IL-8 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-8 Time: Day 8Description: Compare the levels of inflammatory mediators: tumor necrosis factor (TNF)-alfa from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum tumor necrosis factor (TNF)-alfa Time: Day 3Description: Compare the levels of inflammatory mediators: tumor necrosis factor (TNF)-alfa from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum tumor necrosis factor (TNF)-alfa Time: Day 8Description: Compare the levels of inflammatory mediators: interferon-gamma from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum interferon-gamma Time: Day 3Description: Compare the levels of inflammatory mediators: interferon-gamma from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum interferon-gamma Time: Day 8Description: Compare the levels of inflammatory mediators: monocyte chemoattractant protein (MCP)-1 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum monocyte chemoattractant protein (MCP)-1 Time: Day 3Description: Compare the levels of inflammatory mediators: monocyte chemoattractant protein (MCP)-1 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum monocyte chemoattractant protein (MCP)-1 Time: Day 8Description: Evaluate evolution of complete blood count with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Complete blood count Time: Day 3Description: Evaluate evolution of complete blood count with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Complete blood count Time: Day 8Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein - absolute number Time: Day 3Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein - absolute number Time: Day 8Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the percentage between the two group.
Measure: C-reactive protein - percentage Time: Day 3Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by laboratory tests and expressed by the percentage between the two groups.
Measure: C-reactive protein - percentage Time: Day 8Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Adverse events - percentage Time: Day 8Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Adverse events - absolute number Time: Day8Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Treatment discontinuation rate - absolute number Time: Day8Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Treatment discontinuation rate - percentage Time: Day8Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up. Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research) Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients. Material and methods: Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022 Expected results: Better knowledge of the cares of patients with CoViD-19
Description: status : dead or alive persistante respiratory distress (yes / no)
Measure: Health status in the 2 years after CoViD-19 diagnosis Time: 2 years follow upThis pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.
Description: Total number of grade 3 and above throughout study period
Measure: Cumulative incidence of serious adverse events related to the treatment intervention. Time: up to 60 days post-transfusionDescription: All cause mortality at day 28
Measure: Mortality at Day 28 post-hospital admission. Time: up to 28 days post-transfusionDescription: Total number of days subjects are hospitalized during study period
Measure: Length of hospital stay Time: up to 60 days post-transfusionDescription: Total number of days subjects requires supplemental oxygen during study period
Measure: Length of supplemental oxygen requirement. Time: up to 60 days post-transfusionDescription: Total number of days subjects require mechanical ventilation during study period
Measure: Length of mechanical ventilation requirement. Time: up to 60 days post-transfusionDescription: Total number of days subject is subject stays in the ICU
Measure: Length of ICU stay Time: up to 60 days post-transfusionThis study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.
Description: Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.
Measure: Diagnostic performance characteristics Time: through study completion, an average of 2 weeksThe purpose of this study is to assess the feasibility of establishing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing at a federally-qualified health center (FQHC) during a global health crisis to mitigate COVID-19 disparities in socioeconomically disadvantaged populations.
Description: FQHC staff will complete a comprehensive electronic survey adapted from the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) instrument to assess feasibility of community-engaged research partnership to support testing site (Weiner BJ, et al. Implementation Science. 2017;12(1):108.).
Measure: Intervention Feasibility Measures - FQHC Staff Time: 6-months after intervention startDescription: Comparison of number of tests completed per group (intervention vs. control)
Measure: 2. Uptake of rapid SARS-CoV-2 testing strategy at the FQHC- Effectiveness of community-driven messaging to patients Time: 6-months after intervention startDescription: Comparison of number of tests completed per group (intervention vs. control)
Measure: Uptake of rapid SARS-CoV-2 testing strategy at the FQHC Time: 9-months after intervention startDescription: All randomized patients will complete a comprehensive survey with questions probing satisfaction with the drive-through testing site (ease of use, process, return of results, etc.).
Measure: Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing Time: 6-months after intervention startDescription: Compare the satisfaction of community-driven messaging on availability of rapid SARS-CoV-2 testing at the FQHC (intervention vs. control)
Measure: 5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging Time: 6-months after intervention startThe purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.
Description: RNA will be extracted from all sample types and SARS-CoV-2 primers used to amplify any present viral RNA using real-time qPCR. Repeated measures analysis will be used to compare the changes in sample viral load over time between women with mild to severe symptoms.
Measure: mean change in SARS-Cov-2 viral load in breast milk Time: baseline, days 3, 10, 19, 28 and 90The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Description: dead or alive
Measure: Vital status Time: at day 28Description: dead or alive
Measure: day 90 mortality Time: at day 90Description: to assess the ventilator free days
Measure: number of ventilator-free days at day 28 Time: at day 28Description: to assess the number of renal replacement therapy free days
Measure: number of renal replacement therapy free days at day 28 Time: at day 28Description: to assess the number of vasopressors free-days
Measure: number of vasopressors free-days at day 28 Time: at day 28Description: to assess if ECMO was required
Measure: use of ECMO before day 28 Time: till day 28Description: to assess the value of SOFA score
Measure: value of the SOFA score at days 7, 14 and 28 Time: Day 1, 7, 14, 28Description: to assess the changes in SOFA scores (delta SOFA)
Measure: changes in SOFA scores (delta SOFA) over 7, 14 and 28 days Time: Day 7, 14 and 28 daysDescription: assessment of the SARS-CoV-2 viral load, expressed as cycle threshold, [2] in the tracheal aspirates (for intubated patients) or nasopharyngeal swabs (for extubated patients) at days 7, 14 and 28
Measure: assessment of the SARS-CoV-2 viral load Time: Days 7, 14 and 28Description: to assess the concentrations of C reactive protein (CRP)
Measure: blood C reactive protein (CRP) concentration Time: Days 7, 14 and 28Description: to assess the concentration of ferritin
Measure: ferritin concentration Time: Days 7, 14 and 28Description: to assess the count of lymphocyte
Measure: lymphocyte count Time: Days 7, 14 and 28Description: to assess the lenght of stay in the acute care
Measure: length of stay in the acute care hospital Time: through study completion, 1 yearDescription: to assess the location of the patient : acute care hospital, post acute care hospital, long-term residency, home
Measure: location of the patient Time: Day 90Description: to assess the Activity Day Living functional Min value: 0 = Low (patient very dependent) Max value: 6 = High (patient independent)
Measure: Katz Index of independence in Activity Day Living functional score Time: Day 90 and 365Description: to evaluate the anxiety-depression For each item 0-7 : Normal 8-10 : Bordeline abnormal (borderline case) 11-21 : Abnormal case
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 90 and 365Description: The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.
Measure: Quality of life scale EQ-5D-5L Time: Day 90 and 365Description: to assess the transfusion related adverse events
Measure: Transfusion related adverse events Time: till 28 daysIn COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS. Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials
Description: Clinical improvement of COVID-19 patients by methylprednisolone.
Measure: Clinical response after administration Time: 10 daysDescription: Overall survival of COVID-19 patients after drug administration.
Measure: Clinical response to treatment Time: 28 daysDescription: Number of days of hospital admission either in ICU or HDUs till date of discharge
Measure: Duration of hospitalization Time: 28 daysThe most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.
Description: Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.
Measure: Clinical response after administration Time: 10 daysDescription: Overall survival of COVID-19 patients after drug administration.
Measure: Clinical response to treatment Time: 15 daysDescription: Number of days of hospital admission either in ICU or HDUs till date of discharge
Measure: Duration of hospitalization Time: 15 daysDescription: Mortality rate
Measure: Clinical outcome of the treatment Time: 15 daysDescription: Duration of increased supplemental oxygen requirement from baseline
Measure: Supplemental Oxygen Requirement from Baseline Time: 15 daysRemdesivir is a monophosphoramidate prodrug of an adenosine analogue and it has a broad-spectrum antiviral activity against paramyxoviruses, falviviruses and coronaviruses. It showed in vitro activity on human airway epithelial cells against SARS-CoV-2. It is an investigational drug and granted an Emergency Use Authorization by Food and Drug Administration FDA, so it is under clinical trial. The potent mechanism of action of this drug is still unclear but it effects through several processes. It can interfere with nsp12 polymerase even when exoribonuclease proofreading is intact. It can also produce nucleoside triphosphate NTP that acts pharmacologically active alternate substrate of RNA-chain terminator, as a result NTP can constrain active triphosphates into viral RNA of coronaviruses. There is evidence of high genetic barrier to develop resistance against Remdesivir in coronavirus as a result of which is maintains its effectiveness in antiviral therapies against these viruses. Effectiveness of Remdesivir has been reported against different groups of coronaviruses including Alphacoronavirus NL63 and several SARS/MERS-CoV coronaviruses.
Description: Clinical improvement of COVID-19 patients by Remdesivir.
Measure: Clinical response after administration Time: 10 daysDescription: Overall survival of COVID-19 patients after drug administration.
Measure: Clinical response to treatment Time: 15 daysDescription: Number of days of hospital admission either in ICU or HDUs till date of discharge
Measure: Duration of hospitalization Time: 15 daysDescription: Duration of increased supplemental oxygen requirement from baseline
Measure: Supplemental Oxygen Requirement from Baseline Time: 15 daysMany non-invasive ventilatory choices are available for COVID-19 patient who are having mild to moderate respiratory distress and their use will decrease the chance of ICU admission, intubation and mechanical ventilation in severe cases of COVID-19. However, all these respiratory supports and oxygen supply devices are aerosol generating and their selection should be precised enough to control nosocomial spread. High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen. In acute respiratory failure HFNC is proven to be very effective and it also reduced the need of mechanical ventilation in severe patients. Apart from the supply of oxygen, HFNC generating positive airway pressure and decreasing the rebreathing from anatomical dead space. Prone position is also a save therapy and has been proven to be effective for refractory hypoxia by increasing tidal volume, oxygenation and diaphragmatic functions in ARDS patients. Recent studies showed that prone positioning and HFNC might avoid the prerequisite of intubation in moderate to severe patients of ARDS and as a result it decreases the nosocomial infection in physicians who are doing these aerosol generating procedures.
Description: The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)
Measure: Clinical response of HFNC Time: 10 daysDescription: Length of HFNC therapy to COVID-19 patients
Measure: Duration of intervention Time: 15 daysDescription: Number of days of hospital admission either in ICU or HDUs till date of discharge
Measure: Duration of hospitalization Time: 15 daysDescription: Duration of increased supplemental oxygen requirement from baseline
Measure: Supplemental Oxygen Requirement from Baseline Time: 15 daysDescription: Follow up radiological response HR-CT.
Measure: Radiological outcome Time: 15 daysThis is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.
Description: Number of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology.
Measure: Number of SARS-CoV-2 infections Time: 6 monthsDescription: Duration of symptoms for each symptomatic infection
Measure: Duration of symptoms Time: 6 monthsDescription: Maximum score on WHO Ordinal Scale for Clinical Improvement for each symptomatic infection. Score of 0 being uninfected and a score of 8 being dead.
Measure: Maximum score on WHO Ordinal Scale Time: 6 monthsDescription: Time to onset of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology
Measure: Time to onset of SARS-CoV-2 infection Time: 6 monthsDescription: Number of symptomatic SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology
Measure: Number of symptomatic SARS-CoV-2 infections Time: 6 monthsDescription: Number of asymptomatic • Asymptomatic SARS-CoV-2 infection suggested by serological outcome
Measure: Number of asymptomatic SARS-CoV-2 infections Time: 6 monthsDescription: Peak score on modified Flu-PRO during each symptomatic infection. 37-item questionairre assessing the severity of flu like symptoms one a scale of 0 - not at all to 5 - very much.
Measure: Peak score on modified Flu PRO Time: 6 monthsMulticenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
Description: Compare the intubation rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by percentage.
Measure: Orotracheal intubation rate Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed free of mechanical ventilation, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Mechanical ventilation free days Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the hospital, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Hospitalisation days Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the ICU, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: ICU days Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed with the support of oxygen nasal cannula, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Intranasal oxygen support days Time: 14 daysDescription: Compare the mortality rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Mortality rate Time: 14 daysDescription: Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
Measure: Days with fever Time: 14 daysDescription: Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
Measure: Days with cough Time: 14 daysDescription: Reduction in the duration of dyspnea of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
Measure: Days with dyspnea Time: 14 daysDescription: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.
Measure: Radiologic findings Time: Day1Description: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.
Measure: Radiologic findings Time: Day7Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.
Measure: Cardiologic findings Time: Day1Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.
Measure: Cardiologic findings Time: Day7Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein - absolute number Time: Day 1Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein serum levels Time: Day 3Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein serum levels Time: Day 7Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Lactate dehydrogenase (LDH) serum levels Time: Day 1Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Lactate dehydrogenase (LDH) serum levels Time: Day 3Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Lactate dehydrogenase (LDH) serum levels Time: Day 7Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Troponin serum levels Time: Day 1Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Troponin serum levels Time: Day 3Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Troponin serum levels Time: Day 7Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Electrolytes serum levels Time: Day 1Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Electrolytes serum levels Time: Day 3Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Electrolytes serum levels Time: Day 7Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Glucose serum levels Time: Day 1Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Glucose serum levels Time: Day 3Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Glucose serum levels Time: Day 7Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Renal function Time: Day 1Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Renal function Time: Day 3Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Renal function Time: Day 7Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Coagulogram Time: Day 1Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Coagulogram Time: Day 3Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Coagulogram Time: Day 7Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Liver function panel Time: Day 1Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Liver function panel Time: Day 3Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Liver function panel Time: Day 7Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Ferritin Time: Day 1Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Ferritin Time: Day 3Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Ferritin Time: Day 7Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: D-dimer Time: Day 1Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: D-dimer Time: Day 3Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: D-dimer Time: Day 7Description: To evaluate blood cell count of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, for 7 days; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Blood cell count Time: 7 daysDescription: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Inflammatory mediators Time: Day 1Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Inflammatory mediators Time: Day 3Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Inflammatory mediators Time: Day 7Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Adverse events - percentage Time: Day 14Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Adverse events - absolute number Time: Day 14Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Treatment discontinuation rate - absolute number Time: Day 14Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Treatment discontinuation rate - percentage Time: Day 14This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 48 hours prior to testing.
Description: Rate of decline in viral load over the 10 days after randomization between participants treated with RBV and NTZ for COVID-19 and placebo
Measure: Rate of decline in viral load Time: 10 daysDescription: Time to resolution of viral load, defined by reduction of virus below LLOQ and maintaining it for 2 days.
Measure: Time to resolution of viral load Time: 28 daysDescription: Comparison of proportion of subjects who are asymptomatic and symptomatic at day 10
Measure: Comparison of proportion of subjects who are asymptomatic and symptomatic Time: 10 daysDescription: To assess the rate of decline in viral load over days 3 and 6 after randomization
Measure: Rate of decline in viral load Time: Days 3 and 6Description: Assess change in modified National Early Warning System-2 items on a scale of 0 to 20. HIgher scores meaning greater clinical risk.
Measure: Change in modified NEWS-2 Time: 28 daysDescription: Proportion of subjects with treatment emergent adverse events leading to study drug discontinuation
Measure: Proportion of subjects with treatment emergent adverse events Time: 28 daysPassive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms
Description: Clinical Improvement of COVID-19 patients by giving them passive immunization
Measure: clinical outcome after plasma therapy Time: 10 daysDescription: Overall survival of COVID-19 patients after plasma administration.
Measure: Clinical response to treatment Time: 10 daysA new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020. The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on. Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic. Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm. Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2. The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia. They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases. Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization. Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.
As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that we determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. We have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), we will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; we will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.
Description: Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR.
Measure: The 12-month cumulative incidence of acquired COVID infection in the study cohort. Time: Weekly for 12 monthsThe primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants. The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.
Description: Clinically significant in the judgement of the investigator.
Measure: Number of Participants With Clinically Significant Findings in Physical Examinations Time: up to 21 daysDescription: Clinically significant in the judgement of the investigator.
Measure: Number of Participants With Clinically Significant Changes From Baseline in ECG Data Time: up to 21 daysDescription: Clinically significant in the judgement of the investigator.
Measure: Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters Time: up to 21 daysEstablish a COVID-19 biorepository to aid in developing our knowledge of the disease.
Description: Establish a collection of biospecimens from patients with COVID-19.
Measure: Biospecimen Collection Time: From Enrollment to 3 MonthsDescription: Establish a link between biospecimens and longitudinal individual patient data
Measure: Establishing Connections Time: From Enrollment to 3 MonthsDescription: Provide biospecimens and unique patient data to researchers investigating COVID-19
Measure: Continuing COVID Research Time: From Enrollment to 3 MonthsThere is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.
Description: Mortality in each study group represented in frequency and time-to-event at day 28 after randomization
Measure: Mortality Time: one monthThe primary objectives of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike serum neutralizing antibody, as measured by plaque reduction neutralization test (PRNT), compared to placebo.
Description: An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs (redness, swelling, and tenderness/pain) will be assessed.
Measure: Percentage of Participants with at Least 1 Solicited Injection Site Adverse Event Time: Up to 5 days post-vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs (muscle pain, joint pain, headache, tiredness, fatigue, rash, nausea, joint swelling, oral lesions, and sweating more than usual) will be assessed.
Measure: Percentage of Participants with at Least 1 Solicited Systemic Adverse Event Time: Up to 28 days post-vaccinationDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be assessed.
Measure: Percentage of Participants with at Least 1 Unsolicited Adverse Event Time: Up to 28 days post-vaccinationDescription: A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. Any MAAE will be assessed.
Measure: Percentage of Participants with at Least 1 Medically Attended Adverse Event Time: Up to 180 days post-vaccinationDescription: A serious adverse event is "life threatening," requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and is a congenital anomaly/birth defect. Any SAE will be assessed.
Measure: Percentage of Participants with at Least 1 Serious Adverse Event Time: Up to 365 days post-vaccinationDescription: Serum samples will be collected and the presence of serum neutralization antibodies (SNAs) will be assessed using plaque reduction neutralization test (PRNT).
Measure: Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test (Panels A - H) Time: Day 28 post-vaccinationDescription: Serum samples will be collected and the presence of SNAs will be assessed using PRNT.
Measure: Geometric Mean Titers for SNAs as Measured by PRNT (Panels A-H) Time: Days 7, 14, 90, 180, 270, and 365 post-vaccinationDescription: Serum samples will be collected and the total anti-spike IgG antibodies will be assessed using enzyme-linked immunosorbent assay (ELISA).
Measure: Geometric Mean Concentration of Total Anti-SARS-CoV-2 Spike SNAs as Measured by Enzyme-Linked Immunosorbent Assay (Panels A-H) Time: Days 7, 14, 28, 90, 180, 270, and 365 post-vaccinationDescription: The percentage of participants with viremia detected by reverse transcription polymerase chain reaction (RT-PCR) of blood specimens will be assessed.
Measure: Percentage of Participants with Vaccine Viremia as Measured by Reverse Transcription-Polymerase Chain Reaction Time: Days 1, 2, 3, 4, 5, 6, 7, 14 and 28 post-vaccinationDescription: The percentage of participants with viral shedding detected by RT-PCR in urine or saliva specimens will be assessed.
Measure: Percentage of Participants with Vaccine Shedding in Saliva or Urine as Measured by RT-PCR Time: Days 1, 2, 3, 4, 5, 6, 7, 14, and 28 post-vaccinationDescription: The percentage of participants with vaccine shedding in stool as measured by RT-PCR will be assessed. Total of 2 stool samples collected if produced: one sample on Days 2 to 4; one sample on Days 5 to 7.
Measure: Percentage of Participants with Vaccine Shedding in Stool as Measured by RT-PCR Time: Days 2-4, 5-7 post-vaccinationTo assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.
Description: Need for mechanical ventilation within 15 days after randomization
Measure: Mechanical ventilation Time: During 15 daysDescription: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Clinical status of subject at day 15 and day 29 (on a 7-point ordinal scale): Time: At day 15 and day 29Description: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] will be measured at day 0 (day before first dose), day 1-9, and day 15
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: At day 0 (day before first dose), day 1-9, and day 15Description: Need for oxygen supply (l/min) to reach peripheral oxygen saturation of 98%
Measure: Oxygen supply Time: At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15Description: Clinical parameter (4 times daily): temperature (°C degree)
Measure: Clinical parameter: temperature Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15Description: Clinical parameter (4 times daily): blood pressure (mmHg)
Measure: Clinical parameter: blood pressure Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15Description: Clinical parameter (4 times daily): hear beat (beats per minute)
Measure: Clinical parameter: heart beat Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15Description: Clinical parameter (4 times daily): respiratory rate (breaths per minute)
Measure: Clinical parameter: respiratory rate Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15Description: Presence of Severe acute respiratory syndrome coronavirus 2 nucleic acid by PCR test in swabs or tracheal aspirates/bronchoalveolar lavage
Measure: Severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (PCR) Time: Max. 48 hours before day 0 and at day 8-9Description: C-reactive protein test measures the amount of C-reactive protein in blood (mg/L)
Measure: Laboratory: C-reactive protein test Time: At day 0, day 1-7, day 8-9 and day 15Description: Ferritin test measures the amount of ferritin in the blood (ng/ml)
Measure: Laboratory: ferritin Time: At day 0, day 1-7, day 8-9 and day 15Description: Interleukin-6 test (IL-6) measures the amount of IL-6 in the blood (pg/ml)
Measure: Laboratory: Interleukin-6 Time: At day 0, day 1-7, day 8-9 and day 15Description: Procalcitonin (PCT) test measures the amount of PCT in the blood in (μg/l)
Measure: Laboratory: procalcitonin Time: At day 0, day 1-7, day 8-9 and day 15Description: Occurrence of secondary bacterial pneumonia
Measure: Bacterial pneumonia Time: At day 0, day 1-7, day 8-9 and day 15Description: Days on vaso-active drugs in a 29-day period
Measure: Vaso-active drugs Time: At day 29Description: All-cause mortality
Measure: Mortality Time: At day 29Description: GM-CSF levels in serum
Measure: GM-CSF Time: At day 0 and day 1-7Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours
Description: Reduction in days from first low-risk score to discharge
Measure: Reduction in days from first low-risk score to discharge Time: 96 HoursDescription: Reduction in LOS for green patients that have not been in the ICU
Measure: Reduction in length of stay (LOS) Time: 96 hoursDescription: Reduction in GTD vs. LOS for all green patients discharged alive vs all patients discharged alive
Measure: Reduction in GTD vs. LOS Time: 96 hoursDescription: No change in 30 day re-ED presentation or hospital admission rate for cohort
Measure: No change in 30 day re-ED presentation or hospital admission rate for cohort Time: 96 hoursRehabilitation interventions can help address the consequences of COVID-19. These include medical, physical, cognitive and psychological related problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital. The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in recovering COVID-19 patients. A further aim will be to examine how Chinese herbal medicines, gut microbiome and its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.
Description: To assess the functional exercise capacity that reflects daily physical activities and to measure the distance the participant is able to walk over six minutes on a hard, flat surface. Items measured during 6MWT are: Distance Walked (m) Number of Rests
Measure: Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test Time: 6 monthsDescription: Blood pressure (Systolic/Diastolic) in mmHg will be measured before & after 6MWT
Measure: Blood Pressure Time: 6 monthsDescription: Heart rate in beats per minute will be measured before & after 6MWT
Measure: Heart Rate Time: 6 monthsDescription: SpO2 in % will be measured before & after 6MWT
Measure: Peripheral oxygen saturation (SpO2) Time: 6 monthsDescription: The Borg Category Ratio 10 (CR10) Scale® (Borg Dyspnea Scale), will be used to rate the patients' dyspnea and overall fatigue level. At the beginning and end the end of the 6 MWT. The scale will also be used during Cardiopulmonary Exercise Test (CPET). Scale: 0=Rest; 0.5=Really Really Easy; 1=Really Easy; 2=Easy; 3=Moderate; 4=Sort of Hard; 5,6=Hard; 7,8,9=Really Hard; 10=Maximal
Measure: Borg Dyspnea Scale Time: 6 monthsDescription: Bio-impedance analysis approach will be used to assess patient's segmental muscle mass in percentage (%).
Measure: Body composition - Segmental Muscle Mass Time: 6 monthsDescription: A stadiometer will be used to measure stature (in metres) and weight is measured in kg to calculate body mass index (BMI) . Body Mass Index (BMI): weight (in kilograms) divided by the square of your height (in metres)
Measure: Body composition - Body Mass Index (BMI) Time: 6 monthsDescription: Anatomical circumferences - waist (cm) & Hip (cm) will be measured using a steel measuring tape, to calculate the Waist-to-Hip Ratio.
Measure: Body composition - Anatomical Circumferences Time: 6 monthsDescription: Forced vital capacity test (FVC) will be measured and used to calculate FEV1/FVC ratio to assess the functional severity and capacity of the patient's lung.
Measure: FVC (L) in Lung function Test using Spirometry Time: 6 monthsDescription: Forced expiratory volume (FEV1) will be measured and used to calculate FEV1 /FVC ratio to assess the functional severity and capacity of the patient's lung.
Measure: FEV1 (L) in Lung function Test using Spirometry Time: 6 monthsDescription: Maximal Voluntary Ventilation (MVV) measures peak performance of the lungs and respiratory muscles to assess overall pulmonary ventilation.
Measure: MVV (L/min) in Lung function Test using Spirometry Time: 6 monthsDescription: Fractional exhaled Nitric Oxide (FeNO), the results will be in parts per billion (ppb) of nitric oxide in patient's breath, will be used to assess inflammatory response to exercise and medicinal intervention.
Measure: Fractional exhaled Nitric Oxide (FeNO) Time: 6 monthsDescription: Diffusing capacity of the lungs for carbon monoxide (DLCO), measured in millilitre/minute/Kilopascal (ml/min/kPa), will be used to evaluate gas diffusion in the lungs.
Measure: Diffusing capacity of the lungs for carbon monoxide (DLCO) Time: 6 monthsDescription: CPET provides information concerning the level of exercise that the patient can perform without undue stress. The test results will guide the research team regarding exercise prescription for physical rehabilitation methodologies, and provides quantitative evidence of the benefits of a rehabilitation program as well as information on the mechanism(s) involved. Work Rate(WR), an incremental ergometry exercise test, will be used to assess the cellular, cardiovascular, and ventilatory systems' responses under precise conditions of metabolic stress
Measure: Cardiopulmonary Exercise Test (CPET) - Work Rate(WR) Time: 6 monthsDescription: Breath by breath measurements of minute ventilation (VE) in L/min will be measured and used to calculate ventilatory efficiency - VE/VCO2 and VE/VO2, ventilatory equivalents for carbon dioxide and oxygen.
Measure: Cardiopulmonary Exercise Test (CPET) - Breath by Breath Measurements of Minute ventilation (VE) Time: 6 monthsDescription: CO2 output (VCO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VCO2, ventilatory equivalents for carbon dioxide.
Measure: Cardiopulmonary Exercise Test (CPET) - CO2 output (VCO2) Time: 6 monthsDescription: O2 uptake (VO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VO2, ventilatory equivalents for oxygen.
Measure: Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2) Time: 6 monthsDescription: The changes in participants' health as characterized by CM diagnostic pattern & clinical characteristics using CM Syndrome Differentiation according to the Guidelines for Chinese Medicine New Drug Clinical Study (China Medical Science Press, 2002) will be assessed.
Measure: Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment Time: Change from baseline the CM Diagnostic Pattern & Clinical Characteristics at 6 monthsDescription: The changes in participants' health as characterized by body constitution scores using the Body Constitution Questionnaires for the nine specific types of body constitutions will be assessed on each visit during the treatment and follow up period.
Measure: Change in Body Constitution Scores using Body Constitution Questionnaires Assessment Time: Change from baseline the Body Constitution at 6 monthsDescription: Venous blood will be drawn & after coagulation at room temperature for 30 minutes, the samples will be centrifuged at 3000 rpm for 20 minutes. Serum as supernatant will be extracted & stored at -80˚C until assay. Serum levels of insulin will be assessed by a commercially available Enzyme-linked immunosorbent Assay (ELISA) kit (Merck).
Measure: Blood Biochemistry Tests - Serum Levels of Insulin (pmol/l) Time: 6 monthsDescription: The Prothrombin time test will be used to measure blood coagulation. Venous blood will be collected by venepuncture in a tube with sodium citrate. Plasma will be isolated after centrifugation at 1000rpm for 30 min, 4°C. Thromboplastin will be added into the plasma and kept at 37°C for two minutes. Calcium chloride will be added to the mixture, and the plasma is allowed to coagulate. The time needed for the coagulation will be recorded as the Prothrombin Time.
Measure: Blood Biochemistry Tests - Prothrombin Time (seconds) Time: 6 monthsDescription: Quality of life (QoL) will be measured using the Personal Well-being Index-Chinese Version (PWI-C). It is a subjective QoL measure with questionnaires that have been translated and validated. Questions included are: How satisfied are you with…?" your standard of living ? your health ? what you are achieving in life ? your personal relationships ? how safe you feel ? feeling part of your community ? your future security ? Answers are measured using scale from zero to 10 (0...1…2...3...4…5...6...7...8...9…10). Zero means feel no satisfaction at all; 10 means feel completely satisfied.
Measure: Quality of Life - Personal Wellbeing Index - Chinese Version (Adult) Time: 6 monthsDescription: Anxiety and stress will be measured using the Chinese version of the Depression Anxiety Stress Scale (DASS-21). The scale will discriminate between the negative emotional syndromes of depression, anxiety, and stress in Chinese populations. Only the subscales of anxiety and stress will be used. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive & impatient. The rating scale is as follows: 0=Did not apply to me at all Applied to me to some degree, or some of the time Applied to me to a considerable degree or a good part of time Applied to me very much or most of the time Scores are calculated by summing the scores for the relevant items. Higher scores indicate greater degrees of anxiety and stress.
Measure: Other mental health-related measures - Depression Anxiety Stress Scale (DASS-21) Time: 6 monthsDescription: Loneliness will be measured using the Revised UCLA Loneliness Scale (R-UCLA). It consists of 20 items and participants are to indicate how often they feel the way described by placing a check in the space provided, using the following scale: Never Rarely Sometimes Often Score scale for item 1,5,6,9,10,15,16,19,20 are reversed, and score for each item then summed together. Higher scores indicate greater degrees of loneliness.
Measure: Other mental health-related measures - Revised UCLA Loneliness Scale (R-UCLA) Time: 6 monthsDescription: General mental health will be measured using the General Health Questionnaire (GHQ), which is commonly used to screen minor psychiatric symptoms (Hu 2007). It consists of 12 items, beginning by asking "Have you recently…", each assessing the severity of a mental problem over the past few weeks using a 4-point scale of: (always) 0...1…2…3 (never). The score was used to generate a total score ranging from 0 to 36, with higher scores indicating worse conditions.
Measure: Other mental health-related measures - General Health Questionnaire (GHQ) Time: 6 monthsDescription: Patient is to self-sample morning first feces & immediately freeze it in a home freezer (-20℃) & transport to facilities in a provided freezer pack stored at -80℃. Total DNA of 200 mg fecal samples will be extracted & purified. The DNA concentration & size distribution will be estimated by a Nano drop instrument & agarose gel electrophoresis respectively. The DNA one paired-end (PE) library will be prepared using a DNA high-throughput (HT) Sample Prep Kit, & whole-genome shotgun sequencing of samples will be carried out by the Illumina platform. The high quality sequences will be mapped with the published gene catalog of reference genes in the human gut microbiome (Li 2014). Taxonomic assignment of the predicted genes and Kyoto Encyclopedia of Genes & Genomes (KEGG) analysis will be performed as described (Feng 2015). Relative abundances of phyla, genera, species, & Kegg Orthology (KOs) will be calculated from the relative abundances of the respective genes.
Measure: Gut microbiome Test Time: 6 monthsDescription: Metabolomics analysis of selected neurotransmitters as potential markers of depression: Ultra-performance liquid chromatography triple quadrupole mass spectrometry will be used to quantitatively measure the metabolites selected (neurotransmitters) as potential markers of depression. Briefly, an aliquot of 40 μl of urine or plasma will be spiked with 10 μL of internal standard (L-4-chlorophenylalanine in water, 30 μg/mL), and extracted with 200 μL of acetonitrile and methanol (9:1, v/v). The mixture will be vortexed and centrifuged. After centrifugation, the supernatant will be transferred to the sampling vials and subject to analysis. The raw data generated will be processed using the Target Lynx Applications Manager Version 4.1 (Waters Corp., Milford, MA) for targeted metabolite annotation and to obtain calibration equations and the concentration of each metabolite in the samples Metabolomics analysis
Measure: Metabolomics-related Measurement of Depression - Metabolomics Analysis Time: 6 monthsThis pilot study will assess the safety and effectiveness of UV light treatment in hospitalized patients with COVID-19.
Description: Change of viral load in upper airway in patients admitted to hospital for COVID-19
Measure: Change in viral load Time: 5 daysDescription: Change of bacterial load in upper airway
Measure: Change in bacterial load Time: 5 daysDescription: Percentage of patients developing ventilated pneumonia (VAP)
Measure: Ventilated associated pneumonia Time: 1 monthDescription: Number of days patient is intubated
Measure: Days to extubation Time: 1 monthDescription: Number of days patient is discharged
Measure: Days to discharge Time: 1 monthDescription: Change in C-reactive protein
Measure: Change in C-reactive protein Time: 5 daysDescription: Change in 7-point clinical outcome: 7- Death, 6-Hospitalized on ventilatory or ECMO, 5-Hospitalized on non-invasive ventilation, 4-Hospitalized on supplemental O2, 3-Hospitalized not on O2, 2-Not hospitalized but with limitations, 1-Not hospitalized and no limitations
Measure: 7-point clinical outcome Time: 1 monthDescription: Assessment of total bacterial load on the UV catheter tip on the last day of treatment
Measure: Catheter tip assessment Time: 5 daysBackground: People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 in different ways. In this study, researchers will use survey data to describe the different ways people experience and recover from COVID-19. They will also use the data to help create future studies to understand why some people do not fully recover. Objective: To learn more about the range and timing of symptoms that people have before, during, and after COVID-19 infection. Eligibility: People ages 18 and older who have recovered from COVID-19 in the last 6 months and can give documentation of a positive COVID-19 or antibody test. Design: Participants will be screened with a telephone interview. It will take 15 minutes. They will provide their COVID-19 test results and medical records. Participants will complete a second telephone interview. It will take 30-60 minutes. They will also take online surveys every 3 months for 3 years. The interview and surveys will ask participants about their health before they got COVID-19, what happened while they had COVID-19, and what their recovery has been like. Participants will get log-in data to take the online surveys. Completing all of the surveys the first time may take up to 3 hours. Follow-up surveys will take up to 30 minutes. Participants do not have to complete the surveys in one sitting. They will be able to save their progress and finish the surveys later. Participants may be contacted to take part in other research studies.
Description: The number and severity of persistent symptoms associated with COVID-19 convalescence. Collected data will be used to characterize different narratives of COVID-19 convalescence.
Measure: Screening Phase Time: End of StudyThe analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations. The purpose of this study is to evaluate the T cells reactivity to SARS COV 2 immunogenic selected peptides by Metabolic Activity Method in convalesce and healthy individuals and to compare it with Antibody response (ELISA) and clinical information
Description: T cells reactivity to SARS COV 2 immunogenic
Measure: Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR) Time: weekDescription: Antibody response (ELISA)
Measure: Prevalence of positive for SARS - COV2 - in healthy donors. Time: weekThe co-primary objectives of this study are to: 1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection 2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals
Description: Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test.
Measure: Prevalence of COVID-19 Time: 2 yearsDescription: Determine the average time point at which PCR conversion occurs following exposure.
Measure: PCR Conversion in Exposed Individuals Time: 14 daysThis study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.
Description: Sustained recovery is defined as: the participant is alive and not hospitalized; or the participant is alive and medically ready for discharge as determined by the investigator.
Measure: Time-to-sustained recovery Time: Up to 29 daysDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of participants with an adverse event (AE) Time: Up to 7 monthsDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of participants who discontinued study intervention due to an AE Time: Up to 6 daysDescription: All-cause mortality is death due to any cause
Measure: Percentage of participants with all-cause mortality Time: Up to 29 daysDescription: Pulmonary score is a score on an ordinal scale which focuses on respiratory sequalae based on oxygen requirements using 7 mutually exclusive categories. The score ranges from 1 to 7 with a higher score indicating more severe respiratory sequalae.
Measure: Pulmonary score on a scale Time: Up to 29 daysDescription: Pulmonary+ score is a score on an ordinal scale which is a 7-category assessment that captures the range of disease severity, including coagulation-related complications and respiratory dysfunction. The score ranges from 1 to 7 with a higher score indicating more severe sequalae.
Measure: Pulmonary+ score on a scale Time: Up to 29 daysDescription: The National Early Warning Score assesses a participant's degree of illness as assessed by clinical risk prediction categories for poor clinical outcomes including mortality within 24 hours of a set of vital sign measurements. There are 7 physiological parameters, of which 6 are assigned a point value ranging from 0 to 3, and 1 is assigned a point value ranging from 0 to 2. The total aggregate score may range from 0 to 20 with an increasing aggregate score indicating increasing clinical risk.
Measure: National Early Warning Score on a scale Time: End of Treatment (EOT) (Up to 6 days)Description: The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 to 10 with higher score indicating clinical progression.
Measure: WHO 11-point outcomes score on a scale Time: Up to 29 daysThis study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29
Description: Hospitalization (all cause) is ≥24 hours of acute care in a hospital or similar acute care facility. Death is due to any cause.
Measure: Percentage of participants who are hospitalized and/or die Time: Up to 29 daysDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of participants with an adverse event (AE) Time: Up to ~7 monthsDescription: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measure: Percentage of participants who discontinued study intervention due to an AE Time: Up to 6 daysDescription: The number of days from randomization to the first day on or before study Day 29 for sustained resolution or improvement of each sign/symptom will be assessed.
Measure: Time to sustained resolution or improvement of each targeted COVID-19 sign/symptom Time: Up to 29 daysDescription: The number of days from randomization to the first day on or before study Day 29 for each targeted self-reported sign/symptom will be assessed.
Measure: Time to progression of each targeted COVID-19 sign/symptom Time: Up to 29 daysDescription: The World Health Organization (WHO) outcome scale is an 11-point ordinal score that categorizes clinical progression. Score ranges from 0 to 10 with higher score indicating clinical progression.
Measure: WHO 11-point outcomes score on a scale Time: Up to 29 daysThis is a phase I/II clinical trial using adoptive cell therapy with NK cells or memory T cells in patients affected by COVID-19. Severe cases with COVID-19 present a dysregulated immune system with T cell lymphopenia, specially NK cells and memory T cells, and a hyper-inflammatory state. This clinical trial proposes the use of cell therapy for the treatment of patients with worse prognosis due to SARS-CoV-2 infection (those with pneumonia and/or lymphopenia). This is an innovative and a non-pharmacological intervention.
Description: Any grade 3 or higher toxicity with an attribution of definitely or probably related to the infusion of the cells and any lower grade toxicity that increases to a grade 3 or higher as a direct result of the cell infusion.
Measure: Occurrence of DLTs in all patients during the study treatment, until 21 days after cell infusion and the MTD Time: 3 monthsBackground: COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19. Objective: To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes. Eligibility: Adults age 18 and older who are hospitalized with COVID-19. Design: Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed. Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit. Participation will last for about two months
Description: The safety primary endpoint is cumulative incidence of SAEs through day 29
Measure: Cumulative Incidence of SAEs Time: Day 29Description: Number of days in the ICU
Measure: Number of days in the ICU Time: entire hospitalizationDescription: Change in CRP, IL-6, d-dimer, ferritin, fibrinogen, absolute lymphocyte count, absolute neutrophil count, and platelet count from baseline
Measure: Change in CRP, IL-6, d-dimer, ferritin, fibrinogen, absolute lymphocyte count, absolute neutrophil count, and platelet count from baseline Time: day 3, 5, 8, 11, 15, 29Description: Ordinal scale
Measure: Ordinal scale Time: day 15, 29Description: Days of hospitalization
Measure: Days of hospitalization Time: entire hospitalizationDescription: Time to recovery
Measure: Time to recovery Time: day 29Description: Number of days free of mechanical ventilation [entire hospitalization cohort 1]
Measure: Number of days free of mechanical ventilation [entire hospitalization cohort 1] Time: entire hospitalizationDescription: Number of days on oxygen
Measure: Number of days on oxygen Time: entire hospitalizationDescription: Change in SOFA score from baseline
Measure: Change in SOFA score from baseline Time: day 3, 5, 8, 11, 15, 29Description: Days free of renal failure
Measure: Days free of renal failure Time: entire hospitalizationDescription: Clinically relevant deep vein thrombosis
Measure: Clinically relevant deep vein thrombosis Time: entire hospitalizationDescription: Relative change in PaO2/FiO2 or SpO2/FiO2 ratio
Measure: Relative change in PaO2/FiO2 or SpO2/FiO2 ratio Time: d29This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.
Description: Prevalence and risk-factors for SARS-CoV-2 infection
Measure: Prevalence and risk-factors for SARS-CoV-2 infection Time: inclusion during 4 monthsDescription: Prevalence and risk-factors for COVID-19
Measure: Prevalence and risk-factors for COVID-19 Time: inclusion during 4 monthsDescription: Durability of IgG positivity/immunity
Measure: Durability of IgG positivity Time: 12 monthsThe purpose of this study is to measure immunity to the flu vaccine over time in patients who had COVID-19. Adults who have been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.
This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.
Description: Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples
Measure: Incidence of SARS-CoV-2 infection in infants, children and adolescents Time: 12 monthsDescription: Change of incidence of SARS-CoV-2 infection in children during 2020/2021
Measure: Incidence of SARS-CoV-2 Time: 12 monthsDescription: SARS-CoV-2 antibodies persistence in peripheral blood and saliva
Measure: SARS-CoV-2 antibody persistence Time: 12 monthsDescription: Saliva samples as alternative for the detection of antibodies against SARS-CoV-2
Measure: Antibodies presence in saliva samples Time: 18 monthsThe Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.
Description: Scale range from 0 (uninfected) to 9 (dead)
Measure: Absolute change in pneumonia severity on the modified WHO COVID-19 Ordinal Scale Time: Day 14, 28The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. These patients represent a significant infection risk to the medical staff. According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form. Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection, especially in healthcare workers who are at high risk of infection.
Description: This is the proportion of patients with at least one positive serology between W2 and W19. The time of S19 takes into account a seroconversion delay of 5 weeks in relation to the SARS-CoV2 contamination.
Measure: SARS-COV2 seroconversion between W0 and W19 after randomization Time: Between week 0 and week 19Description: This is the proportion of patients with at least one positive serology between W2 and W16.
Measure: SARS-COV2 seroconversion Time: Week 16Description: Asymptomatic COVID-19 infection is defined as SARS-CoV2 seroconversion at Week 19 without symptoms suggestive of COVID until the end of Week 16 to take in account of the two weeks of incubation period
Measure: Asymptomatic COVID-19 infection proportion at week 14 Time: Week 14Description: documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared before W8 and W16 respectively, and requiring hospitalization or home oxygen therapy, or having resulted in death
Measure: Proportion of severe COVID-19 infection Time: Week 8, Week16The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.
Description: The investigators will analysis total gene expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole transcriptome will be extracted and processed for analysis (about 25000 genes) using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).
Measure: Differential gene expression profile. Time: 3 monthsDescription: The investigators will analysis total miRNA expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole miRNA expression will be extracted and processed for analysis using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).
Measure: Differential miRNA expression profile. Time: 3 monthsDescription: This assay will be done on plasma of patients. The investigators will analysis the different cytokine profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using xMAP (Multi-Analyte Profiling) technology & Luminex 200. The obtained data will be analyzed using statistical software to study the different profile between the selected participants. The obtained data will be also correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).
Measure: Multiplex Cytokine assay Time: 3 monthsCoronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19 study is to evaluate the clinical performance and to provide data for clinical validation for the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and secondary aims. This assay is intended to detect immune response to the virus that causes coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot.
Description: To demonstrate the clinical agreement of the T-Detect™ SARS-CoV-2 Assay in participants with a positive and negative result from an EUA approved RT-PCR assay.
Measure: Demonstrate clinical agreement of T-Detect™ SARS-CoV-2 Assay Time: Initial VisitCOVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome
Description: Recovery defined as resolution of fever without the use of antipyretics, improvement of respiratory symptoms (e.g., cough, dyspnea) and no need for supplemental oxygen
Measure: Recovery Time: Until patient is discharged or up to 12 weeks whichever comes firstDescription: All cause mortality
Measure: Mortality Time: Until patient is discharged or up to 12 weeks whichever comes firstDescription: Detected by Polymerase Chain Reaction (PCR) test for nasopharyngeal swab
Measure: Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative. Time: Until patient is discharged or up to 12 weeks whichever comes firstDescription: detected by measuring the extent of pulmonary lesion in high resolution computed tomography (HRCT) of the chest
Measure: Radiological progression of the COVID 19 disease Time: Until patient is discharged or up to 12 weeks whichever comes firstDescription: increase oxygen demands detected by arterial blood gases analysis and/or pulse oximeter
Measure: Functional progression of the COVID 19 disease Time: Until patient is discharged or up to 12 weeks whichever comes firstThis study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.
Description: Based on therapy outcome measures from FEES, VoiS
Measure: Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation). Time: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months) Time: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 monthsDescription: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only. Time: t = day 5, day 10, day 14, day 21 - For in-patients only.Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: Relationship between severity of dysphonia and/or dysphagia with grade of ARDS Time: t = day 0 and 9 monthsDescription: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: Relationship between severity of dysphonia and/or dysphagia with length of intubation Time: t = day 0 and 9 monthsDescription: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation Time: t = day 0 and 9 monthsDescription: Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28
Measure: Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months. Time: t = day 0, 1 month and 9 months.Description: Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).
Measure: Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months Time: t = day 0, 1 month and 9 monthsRandomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.
Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 15 Minutes Time: Baseline, 15 minutesDescription: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 30 Minutes Time: Baseline, 30 MinutesDescription: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 45 Minutes Time: Baseline, 45 MinutesDescription: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 60 Minutes Time: Baseline, 60 MinutesThe purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days Time: at days 0, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0, 28, 42Description: Determination of antigen-specific cellular immunity
Measure: Changing of antigen-specific cellular immunity level Time: Time Frame: at days 0,28The primary objectives of this study are: - To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and - To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.
Description: Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).
Measure: Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation Time: 6 Months Post Illness Presentation (Enrollment)Description: Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).
Measure: Proportion of Participants with Coronavirus Disease 2019 (COVID-19)-Related Death after Multisystem Inflammatory Syndrome in Children (MIS-C) at 1 Year Post Illness Presentation Time: 1 Year Post Illness Presentation (Enrollment)Description: The occurrence of death in participants regardless of relationship to Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Measure: All-Cause Mortality Time: 1 Year Post Illness Presentation (Enrollment)Description: The occurrence of SARS-CoV-2 related death in participants.
Measure: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality Time: 1 Year Post Illness Presentation (Enrollment)Description: Characterization of Participants who require: Hospitalization subsequent to enrollment as an outpatient for SARS-CoV-2/COVID-19 related illness and/or MIS-C, or Rehospitalization after discharge from their initial admission for SARS-CoV-2/COVID-19 related illness and/or MIS-C. Abbreviations: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Disease 2019 (COVID-19) Multisystem Inflammatory Syndrome in Children (MIS-C)
Measure: Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.
Measure: Coagulation Abnormality by D-Dimer Biomarker Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.
Measure: Coagulation Abnormality by Fibrinogen Biomarker Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.
Measure: Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of dysregulation involving the coagulation system by INR laboratory test.
Measure: Coagulation Abnormality by International Normalised Ratio (INR) Biomarker Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).
Measure: Coronary Artery Abnormalities Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.
Measure: Pulmonary Hypertension Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of cardiovascular system dysregulation by BNP laboratory test.
Measure: Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of cardiovascular system dysregulation by Troponin I laboratory test.
Measure: Cardiovascular System Dysregulation by Troponin I Biomarker Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of cardiac function by echocardiogram (Echo), a test that uses high frequency sound waves (ultrasound) to make pictures of the heart. The test is also referred to as a diagnostic cardiac ultrasound.
Measure: Cardiovascular System Dysregulation by Echocardiogram Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of cardiovascular system dysregulation(s) evaluated by standardized 12-lead electrocardiogram. ECG rhythms, intervals and voltages will be assessed. Cross reference: ECG and EKG are used interchangeably.
Measure: Cardiovascular System Dysregulation by Electrocardiogram (ECG) Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.
Measure: Pulmonary Abnormalities Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization by pulmonary function tests (spirometry without bronchodilators).
Measure: Pulmonary Function Characteristics Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests
Measure: Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN) Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Measure: Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR) Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of liver/metabolic function by the following laboratory tests: alkaline phosphatase alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT).
Measure: Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT) Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of liver/metabolic function by serum total bilirubin laboratory test.
Measure: Hepatic/Metabolic Biomarker: Total Bilirubin Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Characterization of neurologic sequelae of infection/disease.
Measure: Neurologic Abnormalities Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Identified by and characterized during standard of care assessments.
Measure: Other End Organ and/or functional abnormalities Occurring After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection/ Coronavirus Disease 2019 (COVID-19) and/or Multisystem Inflammatory Syndrome in Children (MIS-C) Time: Up to 1 Year Post Illness Presentation (Enrollment)Description: Assessment of health-related quality of life (HRQOL) after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/ Coronavirus Disease 2019 (COVID-19) and/or multisystem inflammatory syndrome in children (MIS-C). The Pediatric Quality of Life Inventory is a series of assessment instruments designed to measure the health-related quality of life of children. The PedsQL 4.0 provides an opportunity for the assessment of both overall (generic) quality of life as well as disease-specific quality of life. The PedsQL 4.0 Generic Core Scales are appropriate for assessing health-related quality of life in both healthy and chronically ill children. The four scales making up this generic battery include Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items).
Measure: Health Related Quality of Life Time: Up to 1 Year Post Illness Presentation (Enrollment)Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.
Description: The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.
Measure: Percentage of individuals who develop COVID-19 symptoms Time: 6 months from study startThis clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.
Description: Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8)
Measure: Ordinal scale for measuring clinical improvement by the World Health Organization (WHO) Time: 14 daysDescription: Duration of symptoms (fever, respiratory rate or shortness of breath, and cough) that is calculated according to the start of VCO or placebo administration until symptoms disappear, obtained based on anamnesis and physical examination
Measure: Clinical symptoms improvement, determined with interview and examination Time: 14 daysDescription: Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10)
Measure: Pain as side effects of the drugs, measured by Visual Analog Scale Time: 14 daysDescription: Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction.
Measure: Allergic reaction severity in mild, moderate, or severe Time: 14 daysDescription: leucocyte count, measured in 1000/micro liter
Measure: Laboratory outcome of leucocyte count Time: 14 daysDescription: lymphocyte count, measured in percentage
Measure: Laboratory outcome of lymphocyte count Time: 14 daysDescription: Neutrophil count, measured in percentage
Measure: Laboratory outcome of neutrophil count Time: 14 daysDescription: neutrophil to lymphocyte ratio, in scale
Measure: Laboratory outcome of neutrophil to lymphocyte ratio, in scale Time: 14 daysDescription: D-dimer measured in microgram/Liter
Measure: Laboratory outcome of D-dimer Time: 14 daysDescription: TNF-alpha, measured in pg/ml
Measure: Laboratory outcome of TNF-alpha Time: 14 daysDescription: CRP value measured in qualitative value
Measure: Laboratory outcome of CRP value Time: 14 daysDescription: IL-6 value measured in pg/ml
Measure: Laboratory outcome of IL-6 Time: 14 daysDescription: Ferritin value measured in mcg/liter
Measure: Laboratory outcome of ferritin Time: 14 daysDescription: procalcitonin in microgram/liter
Measure: Laboratory outcome of procalcitonin Time: 14 daysDescription: chest radiology outcome, measured as improvement of infiltrate based on expert assessment in day 1 and 14
Measure: chest radiology outcome, measured as improvement of infiltrate based on expert assessment Time: 14 daysThis study is a multicenter, randomized, open, parallel-controlled study. Qualified subjects will randomly be assigned to the experimental arm or the control arm according to the ratio of 1:1, with age (> 60 years or ≤ 60 years), smoking status (yes/no) and forced expiratory volume in one second/prediction (FEV1 %pred > 60% or ≤ 60%) as the random stratification factors.
Description: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 12 of treatment.
Measure: (VO2max) Time: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 12 of treatment.Description: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 4 of treatment.
Measure: (VO2max) Time: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 4 of treatment.Description: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 8 of treatment.
Measure: (VO2max) Time: The change from baseline in maximum oxygen consumption (VO2max) at maximum exercise load at Week 8 of treatment.Description: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 4 of treatment.
Measure: (VE /VCO2) Time: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 4 of treatment.Description: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 8 of treatment.
Measure: (VE /VCO2) Time: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 8 of treatment.Description: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 12 of treatment.
Measure: (VE /VCO2) Time: Differences in the change from baseline in ventilatory equivalent for carbon dioxide (VE /VCO2) at maximum exercise load at Week 12 of treatment.Description: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 4 of treatment.
Measure: (VE /VO2) Time: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 4 of treatment.Description: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 8 of treatment.
Measure: (VE /VO2) Time: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 8 of treatment.Description: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 12 of treatment.
Measure: (VE /VO2) Time: Differences in the change from baseline in ventilatory equivalent for oxygen (VE /VO2) at maximum exercise load at Week 12 of treatment.Description: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 4 treatment.
Measure: (VO2 /HR) Time: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 4 of treatment.Description: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 8 of treatment.
Measure: (VO2 /HR) Time: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 8 of treatment.Description: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 12 of treatment.
Measure: (VO2 /HR) Time: Differences in the change from baseline in oxygen pulse (VO2 /HR) at maximum exercise load at Week 12 of treatment.Description: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 4 of treatment.
Measure: (P (A-a) O2) Time: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 4 of treatment.Description: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 8 of treatment.
Measure: (P (A-a) O2) Time: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 8 of treatment.Description: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 12 of treatment.
Measure: (P (A-a) O2) Time: The change from baseline in the alveolar-arterial oxygen tension gradient (P (A-a) O2) at maximum exercise load at Week 12 of treatment.Description: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 4 of treatment.
Measure: (P (a-et) CO2) Time: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 4 of treatment.Description: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 8 of treatment.
Measure: (P (a-et) CO2) Time: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 8 of treatment.Description: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 12 of treatment.
Measure: (P (a-et) CO2) Time: The change from baseline in the arterial-to-end-tidal CO2 difference (P (a-et) CO2) at maximum exercise load at Week 12 of treatment.Description: The change from baseline in maximum exercise power at Week 4 of treatment.
Measure: maximum exercise power Time: The change from baseline in maximum exercise power at Week 4 of treatment.Description: The change from baseline in maximum exercise power at Week 8 of treatment.
Measure: maximum exercise power Time: The change from baseline in maximum exercise power at Week 8 of treatment.Description: The change from baseline in maximum exercise power at Week 12 of treatment.
Measure: maximum exercise power Time: The change from baseline in maximum exercise power at Week 12 of treatment.Description: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 4 of treatment.
Measure: RER Time: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 4 of treatment.Description: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 8 of treatment.
Measure: RER Time: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 8 of treatment.Description: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 12 of treatment.
Measure: RER Time: The change from baseline in respiratory quotient (RER) at maximum exercise load at Week 12 of treatment.Description: The change from baseline in total exercise duration at maximum exercise load at Week 4 of treatment.
Measure: The change from baseline in total exercise duration at maximum exercise load at Week 4 of treatment. Time: The change from baseline in total exercise duration at maximum exercise load at Week 4 of treatment.Description: The change from baseline in total exercise duration at maximum exercise load at Week 8 of treatment.
Measure: The change from baseline in total exercise duration at maximum exercise load at Week 8 of treatment. Time: The change from baseline in total exercise duration at maximum exercise load at Week 8 of treatment.Description: The change from baseline in total exercise duration at maximum exercise load at Week 12 of treatment.
Measure: The change from baseline in total exercise duration at maximum exercise load at Week 12 of treatment. Time: The change from baseline in total exercise duration at maximum exercise load at Week 12 of treatment.Description: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 4 of treatment.
Measure: (SpO2) Time: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 4 of treatment.Description: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 8 of treatment.
Measure: (SpO2) Time: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 8 of treatment.Description: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 12 of treatment.
Measure: (SpO2) Time: The change from baseline in fingertip oxygen saturation (SpO2) at rest and without oxygen inhalation at Week 12 of treatment.Description: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 4 of treatment.
Measure: (mMRC) Time: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 4 of treatment.Description: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 8 of treatment.
Measure: (mMRC) Time: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 8 of treatment.Description: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 12 of treatment.
Measure: (mMRC) Time: The change from baseline in the modified Medical Research Council (mMRC) Dyspnea Scale score at week 12 of treatment.This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
Description: Safety and tolerability
Measure: Incidence of treatment emergent adverse events Time: Day 1 (Date of Consent) to Day 28Description: Safety and tolerability with adverse event graded at 2 or higher
Measure: Incidence of device related adverse events Time: Day 1 (Date of Consent) to Day 14Description: Safety and tolerability
Measure: Incidence of serious adverse events Time: Day 1 (Date of Consent) to Day 28Description: Length of ICU stay in days
Measure: Length if Stay in ICU Time: Day 1 (Date of Consent) to Day 28Description: Number of deaths during hospitalization
Measure: In-hospital mortality Time: Day 1 (Date of Consent) to Day 28Description: Number of days without ventilatory support
Measure: Days free of ventilatory dependency Time: Day 1 (Date of Consent) to Day 28Description: Number of days without vasopressor support
Measure: Vasopressor-free days Time: Day 1 (Date of Consent) to Day 28Description: SOFA scoring system predicts the clinical outcome of critically ill patients.
Measure: Sequential Organ Failure Assessment (SOFA) Time: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)Description: Measures the severity of disease for adult patients admitted to an ICU
Measure: Acute Physiology and Chronic Health Evaluation (APACHE) Time: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)Description: Measures viral exposure and levels of circulating virus
Measure: SARS CoV-2 RNA levels in plasma and nasopharyngeal samples Time: Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinuedDescription: Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.
Measure: Total lymphocyte count Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measurement of inflammatory marker levels play a role in systemic vasculitis and cytokine mediated coagulation disorders as the principal actors of multi organ failure in patients with severe COVID-19 complication.
Measure: C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measurement of D-dimer levels as levels are elevated in patients with COVID-19 and correlate with disease severity, are a reliable prognostic marker for in-hospital mortality.
Measure: D-dimer Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.
Measure: Troponin-T Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measures the levels of SARS-CoV-2 RNA captured in the filter
Measure: Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges Time: Until study completion, 1 week or for the duration of ICU admissionDescription: Measures the levels of viral particles captured in the filter
Measure: Evaluation of viral particle load post-treatment Hemopurifier cartridges Time: Until study completion, 1 week or for the duration of ICU admissionThis is a double blind randomized placebo controlled study will be conducted on 124 subjects, 50 years and older with mild or asymptomatic COVID-19. If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath. The study will be conducted at two centers. There will be a screening visit at Day -4 followed by three visits at the center at Days 1, 7 and 15 and a follow-up visit on Day 28. All participants will be randomized to receive either ViraCide (investigational product) or matching placebo. All subjects will receive SOC therapy. Note: If subject is discharged before Day 15 PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
Description: Time to Clinical Improvement (TTCI) using NEWS Score23 [Time Frame:First treatment date up to discharge day (PI's discretion as per patient's health condition)] The median time in days from the start of treatment with the study drug / placebo to the persistent achievement of all of the following criteria: i. Stopping a fever (which is defined as a decrease in axillary temperature below 37 ° C without the use of antipyretic drugs); ii. Respiratory rate <22 /min; iii. Oxygen saturation (SPO2) > 95% when breathing in atmospheric air. Measured using pulse oximetry iv. Systolic blood pressure ≤200mmHg v. Pulse rate 51-90beats/minute vi. Is conscious and alert
Measure: NEWS Score Time: First treatment date up to day 15Description: TTIC using 7-point ordinal scale3 [Time Frame: First treatment date up to discharge day (PI's discretion as per patients health condition)]
Measure: 7-point ordinal scale Time: First treatment date up to day 15Description: Rate of progression to severe/critical COVID-19 disease based on NEWS score
Measure: Rate of progression on NEWS score Time: First treatment date up to 15 daysDescription: Rate of progression to severe/critical COVID-19 disease based on 7-point
Measure: Rate of progression on 7 point ordinal score Time: First treatment date up to 28daysDescription: Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Measure: Time to COVID-19 nucleic acid testing Time: Time Frame: First treatment date up to 28daysDescription: Incidence of ICU admissions
Measure: ICU admissions Time: Time Frame: 28daysDescription: Subject survival rate
Measure: survival rate Time: Time Frame: 28 daysDescription: Incidence of mechanical ventilation
Measure: mechanical ventilation Time: Time Frame: First treatment date up to 28 days]Description: Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Measure: Time to COVID-19 nucleic acid testing Time: Time Frame: Days 1, 7, 15Description: Change in clinical or laboratory assessment of comorbid condition
Measure: Assessmentofcomorbidcondition Time: Time Frame: First treatment date up to 28days]Description: Percent of participants with worsening comorbid condition
Measure: worsening comorbid condition Time: Time Frame: First treatment date up to 28days]The overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health.
Description: All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.
Measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit Time: At study startDescription: Participants who tested positive for SARS-CoV-2 antibodies at first study visit will be tested for antibodies to SARS-CoV-2 again at 4 weeks.
Measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit Time: At 4 weeksDescription: Participants who tested positive for SARS-CoV-2 antibodies at second study visit will be tested for antibodies to SARS-CoV-2 again at 3 months.
Measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit Time: At 3 monthsBackground - A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in December 2019 as the cause of a respiratory illness COVID-19 in Wuhan City, China. WHO declared a public health emergency outbreak of this virus on 30 January 2020 and declared COVID-19 a global pandemic on 11 March, 2020. Bangladesh reported its first case on March 8, 2020 and first fatality on April 1, 2020. Bangladesh had shown a staggered course of COVID-19 transmission initially but a surge in cases was observed from April, 2020. Remdesivir remains as the only potential therapy for the treatment of COVID-19 till date. Based on several pre-clinical studies in SARS-CoV and MERS-CoV infections, Animal trials in COVID-19 and data from human trials, this randomized, controlled, open label trial will evaluate the antiviral activity and safety of Remdesivir in Bangladeshi hospitalized patients with severe COVID-19. This study finding will provide knowledge if Remdesivir is effective enough to treat Bangladeshi COVID-19 hospitalized patients with adequate safety and tolerability. The result of this study will help the key opinion leaders regarding the matter, to take appropriate decision regarding usage of Remdesivir for the treatment of COVID-19 in Bangladesh. Study Procedure - All patients will receive the standard medical care for COVID-19+ve at the respective hospitals. Vital signs will be recorded every 24 hrs for 1st 5 days then once in 2 days till discharge or as per the discretion of the attending physicians. After screening the COVID-19 confirmed patients will be randomized into 2 treatment arms. Patient's safety assessment e. g. blood parameters (CBC, Creatinine, SGPT, RBS, Creatinine, Creatinine Clearance) will be done on screening, day 5 and day 14 or discharge; Chest X-ray and ECG on screening and day 14 or discharge. SARS-CoV-2 (viral load) will be looked in on day 5, day 10 and day 14 or at the time of discharge. In case any study patient deteriorates during the study period will be managed as per the guideline of that particular hospital and if needed will be shifted to ICU. Patients who will recover will be discharged as per the national guideline for the COVID-19 hospitalized patients. Patients will be contacted at 28 days either over phone or in person to get their health status since discharge.
Description: Time to clinical improvement (censored at Day 28), defined as the time (in days) from randomization of study treatment until a decline of two categories on a six-category ordinal scale of clinical status (1 ꞊ discharged; 6 ꞊ death) or live discharge from hospital. Six-category ordinal scale: Hospital discharge or meet discharge criteria Hospitalization, not requiring supplemental oxygen; Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); ICU/hospitalization, requiring NIV/ HFNC therapy; ICU, requiring ECMO and/or IMV; Death;
Measure: Time to Clinical Improvement (TTCI) Time: 28 DaysProtocol summary Title A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label, chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19 Study Periods & Duration of Treatment Study Duration: 6 months Approval (IRB and regulatory bodies) 1 month Recruitment and follow-up: 3 months Analysis, report writing and submission of publications 1 month This study is a parallel study of one period with an expected duration of treatment (for each subject) of 28 days, Objectives - To evaluate if hydroxychloroquine with the proposed dose can provide potent chemoprophylaxis against the development of COVID-19 positive patients in subjects who had primary exposure to COVID-19 positive patients. - To measure the incidence of potential adverse drug reaction rates for giving hydroxychloroquine for prevention of COVID-19 amongst close contacts - To provide early analysis of results and redefine sample size accordingly. - identifying subjects most likely to benefit during the phase II and focusing recruitment efforts on them during phase III - stopping one arm or the whole trial at an early stage for success or lack of efficacy based on phase II study results Design Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following: Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5. Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5. Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.
Description: Study will seek to find direct correlation between the administration of Hydroxychloroquine and incidence of COVID-19: A reduced positive RT-PCR samples in subjects who were exposed to COVID-19patients. Positive RT-PCR samples in close contacts on day 14 of randomization.
Measure: Incidence rate of COVID-19 on day 14 according to positive results of RT-PCR rate at day 14 Time: 14 daysDescription: Safety and adverse events (AEs) incidence rate at day 14
Measure: Safety and adverse events (AEs) incidence rate at day 14 Time: 14 daysDescription: Positive IgM antibodies
Measure: IgM antibodies positive rate for COVID-19 at day 28 Time: 28 daysDescription: Positive at 28 days
Measure: Incidence rate of COVID-19 on day 28 according to positive results of RT-PCR rate at day 28 Time: 28 daysDescription: Safety and adverse events (AEs) incidence rate on day 28
Measure: Safety and adverse events (AEs) incidence rate on day 28 Time: 28 daysThis study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).
Description: Ventilator free days (VFD)
Measure: Ventilator free days (VFD) Time: at day 15 after LD-RTDescription: Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
Measure: Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2) Time: at day 5, 10, 15, 28 after LD-RTDescription: Overall mortality
Measure: Overall mortality Time: at day 15 and 28 after LD-RTDescription: Change in levels of ferritin (ng/ml)
Measure: Change in levels of ferritin (ng/ml) Time: up to day 15 after LD-RTDescription: Change in levels of c-reactive protein (mg/l)
Measure: Change in levels of c-reactive protein (mg/l) Time: up to day 15 after LD-RTDescription: Change in levels of white blood cell counts (number of white blood cells per volume of blood)
Measure: Change in levels of white blood cell counts (number of white blood cells per volume of blood) Time: up to day 15 after LD-RTThere is currently no known treatment for COVID19. Active smokers are infrequent among patients with COVID-19 which has led our team to hypothesize that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). In fact, nAChR possess the ability to modulate ACE2 expression, the cellular doorway for SARS-CoV2. nAChR modulation by the virus would be responsible for the numerous clinical signs observed in COVID-19, including the cytokine storm manifested in intensive care hyperinflammatory patients. Based on epidemiological data and experimental data from scientific literature, our team hypothesize that nicotine could inhibit the penetration and propagation of SARS-CoV2. Our team also claim that nicotine could attenuate the hyperinflammatory response and cytokine storm leading to acute respiratory failure and a probable multi-organ failure associated with COVID19.
Description: Without reintubation or death in the following 48 hours for tracheotomized patients: alive and not ventilated for 48 hours (with death and LATA in competitive risks).
Measure: Time before successful extubation Time: Day 60Description: This is a ranked composite score that incorporates death and days free from mechanical ventilation through day 28, calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.16 Time free from mechanical ventilation was calculated as the number of days between successful liberation from the ventilator and study day 60. Each patient was compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better
Measure: Composite score incorporating death and the number of days living without mechanical ventilation Time: Day 60Description: measured each day from day 1 to day 14
Measure: Mean evolution of blood gases Time: Day 1 to Day 14Description: measured each day from day 1 to day 14
Measure: Mean evolution of Tidal Volume (ventilator parameters) Time: Day 1 to Day 14Description: measured each day from day 1 to day 14
Measure: Mean evolution of respiratory rate (ventilator parameters) Time: Day 1 to Day 14Description: measured each day from day 1 to day 14
Measure: Mean evolution of Positive Expiratory Pressure (ventilator parameters) Time: Day 1 to Day 14Description: measured each day from day 1 to day 14
Measure: Mean evolution of plateau pressure (ventilator parameters) Time: Day 1 to Day 14Description: measured each day from day 1 to day 14
Measure: Mean evolution of fraction of inspired oxygen (ventilator parameters) Time: Day 1 to Day 14Description: A higher score indicate a worse outcome
Measure: Evolution of the Sequential Organ Failure Assessment (SOFA) score and its components by organ Time: Day 1 to Day 28Description: samples taken on D7 and D14 or the day of discharge from intensive care unit if before D14
Measure: Evolution of viral load Time: Day 7, Day 14 or day of ICU discharge if before day 14The main objective of this study is to assess if analysis of exhaled breath condensate (EBC) can provide useful prognostic markers for admission to the intensive care unit (ICU) due to acute respiratory insufficiency among patients with Coronavirus disease 2019 (COVID-19). Additionally, to give a characterization of the lung damage caused by COVID-19 by analysis of daily blood samples. The hypothesis is that the protein content of the EBC from COVID-19 patients who require admission to the ICU differs from the EBC from COVID-19 patients with uncomplicated hospitalization, potentially providing diagnostic markers of COVID-19 related pulmonary damage.
Description: The primary outcome is prediction of admission to ICU in hospitalized COVID-19 patients by use of one or more novel biomarkers in the EBC
Measure: Prediction of admission to ICU in hospitalized COVID-19 patients Time: 1 yearDescription: In a sub-study, we will collect the daily blood samples for analysis in order to investigate the pathophysiology in COVID-19, and for standardization and validation of putative EBC markers in the blood.
Measure: Pathophysiology in COVID-19 patients Time: 1 yearThis is a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate SARS-CoV-2 infected patients and safety during after study drug injection.
Description: Proportion of patient with negative conversion in nasopharyngeal swab specimen based on reverse transcription quantitative polymerase chain reaction(RT-qPCR)or cell culture at each visit.
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 14Description: Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 14Description: Time to clinical recovery
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 14Description: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 28Description: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 2 (Phase III) Time: Up to Day 28Description: Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection.
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients with all-cause mortality
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Time to clinical recovery
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Duration of fever defined as the last day in the patient diary on which the temperature >38°C (100.4°F) is recorded, or a potentially antipyretic drug (acetaminophen or ibuprofen) is taken
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients with hospital admission due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of mechanical ventilation due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients requiring additional prescription medication due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients reporting Adverse events (AEs, including serious adverse events)
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Proportion of patients reporting Adverse events of special interest (Infusion related reactions, hypersensitivity and anaphylactic reactions)
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Incidence of ADE (Antibody Dependent Enhancement)
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Proportion of patients with anti-drug antibodies Immunogenicity
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Proportion of patients with anti-drug antibodies S evere Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection related signs and symptoms.
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Viral shedding in nasopharyngeal swab specimen based on RT-qPCR and cell culture
Measure: To evaluate virology for part 1 and part 2 Time: Up to Day 90Description: Genotype and phenotype of SARS-CoV-2 viral isolates
Measure: To evaluate virology for part 1 and part 2 Time: Up to Day 90Description: Viral serology for SARS-CoV-2 antibody
Measure: To evaluate virology for part 1 and part 2 Time: Up to Day 90Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.
Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function), and at 3,6,9 and 12-months post hospital dischargeDescription: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity Time: 3,6,9 and 12-months post hospital dischargeDescription: The SPPB combines the results of gait speed over 3 meters, the 5-repetition chair-stand, and a progressive balance test to assess lower extremity function.
Measure: Change in Short Physical Performance Battery (SPPB) Time: 3,6,9 and 12-months post hospital dischargeDescription: The CFS is an interview-based scale wherein the assessor may ask the patient questions about things such as their independence or physical abilities to determine where the patient falls along the 9-point scale, from 1 (Very Fit) to 9 (Terminally Ill).
Measure: Change in Clinical Frailty Scale (CFS) for participants over 60 years of age Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function ), and at 3,6,9 and 12-months post hospital dischargeDescription: The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation as measured by spirometry.
Measure: Change in Forced Expiratory Volume (FEV1) Time: 3,6,9 and 12-months post hospital dischargeDescription: The amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. FVC is the total amount of air exhaled during the FEV test.
Measure: Change in Forced Vital Capacity (FVC) Time: 3,6,9 and 12-months post hospital dischargeDescription: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value.
Measure: Change in Forced Expiratory Volume Percentage (FEV1%) Time: 3,6,9 and 12-months post hospital dischargeDescription: The BDI rates the severity of dyspnea at a single point in time (baseline) based on a 24-item interviewer administered rating scale.
Measure: Baseline Dyspnea Index (BDI) Time: 3 months post hospital dischargeDescription: Measures changes in dyspnea severity from the baseline as established by the BDI.
Measure: Change in Transition Dyspnea Index (TDI) Time: 6,9 and 12-months post hospital dischargeDescription: The PHQ-9 is a self-rating instrument for depression based on nine questions that the patient responds to by indicating how much they have been bothered by these symptoms over the last two weeks.
Measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Time: 3,6,9 and 12-months post hospital dischargeDescription: The FIM assesses the functional status of a person based on the level of assistance the person requires.
Measure: Change in Functional Independence Measure (FIM) Time: 3 and 6 months post hospital dischargeDescription: The IES-R is a 22-item self-report measure that asks questions about subjective distress caused by traumatic events. Each item is rated on a 5-point scale, from 0 ("not at all") to 4 ("extremely").
Measure: Change in Impact of Event Scale - Revised (IES-R) Time: 3,6,9 and 12-months post hospital dischargeDescription: The EQ-5D-5L is a generic and well-established instrument for describing health status or disease-specific outcome measures. It defines health in terms of five dimensions: Mobility, Self- Care, Usual Activities, Pain/Discomfort, and Anxiety/ Depression. The response options are of five levels, from no, slight, moderate, severe, to extreme problems
Measure: Change in Health status (EQ-5D-5L) Time: 3,6,9 and 12-months post hospital dischargeBoth mindfulness meditation and expectancy effects are known to reduce anxiety, stress and catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.
Description: assessed via a covid-19-related catastrophizing scale (CCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)
Measure: Coronavirus-related catastrophizing Time: 40 minutesDescription: assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)
Measure: Expectancy Time: 40 minutesDescription: assessed via the Cognitive Emotion Regulation Questionnaire (CERQ-R; 4=lowest reappraisal, 20=highest reappraisal)
Measure: Reappraisal Time: 40 minutesDescription: assessed via the Five Facet Mindfulness Questionnaire Observing subscale (FFMQ-O; 1=lowest observing, 5=highest observing)
Measure: Mindful observing Time: 40 minutesDescription: assessed via the Five Facet Mindfulness Questionnaire Non-reacting subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity)
Measure: Mindful non-reactivity Time: 40 minutesDescription: assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)
Measure: State Mindfulness Time: 40 minutesDescription: assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)
Measure: State Decentering Time: 40 minutesThis study explores the actual situation of communication during the Coronavirus disease 2019 (COVID-19) pandemic in the South Asia and Middle East region. The purpose is to assess the effect of the limited visitor policy during the COVID-19 pandemic, on the pattern of interaction of critically ill patients to their kin/ guardian and doctor-family members communication. Primary objective of this study are as follows: 1. Explore the changes in communication pattern with limited contact during the COVID-19 pandemic. 2. Assess the methods of informed consent in Intensive care units (ICUs) during the same period
Description: Using a questionnaire the changes in visiting policy for family members or friends will be recorded from last year (before COVID-19 pandemic). This will include, visiting policy, visiting hours and their change after pandemic at the time of study (November 2020).
Measure: Changes in the pattern of family members visiting process Time: 12 monthsDescription: Through a questionnaire, the process of communication between HCWs and family members or friends before pandemic (November 2019) and November 2020 will be recorded. This will include the responsible HCW for communication, place of communication and method of communication (in person versus electronic)
Measure: Changes in process of communication between health care workers(HCWs) and family members Time: 12 monthsDescription: Through a questionnaire, the process of informed consent for procedures and end of life (EOL) or do not attempt to resuscitation (DNAR) in ICU will be collected and its change in last 12 months (from November 2019 to November 2020)
Measure: Changes in process of informed consent in ICU Time: 12 monthsSince the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications. Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation. An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers. Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease. Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.
Description: Cumulative incidence of ICU admission.
Measure: Admission to the intensive care unit. Time: 21 daysDescription: Duration of hospitalization (days).
Measure: Hospital length of stay. Time: 21 daysDescription: 21-day mortality.
Measure: Mortality rate. Time: 21 daysDescription: Number of days in ICU.
Measure: ICU length of stay. Time: 21 daysDescription: Number of days with mechanical ventilator.
Measure: Length of stay in ventilator time. Time: 21 daysDescription: Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.
Measure: Adverse effects of ivermectin. Time: 21 daysThere are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved. If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19. However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.
Description: The percentage of derecruitment of dependent areas will be measured every day with Electrical Impedance Tomography. The response to prone position will be assessed every day.
Measure: Coefficient of correlation between the percentage of derecruitment of dependent areas (measured with Electrical Impedance Tomography) and the response to prone position Time: Up to 7 daysThis is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) using self-collected saliva as the specimen. We will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. We will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube.
Description: Percent positive agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).
Measure: Percent positive agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples Time: within 1 day of SARS-CoV-2 testingDescription: Percent negative agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).
Measure: Percent negative agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples Time: within 1 day of SARS-CoV-2 testingDescription: Percent overall agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).
Measure: Percent overall agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples Time: within 1 day of SARS-CoV-2 testingThe objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.
Description: Job Content Questionnaire (Karasek, 1979)
Measure: stress at work Time: change from baseline at one yearDescription: Nursing Stress Questionnaire (Gray-Toft, 1981)
Measure: stress in a medical unit Time: change from baseline at one yearDescription: We will ask if they are used to do activities like hypnosis, yoga, mediation, sport, etc. This factor could help us to know if these activities can help and if we have to promote them in the hospital.
Measure: hobby activities Time: change from baseline at one yearNew outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.
Description: qPCR measured via nasal swab
Measure: Rate of decline in viral load over the 10 days after randomization Time: 10 days after randomizationThis is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.
Description: Proportion of subjects who have recovered at Day 28.
Measure: Proportion of subjects who have recovered at Day 28. Time: Day 28Description: Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
Measure: Proportion of subjects deceased or requiring mechanical ventilation at Day 28. Time: Day 28Description: Proportion of subjects deceased at Day 28.
Measure: Proportion of subjects deceased at Day 28. Time: Day 28Description: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Measure: Incidence of treatment-emergent adverse events (TEAEs). Time: Day 90Description: Time to maximum itolizumab serum concentration, Tmax
Measure: Time to maximum itolizumab serum concentration, Tmax Time: Day 28Description: Maximum itolizumab serum drug concentration, Cmax
Measure: Maximum itolizumab serum drug concentration, Cmax Time: Day 28Description: Total itolizumab exposure across time, AUC (from zero to last)
Measure: Total itolizumab exposure across time, AUC (from zero to last) Time: Day 28Description: Including but not limited to IL-1, IL-6, IL-17, TNF-α.
Measure: Inflammatory biomarkers Time: Day 28Description: sCD6, sALCAM
Measure: Pharmacodynamic markers Time: Day 28The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
Measure: incidence of Serious Adverse Events Time: 30 daysDescription: Time to fever resolution
Measure: fever resolution Time: Baseline to 30 daysDescription: Number of patients requiring admission to ICU
Measure: ICU admission Time: Baseline to 30 daysDescription: Time until patient no longer requires supportive oxygen
Measure: Oxygen support Time: Baseline to 30 daysDescription: b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower
Measure: Stable room air saturation Time: Baseline to 30 daysSARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that we call "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response. ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARB, losartan, limits lung injury in murine influenza H7N9 and decreases viral titre and RNA. We have a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARB, losartan) to decrease the mortality of hospitalized COVID-19 patient.
Description: Location within hospital (ICU or wards)
Measure: ICU Admission Time: up to 6 monthsDescription: Sequential Organ Failure Assessment (SOFA) score
Measure: SOFA score Time: 28 daysDescription: Use of inotropic agents and increase(s) of of troponin and/or NT-proBNP from admission level
Measure: Acute cardiac injury Time: 6 monthsDescription: Severe adverse effects of ARBs and mortality
Measure: Severe adverse events Time: 6 monthsThere is little information on the characteristics of airborne severe acute respiratory syndrome coronavirus containing aerosols, their concentration, or their infectivity.The aim was to determine airborne severe acute respiratory syndrome coronavirus transmission, their infectivity in different areas such as patient's room and in medical staff área.
Description: Detection of Severe Acute Respiratory Syndrome CoronaVirus 2 RNA by Real Time Polymerase Chain Reaction and cell culture
Measure: Airborne transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 Time: 9 mothsThe purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia. Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.
Description: PaO2/FiO2 ratio
Measure: alveolar-capillary gas exchange after two days of treatment Time: At 48 hours after the first treatment administrationDescription: PaO2/FiO2 ratio : a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care Time: From day 0 to day 21 or until coming out of intensive careDescription: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Ventilator-free days Time: At day 28 and at day 90Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : CRP Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : LDH Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6 Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Antithrombotic activity of Intravenous Lidocaine on platelets Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Antithrombotic activity of Intravenous Lidocaine on ACT ratio Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Antithrombotic activity of Intravenous Lidocaine on fibrinogen Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Antithrombotic activity of Intravenous Lidocaine on D-Dimers Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Antithrombotic activity of Intravenous Lidocaine on TEG Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Antithrombotic activity of Intravenous Lidocaine on thromboembolic events Time: At Day 0, day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Plasma concentration of albumin and Lidocaine Time: 4 hours after first administration, at day 2, day 7, day 14 and at day 21Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Blood pressure in mmHg will be measured
Measure: Search for hemodynamic dysfynction: Blood pressure measurement in mmHg Time: daily from day one to day 14Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Cardiac frequency in beats per minute will be assessed
Measure: Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed Time: daily from day one to day 14Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Sinus rythm will be assessed
Measure: Search for hemodynamic dysfynction: Sinus rythm will be assessed Time: daily from day one to day 14Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Vasopressors and inotropes drugs use will be reported
Measure: Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported Time: daily from day one to day 14Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. EKG : PR, QRS, QTc intervals in ms will be measured
Measure: Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured Time: daily from day one to day 14Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: ICU ileus: laxation response Time: daily from Day 0 to Day 28Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Opioids, sedative and curare sparing effect (drugs dosage) Time: daily from Day 0 to Day 28Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation Time: From Day0 to Day28 and at Day90Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay Time: From Day0 to Day28 and at Day90Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications Time: From Day0 to Day28 and at Day90Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.
Measure: Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy) Time: extubation dayThis study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protects individual privacy but promotes rapid dissemination and implementation of knowledge.
Description: determine the risk of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in those with symptoms of SARSCOV2 infection with vs. without a positive confirmatory test.
Measure: Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Time: 18 months post enrollmentDescription: Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR
Measure: Ambulatory care and/or ED visits post enrollment Time: 18 months post enrollmentDescription: Count of hospitalizations post enrollment as obtained from the EMR
Measure: Hospitalizations post enrollment Time: 18 months post enrollmentDescription: death during hospital admission as determined by data from the EMR
Measure: Death during hospital admission Time: 18 months post enrollmentDescription: Hospital-free survival as determined by data from the EMR
Measure: Hospital-free survival Time: 18 months post enrollmentDescription: ICU-free survival as determined by data from the EMR
Measure: ICU-free survival Time: 18 months post enrollmentThe investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease. A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3 times, during in hospital treatment.
Description: Compare the duration of hospital stay between groups
Measure: Duration of hospital stay Time: 30 days after randomizationDescription: The secondary outcome is the need for mechanical ventilation between groups
Measure: Number of participants requiring mechanical ventilation Time: 15 days after randomizationDescription: The secondary outcome is the need for vasoactive drugs between groups
Measure: Number of participants requiring vasoactive drugs Time: 15 days after randomizationDescription: The secondary outcome is the need for renal replacement therapy between groups
Measure: Number of participants requiring renal replacement therapy Time: 15 days after randomizationDescription: The secondary outcome is the incidence of secondary infection between groups
Measure: Incidence of secondary infection Time: 15 days after randomizationDescription: The secondary outcome is the comparison of Sequential Organ Failure Assessment (SOFA) score between groups
Measure: Sequential Organ Failure Assessment (SOFA) score Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of World Health Organization (WHO) COVID-19 clinical score between groups
Measure: World Health Organization (WHO) COVID-19 score Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of IL-6 levels between groups
Measure: Interleukin 6 (IL-6) Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of dimer-D levels between groups
Measure: Dimer-D Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of chest CT scan between groups
Measure: Chest CT scan Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of red blood cells; white blood cells;Platelets; Urea;Creatinine levels between groups
Measure: Incidence and severity of laboratory alterations Time: 30 days after randomizationDescription: Compare the incidence of clinical significant symptoms (new and persistent stomatitis, vomiting, diarrhea, alopecia, neurotoxicity, bradycardia, hypotension, local pain) reported between groups.
Measure: Clinical side effects Time: 30 days after randomizationDescription: Compare the incidence of other adverse events (not expected) between groups
Measure: Other adverse events Time: 30 days after randomizationCoronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois. Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled. Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks. There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.
Description: SARS-CoV-2 infection prior to enrollment is assessed by Immunoglobulin G (IgG) serology testing and/or self-reported diagnosis.
Measure: Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection Time: Baseline (Week 0)Description: SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing.
Measure: Percentage of Participants With Current SARS-CoV-2 Infection Time: Baseline (Week 0)Description: Incidence of SARS-CoV-2 Infection is assessed by positive PCR test, positive IgG serology test or COVID-19 diagnosis.
Measure: Percentage of Participants With Incidence of SARS-CoV-2 Infection Time: Up to Approximately 9 monthsDescription: Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded.
Measure: Percentage of Participants With COVID-19 Hospitalization Time: Up to approximately 9 monthsDescription: Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.
Measure: Percentage of Participants With Influenza and COVID-like Illness Time: Up to approximately 9 monthsDescription: The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.
Measure: Time to Infection Time: Up to approximately 9 monthsDescription: The analysis for overall time to symptom onset will be conducted using the Kaplan-Meier method.
Measure: Time to Symptom Onset Time: Up to approximately 9 monthsDescription: The analysis for overall time to symptom resolution will be conducted using the Kaplan-Meier method.
Measure: Time to Symptom Resolution Time: Up to approximately 9 monthsDescription: Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L)
Measure: Change in Quality of Life (QOL) Time: Up to approximately 9.5 monthsThis is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Up to 30,000 participants will take part in the study.
Description: Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Measure: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19) Time: Day 28 to Day 750Description: Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Measure: Participants with Symptomatic Moderate or Severe COVID-19 Time: Day 28 to Day 750Description: Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Measure: Participants with Any Symptomatic COVID-19 Time: Day 28 to Day 750Description: Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and Month 3.
Measure: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs) Time: Day 0 to Day 105Description: Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and Month 3.
Measure: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs) Time: Day 0 to Day 105Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and Month 3.
Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs Time: Day 0 to Day 105Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and Month 3.
Measure: Serum IgG Antibody Levels Expressed as GMFRs Time: Day 0 to Day 105Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and Month 3.
Measure: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs Time: Day 0 to Day 105Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and Month 3.
Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs Time: Day 0 to Day 105Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.
Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points Time: Day 165 to Day 750Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.
Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points Time: Day 165 to Day 750Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.
Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points Time: Day 165 to Day 750Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.
Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points Time: Day 165 to Day 750Description: Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.
Measure: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points Time: Day 165 to Day 750Description: Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.
Measure: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points Time: Day 165 to Day 750Description: Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.
Measure: Description of Course, Treatment and Severity of COVID-19 Time: Day 28 to Day 750Description: Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Measure: Reactogenicity Incidence and Severity Time: Day 0 to Day 27Description: Number of participants with mild, moderate, or severe MAAEs through Day 49.
Measure: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49. Time: Day 0 to Day 49Description: Number of participants with mild, moderate, or severe AEs through Day 49.
Measure: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49. Time: Day 0 to Day 49Description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through Month 12.
Measure: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12. Time: Day 0 to Day 375Description: Number of participants with mild, moderate, or severe SAEs through Month 12.
Measure: Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12. Time: Day 0 to Day 375Description: Number of participants with mild, moderate, or severe AESIs through Month 12.
Measure: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12. Time: Day 0 to Day 375Description: Number of participants with mild, moderate, or severe SAEs from Month 12 to Month 24.
Measure: Incidence and Severity of SAEs from Month 12 to Month 24. Time: Day 360 to Day 750Description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine from Month 12 to Month 24.
Measure: Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24. Time: Day 360 to Day 750Description: Number of participants with mild, moderate, or severe AESIs attributed to study vaccine from Month 12 to Month 24.
Measure: Incidence and Severity of AESIs from Month 12 to Month 24. Time: Day 360 to Day 750Description: Number of participants who died during the study due to any cause.
Measure: Deaths Due to Any Cause Time: Day 0 to Day 750Description: Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or Months 3, 6, 12, 18 and 24 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Measure: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points Time: Day 0 to Day 750Description: Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Measure: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point Time: Day 0 to Day 750The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.
Description: Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3
Measure: Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative Time: until 3 daysDescription: Duration of hospitalization is defined as the number of days in the hospital until Day 19, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.
Measure: Duration of hospitalization Time: until 19 daysBased on studies in China, Iceland, the Netherlands and Italy it seems that children are less affected by SARS-CoV-2 infections and play a lesser role in the dissemination of the SARS-CoV-2 virus. It is unclear to which extend this is due to lesser exposure or an inherent decreased susceptibility to become infected. The low reported number of cases in children can be partially explained by the lower testing rates in the pediatric population. To get insight in the transmission of SARS-CoV-2 virus in school-aged children it is necessary to compile data on infection of SARS-CoV-2 virus in the child and (pre-)adolescent population. The main objective of this study is to determine the sero-prevalence and sero-conversion of antibodies against SARS-CoV-2 in a sample of school-aged children (primary and secondary school) in Belgium at different time points. Additionally this study will gain insight in the incidence of SARS-CoV-2, the proportion of asymptomatic infections with SARS-CoV-2 and the role of COVID-19 infection in household members. It will give us the possibility to investigate potential risk factors for infection. The study population includes primary and secondary school children from two predefined age groups (8-9 and 13-14 years old). These two groups are chosen because studies have shown more pronounced symptoms of infection and disease depending on age and because transmission dynamics also vary by age. The study population will be recruited in all Belgian schools including Brussels-Capital, Flemish and Walloon Region (including the German speaking community). The study is a prospective cohort study. In total there will be 3 testing points with 3 months between each point. The sample size calculation indicated the inclusion of 41 randomly selected primary and 41 secondary schools and in each school 20 randomly selected pupils of the defined age groups. Parents/legal child caregiver will complete a questionnaire at each of the testing points providing basic socio-demographic characteristics (at baseline only) and risk-behavior and health characteristics including presence of symptoms during the time since the previous testing point (at each of the testing points). The questionnaire will be completed through a secured online application during the same week as the child had the saliva sample for serological testing taken. Saliva samples will be sent to the Sciensano laboratory for serological analysis. The child's parent/legal caregiver will be informed of the serological result. Study data will guide the Belgian policy makers in their advices to limit circulation of SARS-CoV-2 in Belgium and more specifically in their advice on measures for school-age children. This data might also be used to guide health authorities that have to decide on vaccination strategies once a vaccine is available; to decide whether children should be included for vaccination to create herd immunity or not.
Description: Change in percentage of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested
Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years Time: "Month 1", "Month 4" and "Month 7"Description: Change in the absolute numbers of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested
Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years Time: "Month 1", "Month 4" and "Month 7"Description: Change in percentage of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested
Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years Time: "Month 1", "Month 4" and "Month 7"Description: Change in the absolute numbers of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested
Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years Time: "Month 1", "Month 4" and "Month 7"Description: Change in the percentage of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years Time: "Month 4" and "Month 7"Description: Change in the percentage of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years Time: "Month 4" and "Month 7"Description: Change in the absolute number of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years Time: "Month 4" and "Month 7"Description: Change in the absolute number of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.
Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years Time: "Month 4" and "Month 7"Description: Proportion (%) infected children by probable exposure (probable or confirmed COVID-19 case in family or school), risk behavior and by health characteristics (co-morbidities, presence of symptoms, use of medications).
Measure: Potential risk factors for the infection Time: "Month 1", "Month 4" and "Month 7"Description: Percentage of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months
Measure: The proportion of asymptomatic cases among new cases that develop during a period of 7 months Time: "Month 1", "Month 4" and "Month 7"Description: Absolute number of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months
Measure: The proportion of asymptomatic cases among new cases that develop during a period of 7 months Time: "Month 1", "Month 4" and "Month 7"The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
Description: Higher score means better outcome.
Measure: Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 12 weeks. Time: Baseline and 12 weeks.Description: Higher score means worse outcome.
Measure: Change from baseline on fatigue evaluated by the fatigue severity scale at 12 weeks. Time: Baseline and 12 weeks.Description: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Measure: Change from baseline on lipid profile at 12 weeks. Time: Baseline and 12 weeks.Description: Fasting serum concentrations of glucose and insulin.
Measure: Change from baseline on insulin sensitivity at 12 weeks. Time: Baseline and 12 weeks.Description: Higher score means worse outcome.
Measure: Change from baseline on anxiety symptoms assessed by Back Scale at 12 weeks. Time: Baseline and 12 weeks.Description: Higher score means worse outcome.
Measure: Change from baseline on depression symptoms assessed by Back Scale at 12 weeks. Time: Baseline and 12 weeks.Description: Higher score means worse outcome.
Measure: Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 12 weeks. Time: Baseline and 12 weeks.The study proposes to test photodisinfection (PDF) on SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in he nostril of patients infected with SARS-CoV-2. Participants are swabbed for SARS-CoV-2 before and after the PDF treatment. For the study, a small group of healthcare workers who have tested positive for SARS-CoV-2 will be included. They will not undergo the treatment but will need to swab their noses multiple times over the next 5 days. This nil group will provide the effect (if any) of swabbing SARS-CoV-2 levels in the nose.
Description: The main endpoint is microbiological; RT-qPCR will be conducted on the pre and post treatment swabs and the change in cycle threshold value will be measured
Measure: RT-qPCR Time: 30 minutesThe purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.
Description: Assess hospital length of stay after mechanical ventilation
Measure: Hospital length of stay Time: Up to 60 daysDescription: Analyze the blood to assess the human metabolome and proteome in patients with COVID-19 receiving IVIG including production of inflammatory and anti-inflammatory cytokines, markers of endothelial injury, and coagulation using Mass Spectrometry
Measure: Human metabolome and proteome Time: Up to 60 daysFor the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS. The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).
Description: Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
Measure: Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care Time: month 12Description: psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms
Measure: psychological disorders measured by QIDS Time: Month 3Description: psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety
Measure: psychological disorders measured by STAI-YA Time: Month 3Description: psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms
Measure: psychological disorders measured by QIDS Time: Month 6Description: psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety
Measure: psychological disorders measured by STAI-YA Time: Month 6Description: psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms
Measure: psychological disorders measured by QIDS Time: Month 12Description: psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety
Measure: psychological disorders measured by STAI-YA Time: Month 12Description: Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life
Measure: quality of life by EQL-5 Time: Month 3Description: Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life
Measure: quality of life by EQL-5 Time: Month 6Description: Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life
Measure: quality of life by EQL-5 Time: Month 12Description: nutritional status measured by Nutritional Risk Screening 2002
Measure: nutritional status Time: Month 3Description: nutritional status measured by Nutritional Risk Screening 2002
Measure: nutritional status Time: Month 6Description: nutritional status measured by Nutritional Risk Screening 2002
Measure: nutritional status Time: Month 12This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.
Description: COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit
Measure: Number of participants hospitalized and/or requiring repeat emergency room visits Time: 21 daysDescription: If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Measure: Number of participants admitted to the Intensive care unit (ICU) Time: 30 daysDescription: If placed on ventilator, number of days on a ventilator
Measure: Number of participants on a ventilator Time: 30 daysDescription: Total number of deaths in the cohort.
Measure: All-cause mortality Time: Up to 30 daysDescription: Time at which the patient is completely symptom free.
Measure: Time to resolution of COVID-19 symptoms Time: Evaluated at day 2, 6, day 14, and day 21Description: Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)
Measure: Severity of symptoms Time: Evaluated at day 2, 6, day 14, and day 21Primary Objective: • To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19 Secondary Objectives: - To assess the clinical efficacy of SIR1-365 in patients with severe COVID-19 - To assess the effects of SIR1-365 on multiple inflammatory biomarker levels including C-reactive protein (CRP), ferritin, lymphocyte and neutrophil counts, cytokines, and chemokines - To assess the effects of SIR1-365 on biomarkers indicative of target engagement in patients with severe COVID-19 - To assess the effects of SIR1-365 on biomarkers indicative of kidney injury in patients with severe COVID-19 - To assess the effects of SIR1-365 on biomarkers indicative of cardiovascular endothelial cell damage in patients with severe COVID-19 - To characterize plasma pharmacokinetics (PK) of SIR1-365 in patients with severe COVID-19
Description: Primary Safety Endpoint
Measure: Proportion of patients with any TEAEs during the treatment period Time: Baseline to Day 14Description: Secondary Safety Endpoint
Measure: Proportion of patients with any AEs, SAEs and drug-related AEs during the study Time: Baseline to Day 14 and Day 28Description: Secondary Safety Endpoint
Measure: Proportion of patients with clinically significant abnormality in clinical laboratory tests and ECG during the study Time: Baseline to Day 14 and Day 28Description: Clinical Efficacy Endpoint
Measure: Change from Baseline to Day 7 and Day 14 in PaO2/FiO2 ratio Time: Baseline to Day 7 and Day 14Description: Clinical Efficacy Endpoint
Measure: Time to improvement of oxygenation defined as oxygen saturation (pulse oximetry) >93% and increased ≥1% from Baseline breathing only room air in the 48 hours preceding the measurement during the study Time: Baseline to Day 28Description: Clinical Efficacy Endpoint
Measure: Number of days without oxygen use during the study Time: Baseline to Day 28Description: Clinical Efficacy Endpoint
Measure: Proportion of patients with clinical improvement defined as a reduction of 2 points in the WHO ordinal scale during the study Time: Baseline to Day 28Description: Clinical Efficacy Endpoint
Measure: Number of days hospitalized during the study Time: Baseline to Day 28Description: Clinical Efficacy Endpoint
Measure: Proportion of patients free of respiratory failure during the study Time: Baseline to Day 28Description: Clinical Efficacy Endpoint
Measure: All-cause mortality rate during the study Time: Baseline to Day 28Description: Inflammatory Biomarker Measure
Measure: Change from Baseline to Day 7 and to Day 14 in plasma CRP level Time: Baseline to Day 7 and to Day 14Description: Inflammatory Biomarker Measure
Measure: Time to reach 50% reduction from Baseline in plasma CRP level during the treatment period Time: Baseline to Day 14Description: Inflammatory Biomarker Measure
Measure: Number of the patients to reach 50% reduction from Baseline in plasma CRP level during the treatment period Time: Baseline to Day 14Description: Inflammatory Biomarker Measure
Measure: Change from Baseline to Day 7 and Day 14 in serum cytokine levels Time: Baseline to Day 7 and Day 14Description: Biomarker Assessment for Target Engagement
Measure: Change from Baseline to Day 7 and Day 14 in plasma pRIP1 and pMLKL levels Time: Baseline to Day 7 and Day 14Description: Biomarker Assessment for Kidney Injury
Measure: Change from Baseline to Day 7 and Day 14 in urine NGAL and KIM-1 levels Time: Baseline to Day 7 and Day 14Description: Assessment of PK profile
Measure: Plasma drug levels Time: Baseline to Day 7 and Day 14Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.
Description: Ordinal scale defined as follows: 1. Not hospitalized, no limitations on activities; 2.Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Measure: Clinical status of patients at day-15 using a 7-point ordinal scale Time: 15 daysProspective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection
Description: To develop a database of physiological and behavioral data via wearable devices and self-reported questionnaires (e.g.,symptoms) combined with laboratory confirmation of SARS- CoV-2 infection.
Measure: Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection Time: Through study completion, an average of 7 monthsDescription: Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.
Measure: Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data Time: Through study completion, an average of 7 monthsDescription: Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.
Measure: Development of analytical models for real-time COVID-19 surveillance at the individual and population levels Time: Through study completion, an average of 7 monthsDescription: Model performance and accuracy characteristics of the analytical models on hold out data sets
Measure: Performance of the analytical models for real-time COVID-19 surveillance at the individual and population levels. Time: Through study completion, an average of 7 monthsAn observational study is carried out in the university population of the University of Salamanca to know the impact of the COVID-19 pandemic and the influence of physical exercise on the severity of symptoms.
Description: Number of positives
Measure: Impact of COVID-19 Time: Through study completion, an average of 3 monthsDescription: Quantity of physical exercise
Measure: Influence of exercise in COVID-19 infection Time: Through study completion, an average of 3 monthsDescription: Change at exercise habits on University population
Measure: Change in the practice of physical exercise after home confinement Time: Through study completion, an average of 3 monthsThis study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.
Description: For all qualitative method validation, the qualitative and quantitative result of the Foederatio Analyticorum Medicinalium Helveticorum (FAMH) performed RT-PCR (patient does / does not have SARS-Cov-2 and if yes, how many "ct" values for detection) is considered as the gold standard against which the crude extraction in combination with the LAMP or the NGS method using univariate measures is compared.
Measure: qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection) Time: single point assessment at baselineThe purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.
Description: Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Measure: Viral load Time: Day 0 to Day 28 or patient discharge dayDescription: Clinical status assessed by measurement of consciousness level: alertness
Measure: consciousness level Time: Day 0 to Day 28 or patient discharge dayDescription: Clinical status assessed by measurement of axillary body temperature in °C: <37.2.
Measure: temperature Time: Day 0 to Day 28 or patient discharge dayDescription: Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.
Measure: systolic blood pressure Time: Day 0 to Day 28 or patient discharge dayDescription: Clinical status assessed by measurement of oxygen saturation in %: >90.
Measure: Oxigen saturation Time: Day 0 to Day 28 or patient discharge dayDescription: Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.
Measure: Heart rate Time: Day 0 to Day 28 or patient discharge dayDescription: Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,
Measure: respiratory rate Time: Day 0 to Day 28 or patient discharge dayDescription: Assess length of hospitalization
Measure: Days of hospitalization Time: Day 0 to Day 28 or patient discharge dayDescription: Assess length of supplementary oxygen
Measure: Days of supplementary oxygen if applies Time: Day 0 to Day 28 or patient discharge dayDescription: Assess length of mechanical ventilation
Measure: Days of supplementary mechanical ventilation Time: Day 0 to Day 28 or patient discharge dayDescription: Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)
Measure: Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4) Time: Day 0 to Day 28 or patient discharge dayDescription: Changes in serum levels from security laboratories compared to baseline levels and between groups.
Measure: Changes in laboratory test results Time: Day 0 to Day 28 or patient discharge dayThe International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global), is an international registry of approximately 10,000 healthcare workers in low- and middle-income countries experiencing increasing numbers of COVID-19 cases and commensurate increased exposure to the SARS-CoV-2 virus among their healthcare worker populations.
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
Description: Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Measure: Viral Load Time: Day 0 to Day 8 or patient discharge dayDescription: Assess length of supplementary oxygen
Measure: Days of supplementary oxygen if apply Time: Day 0 to day 28 or patient discharge dayDescription: Assess length of mechanical ventilation
Measure: Days of supplementary mechanical ventilation if apply Time: Day 0 to day 28 or patient discharge dayDescription: Assess length of hospitalization
Measure: Days of Hospitalization Time: Day 0 to day 28 or patients discharge dayDescription: Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Measure: Normalization of fever Time: Day 0 to day 28 or patient discharge dayDescription: Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Measure: Normalization of oxigen saturation Time: Day 0 to day 28 or patient discharge dayDescription: Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Measure: Number of deaths Time: Day 0 to day 28 or patient discharge dayDescription: Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Measure: Change in Serum creatinine levels Time: Day 0 to day 28 or patients discharge dayDescription: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Measure: Change in serum Troponin I Time: Day 0 to day 28 or patients discharge dayDescription: Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Measure: Change in serum aspartate aminotransferase levels Time: Day 0 to day 28 or patients discharge dayDescription: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Measure: Change in serum Creatine kinase-MB levels Time: Day 0 to day 28 or patients discharge dayDescription: Assess by incidence of grade 3, grade 4 and Serious adverse events
Measure: Incidence of adverse event Time: Day 0 to day 28 or patients discharge dayCurrently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C. In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.
Description: Range 0-40
Measure: CT Severity score Time: 28 daysThe purpose of this study is to assess the efficacy and safety of chloroquine prophylaxis on the incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections in healthcare workers exposed to patients with confirmed Coronavirus Disease 2019 (COVID-19)
Description: Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Measure: COVID-19 infection Time: Day 15Description: Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Measure: COVID-19 infection Time: Day 30Description: Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Measure: COVID-19 infection Time: Day 45Description: Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Measure: COVID-19 infection Time: Day 60Description: Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Measure: COVID-19 infection Time: Day 75Description: Symptomatic COVID-19 infection confirmed by reverse transcriptase polymerase chain reaction in healthcare workers, in any respiratory sample
Measure: COVID-19 infection Time: Day 90Description: Number of participants with IgG antibodies seropositivity against SARS-CoV-2 in the final sample.
Measure: IgG antibodies seropositivity against SARS-CoV-2 Time: Day 90Description: Number of participants with at least one adverse drug event
Measure: Adverse drug event Time: Day 15, day 30, day 45, day 60, day 75 and day 90Description: Number of participants with unexpected adverse events
Measure: Unexpected adverse events Time: Day 15, day 30, day 45, day 60, day 75 and day 90Description: Number of participants who did not completed prophylaxis because of discontinuing medication, withdrawal of consent, or lost to follow-up
Measure: Participant drop-out Time: Baseline and day 90Description: Number of participants who were not-adherent to the medication scheme
Measure: Non-adherence Time: Baseline and day 90Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.
Description: Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.
Measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population. Time: 8 monthsDescription: Prevalence of asymptomatic cases into seropositive population
Measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies Time: 8 monthsThe study is a double-blind, randomized, placebo-controlled, adaptive design, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.
Description: Progression to severe/critical disease within 29 days of first dose of study treatment
Measure: Progression to severe/critical disease within 29 days of first dose of study treatment Time: 29 daysDescription: Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29
Measure: Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29 Time: 29 daysDescription: Total number of calendar days hospitalized through Day 29
Measure: Total number of calendar days hospitalized through Day 29 Time: 29 daysA Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals
Description: Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 3 MonthDescription: Reactogenicity Events occurring during the first week after study drug administration will be separately summarized based on their relationship to the study drug.
Measure: Incidence of Reactogenicity Adverse Events [Safety and Tolerability] Time: 1. WeekDescription: AUC0-672 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 672 hours (Day 28))
Measure: Pharmacokinetic parameter AUC0-672 Time: 0 to 672 hoursDescription: AUC0-504 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 504 hours) in healthy volunteers
Measure: Pharmacokinetic parameter tmax Time: 0 to 504 hoursDescription: AUC0-inf (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 extrapolated to infinity)
Measure: Pharmacokinetic parameter AUC0-inf Time: 3 MonthDescription: Cmax (maximum measured concentration of DZIF-10c in serum)
Measure: Pharmacokinetic parameter Cmax Time: 3 MonthDescription: t1/2 (the terminal elimination half-life of DZIF-10c in serum)
Measure: Pharmacokinetic parameter t1/2 Time: 3 MonthDescription: CL (total clearance of DZIF-10c in serum following i.v. administration)
Measure: Pharmacokinetic parameter CL Time: 3 MonthDescription: Vss (volume of distribution at steady state following i.v. administration)
Measure: Pharmacokinetic parameter Vss Time: 3 MonthDescription: Vz (volume of distribution during the terminal phase following i.v. administration)
Measure: Pharmacokinetic parameter Vz Time: 3 MonthDescription: The frequency of participants with antibodies and magnitude of antibodies targeting DZIF-10c will be calculated and described in tables.
Measure: Anti-Drug Antibodies Time: 3 MonthDescription: Viral Shedding Determined by qRT-PCR in nasopharyngeal swabs
Measure: Viral Shedding nasopharyngeal Time: Day 0-28Description: Viral Shedding Determined by qRT-PCR in oropharyngeal swabs
Measure: Viral Shedding oropharyngeal Time: Day 0-28Description: Frequency of viral shedding by as determined by successful isolation of infectious virus in virus isolation assays will be analysed by visit at baseline and at days 1 and 3 (Groups 2C-2D).
Measure: Viral Shedding Determined by the Isolation of Infectious Virus Time: Day 0-3Description: Levels of subgenomic SARS-CoV-2 mRNA will be determined swab samples by qRT-PCR (Groups 2C-2D).
Measure: Viral Replication Determined by Subgenomic SARS-CoV-2 mRNA Time: 3 MonthDescription: The frequency of unplanned hospitalizations and medically-attended contacts deemed to be related to COVID-19 by the Investigator will be described (Groups 2C-2D).
Measure: Frequency of COVID-19-related hospitalizations and medically-attended contacts Time: 3 MonthDescription: The duration of COVID-19-related symptoms will be described based on participants's self-assessment documented on patient diaries.
Measure: Duration of COVID-19 symptoms Time: 3 MonthDescription: SARS-CoV-2-reactive B cells and T cells are evaluated as number of participants with reactive cells and as activity of reactive cells. This analysis only takes place in SARS-CoV-2-infected individuals (2C, 2D).
Measure: Activity and Frequency of SARS-CoV-2-reactive immune responses Time: 3 MonthA Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected individuals
Description: Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 3 MonthDescription: Reactogenicity Events occurring during the first week after study drug administration will be separately summarized based on their relationship to the study drug.
Measure: Incidence of Reactogenicity Adverse Events [Safety and Tolerability] Time: 1. WeekDescription: AUC0-672 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 672 hours (Day 28))
Measure: Pharmacokinetic parameter AUC0-672 Time: 0 to 672 hoursDescription: AUC0-504 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 504 hours) in healthy volunteers
Measure: Pharmacokinetic parameter tmax Time: 0 to 504 hoursDescription: AUC0-504 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 504 hours) in healthy volunteers
Measure: Pharmacokinetic parameter AUC0-inf Time: 0 to 504 hoursDescription: Cmax (maximum measured concentration of DZIF-10c in serum)
Measure: Pharmacokinetic parameter Cmax Time: 3 MonthDescription: t1/2 (the terminal elimination half-life of DZIF-10c in serum)
Measure: Pharmacokinetic parameter t1/2 Time: 3 MonthDescription: CL (total clearance of DZIF-10c in serum following i.v. administration)
Measure: Pharmacokinetic parameter CL Time: 3 MonthDescription: Vss (volume of distribution at steady state following i.v. administration)
Measure: Pharmacokinetic parameter Vss Time: 3 MonthDescription: Vz (volume of distribution during the terminal phase following i.v. administration)
Measure: Pharmacokinetic parameter Vz Time: 3 MonthDescription: The frequency of participants with antibodies and magnitude of antibodies targeting DZIF-10c will be calculated and described in tables.
Measure: Anti-Drug Antibodies Time: 3 MonthDescription: Viral Shedding Determined by qRT-PCR in nasopharyngeal swabs
Measure: Viral Shedding nasopharyngeal Time: Day 0-28Description: Viral Shedding Determined by qRT-PCR in oropharyngeal swabs
Measure: Viral Shedding oropharyngeal Time: Day 0-28Description: Frequency of viral shedding by as determined by successful isolation of infectious virus in virus isolation assays will be analysed by visit at baseline and at days 1 and 3 (Groups 2C-2D).
Measure: Viral Shedding Determined by the Isolation of Infectious Virus Time: Day 0-3Description: Levels of subgenomic SARS-CoV-2 mRNA will be determined swab samples by qRT-PCR (Groups 2C-2D).
Measure: Viral Replication Determined by Subgenomic SARS-CoV-2 mRNA Time: 3 MonthDescription: The frequency of unplanned hospitalizations and medically-attended contacts deemed to be related to COVID-19 by the Investigator will be described (Groups 2C-2D).
Measure: Frequency of COVID-19-related hospitalizations and medically-attended contacts Time: 3 MonthDescription: The duration of COVID-19-related symptoms will be described based on participants's self-assessment documented on patient diaries.
Measure: Duration of COVID-19 symptoms Time: 3 MonthDescription: SARS-CoV-2-reactive B cells and T cells are evaluated as number of participants with reactive cells and as activity of reactive cells. This analysis only takes place in SARS-CoV-2-infected individuals (2C, 2D).
Measure: Activity and Frequency of SARS-CoV-2-reactive immune responses Time: 3 MonthTo evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.
Description: Incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Measure: Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events Time: 52 daysDescription: Adverse Events of Special Interest to be assessed: Incidence of hospitalizations incidence of cytokine release syndrome hemophagocytic lymphohistiocytosis acute respiratory distress syndrome need for oxygen supplementation
Measure: Safety as assessed by the incidence of adverse events of special interest: Time: 52 daysDescription: Changes as assessed by respiration rate
Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by heart rate
Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by oxygen saturation
Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by temperature
Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by blood pressure
Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by physical exam
Measure: Tolerability as assessed by changes in clinical symptoms from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by serum chemistry
Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by hematology
Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by coagulation
Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1) Time: 22 daysDescription: Changes as assessed by urinalysis
Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1) Time: 22 daysDescription: Defined as the time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from swab specimen
Measure: Time to viral load undetectability; Time: 22 daysDescription: Assessed by swab specimen
Measure: Proportion of patients with SARS-CoV-2 viral load below the level of detectability; Time: 22 daysDescription: Assessed by swab specimen
Measure: Mean change in SARS-CoV-2 viral load; Time: 22 daysDescription: Defined as resolution of symptoms on the WHO 9-point ordinal scale for clinical improvement.
Measure: The time to clinical resolution; Time: 52 daysDescription: Concentrations at end of infusion, end of dosing interval, and on defined timepoint periods.
Measure: Zotatifin plasma concentrations Time: 15 daysDescription: Time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from daily samples
Measure: Time to viral load undetectability Time: 22 daysDescription: Assessed from daily saliva and anterior nasal samples
Measure: Proportion of patients below the limit of detection Time: 22 daysDescription: Assessed from daily saliva and anterior nasal samples
Measure: Mean change in viral load in saliva and nasal samples Time: 22 daysDescription: Assessed from plasma collected
Measure: Mean change in viral load in plasma Time: 22 daysDescription: Assessed by plaque-based or comparable assay
Measure: Assessment and quantification of infectious virus Time: 22 daysDescription: According Virus Analysis Plan
Measure: Virus resistance Time: 22 daysDescription: Assessed in change from baseline to post infusion
Measure: Change in the WHO 9-point ordinal scale for clinical improvement Time: 38 daysThe renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that could be altered in COVID-19 patient and its supplementation may potentially helpful in this setting.
Description: 28 - x, where x = number of days on which the patient is released from supplemental oxygen therapy after start
Measure: supplemental oxygen-free days (SOFDs) Time: 28 daysDescription: Hospital length of stay
Measure: Hospital length of stay Time: through study completion, on average 60 daysDescription: composite outcome of mortality and necessity of mechanical ventilation
Measure: ventilator free days Time: 28 daysDescription: number of days free from intensive care unit
Measure: ICU free days Time: through study completion, on average 40 daysDescription: Ang II and Ang-(1-7) circulating levels using mass spectrometry
Measure: RAS effectors levels Time: Baseline, 3 and 24 hours after randomization and 72 hours after randomizationDescription: CT scan evolutions compared to baseline including findings compatible with late pulmonary fibrosis.
Measure: CT scan findings Time: through study completion, on average 30 daysDescription: C-reactive protein levels daily measurements
Measure: Changes in inflammatory markers: C reactive protein Time: through study completion, on average 30 daysDescription: use of vasopressors during hospitalization
Measure: Changes in clinical state: vasopressors usage Time: through study completion, on average 30 daysDescription: Chest X-ray modifications until hospital discharge
Measure: Chest X ray findings Time: through study completion, on average 30 daysDescription: pro-inflammatory chemokine levels (IL-1/IL-6) at baseline day 3 and 7
Measure: Changes in inflammatory markers: chemokines Time: Baseline, 3 and 24 hours after randomization and 72 hours after randomizationDescription: Troponin plasmatic levels
Measure: Changes in inflammatory markers: troponin Time: Baseline, 3 and 24 hours after randomization and 72 hours after randomizationDescription: D-Dimer
Measure: Changes in thrombotic markers: D-Dimer Time: Baseline, 3 and 24 hours after randomization and 72 hours after randomizationDescription: Secondary infections recorded during hospitalization
Measure: Changes in clinical state: secondary infections Time: through study completion, on average 30 daysDescription: deep venous thrombosis recorded during hospitalization
Measure: Changes in clinical state: deep venous thrombosis Time: through study completion, on average 30 daysAll health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.
Description: Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers
Measure: positive nasal swab and serological test Time: 2 monthsDescription: Relation of positive SARS-CoV2 tests to history of contacts with COVID-19 infected patients since the beginning of pandemia
Measure: Relation of positive SARS-CoV2 tests to risky contact history Time: 8 monthsSAINT-PERU is a triple-blind, randomized controlled trial with two parallel groups to compare the efficacy of ivermectin versus placebo to obtain negative PCR results in patients with early phase COVID-19. The trial is currently planned at a single center in Lima.
Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment
Measure: Proportion of patients with a positive SARS-CoV-2 PCR. Time: 7 days post-treatmentDescription: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab
Measure: Mean viral load Time: Baseline and on days 4, 7, 14 and 21Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial
Measure: Fever and cough progression Time: Up to and including day 21Description: Proportion of participants with positive IgG at day 21
Measure: Seroconversion at day 21 Time: Up to and including day 21Description: Proportion of drug-related adverse events
Measure: Proportion of drug-related adverse events Time: 7 days post treatmentDescription: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry
Measure: Frequency of innate immune cells Time: Up to and including day 7Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry
Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells Time: Up to and including day 7Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)
Measure: Results from cytokine Human Magnetic 30-Plex Panel Time: Up to and including day 21Description: Proportion and parasitic load of intestinal helminths by quantitative Kato-katz and Baerman method
Measure: Presence of intestinal helminths Time: Baseline and on day 14.Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures
Low-dose glucocorticoid treatment is the only intervention shown to significantly reduce mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support. In particular, a large UK randomized controlled trial (RECOVERY trial) demonstrated the efficacy of dexamethasone at a dosage of 6mg/day for 10 days in reducing mortality compared to usual therapy, with a greater impact on patients requiring mechanical ventilation (36% reduction) or oxygen therapy (18% reduction) than on those who did not need respiratory support (doi: 10.1056/NEJMoa2021436). However, there is still paucity of information guiding glucocorticoid administration in severe pneumonia/ARDS and no evidence of the superiority of a steroid drug -nor of a therapeutic scheme- compared to the others, which led to a great heterogeneity of treatment protocols and misinterpretation of available findings. In a recent longitudinal observational study conducted in Italian respiratory high-dependency units, a protocol with prolonged low-dose methylprednisolone demonstrated a 71% reduction in mortality and the achievement of other secondary endpoints such as an increase in ventilation-free days by study day 28 in a subgroup of patients with severe pneumonia and high levels of systemic inflammation (doi: 10.1093/ofid/ofaa421). The treatment was well tolerated and did not affect viral shedding from the airways. In light of these data, the present study aims to compare the efficacy of a methylprednisolone protocol and that of a dexamethasone protocol based on previous evidence in increasing survival by day 28, as well as in reducing the need and duration for mechanical ventilation, among hospitalized patients requiring noninvasive respiratory support (oxygen supplementation and/or noninvasive ventilation).
Description: Survival proportion at 28 days in both arms
Measure: Survival Time: 28 daysDescription: Number of days free from mechanical ventilation (either noninvasive or invasive) by study day 28 in both arms
Measure: Reduction in the need for mechanical ventilation Time: 28 daysDescription: Number of days of hospitalization for patients discharged alive in both arms
Measure: Length of hospitalization Time: From date of randomization until the date of hospital discharge, assessed up to 60 daysDescription: Proportion of patients requiring tracheostomy in both arms
Measure: Need for tracheostomy Time: Day 28Description: C-reactive protein level (mg/L) at study day 3, 7 and 14 in both arms
Measure: Reduction in systemic inflammation markers Time: Day 3, 7 and 14Description: PaO2/FiO2 ratio (mmHg) at study day 3, 7 and 14 in both arms
Measure: Amelioration of oxygenation Time: Day 3, 7 and 14Description: WHO clinical progression scale at study day 3, 7 and 14 in both arms
Measure: Disease progression Time: Day 3, 7 and 14This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
Description: Percentage, intensity, and relationship to vaccination of immediate AEs
Measure: Phase 2 portion: Immediate adverse event (AEs) Time: 30 minutesDescription: Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
Measure: Phase 2 portion: Solicited local and systemic adverse events (AEs) Time: 7 daysDescription: Percentage, intensity, and relationship of unsolicited AEs
Measure: Phase 2 portion: Unsolicited adverse events (AEs) Time: 21 daysDescription: Number of subjects with normal and abnormal clinically significant urine values
Measure: Phase 2 portion: Number of subjects with normal and abnormal clinically significant urine values Time: 3 daysDescription: Number of subjects with normal and abnormal clinically significant haematological values
Measure: Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values Time: 3 daysDescription: Number of subjects with normal and abnormal clinically significant biochemical values
Measure: Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values Time: 3 daysDescription: Percentage of subjects with normal and abnormal clinically significant urine values
Measure: Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant urine values Time: 3 daysDescription: Percentage of subjects with normal and abnormal clinically significant haematological values
Measure: Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant haematological values Time: 3 daysDescription: Percentage of subjects with normal and abnormal clinically biochemical values
Measure: Phase 2 portion: Percentage of subjects with normal and abnormal clinically biochemical values Time: 3 daysDescription: Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Measure: Phase 2 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: 21 daysDescription: Nab response induced in each Study Population against the SARS-CoV-2 virus
Measure: Phase 2 portion: Neutralizing antibody (Nab assay) response Time: Day 21Description: Nab response induced in each Study Population against the SARS-CoV-2 virus
Measure: Phase 2 portion: Neutralizing antibody (Nab assay) response Time: Day 42Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot
Measure: Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response Time: Day 21Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot
Measure: Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response Time: Day 42Description: First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Measure: Phase 3 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection Time: 14 daysDescription: Relative percentage of solicited local and systemic AEs following each vaccine administration between the healthy adults (Study Population #1) and the healthy elderly population (Study Population #2, each age strata);
Measure: Phase 2 portion: Solicited local and systemic AEs Time: 7 daysDescription: Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Measure: Phase 2 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: Day 43 to 386Description: Percentage, intensity, and relationship to vaccination of immediate AEs
Measure: Phase 3 portion: Immediate adverse event (AEs) Time: 30 minutesDescription: Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
Measure: Phase 3 portion: Solicited local and systemic AEs Time: 7 daysDescription: Percentage, intensity, and relationship of unsolicited AEs
Measure: Phase 3 portion: Unsolicited adverse events (AEs) Time: 21 daysDescription: Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Measure: Phase 3 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: Day 0 to 386Description: Relative neutralizing antibody response between the healthy adults (Study Population #1) and the healthy elderly population (Study Population #2; each age strata) will be analyzed using the Following parameter: Geometric mean tiers (GMT)
Measure: Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response Time: 21 daysDescription: Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
Measure: Phase 2 portion: Neutralizing antibody (Nab assay) response Time: Day 128Description: Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
Measure: Phase 2 portion: Neutralizing antibody (Nab assay) response Time: Day 201Description: Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus
Measure: Phase 2 portion: Neutralizing antibody (Nab assay) response Time: Day 386Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels
Measure: Phase 2 portion: Specific antibody (IgG) response Time: Day 128Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels
Measure: Phase 2 portion: Specific antibody (IgG) response Time: Day 201Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels
Measure: Phase 2 portion: Specific antibody (IgG) response Time: Day 386Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 128Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 201Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 386Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response Time: Day 201Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response Time: Day 386Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 21Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 42Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 201Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 386Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 21Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response Time: Day 21Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 21Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 42Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response Time: Day 42Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 42Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 128Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response Time: Day 128Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 128Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 201Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) Time: Day 201Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response Time: Day 201Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 386Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 386Description: In a subset of subjects, Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response Time: Day 386Description: In a subset of subjects, specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Phase 3 portion: Specific antibody (IgG) response Time: Day 21Description: In a subset of subjects, specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Phase 3 portion: Specific antibody (IgG) response Time: Day 42Description: In a subset of subjects, specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Phase 3 portion: Specific antibody (IgG) response Time: Day 128Description: In a subset of subjects, specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Phase 3 portion: Specific antibody (IgG) response Time: Day 201Description: In a subset of subjects, specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Phase 3 portion: Specific antibody (IgG) response Time: Day 386Description: In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 21Description: In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 42Description: In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 128Description: In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 201Description: In a subset of subjects, the ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 386Description: In a subset of subjects, specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response Time: Day 21Description: In a subset of subjects, specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response Time: Day 42Description: In a subset of subjects, specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response Time: Day 201Description: In a subset of subjects, specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response Time: Day 386Description: In a subset of subjects, specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 21Description: In a subset of subjects, specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 42Description: In a subset of subjects, specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 201Description: In a subset of subjects, specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response Time: Day 386Description: In a subset of subjects, specific CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by the percentage of CD4+ T cells expressing functional markers
Measure: Phase 3 portion: Specific cell-mediated immunity (CMI) response Time: Day 0 to 42Description: In a subset of subjects, specific CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by the percentage of CD4+ T cells expressing functional markers
Measure: Phase 3 portion: Specific cell-mediated immunity (CMI) response Time: Day 201 and 386Description: First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Measure: Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection Time: Day 35 to 386Description: Percentage of severe COVID-19 disease
Measure: Phase 2 portion: Severe COVID-19 disease Time: Day 35 to 386Description: Percentage of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARS-CoV-2 infection
Measure: Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection Time: Day 201Description: Percentage of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARS-CoV-2 infection
Measure: Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection Time: Day 386Description: Percentage of severe COVID-19 disease
Measure: Phase 3 portion: Severe COVID-19 disease Time: Day 35 to 386Description: Percentage and intensity of COVID-19-related symptoms
Measure: Phase 3 portion: COVID-19-related symptoms Time: 1 yearCSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.
Description: The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms. Remission -minimal to absence of symptoms; PHQ-9 score < 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity.
Measure: Change in Score of Patient Health Questionnaire-9 Time: Baseline and week 4 (End of Treatment)A total of 25 healthy volunteers between the ages of 18 and 80 with no previous history of COVID-19 will be entered into the study and will receive IPV by injection on Day 1. Blood specimens collected pre-inoculation will be tested for cross-reactivity to poliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected on Day 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus and SARS-CoV-2. The number of subjects with an immune response to SARS-CoV-2 antigens following inoculation with IPV will be summarized.
Description: Percentage of all subjects vaccinated with IPV with antibodies to SARS-CoV-2 RdRp
Measure: Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination Time: Day 28Description: Antibodies raised following IPV vaccination will be evaluated for neutralizing titer to both polio virus and SARS-CoV-2
Measure: Determination of neutralizing titer of antibodies raised to SARS-CoV-2 following vaccination with polio vaccine Time: Day 28The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.
Description: (RT-PCR positive) symptomatic cases of COVID-19.
Measure: First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19. Time: Day 42 to Month 12Description: (RT-PCR positive) symptomatic cases of COVID-19.
Measure: First occurence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint. Time: Day 42 to Month 12Description: (RT-PCR positive) severe symptomatic cases of COVID-19.
Measure: Virologically confirmed (RT-PCR positive) severe cases of COVID-19 Time: Day 42 to Month 12Description: (RT-PCR positive) symptomatic cases of COVID-19
Measure: Virologically confirmed COVID-19 cases of any severity occurring among participants 18 through 59 years of age and ≥60 years of age. Time: Day 42 to Month 12Description: (RT-PCR positive) asymptomatic/symptomatic cases of COVID-19.
Measure: Virologically confirmed COVID-19 asymptomatic and symptomatic cases occurring from two weeks after the second vaccination. Time: Day 42 to Month 12Description: Solicited, Unsolicited, Serious Adverse Events
Measure: Reactogenicity and Safety Time: Day 42 to Month 12Description: Reported by participant/documented in hospital records throughout the trial.
Measure: The occurrence of enhanced respiratory disease episodes. Time: Day 42 to Month 12Description: Assessed based Wild-type SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Measure: Immunogenicity: Lot-to-Lot consistency of three consecutive GMP Lots Time: Day 0 to Day 42Description: Specific Neutralizing Antibody (nAb)
Measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Time: Day 0 to Month 12This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 6178 participants.
Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.
Description: Defined as WHO Clinical Progression score of <6 [patient alive, not requiring invasive, non-invasive, or high flow oxygen therapy, vasopressors, dialysis or Extracorporeal membrane oxygenation (ECMO)].
Measure: Treatment Success at day 14 Time: Day 14Description: Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]
Measure: Change in WHO Clinical Progression Score Time: Day 7Description: Time to ICU admission up to 28 days
Measure: Time to ICU admission Time: Day 28Description: Incidence of adverse events up to 28 days
Measure: Incidence of Adverse Events Time: Day 28Description: Length of hospital stay up to 28 days
Measure: Length of hospital stay Time: Day 28Description: All-cause mortality rate at hospital discharge or at 28 days, whichever is first
Measure: All-cause Mortality Time: Day 28Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 in participants hospitalized with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug. ABBV-47D11 is an investigational anti-SARS-CoV-2 monoclonal antibody being developed for the treatment of COVID-19. Participants will receive either placebo or ABBV-47D11. There is a 1 in 4 chance that participants will be assigned to placebo. Around 32 adult participants hospitalized for a diagnosis of COVID-19 will be enrolled in approximately 10 to 30 sites globally. Participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Measure: Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) Time: Up to Day 106Description: Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
Measure: Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions Time: Up to Day 106Description: Maximum observed serum concentration (Cmax) of ABBV-47D11.
Measure: Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 Time: Up to Day 85Description: Time to maximum serum concentration of ABBV-47D11.
Measure: Time to Cmax (Tmax) of ABBV-47D11 Time: Up to Day 85Description: Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11.
Measure: Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11 Time: Up to Day 29Description: Terminal phase elimination half-life (t1/2) of ABBV-47D11.
Measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11 Time: Up to Day 85Description: AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.
Measure: AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 Time: Up to Day 85Description: Anti-drug antibodies will be detected using a tiered approach.
Measure: Detection of Anti-Drug Antibodies (ADA) Time: Up to Day 85Description: Neutralizing anti-drug antibodies will be detected using a tiered approach.
Measure: Detection of Neutralizing Anti-Drug Antibodies (nADA) Time: Up to Day 85Description: Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.
Measure: AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Time: Baseline (Day 1) through Day 29Description: Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.
Measure: Time to Negative SARS-CoV-2 by RT-PCR Time: Up to Day 29Description: Number of participants with negative SARS-CoV-2 RNA by RT-PCR.
Measure: Negative SARS-CoV-2 RNA by RT-PCR Time: Up to Day 15An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools. The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.
Description: Description of the serological status of individuals
Measure: Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. Time: 2 yearsDescription: Detection over time the specific T cell response to the SARS-CoV-2 virus.
Measure: Presence of specific T cell response to the SARS-CoV-2 Time: 2 yearsFacebook ads will be shown before the Thanksgiving holiday and will focus on staying safe during the COVID pandemic by limiting travel, social distancing and mask-wearing.
Description: COVID-19 cases: plan to measure new COVID-19 case rate at the zip code level.
Measure: Covid Case Rate Time: up to one monthDescription: Facebook population data to track the number of active users in each geographical location in our study. Facebook provides this data to researchers every 8 hours at a fine geographical resolution (Bing Tile, level 16).
Measure: Population count Time: up to one monthDescription: Mobility date from Facebook provides flows in and out of the study zip codes at the resolution of level 13 Bing Tiles. These mobility data are available on a daily basis. Investigators will use mobility data from as far back as Facebook has saved (as old as February 2020).
Measure: Facebook mobility rate Time: up to one monthDescription: Facebook will ask a set of users in treated zip codes to answer four survey questions (each user answers only one question each). A small within-zip control group will be held from being treated, enabling comparisons between those who see the videos and those who don't. These questions will be asked a few days after the ad is shown on the User's feed and will include 1) recall of the ad; 2) intention of traveling over Thanksgiving; 3) intention of wearing a mask; and 4) beliefs about whether people should travel over Thanksgiving.
Measure: Knowledge of COVID-19 thanksgiving prevention message (recall of ad, intent to travel, mask wearing and beliefs about travel) Time: up to one monthDescription: this measures each day "how much people move around by counting the number of level-16 Bing tiles they are seen in within a day. People seen in more tiles are probably moving around more, while people seen in fewer are probably moving around less. Each day take eligible people in a given region and compute the number of distinct tiles they were seen in." This is aggregated to the county level.
Measure: average number of tiles people occupy (Mobility measure) Time: up to one monthDescription: Facebook "Stay-put" data: this measures each day "the percentage of eligible people who are only observed in a single level-16 Bing tile (600m x 600m) during the course of a day" aggregated to they county level.
Measure: percentage of eligible participants only observed in a single level-16 Bing tile (no change in movement) Time: up to one monthThe main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (BEMPEG; NKTR-214) in combination with standard of care (SOC) in adult patients with mild COVID-19 (coronavirus disease 2019). The trial will also define the recommended phase 2 dose (RP2D) of bempegaldesleukin in patients with mild COVID-19.
Description: Area under the serum concentration-time curve (AUC) of BEMPEG /SOC.
Measure: AUC of BEMPEG/standard of care (SOC) (PK). Time: Approximately 30 daysDescription: Maximum observed serum concentration (Cmax) of BEMPEG /SOC.
Measure: Cmax of BEMPEG /SOC (PK). Time: Approximately 30 daysDescription: Time to Cmax (Tmax) of BEMPEG /SOC.
Measure: Tmax of BEMPEG /SOC (PK). Time: Approximately 30 daysDescription: The WHO Clinical Progression Scale scores and descriptors are as follows: 0- Uninfected; no viral RNA detected; 1- Asymptomatic; viral RNA detected; 2- Symptomatic; independent; 3- Symptomatic; assistance needed; 4- Hospitalized, no oxygen therapy; 5- Hospitalized; oxygen by mask or nasal prongs ; 6- Hospitalized; oxygen by non-invasive ventilation or high-flow; 7- Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200; 8- Mechanical ventilation, PaO2/FiO2 < 150 (SpO2/FiO2 < 200) or vasopressors; 9- Mechanical ventilation, PaO2/FiO2 < 150 and vasopressors, dialysis, or ECMO; 10- Death Abbreviations: ECMO = extracorporeal membrane oxygenation; FiO2 = fraction of inspired oxygen; PaO2 = partial pressure of arterial oxygen; SpO2 = oxygen saturation If hospitalized for isolation only, record status as for ambulatory patient. Source: WHO 2020.
Measure: Change from baseline on the daily collection World Health Organization (WHO) Clinical Progression Scale, an 11-point clinical status ordinal scale. Time: Approximately 30 daysCountries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes. The aim of the study is to answer the following questions: 1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)? 2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects? 3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result? A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*. Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19. * to measure the level of cytokines involved in cell-mediated immunity process
Description: shock - when catecholamines are required despite initial fluid resuscitation severe respiratory failure - the need for non-invasive or invasive ventilation severe renal failure - the need for renal replacement therapy (for undialysed individuals, i.e. with end-stage renal failure (ESRD)
Measure: death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia) Time: throughout the period of 18 months from inclusionDescription: Present symptoms (determined in the Telephone Contact Card) appear to indicate a possible SARS-CovV-2 infection
Measure: Onset of clinical symptoms of COVID-19 Time: 12 weeks from the date of the third visit - V3Description: based on anti SARS-CoV-2 IgG serological tests
Measure: asymptomatic SARS-CovV-2 infection Time: 12 weeks from the date of the third visit - V3Description: the need for hospitalisation and its duration
Measure: Hospitalisation Time: 12 weeks from the date of the third visit - V3Description: the need for hospitalisation in the ICU and its duration
Measure: ICU Hospitalisation Time: 12 weeks from the date of the third visit - V3Description: requiring passive oxygen therapy to eliminate the symptom or maintain saturation >92%
Measure: Dyspnoea Time: 12 weeks from the date of the third visit - V3The emergence & rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation on 11 March 2020. To date, tens of millions of cases have been reported and over 3% of these cases have died. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets/close contact. Fomite transmission has also been shown as a transmission route. Common respiratory symptoms such as fever, sore throat, cough & shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality rate. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed to treat disease & reduce further transmission in order to disrupt the ongoing pandemic. To date, there are no specific proven antiviral treatment to prevent disease progression from mild to severe respiratory dysfunction among COVID-19 patients. Supportive care is recommended for symptom relief & for severe cases. Numerous vaccine candidates against SARS-CoV-2 are under development. Tychan's TY027, a fully engineered human IgG, is one of the first few biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. Preliminary data from our phase 1 healthy volunteer trial (SCT-001; ClinicalTrials.gov Identifier NCT04429529) reveals that TY027 is safe & well-tolerated up to 20 mg/kg tested. A total of 10 adverse events (AEs) were observed, all were of mild in intensity with none resulting in subject withdrawal from the study. There were no serious adverse events & no clinically relevant trends in mean clinical laboratory, physical examinations, vital signs or ECG results were observed. Pharmacokinetic profile of subjects across dose cohorts 1 - 4, up to Day 14, were comparable to those typical of human IgG1 antibody with serum concentrations declining in a biphasic manner. Exposure of TY027, based on Cmax, increased in a linear & generally dose proportional manner. It is anticipated that TY027, when administered to acutely infected COVID-19 patients, could reduce disease severity. It may potentially also be used as a prophylaxis against COVID-19 amongst high risk contacts.
Description: Proportion of COVID-19 patients with disease progression, defined as progression to score 4 and below on the COVID Scale, within the first 14 days after a single dose IV infusion of TY027 as compared to placebo
Measure: To evaluate the efficacy of a single dose intravenous (IV) infusion of TY027 in reducing disease progression, defined as progression to score 4 and below on COVID scale Time: Within the first 14 daysDescription: Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients after a single dose IV infusion of TY027 as compared to placebo
Measure: Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients Time: 28 daysDescription: All cause mortality rate by Day 28 in COVID-19 patients who receive a single dose IV infusion of TY027 as compared to placebo
Measure: All cause mortality rate Time: 28 daysDescription: Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale at Day 7, Day 14 and Day 28
Measure: Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale Time: Up to Day 28Description: Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) after a single dose IV infusion of TY027 as compared to placebo up to Day 28
Measure: Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) Time: 28 daysDescription: Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 3, Day 5, Day 7, Day 14 and Day 28 after a single dose IV infusion of TY027 as compared to placebo
Measure: Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) Time: Up to Day 28Description: Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR, at Day 7 post-dose or day of discharge, whichever is earlier, as compared to baseline between study groups
Measure: Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR Time: Day 7 post-dose or day of discharge, whichever is earlierThe study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline).
Description: Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio inspired oxygen- P:F ratio (PaO2:FiO2), a higher value indicates better oxygenation. Range 20 to 500.
Measure: Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio Time: change from baseline compared to one to six hours after initial device interventionDescription: Improved symptoms related to dyspnea as measured by the change in the Modified Medical Research Council (MMRC).. Range 0 to 4 with lower values being better.
Measure: Subject dyspnea symptoms Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)Description: Improved symptoms related to cough as measured by the change in Leicester Cough Questionnaire (LCQ) questionnaire, score range 3-21, a higher score indicates better quality of life.
Measure: Subject cough symptoms Time: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patientsDescription: Improve subjective symptoms related to cough as measured by the change in St George Respiratory Questionnaire (SGRC) questionnaire, score range 0-100, a higher score indicates worse quality of life.
Measure: Subject respiratory symptoms Time: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patientsDescription: Reduce risk of respiratory deterioration as measured by change from baseline to end of hospitalization (discharge or patient death) to high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or invasive ventilation
Measure: Reduced risk progression of respiratory deterioration Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)Description: Reduced intensive care unit (ICU) transfer risk, as measured by a change from baseline to end of hospitalization of ICU admission.
Measure: Reduced risk of ICU transfer Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)Description: Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death)
Measure: Reduced risk for intubation Time: baseline to end of hospitalization, (discharge from hospital, or death, 1 - 30 days range)Description: Reduced hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.
Measure: Reduced hospitalization length of stay Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)Description: Increased patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)
Measure: Increased patient survival to discharge Time: baseline to end of hospitalization, (discharge from hospital- 1 - 30 days expected range)As a direct consequence of the COVID-19 pandemic, it is assumed that the number of patients with COVID-19-related disabilities will increase significantly. Patients with mild, severe, and critical forms of the disease show long-term sequelae in different systems (respiratory, muscular, psychological, cognitive etc.). Persistent dyspnea is a frequently described symptom after the acute phase of the disease. Coupled with reduced oxygen saturation, an increased risk of developing lung fibrosis has been observed. Specialized rehabilitation medicine (e.g. pulmonary rehabilitation) might counteract these long-term consequences and therefore seems to be a promising approach to treat long-term COVID-19 consequences. Further, there is scarce evidence about COVID-19 specific rehabilitation contents. It was suggested to use treatment regimes in analogy to patients with idiopathic pulmonary fibrosis. There is evidence that pulmonary rehabilitation improves physical performance, quality of life and reduces anxiety and depression symptoms in patients with idiopathic pulmonary fibrosis and other chronic respiratory diseases. Since impairments related to idiopathic pulmonary fibrosis also play an important role in COVID-19, the aim of this study is to evaluate the short and medium-term effects of a standardized 3-week pulmonary rehabilitation program. The results will be analyzed within the two cohorts (mild/moderate and severe/critical COVID 19) as well as between the two cohorts for the primary outcome. Furthermore, the effects of pulmonary rehabilitation will be compared with a retrospective cohort of idiopathic pulmonary fibrosis.
Description: measure in meter
Measure: Change in 6-minute walk distance Time: Day 1 and day 21 of pulmonary rehabilitationDescription: measure provided in seconds
Measure: change in endurance shuttle walk distance Time: Day 1 and day 21 of pulmonary rehabilitationDescription: measure provided in % predicted
Measure: Change in Diffusion capacity of the lungs for Carbon monoxide Time: Day 1 and day 21 of pulmonary rehabilitationDescription: measure provided in % predicted
Measure: Change in Forced Vital Capacity Time: Day 1 and day 21 of pulmonary rehabilitationDescription: measure provided in % predicted
Measure: Change in total lung capacity Time: Day 1 and day 21 of pulmonary rehabilitationDescription: score ranges from 0 to 30 with lower score indicating higher cognitive impairment
Measure: change in Montreal cognitive assessment test Time: Day 1 and day 21 of pulmonary rehabilitationDescription: score ranges from 0 to 100 with higher scores indicating better Quality of life
Measure: change in short-form 36 question health survey Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: A questionnaire designed to measure self-reported physical, mental and social health and wellbeing. Higher scores represent worse symptomatology in relation to the mean value of 50 points with a standard deviation of 10 points.
Measure: change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: score ranges from 0 to 21 with higher scores indicating more severe anxiety
Measure: Change in the scale of general anxiety disorder - 7 questionnaire (GAD-7) Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: score ranges from 0 to 27 with higher scores indicating more severe depression
Measure: Change in the scale of the patient health questionnaire - Depression (PHQ-D) Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: patients will be asked if they still perceive COVID-19 related dyspnea: answer possibilities yes or no
Measure: Change in prevalence of COVID-19 related dyspnea Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: patients will be asked if they still perceive COVID-19 related cough: answer possibilities yes or no
Measure: Change in prevalence of COVID-19 related cough Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: patients will be asked if they still perceive COVID-19 related cognitive impairment: answer possibilities yes or no
Measure: Change in prevalence of COVID-19 related cognitive impairment Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: patients will be asked if they still perceive COVID-19 related loss of appetite: answer possibilities yes or no
Measure: Change in prevalence of COVID-19 related loss of appetite Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: scale from 1 (worst) to 10 (best)
Measure: Change in general perceived well-being Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitationDescription: in mg/l
Measure: change in D-Dimer level Time: Day 1 and day 21 of pulmonary rehabilitationDescription: in mg/l
Measure: change in c-reactive protein level Time: Day 1 and day 21 of pulmonary rehabilitationDescription: in g/l
Measure: change in leukocytes level Time: Day 1 and day 21 of pulmonary rehabilitationDescription: in g/dl
Measure: change in hemoglobin level Time: Day 1 and day 21 of pulmonary rehabilitationDescription: in pg/ml
Measure: change in troponin level Time: Day 1 and day 21 of pulmonary rehabilitationDescription: in pg/ml
Measure: change in pro-brain natriuretic peptide level Time: Day 1 and day 21 of pulmonary rehabilitationBreath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath. In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
Surfactant protein plays important role in innate immunity against respiratory viral infections. However, investigators have shown that the surfactant protein polymorphisms are associated with severity of various pulmonary diseases such as respiratory syncytial virus (RSV), tuberculosis, pediatric acute lung injury. COVID-19 virus gains entry through the respiratory system and responsible for death due to acute respiratory failure. There is a considerable heterogeneity in presentation of COVID-19 infection from asymptomatic patients to severe infection requiring intensive care and some may die. Considering reports of COVID-19 related deaths/severe disease in the same family, it is possible that genetics play an important role in severity of COVID-19 infection. Investigators propose to study the association of surfactant proteins in COVID-19 patients. Key Objectives: a) Characterize genetic markers within the surfactant protein genes in COVID-19 positive patients, b) To determine if there is a correlation between certain genetic markers and the severity of COVID-19 infection which may be used as a prognostic marker, c) To correlate genetic markers with immune studies.
The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray. HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery. The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill.
Description: The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 at day 7.
Measure: Viral load of SARS-CoV-2 Time: up to one weekDescription: The temporal profile of viral load at baseline, day 7, 14 and 28
Measure: The temporal profile of viral load of SARS-CoV-2 Time: up to four weeksDescription: The proportion of patients with virological clearance at day 14 and 28
Measure: The proportion of patients with virological clearance Time: up to four weeksDescription: Increasing SaO2, day 7, 14 and 28
Measure: SaO2 Time: up to four weeksDescription: The hospitalization duration stay
Measure: hospitalization stay Time: through study completion, an average of 3 monthsDescription: Intensive care admission and time to
Measure: Intensive care Time: through study completion, an average of 3 monthsDescription: The COVID-19 Severity Score at day 14 and 28 Score definition: 1 is "no limitation of activities"; 2 is "limitation of activities"; 3 is "hospitalized, no oxygen therapy"; 4 is " hospitalized, oxygen by mask or nasal prongs"; 5 is "non-invasive ventilation or high-flow oxygen"; 6 is "intubation and mechanical ventilation"; 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Measure: COVID-19 Severity Score Time: up to four weeksDescription: Death occurred during hospitalization.
Measure: in-hospital mortality Time: through study completion, an average of 3 months- organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23 - Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25 - Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27 - Additional study using this technique is warranted to look at reliability and cost-28 effectiveness
Description: The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.
Measure: COVID-19 symptom development with positive PCR test Time: within 14 daysDescription: Development of a positive coronavirus PCR test without symptoms by Day 14
Measure: Positive coronavirus PCR test without symptoms Time: By Day 14 (end of study)Description: hospital admission for COVID-19 symptoms by Day 14
Measure: Hospital admission for COVID-19 Time: within 14 days of study entryDescription: Death due to COVID-19 within 14 days of study entry
Measure: Death by Day 14 Time: within 14 days of study entryDescription: All-cause discontinuation of study medication or study withdrawal by Day 14
Measure: HCQ discontinuation or study withdrawal Time: within 14 days of study entryDescription: overall symptom severity at Day 7 and Day 14
Measure: Symptom severity at specified time points Time: at Day 7 and at Day 14 from study entryDescription: household attack rate at study entry
Measure: COVID -19 rate at study entry Time: Day 1 of studyDescription: documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy
Measure: EKG changes during study Time: Day 1 thru Day 14 of studyThis will be a randomized, open-label study to determine if camostat or camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat (Arm 2) or with camostat and bicalutamide (Arm 3).
Description: Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Measure: Number of participants requiring hospitalization Time: up to 28 daysDescription: Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Measure: Number of drug-related adverse events Time: up to 60 daysDescription: Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Measure: Number of drug-related serious adverse events Time: up to 60 daysDescription: Number of participants deceased.
Measure: All-cause mortality Time: up to 60 daysDescription: Number of calendar days in the hospital
Measure: Duration of hospitalization Time: up to 60 daysDescription: Number of calendar days in IMC unit
Measure: Duration of IMC stay Time: up to 60 daysDescription: Number of calendar days in ICU
Measure: Duration of ICU stay Time: up to 60 daysDescription: Number of calendar days requiring mechanical ventilation
Measure: Duration on mechanical ventilation Time: up to 60 daysThe SARS-Cov2 pandemic remains associated with many concerns. One of the them is the real frequency of likely re-infection and subsequently the level of protection conferred by the acquired immunity following primary-infection. We propose to analyze a large set of laboratory data produced since the early beginning of the SARS-Cov2 spread in the French population to identify recurrent infection events and, more generally, gain insight about infection kinetics.
Description: SARS-CoV-2 reinfection rate
Measure: SARS-CoV-2 reinfection rate Time: 1 dayThe prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing
Description: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis
Measure: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis Time: 1 dayDescription: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.
Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments. Time: 1 dayDescription: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease
Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease Time: 1 dayDescription: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics
Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics Time: 1 dayThis study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Description: The geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 , 120±14 and 180±14 days after the first dose
Measure: SARS-CoV-2 glycoprotein-specific antibodies titer Time: 42±4 , 120±14 and 180±14 daysDescription: Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4, 120±14 and 180±14 days after the first dose
Measure: Seroconversion rate Time: 42±4, 120±14 and 180±14 daysDescription: Interferon gamma concentration in response to S protein after re-stimulation with the SARS-CoV-2 glycoprotein in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Measure: IFN-gamma antigen-specific release Time: 28±4 daysDescription: The number of proliferating CD4 and CD8 cells in response to antigen stimulation in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Measure: CD4+/CD8+ proliferating cells Time: 28±4 daysDescription: Geometric mean virus-neutralizing antibodies titer in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 and 120±14 days after the first dose
Measure: Virus-neutralizing antibodies titer Time: 42±4 and 120±14 daysDescription: Incidence and severity of adverse events in trial subjects within 4 & 6 months after injecting the first dose of the study vaccine/placebo.
Measure: Incidence and severity of adverse events Time: within 4 & 6 monthsThis expanded access protocol will provide access to the investigational product ZofinTM (OrganicellTM Flow) for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease.
In the context of COVID-19 pandemic, identifying low-risk patients who can be safely treated at home and high-risk patients requiring hospitalization or even intensive care is crucial for Emergency Departments. Thanks to a consensus of experts using the Delphi method, we previously defined the HOME-CoV rule. The HOME-CoV rule consists of 8 items precluding home treatment for patients consulting in the Emergency Department (ED) with confirmed or highly suspected mild to moderate COVID-19. It has been validated in a prospective study, patients with a negative rule having a very-low rate of invasive ventilation or death within the 7 days following ED presentation (HOME-CoV study, NCT: 02811237). Using logistic regression, we revised the HOME-CoV rule in order to define a score allowing. The revised HOME-CoV score comprises 7 criteria and, retrospectively assessed in the database of the HOME-CoV study, it exhibits promising performances. A revised HOME-CoV score < 2 had a sensitivity of 0.93 (0.84 to 0.98), a specificity of 0.60 (0.58 to 0.61) and negative predictive value of 1.00 (0.99 to 1.00); and a score > 4 had a sensitivity of 0.41 (0.28 to 0.54), a specificity of 0.93 (0.92 to 0.94) and a positive predictive value of 0.11 (0.07 to 0.16). The present study aims to prospectively validate the revised HOME-CoV score, firstly, in identifying a subgroup of COVID-19 patients with a low risk of evolution to severe COVID-19 and who could be safely treated at home. For this purpose, we will perform an interventional multicentric prospective pragmatic cohort study with implementation of the revised HOME-CoV score to triage COVID-19 patients.
Description: The rate of patients with evolution to severe COVID-19 within 7 days after inclusion among patients with a revised HOME-CoV score <2. Severe COVID-19 is defined as a WHO-OSCI≥5, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7), or all-cause death (8). The revised HOME-CoV score strategy will be considered as safe if the rate of patients who experienced a WHO-OSCI≥5, will be ≤0.5% with an upper limit of the 95% confidence interval ≤1%.
Measure: The safety of the revised HOME-CoV score strategy for home treatment Time: 7 daysDescription: The rate of patients treated at home,i.e., discharged home within 24 hours following inclusion.
Measure: The efficacy of the revised HOME-CoV score strategy for home treatment Time: 24 hoursDescription: the rate of patients treated at home, i.e., discharged home within 24 hours following inclusion, among patients with a revised HOME-CoV score <2
Measure: The applicability of the revised HOME-CoV score strategy for home treatment Time: 24 hoursDescription: The rate of patients with a revised HOME-CoV score < 2 and treated at home who were not subsequently hospitalized within the 7 days following inclusion.
Measure: The reliability of the revised HOME-CoV score strategy for home treatment Time: 7 daysDescription: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs. 7 days
Measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5. Time: 7 daysDescription: The rate of patients with a WHO-OSCI≥6 within the 7 days following inclusion, i.e., intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.
Measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6 Time: 7 daysDescription: The rate of patients who dead within the 7 days following inclusion The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.
Measure: The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19 Time: 7 daysDescription: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.
Measure: Subgroup analysis in patients with confirmed COVID-19 (positive SARS-CoV2 RT-PCR) of the predictive performances of the revised HOME-CoV score Time: 7 daysDescription: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC)
Measure: The predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19 Time: 7 daysDescription: The rate of symptomatic and objectively confirmed deep venous thromboembolism or pulmonary embolism, and of unexplained sudden death occurring within the 7 days following ED admission.
Measure: Venous thrombo-embolism in COVID-19 patients (ancillary study) Time: 7 daysA randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study to evaluate the efficacy and safety of glenzocimab in ARDS.
Description: Progression from moderate to severe assessed at Day 4 is a composite failure endpoint defined as the occurrence of at least one of the following failure events : Respiratory rate (RR) ≥ 30/min, or Oxygen Saturation (SpO2) ≤ 93% in resting state, or Oxygen Pressure/ Inspired fraction (PaO2/FiO2) ≤ 200mmHg Death occurring prior to or on Day 4
Measure: Progression from moderate to severe respiratory distress assessed at Day 4 Time: Day 4Description: WHO COVID-19 Ordinal Scoring Scale is 9 point ordinal scale
Measure: WHO-COVID-19 Scale Time: Up to Day 40Description: Determines the degree of illness of a patient and prompts critical care intervention (recommended by NHS over original NEWS): total possible score ranges from 0 to 20. The higher the scores the greater the clinical risk.
Measure: NEWS-2 Scale Time: Up to Day 40Description: Respiratory Rate status defined as:: o Normal:<20/min, Mild:20/min≤RR<24/min, Moderate:24/min≤RR<30/min, o Severe:≥30/min, Death.
Measure: Respiratory Rate status (RR) Time: Up to Day 40Description: Hypoxemia status defined as:: o Normal:>300mmHg,
Mild: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg,
Moderate:100mmHg
Description: SpO2 status defined as: o Normal:>95%
Mild:93%
Description: Changes in one or several of the usual ECG parameters compared to baseline or screening, i.e. sinusal rhythm, cardiac axis, QRS value, QT/QTc segment, Wave direction, and any abnormality.
Measure: ECG over the course of the study versus screening Time: Up to Day 40The American Society of Clinical Oncology (ASCO) Survey on Coronavirus 2019 (COVID-19) in Oncology Registry (ASCO Registry) aims to help the cancer community learn more about the patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how COVID-19 is impacting the delivery of cancer care and patient outcomes. The ASCO Registry is designed to collect both baseline and follow-up data on how the virus impacts cancer care and cancer patient outcomes during the COVID-19 pandemic and into 2021.
Description: Treatments: Yes vs. no response to changes in reported treatment administration for anti-cancer therapeutics
Measure: Changes to Cancer Treatments Time: 12 monthsDescription: Any patient deaths that occurred as measured by number of days after COVID-19 diagnosis
Measure: All-cause mortality at 30 days Time: 30 daysDescription: Yes vs. no response to reported COVID-19 symptoms
Measure: COVID-19 Symptoms Time: 12 monthsDescription: Yes vs. no response to reported treatment administration for anti-COVID-19 therapeutics
Measure: COVID-19 Treatments Time: 12 monthsDescription: Alive vs. dead at 12 months from COVID-19 diagnosis
Measure: Patient vital status Time: 12 monthsDescription: Time to event endpoint measured as the time from covid-19 dx to death, censored at the last time patient was known to be alive if there is no death date provided.
Measure: Overall survival Time: 12 monthsDescription: Categorical variable of cancer status, compared to time at COVID-19 diagnosis (stable, responding to therapy, progressed). This will be measured over time (longitudinally) and can take different values for the same patient at different time points.
Measure: Patient cancer status (for patients who had active cancer at covid-19 dx) Time: 12 monthsDescription: An indicator (yes v no) of whether the patients cancer has relapsed since COVID-19 diagnosis. This will be measured over time (longitudinally) and can take different values for the same patient at different time points.
Measure: Patient cancer status (for patients who are disease-free at COVID-19 diagnosis) Time: 12 monthsThe current global pandemic at COVID-19 is a major public health issue. Transmission of the virus is primarily through direct and close person-to-person contact. The protection of health care personnel and the limitation of transmission of nosocomial COVID is paramount. Protective measures have already shown their effectiveness in limiting the spread of the virus: the use of masks, the wearing of protective gowns, the wearing of protective eyewear, social and physical distancing. A recent U.S. study (Rhee et al. JAMA 2020) reported a very low incidence of 1.7% of nosocomial COVID, but this was achieved with the application of rigorous infection risk management protocols. In addition to the widespread use of masks and protective measures, dedicated COVID units had been created, with air treatment. The implementation of these dedicated units requires the mobilization of considerable human and material resources, which is not feasible in all hospitals over the long term. In view of the second wave of the epidemic in France, with the rising numbers of new cases of COVDI-19 admitted to intensive care units since the end of the summer 2020, it is essential to organize the intensive care units to ensure the protection of personnel and limit the risk of nosocomial COVID-19, while continuing to care for non-COVID patients. In Intensive Care unit (ICU) at the Nantes University Hospital, a strict protocol for the management of suspected or confirmed COVID patients has been in place since early september 2020. The objective of this study is to evaluate the effectiveness of this protocol for managing the infectious risk of SARS-COV-2 on the incidence of nosocomial COVID in patients admitted in ICU. The secondary objectives are to evaluate the incidence of nosocomial-associated COVIDs contracted by caregivers, and the incidence of asymptomatic positive SARS-CoV-2 cases in ICU.
Description: Occurence of a nosocomial COVID-19 that is certain or probable. Community-acquired certain and probable COVIDs will be excluded from the main analysis. The incidence rate of nosocomial COVID will be expressed in patient-days: Ratio of the number of patients with nosocomial COVID to the sum of exposure times, i.e. : for patients without nosocomial COVID: duration of hospitalization in ICU for patients presenting with nosocomial COVID: delay between the date of the start of hospitalization in ICU and the occurrence of nosocomial COVID.
Measure: Incidence of nosocomial COVID-19 Time: up to 6 monthsDescription: Prevalence of community-acquired COVID that is certain and Prevalence of community-acquired COVID that is probable. Prevalence of nosocomial and community-acquired COVID in healthcare workers. Prevalence will be defined as the ratio of the number of caregivers developing a COVID to the number of caregivers working in ICU during the inclusion period. Prevalence of patients with SARS-CoV-2 positive samples but asymptomatic in ICU. Risk factors to development a nosocomial COVID (certain and probable).
Measure: Occurrence of a nosocomial COVID-19 that is certain and Occurrence of a nosocomial COVID-19 that is probable. Time: up to 12 monthsDescription: ICU nosocomial infections rates (ventilator associated acquired pneumonia) Highly resistant bacteria colonization and infection acquired in ICU
Measure: evaluate the occurence Time: up to 12 monthsThis research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.
Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: Interleukin 1-Beta (IL-1B) (pg/mL) Time: Through study completion - up to 12 monthsDescription: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: Interleukin 6 (IL-6) (pg/mL) Time: Through study completion - up to 12 monthsDescription: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: C-reactive protein (CRP) (mg/mL) Time: Through study completion - up to 12 monthsDescription: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: Tumour Necrosis Factor Alpha (TNFa) (pg/mL) Time: Through study completion - up to 12 monthsDescription: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: Neutrophil to Lymphocyte Ratio (NLR) (absolute neutrophils/lymphocytes) Time: Through study completion - up to 12 monthsDescription: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: Serum Ferritin (ng/mL) Time: Through study completion - up to 12 monthsDescription: Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: International Normalized Ratio (INR) Time: Through study completion - up to 12 monthsDescription: Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)
Measure: Prothrombin Time (PTT) Time: Through study completion - up to 12 monthsDescription: ROTEM coagulation assessment using the commercial ROTEM device traditionally used for the assessment of coagulopathy, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point).
Measure: Rotational Thromboelastometry (ROTEM) Time: Through study completion - up to 12 monthsDescription: Number of continuous calendar days or partial calendar days including treatment with invasive ventilation.
Measure: Total duration of mechanical ventilation (number of days) Time: Through study completion - up to 12 monthsDescription: Number of continuous calendar days or partial calendar days admitted to an acute care hospital.
Measure: Intensive Care Unit Length of Stay (number of days) Time: Through study completion - up to 12 monthsDescription: Number of continuous calendar days or partial calendar days admitted to an acute care hospital.
Measure: Hospital Length of Stay (number of days) Time: Through study completion - up to 12 monthsThis is a protocol aimed at children and adolescents contaminated with COVID, treated at the Hospital das Clínicas, University of Sao Paulo, Brazil (HCFMUSP), in the recovery phase. The study aims to evaluate the spectrum of pathogenic lesions of the virus not only in the respiratory system, but digestive, immunological, neurological and others. Clinical, evolutionary, laboratory and functional parameters will be used.
Description: The instrument was translated and validated for the Brazilian population
Measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL) Time: Change from Baseline at 3 monthsDescription: The instrument was translated and validated for the Brazilian population
Measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL) Time: Change from Baseline at 6 monthsDescription: Aims to investigate the mechanisms that lead to dyspnea and, consequently, intolerance to physical effort
Measure: Flow-volume loop assessed by spirometry Time: Baseline, 3 months, 6 monthsDescription: It will also be assessed for school-age children (7-10 years old) and adolescents (11-18 years old) and by their primary caregiver
Measure: Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument Time: Baseline, 3 months, 6 months, 12 monthsDescription: Patchy ground-glass opacities, crazy-paving pattern, and localization and pattern of large, confluent or small nodular lesions will be assessed
Measure: Lung abnormalities will be assessed by pulmonary computed tomography Time: Baseline, 3 months, 6 months, 12 monthsDescription: Conventional transthoracic echocardiogram with color Doppler to assess systolic and diastolic function
Measure: Systolic and diastolic function will be assessed by echocardiogram Time: Baseline, 3 months, 6 months, 12 monthsDescription: Conventional transthoracic echocardiogram with color Doppler to search for valve dysfunction
Measure: Valve dysfunction will be assessed by echocardiogram Time: Baseline, 3 months, 6 months, 12 monthsDescription: Conventional transthoracic echocardiogram with color Doppler to search for pericardial effusion
Measure: Pericardial effusion will be assessed by echocardiogram Time: Baseline, 3 months, 6 months, 12 monthsDescription: Conventional transthoracic echocardiogram with color Doppler to search for aspects of the coronary arteries
Measure: Coronary arteries will be assessed by echocardiogram Time: Baseline, 3 months, 6 months, 12 monthsDescription: Echocardiogram with two-dimensional speckle-tracking technique to identify subclinical changes suggestive of ischemia or myocarditis
Measure: Ischemia will be assessed by echocardiogram Time: Baseline, 3 months, 6 months, 12 monthsDescription: Baseline levels of cytokines IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-y, and IL-17A in serum samples will be tested by flow cytometry using the CBA technique (Cytometric bead array, BD Biosciences)
Measure: Immunocompetence, including thymic function Time: Baseline, 3 months, 6 months, 12 monthsDescription: T cell lineages: CD3CD4, CD3CD8, naive cells (CD45RA+), memory cells (CD45RA-), effector cells (CD38+HLADR+)
Measure: Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry Time: Baseline, 3 months, 6 months, 12 monthsDescription: B cell lineages: CD19, naive cells (CD27-), memory cells (CD27+), plasmablasts (CD27+CD38+CD138-), (plasmocytes CD27+CD38+CD138+)
Measure: Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry Time: Baseline, 3 months, 6 months, 12 monthsDescription: NK cells: (CD3-CD16+CD56+), degranulated: CD107a+
Measure: Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry Time: Baseline, 3 months, 6 months, 12 monthsDescription: The antipneumococcal antibody titer against 6 polysaccharides (serotypes 1, 5, 6B, 9V, 14, and 18C) will be analyzed by ELISA. The seroconversion criteria is IgG values > 1.3 mg/mL for each polysaccharide assessed
Measure: Anti-pneumococcal vaccine response will be assessed by ELISA Time: Baseline, 3 months, 6 months, 12 monthsDescription: TRECs evaluate the peripheral function of the thymus from cells that have recently been released, using the RT-PCR technique
Measure: Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles) Time: Baseline, 3 months, 6 months, 12 monthsDescription: (anti-thyroperoxidase antibodies, anti-thyroglobulin)
Measure: Changes in frequency of the autoantibodies of the thyroid gland Time: Baseline, 3 months, 6 months, 12 monthsDescription: According to the gene sequence studied, the analysis will be performed using the Sanger sequencing technique with capillary electrophoresis in a 3130 automatic sequencer (Applied Biosystems). The genetic polymorphisms of the ABO system gene (rs505922), two polymorphisms of the OPRM1 gene (rs1799971 and rs1799972) and a polymorphism of the BDNF gene (rs6265) will be investigated, with possible contributions to the risk of impaired gait.
Measure: Genetic Polymorphism Analysis will be assessed by salting out methodology followed by q-PCR (Real-time PCR) using the TaqMan assay using Step One Plus equipment Time: Baseline, 3 months, 6 months, 12 monthsDescription: This is an 18-item parent questionnaire for children and adolescents (18 years and younger). This rating scale includes positive "weaknesses" and negative "strengths" scoring, assessing symptoms of Attention-Deficit/Hyperactivity Disorder. Parents are asked to compare their child's behavior in a variety of settings over the past month to other children on a 7-point: 3-Far below, 2-Below, 1-Slightly below, 0-Average, -1-Slightly average, -2-Above, -3-Far above. Higher scores indicate greater symptomology
Measure: Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors" Time: Baseline, 3 months, 6 months, 12 monthsDescription: The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire, and includes 25 items on psychological attribute: emotional symptoms (5 items), conduct problems (5 items) hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behaviour (5 items). Higher scores indicate greater difficulties
Measure: Mental health will be assessed by the "Strengths and Difficulties Questionnaire" Time: Baseline, 3 months, 6 months, 12 monthsDescription: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress (7 items each subscale). Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores for the total DASS-total scale range between 0 and 120. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".
Measure: Mental health will be assessed by the "Depression, Anxiety and Stress Scale" Time: Baseline, 3 months, 6 months, 12 monthsDescription: ActivPAL will be used for 7 days for at least 10 hours/day
Measure: Physical activity levels assessed by ActivPAL Time: Baseline, 3 months, 6 months, 12 monthsDescription: 24-hour recalls will be assessed on three non-consecutive days (two weekdays, and one weekend). Online Dietbox will be used.
Measure: Food consumption levels assessed by food records Time: Baseline, 3 months, 6 months, 12 monthsDescription: Baseline blood flow measurements will be assessed in the brachial artery
Measure: Blood flow will be assessed using a Doppler Ultrasound Time: Baseline, 3 months, 6 months, 12 monthsDescription: Flow-mediated vasodilation (VMF) will be assessed in the brachial artery
Measure: Endothelial function will be assessed using a Doppler Ultrasound Time: Baseline, 3 months, 6 months, 12 monthsThe first case of COVID-19 was identified on December 19 and the world is actually experiencing a pandemic. The surgical procedure in patients with SARS-CoV-2 infection involves the exposure of other patients and the group of health workers who face the care of the patient. Thus, screening with lung ultrasound is an alternative to identify patients with an established or suspected infection that requires urgent surgery. Therefore, the aim of this study is to determinate the operational characteristics of lung ultrasound during the screening process for SARS-CoV-2 infection in patients with an indication for urgent surgery.
Description: To identify the best cut-off point from lung ultrasound that allows the discrimination of suspected cases of active SARS-CoV-2 infection in patients undergoing an emergency surgical procedure since May 2020 at Fundación Valle del Lili Hospital, Cali, Colombia.
Measure: The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection Time: 14 daysDescription: Identify the prevalence of active SARS-CoV-2 infection in the group of patients undergoing an emergency surgical procedure.
Measure: Prevalence of active SARS-CoV-2 infection Time: 14 daysDescription: Calculate the operational characteristics of lung ultrasound for the diagnosis of SARS-CoV-2 infection in the studied group of patients.
Measure: Operational characteristics of lung ultrasound Time: 14 daysDescription: Calculate the operational characteristics of each of suspicious lung ultrasound findings for the diagnosis of SARS-CoV-2 infection in the group of patients studied
Measure: Operational characteristics of each of suspicious lung ultrasound findings Time: 14 daysDescription: Identify the cut-off point resulting from the lung ultrasound score that discriminates between patients with suspected active SARS-CoV-2 infection.
Measure: Cut-off point resulting from the lung ultrasound score Time: 14 daysThis Phase 2 study design will confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. Subjects will be followed for durability of the immune responses for a period of 12 months after the last vaccination.
Description: Percentage, intensity, and relationship to vaccination of immediate AEs
Measure: Immediate adverse event (AEs) Time: 30 minutesDescription: Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
Measure: Solicited local and systemic adverse events (AEs) Time: 7 daysDescription: Percentage, intensity, and relationship of unsolicited AEs
Measure: Unsolicited adverse events (AEs) Time: 21 daysDescription: Number of subjects with normal and abnormal clinically significant urine values
Measure: Number of subjects with normal and abnormal clinically significant urine values Time: 3 daysDescription: Percentage of subjects with normal and abnormal clinically significant urine values
Measure: Percentage of subjects with normal and abnormal clinically significant urine values Time: 3 daysDescription: Number of subjects with normal and abnormal clinically significant haematological values
Measure: Number of subjects with normal and abnormal clinically significant haematological values Time: 3 daysDescription: Percentage of subjects with normal and abnormal clinically significant haematological values
Measure: Percentage of subjects with normal and abnormal clinically significant haematological values Time: 3 daysDescription: Number of subjects with normal and abnormal clinically significant biochemical values
Measure: Number of subjects with normal and abnormal clinically significant biochemical values Time: 3 daysDescription: Percentage of subjects with normal and abnormal clinically significant biochemical values
Measure: Percentage of subjects with normal and abnormal clinically significant biochemical values Time: 3 daysDescription: Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Measure: Serious adverse events (SAEs), Medically attended adverse event (MAAE), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: 21 daysDescription: Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 21Description: Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 42Description: Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Neutralizing antibody Seroconversion (SC) rate response Time: Day 21Description: Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Neutralizing antibody Seroconversion (SC) rate response Time: Day 42Description: Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 21Description: Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 42Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Specific Th1 cell-mediated immunity (CMI) response Time: Day 21Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Specific Th1 cell-mediated immunity (CMI) response Time: Day 42Description: Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Measure: Serious adverse events (SAEs), Medically attended adverse event (MAAE), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths Time: Day 43 to 386Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 128Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 201Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Neutralizing antibody Geometric mean titers (GMT) response Time: Day 386Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Neutralizing antibody Seroconversion (SC) rate response Time: Day 128Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Neutralizing antibody Seroconversion (SC) rate response Time: Day 201Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Neutralizing antibody Seroconversion (SC) rate response Time: Day 386Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 128Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 201Description: Persistence of Nab antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Neutralizing antibody Geometric mean fold rise (GMFR) response Time: Day 386Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Specific antibody (IgG) response Time: Day 21Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus measured by the total IgG levels
Measure: Specific antibody (IgG) response Time: Day 42Description: Specific antibody response CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Specific antibody Geometric mean titers (GMT) response Time: Day 128Description: Specific antibody response CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Specific antibody Geometric mean titers (GMT) response Time: Day 201Description: Specific antibody response CoV-2 virus analyzed, using the following parameters: Geometric mean titers (GMT)
Measure: Specific antibody Geometric mean titers (GMT) response Time: Day 386Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Specific antibody Seroconversion (SC) rate response Time: Day 128Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Specific antibody Seroconversion (SC) rate response Time: Day 201Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Seroconversion (SC) rate
Measure: Specific antibody Seroconversion (SC) rate response Time: Day 386Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Specific antibody Geometric mean fold rise (GMFR) response Time: Day 128Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Specific antibody Geometric mean fold rise (GMFR) response Time: Day 201Description: Specific antibody response induced in each Study Population against the SARS-CoV-2 virus analyzed, using the following parameters: Geometric mean fold rise (GMFR)
Measure: Specific antibody Geometric mean fold rise (GMFR) response Time: Day 386Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 21Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 42Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 128Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 201Description: The ratio of neutralizing antibody titers:IgG ELISA antibody titers
Measure: Neutralizing antibody titers: IgG ELISA antibody titers Time: Day 386Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Specific Th1 cell-mediated immunity (CMI) response Time: Day 201Description: Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IFN-γ ELISpot
Measure: Specific Th1 cell-mediated immunity (CMI) response Time: Day 386Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Specific Th2 cell-mediated immunity (CMI) response Time: Day 21Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Specific Th2 cell-mediated immunity (CMI) response Time: Day 42Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Specific Th2 cell-mediated immunity (CMI) response Time: Day 201Description: Specific Th2 CMI response induced in each Study Population against the SARS-CoV-2 virus; as measured by IL-4 (ELISpot)
Measure: Specific Th2 cell-mediated immunity (CMI) response Time: Day 386Description: Percentage of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARS-CoV-2 infection
Measure: Laboratory-confirmed asymptomatic SARS-CoV-2 infection Time: Day 35 to 386Description: Percentage of severe COVID-19 disease
Measure: Severe COVID-19 disease Time: Day 35 to 386Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.
Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record
Measure: Describe the aetiology of influenza-like illness in hospitalised adults Time: Day 0 to Day 28Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.
Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults Time: Day 0 to Day 28Description: Cytokine levels (in pg/mL) will be measured in plasma and nasal lining fluid samples by MesoScale Discovery
Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults Time: Day 0 to Day 28The investigators aim to develop expert consensus statements on infection control management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in intensive care units (ICU).
Description: Survey questionnaire with seven point Likert scale (1-3 means disagreement and 5-7 means agreement) and multiple choice statements
Measure: Consensus using participating experts opinions. Time: 30 daysThis study focuses on the evaluation of various factors repeatedly discussed in relation to the impaired sedation of intubated ventilated COVID-19 patients. The sedation response of >100 moderately to severely affected COVID-19 ARDS was evaluated. The sedation level was measured at the bedside using the Richmond Agitation and Sedation Scale and ventilator synchrony. The evaluation was performed according to the static evaluation plan with respect to age, storage therapy and organ failure.
Description: Number of positioning therapys during treatment
Measure: Position therapy Time: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.Description: Measurement is performed using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm])
Measure: Agitation and sedation level Time: 30 minutes after study enrolmentDescription: Change of sedation level using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm])
Measure: Agitation and sedation level Time: Change in average dosage within 8 hours.Description: Applied dosage of sufentanil (measured in µg/kg/h)
Measure: Application of opioid analgesic Time: 30 minutes after study enrolmentDescription: Applied dosage of sufentanil (measured in µg/kg/h)
Measure: Change of application of opioid analgesic Time: Change in average dosage within 8 hours.Description: Applied dosage of remifentanil (measured in µg/kg/min)
Measure: Application of opioid analgesic Time: 30 minutes after study enrolmentDescription: Applied dosage of remifentanil (measured in µg/kg/min)
Measure: Change of application of opioid analgesic Time: Change in average dosage within 8 hours.Description: Applied dosage of midazolam (measured in mg/kg/h)
Measure: Application of sedative Time: 30 minutes after study enrolmentDescription: Applied dosage of midazolam (measured in mg/kg/h)
Measure: Change in sedative dosage applied Time: Change in average dosage within 8 hours.Description: Applied dosage of propofol (measured in mg/kg/h)
Measure: Application of sedative Time: 30 minutes after study enrolmentDescription: Applied dosage of propofol (measured in mg/kg/h)
Measure: Change in sedative dosage applied Time: Change in average dosage within 8 hours.Description: Applied dosage of lormetazepam (measured in mg/kg/min)
Measure: Application of sedative Time: 30 minutes after study enrolmentDescription: Applied dosage of lormetazepam (measured in mg/kg/min)
Measure: Change in sedative dosage applied Time: Change in average dosage within 8 hours.Description: Applied dosage of clonidine (measured in µg/kg/h)
Measure: Application of sedative Time: 30 minutes after study enrolmentDescription: Applied dosage of clonidine (measured in µg/kg/h)
Measure: Change in sedative dosage applied Time: Change in average dosage within 8 hours.Description: Applied dosage of Dexmethomidine (measured in µg/kg/h)
Measure: Application of sedative Time: 30 minutes after study enrolmentDescription: Applied dosage of Dexmethomidine (measured in µg/kg/h)
Measure: Change in sedative dosage applied Time: Change in average dosage within 8 hours.Description: Applied dosage of esketamine (measured in mg/kg/h)
Measure: Application of sedative Time: 30 minutes after study enrolmentDescription: Applied dosage of esketamine (measured in mg/kg/h)
Measure: Change in sedative dosage applied Time: Change in average dosage within 8 hours.Description: Age (in years)
Measure: Patient Characteristics Time: The data is recorded at the time of enrolmentDescription: Height (in centimeters)
Measure: Patient Characteristics Time: The data is recorded at the time of enrolmentDescription: Weight (in kilograms)
Measure: Patient Characteristics Time: The data is recorded at the time of enrolmentDescription: The necessity and application of a renal replacement procedure is documented
Measure: Need for renal replacement therapy Time: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.Description: The necessity and application of an extracorporeal oxygenation procedure (ECMO) is documented
Measure: Need for extracorporeal membrane oxygenation (vvECMO) Time: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.
Description: Death or endotracheal intubation
Measure: Treatment failure Time: 28 days within noninvasive respiratory support initiationDescription: Any death during hospital stay
Measure: Hospital mortality Time: Until 28 days from noninvasive respiratory support initiationDescription: Time between admission and discharge from hospital or death in hospital
Measure: Duration of hospital stay Time: Until 28 days from noninvasive respiratory support initiationThis multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1).
Description: Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Measure: Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] Time: Through Day 60Description: Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours.
Measure: To compare time to clinical recovery in CX-4945 treatment group evaluated from randomization through Day 28 as compared to the control arm. Time: Through Day 28Description: Number of days from randomization to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), normalization of respiratory rate (< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours.
Measure: To compare time to clinical recovery in CX-4945 treatment group evaluated from randomization through Day 28 as compared to the control arm. Time: Through hospital discharge, an average of 28 daysDescription: Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
Measure: To compare time to clinical recovery in CX-4945 treatment group evaluated from randomization through Day 28 as compared to the control arm. Time: Through Day 28Description: Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28.
Measure: To compare changes in clinical status of patients enrolled to CX-4945 treatment arm as compared to the control arm at Day 14 and Day 28. Time: Assessed on Day 14 and Day 28Description: Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities)
Measure: To compare changes in clinical status of patients enrolled to CX-4945 treatment arm as compared to the control arm at Day 14 and Day 28. Time: Through Day 28Description: Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28.
Measure: To evaluate preliminary evidence of anti-viral activity of CX-4945 as compared to the control arm. Time: Assessed at Day 1, Day 8, Day 14 and Day 28Description: Changes in chest imaging from Screening to Day 5 or 14
Measure: To evaluate preliminary evidence of anti-viral activity of CX-4945 as compared to the control arm. Time: Through Day 14Description: Days of hospitalization from randomization through Day 28
Measure: Number of Days Hospitalized Time: Through Day 28Description: IL-6 level
Measure: To evaluate changes in IL-6 level Time: Assessed on Days 4, 8, 11, and 14Description: CRP level
Measure: To evaluate changes in CRP Time: Assessed on Days 4, 8, 11, and 14Description: LDH level
Measure: To evaluate changes in LDH Time: Assessed on Days 4, 8, 11, and 14Description: CPK level
Measure: To evaluate changes in CPK Time: Assessed on Days 4, 8, 11, and 14Description: Ferritin level
Measure: To evaluate changes in Ferritin Time: Assessed on Days 4, 8, 11, and 14Description: D-dimer level
Measure: To evaluate changes in D-dimer Time: Assessed on Days 4, 8, 11, and 14Description: Days of supplemental oxygen (if applicable) from randomization through day 28
Measure: Number of Days of Supplemental Oxygen Use Time: Through Day 28Description: The number of deaths occurred in each treatment group from randomization through Day 60
Measure: All-cause Mortality Status Time: Through Day 60Description: Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28
Measure: Number of days of on-invasive ventilation/high flow oxygen Time: Through Day 28Description: Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28.
Measure: Number of days of invasive mechanical ventilation/ECMO Time: Through Day 28Description: Number of patients returned to room air after randomization through Day 14 or Day 28.
Measure: Number of patients returned to room air Time: Through Day 28Description: Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28
Measure: Change in pulse oxygen saturation Time: Days 4, 8, 11, 14, and 28Description: Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events from randomization through Day 28
Measure: Number of thrombosis events Time: Through Day 28Description: Changes in EQ-D5-5L (used as an indicator of symptom improvement) from randomization to Day 8, 14 and 28
Measure: Changes in EQ-D5-5L Time: Days randomization, 8, 14 and 28This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older
Description: Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination
Measure: Percentages of participants reporting solicited local adverse events Time: for 7 days following each dose administrationDescription: Adverse events reported daily in a diary that reflect generalized symptoms following vaccination
Measure: Percentages of participants reporting solicited systemic adverse events Time: for 7 days following each dose administrationDescription: spontaneously reported adverse events
Measure: Percentages of participants reporting adverse events Time: 28 days following each dose administrationDescription: unsolicited adverse events that meet the definition of serious
Measure: Percentages of participants reporting serious adverse events Time: Day 0 to Day 388Description: unsolicited adverse events that lead to healthcare provider visit
Measure: Percentages of participants reporting medically attended adverse events Time: Day 0 to Day 388Description: unsolicited adverse events associated with new diagnosis of chronic disease
Measure: Percentages of participants reporting new onset of chronic disease Time: Day 0 to Day 388Description: chemistry and hematology
Measure: Percentages of participants with abnormal chemistry and hematology values Time: Day 0 to Day 215Description: neutralizing antibody response
Measure: SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs Time: Day 0 to Day 388Description: neutralizing antibody response
Measure: Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs Time: Through Day 388Description: neutralizing antibody response
Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels Time: Through Day 388Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses
Measure: SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels, expressed as GMCs Time: Day 0 to Day 388Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses
Measure: Changes in SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs Time: Through Day 388Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses
Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels Time: Through Day 388The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. People around the United States and Canada can participate.
Description: Defined as both of the following: 1)Presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, 2)) decrease in O2 saturation (<92% on room air) and/or supplemental oxygen requirement to keep O2 saturation ≥92%).
Measure: Clinical deterioration Time: RCT-approximately 15 daysDescription: Self report post Covid Functioning using the PROMIS Global Health Scale. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point, and one 11-point, rating scales. Higher scores indicate better health.
Measure: Post Covid Functioning Time: Day 15 and Day 90This is a randomized, multicenter, placebo-controlled, double-blind clinical study in patients hospitalized due to severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
Description: To evaluate the efficacy and safety of carrimycin compared to SOC in patients hospitalized with severe SARS-CoV-2 pneumonia.
Measure: Percentage of patients alive without need for supplemental oxygen and ongoing in patient-medical care (SOC treatment for COVID-19) at Day 28 Time: At Day 28Description: To evaluate efficacy of carrimycin administered for treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. Time to recovery is defined as time point when a patient reaches level 3 or lower on the 8-Category ordinal scale and does not return to a level > 3 during the 28-day period. The 8-Category ordinal scale score ranges from 1 to 8. Score 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities, home oxygen requirement or both; 3: Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care; 4: Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care; 5: Hospitalized, requiring supplemental oxygen; 6: Hospitalized, requiring noninvasive ventilation or high flow oxygen devices; 7: Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation and score 8: Death. Higher scores indicate worse outcome.
Measure: Time to recovery Time: From screening Day (Day -2 to Day -1) until Day 28Description: To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. The 8-Category ordinal scale score ranges from 1 to 8. Score 1 indicates: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities, home oxygen requirement or both; 3: Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care; 4: Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care; 5: Hospitalized, requiring supplemental oxygen; 6: Hospitalized, requiring noninvasive ventilation or high flow oxygen devices; 7: Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) and score 8 indicates: Death. Higher scores indicate worse outcome
Measure: Mean difference from baseline (Days -2 to -1) to Day 28 as per the 8 category ordinal scale Time: Screening Day (Day -2 to Day -1) until Day 28Description: To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. Radiological imaging (lung computed tomography scan and chest X-ray) will be used to determine change in lung imaging.
Measure: Change in lung imaging Time: Days 7, 14 and 28Description: To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. To evaluate the change in viral load between treatment arms and to evaluate the relationship between change in viral load over time with time to clinical recovery.
Measure: Negative conversion ratio of SARS-CoV-2 RNA in nasopharyngeal samples after treatment. Time: Days 3, 7 and 14Description: To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. The SOFA score ranges from 0 to 4. Lower score predicts better organ functioning and higher score represents severe organ failure.
Measure: Improvement in sequential organ failure assessment (SOFA) score Time: Days 3, 7, 10, 14 and 28 after treatmentDescription: To evaluate length of hospital stay and to evaluate time to successful discharge between patients receiving carrimycin vs placebo.
Measure: Length of hospital stay (in days) Time: From Screening Day (Day -2 to Day -1) until Day 60 or Early WithdrawalDescription: To evaluate mortality rates between patients receiving carrimycin vs placebo.
Measure: Number of patients with all cause mortality at Days 14 and 28 Time: From Screening Day (Day -2 to Day -1) until Day 60 or Early WithdrawalDescription: To evaluate the safety and tolerability of the carrimycin and to describe the safety profile of treatments as reflected by AEs and SAEs.
Measure: Number of patients with adverse event (AEs) and Serious adverse events (SAEs) Time: Day 28 and Day 60Description: To evaluate the safety and tolerability of the carrimycin and to describe the safety profile of treatments. The routine ECG will include heart rate, QTc interval, ST segment and T wave changes
Measure: Number of patients with changes in routine electrocardiogram (ECG) from Day 1 up to Day 14 Time: Day 1 until Day 14Between June 10t h and July 1st, a cross-sectional design study in an Argentina slum, showed a prevalence based on immunoglobuling G-class (IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) of 53.4%. It remains unanswered whether natural infection produces sustained antibodies. The aim of this study is to evaluate the presence of IgG antibodies for Coronavirus disease 2019 (COVID-19) after 5 months in inhabitants of Barrio 31 who consented the Seroprevalence Study for COVID-19.
Description: to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement
Measure: to estimate the proportion of people with positive IgG antibodies for COVID-19 who have positive IgG antibodies after 5 month of the first measurement Time: up to 20 weeksDescription: to estimate the proportion of people with positive IgG antibodies for dengue
Measure: to estimate the proportion of people with positive IgG antibodies for dengue Time: up to 20 weeksThis is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.
Description: Time (in days) from randomization to the receipt of Coronavirus infection (SARS-CoV-2) testing results by the participant.
Measure: Time to receipt of SARS CoV-2 testing results Time: Measured in days from randomization up to 30 days after randomizationDescription: Proportion of those who complete a survey who agree to be randomized to a SARS-CoV-2 testing modality.
Measure: Acceptance of SARS CoV-2 viral testing assessed by proportion of participants who complete a survey Time: Measured from baseline survey completion to enrollment within 30 days of completion of baseline surveyDescription: Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.
Measure: Uptake of SARS CoV-2 testing as assessed by proportion of participants who complete testing Time: Measured from randomization to testing completion (within 20 days of randomization)Description: Time (In days) to completion of SARS CoV-2 testing from randomization.
Measure: Time to completion of SARS CoV-2 testing Time: Measured from randomization to testing completion (Within 20 days of randomization)Description: Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.
Measure: Time from SARS CoV-2 testing to receipt of results Time: Measured from testing completion to receipt of results (within 10 days of testing)This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.
Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measure: Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of participants who tested seronegative on prior to vaccination on Day 1.
Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at prior to vaccination on Day 1 and Day 43.
Measure: Number of Participants Seroconverting to the Nucleocapsid (N) Protein of SARS-SoV-2 Time: Day 1, 43, 211 and 393Description: Measured by a virus neutralizing assay in a subset of participants.
Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Measured by a virus neutralizing assay in a subset of participants.
Measure: Number of Participants Seroconverting to SARS-CoV-2 Time: Days 1, 29, 43, 57, 120, 211 and 393Description: Measured by a virus neutralizing assay in a subset of participants.
Measure: Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2 Time: Days 43, 57, 120, 211 and 393This retrospective analysis of inpatient data obtained from administrative and electronic medical records will investigate the role of empiric antibiotics on admission on the mortality for non-intubated patients presenting with Novel Coronavirus Diseases 2019 (COVID-19) associated pneumonia without extra-pulmonary sources of infection or septic shock.
Description: Death during the hospitalization or discharge to hospice
Measure: In-Hospital Mortality or discharge to hospice Time: From time of admission to death during the hospitalization or discharge to hospiceDescription: Mechanical ventilation initiated after 48 hours into the admission as a marker of clinical deterioration and its relationship to receipt of empiric antibiotic
Measure: Rates of Mechanical Ventilation Time: From 48 hours post admission to discharge or deathDescription: Identify the risk of C. difficile infection on patients according to empiric therapy status as captured by diagnosis codes not present-on-admission
Measure: Rates of C. difficile infection Time: not present-on-admissionDescription: As a marker of morbidity and and its relationship to receipt of empiric antibiotic therapy
Measure: Length of stay for survivors Time: From admission to discharge (not to hospice)Description: As a marker of clinical deterioration and its relationship to receipt of empiric antibiotic therapy among patients who did not require ICU admission upon arrival
Measure: Rates of ICU Admission Time: From 48 hours post admission to dischargeDescription: Identify the risk of acute kidney injury according to empiric therapy status as captured by diagnosis codes not present-on-admission
Measure: Rates of Acute Kidney Injury Time: not present-on-admissionDescription: For patients in hospital for at least 5 days
Measure: Days free of antibiotics Time: 5 days from admission to discharge or primary outcomeDescription: As above, as captured by diagnosis codes not present-on-admission
Measure: Rates of secondary infections due to antibiotic resistant pathogens Time: not present-on-admissionThe purpose of this study is to evaluate the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults.
Description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered an investigational medicinal product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs are defined as injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Measure: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination Time: Up to Day 7 after each vaccinationDescription: Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, nausea/vomiting, chills, and fever.
Measure: Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination Time: Up to Day 7 after each vaccinationDescription: Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.
Measure: Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination Time: Up to Day 28 after each vaccinationDescription: An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.
Measure: Percentage of Participants with Serious AE (SAE) until Day 57 Time: Up to Day 57Description: GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measure: Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57 Time: Day 57Description: GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measure: Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 Time: Day 57Description: SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the limit of detection (LOD) to equal to or above LOD, OR, >= 4-fold rises from baseline.
Measure: Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 Time: Day 57Description: GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measure: GMT of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394 Time: Day 29, Day 43, Day 209 and Day 394Description: GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measure: GMFR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394 Time: Day 29, Day 43, Day 209 and Day 394Description: SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the LOD to equal to or above LOD, OR, >= 4-fold rises from baseline.
Measure: SCR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394 Time: Day 29, Day 43, Day 209 and Day 394Description: GMT of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.
Measure: GMT of serum neutralizing antibody (nAb) against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394 Time: Day 29, Day 43, Day 57, Day 209, and Day 394Description: GMFR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.
Measure: GMFR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394 Time: Day 29, Day 43, Day 57, Day 209, and Day 394Description: SCR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus. SCR is defined at percentage of subjects with a change from below the lower limit of quantification (LLOQ) to equal to or above LLOQ, OR, >= 4-fold rises from baseline.
Measure: SCR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394 Time: Day 29, Day 43, Day 57, Day 209, and Day 394The objective of this research project is to scientifically evidence a pulmonary rehabilitation program that was initiated altruistically during the confinement of those patients who had suffered from COVID-19, through an online platform. Patients are connected telematically 3 times a week from April 6, 2020 to perform the physical therapy program. Due to the clinical improvements that have been referred by patients, they began to take objective data. Our goal is to know if a telematic respiratory therapy program in post-covid 19 patient, improves the level of anxiety, dyspnea on effort, improves quality of life and oxygenation.
Description: The EQ-5D is a generic Quality of Life measurement instrument. The individual himself evaluates his state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression) and each one has three levels of severity (no problems, some moderate problems or problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her state of health in each one of the dimensions, referring to the same day that he or she completes the questionnaire. In each dimension of the EQ-5D, the levels of severity are coded with a 1 if the answer option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".
Measure: Euroqol-5d european quality of life-5 dimensions Time: 1 weekDescription: The EQ-5D is a generic Quality of Life measurement instrument. The individual himself evaluates his state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression) and each one has three levels of severity (no problems, some moderate problems or problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her state of health in each one of the dimensions, referring to the same day that he or she completes the questionnaire. In each dimension of the EQ-5D, the levels of severity are coded with a 1 if the answer option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".
Measure: Euroqol-5d european quality of life-5 dimensions Time: 4 weekDescription: The modified Borg scale is a visual analog scale standardized in Spanish that allows to evaluate the subjective perception of the breathing difficulty or the physical effort exercised. This variable is taken in sedation
Measure: Dysnea scale Borg Time: 5 min before each sessionDescription: The modified Borg scale is a visual analog scale standardized in Spanish that allows to evaluate the subjective perception of the breathing difficulty or the physical effort exercised. This variable is taken in sedation
Measure: Dysnea scale Borg Time: 5 min after each sessionDescription: breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Measure: Respiratory rate Time: 5 min before each sessionDescription: breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.
Measure: Respiratory rate Time: 5 min after each sessionDescription: Effort dyspnea scale, Malher Scale A multidimensional scale that measures 3 magnitudes of dyspnea at a given time: the difficulty of the task, the intensity of the effort and the functional impairment.
Measure: Effort dysnea Scale Time: 1 weekDescription: Effort dyspnea scale, Malher Scale A multidimensional scale that measures 3 magnitudes of dyspnea at a given time: the difficulty of the task, the intensity of the effort and the functional impairment.
Measure: Effort dysnea Scale Time: 4 weekDescription: STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Measure: Anxiety Time: 1 weekDescription: STAI, questionary of anxiety, we will take before the first session and at the end of the last session
Measure: Anxiety Time: 4 weekDescription: pulxe-oximetry, the patient is sitting at rest
Measure: Level oxigen % Time: 1 weekDescription: pulxe-oximetry, the patient is sitting at rest
Measure: Level oxigen % Time: 4 weekThe purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms (> 6 weeks) of COVID-19.
Description: This score is based on a 9-item scale which measures the severity of fatigue and its effects on a person's activities and lifestyle. Scores range from 9 - 63; Higher the score = greater fatigue severity.
Measure: Change from baseline in Fatigue Severity Score at Day 28 Time: Day28Description: Note: A set of common COVID-19-related symptoms (see patient diary template) will be evaluated daily by the patient regardless of which symptoms a subject had at baseline, as new symptoms may appear following the baseline assessment
Measure: Changes in daily COVID-19-related symptom severity score during the treatment phase (56 Days). Time: 56 daysDescription: Duration defined as the last day on or before study Day 56 when any symptoms scored as moderate or severe at study entry (pre-treatment) are still scored as moderate or severe (i.e., not mild or absent), or mild or absent at study entry are scored as mild or worse (i.e., not absent).
Measure: Duration of targeted COVID-19 associated symptoms from start of study treatment (Day 0) based on self-assessment using daily symptom diary. Time: 56 daysDescription: This score is based on a 9-item scale which measures the severity of fatigue and its effects on a person's activities and lifestyle. Scores range from 9 - 63; Higher the score = greater fatigue severity.
Measure: Change from baseline in Fatigue Severity Score at Days 42 and 56. Time: Days 42 and 56Description: Scores range from 0 - 36. Higher the score = greater fatigue severity.
Measure: Change in Mental Fatigue Questionnaire score at Days 28, 42 and 56. Time: Days 28, 42 and 56This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.
Description: daily assessment of subjective COVID-19 symptom score
Measure: Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary Time: 84 daysDescription: weekly assessment of SARS-CoV-2, Influenza A, Human Metapneumovirus, Influenza A - subtype H1, Adenovirus, Influenza A - subtype H3, Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B, Parainfluenza 3, Parainfluenza 4, Coronavirus HKU1, Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila
Measure: Nasal swabs for analysis of viruses by PCR Time: 84 daysDescription: beginn and end of trial
Measure: Serology of antibodies against SARS-CoV-2 Time: 84 daysDescription: weekly nasal swabs for analysis of viruses
Measure: Number of viral co-infections dedected by PCR Time: 84 daysThis study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.
Description: The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28
Measure: WHO ordinal Covid-19 scale up to day 28 Time: up to and including day 28Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8
Measure: Cumulative number WHO categories 4b-8 Time: day 8, day 14, day 56 and day 90Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a
Measure: Cumulative number WHO categories 3-4a Time: day 8, day 14, day 28, day 56 and day 90Description: Cumulative number of participants not hospitalized at day 90
Measure: Not hospitalized Time: at day 90Description: All-cause mortality at day 90
Measure: All-cause mortality Time: at day 90Description: Number of patient with SARS-CoV-2 reinfection up to day 90
Measure: Reinfection Time: up to day 90Description: Number of patient with secondary sclerosis cholangitis at day 90
Measure: Secondary sclerosing cholangitis (SSC) Time: at day 90Description: Number of patient with COVID-19 associated chronic pulmonary disease
Measure: chronic pulmonary disease as sequelae from COVID-19 Time: at day 90Description: The proportion of patients with remdesivir therapy
Measure: patients with remdesivir treatment Time: up to day 90Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death
Measure: COVID-19 WHO status of patients at start of remdesivir treatment Time: up to day 90Description: The proportion of patients on dexamethasone therapy
Measure: patients with dexamethasone treatment Time: up to day 90Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death
Measure: COVID-19 WHO status of patients at start of dexamethasone treatment Time: up to day 90Description: Time to resolution of COVID-19 related symptoms (e.g. fever)
Measure: resolution of COVID-19 symptoms Time: until day of resolution up to day 90Description: Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)
Measure: negative SARS-CoV-2-PCR test Time: until day of first negative test up to day 90Description: Duration of oxygen therapy (in days)
Measure: Oxygen therapy Time: number of days with oxygen therapy up to day 90Description: Frequency of occurrence of COVID-19 pneumonia
Measure: COVID-19 pneumonia Time: up to day 90Description: Percentage of participants in each group with need for mechanical ventilation
Measure: Percentage of participants requiring mechanical ventilation Time: up to day 90Description: Number of ventilation days per participant up to day 90
Measure: Number of ventilation days per participant up to day 90 Time: up to day 90Description: Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)
Measure: hospital stay and intensive care Time: up to day 90Description: All-cause mortality at day 28
Measure: Mortality Time: at day 28Description: Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up
Measure: SAEs Time: up to day 90Description: Cumulative incidence of grade 3/4 Adverse Events (AE) per group
Measure: Grade 3/4 AEs Time: up to day 90Description: SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90
Measure: SARS-CoV-2 antibody IgA concentrations Time: on day 8, day 14, day 90Description: SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90
Measure: SARS-CoV-2 antibody IgG concentrations Time: on day 8, day 14, day 90Description: SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90
Measure: SARS-CoV-2 neutralizing antibody titers Time: on day 8, day 14, day 90Description: Number of screening failures due to the lack of a suitable plasma preparation
Measure: Plasma treatment screening failures Time: up to day 8 (End of treatment)The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress and anxiety in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.
Description: The Impact of Event Scale- Revised Scale assess intrusion, avoidance, and hyperarousal. The scale includes five new questions in addition to the original Impact of Event Scale created by Mardi Horowitz. Scores range from 0 to 88. Total scores ranging between 24-43 suggest that PTSD is a clinical concern; scores between 33-38 suggest best cutoff for probably PTSD; and scores of 39 and above suggest suppressed immune system functioning. The higher the score, the larger the impact of recent stress. There are three subscales evaluating intrusion avoidance, and hyperarousal.
Measure: Change in Impact of Event Scale-Revised (IES-R) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.
Measure: Change in Insomnia Severity Index (ISI) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression.
Measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.
Measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Measure: Change in PTSD Checklist for Civilians (PCL-C) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.
Measure: Change in Perceived Stress Scale (PSS) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).
Measure: Change in Quality of Life Scale (QOLS) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.
Measure: Change in Interpersonal Support Evaluation List (ISEL-12) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Description: The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.
Measure: Change in Multiple Ability Self-Report Questionnaire (MASQ) Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)Vitamin C (ascorbic acid) is a water-soluble vitamin having anti-inflammatory, immunomodulatory, anti-oxidative, antithrombotic and antiviral properties. Considering these effects vitamin C should have beneficial impact in patients suffering from sepsis and acute respiratory distress syndrome (ARDS). The current study is designed to assess the beneficial effects of Vitamin C in COVID-19 infected patients.
Description: duration of hospital stay
Measure: Hospital stay Time: 2 weeksThis is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.
Description: Safety and Tolerability
Measure: The incidence of local reactions, solicited systemic events, AEs, MAAEs, SAEs and AESIs Time: Day 1 to 24 monthsDescription: Percentage of subjects with changes in lab values at different time points
Measure: Change in safety chemistry blood lab values for assessment of risk in Phase 3 Time: Phase 2 -Day 1 to Day 36Description: Percentage of subjects with changes in lab values at different time points
Measure: Change in safety hematology blood lab values for assessment of risk in Phase 3 Time: Phase 2 -Day 1 to Day 36Description: SARS-CoV-2 incidence based on qPCR nasopharyngeal swab
Measure: Prevention of SARS-CoV-2 infection in adults Time: Day 29 to 24 MonthDescription: Immunogenicity of UB-612 vaccine
Measure: Change after second dose through the end of study in antibody titers Time: Month 1, 6, 12 and 24 following Dose 2Description: COVID-19 incidence confirmed by qPCR nasopharyngeal swab
Measure: Prevention of COVID-19 in adults Time: Day 42 to 24 MonthDescription: Efficacy of UB-612 vaccine
Measure: Reduction in severity of COVID-19 in adults Time: Day 42 to 24 MonthDescription: Efficacy of UB-612 vaccine
Measure: Prevention of COVID-19 death in adults Time: Day 42 to 24 MonthDescription: Measured by comparing the SARS-CoV-2 shedding in vaccine and placebo subjects
Measure: Change in SARS CoV-2 shedding Time: Day 42 to 24 MonthDescription: Number of cytokine secreting spots
Measure: Immunogenicity of UB-612 vaccine in young and older adults, with or without comorbidities, and no serological or virological evidence of past infection with SARS-CoV-2 Time: baseline, 7 days, 6, 12, and 24 months after Dose 2Description: Efficacy of UB-612 vaccine
Measure: Change in SARS CoV-2 infection Time: Month 1, 6, 12 and 24 following Dose 2The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level. In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.
Description: Number of participants who get COVID19 infection during the application of S-HClO
Measure: Prevention of infection by COVID19 Time: Through study completion, an average of 6 monthsDescription: Determine the occurrence of ADR by the use of S-HClO
Measure: Adverse drug reaction (ADR) Time: Through study completion, an average of 6 monthsDescription: Determine the frequency of seroconversion due to COVID 19
Measure: Seroconversion Time: Through study completion, an average of 6 monthsDescription: Number of participants who fell ill from COVID-19 and was not hospitalized
Measure: Hospitalization Time: Through study completion, an average of 6 monthsDescription: Number of participants who fell ill from COVID-19 and was hospitalized in ICU
Measure: ICU Time: Through study completion, an average of 6 monthsIn current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).
Description: Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR Test.
Measure: Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator. Time: through study completion; an average of 18 weeksBackground: Viral infections such as COVID-19 may lead to flare-ups in people with systemic autoimmune diseases (SAD). These infections may also change the function of their immune system and/or cause problems with their blood vessels. Researchers want to learn how people with SAD respond to treatments or vaccines for COVID-19. Objective: To understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases. Eligibility: People ages 15 and older who have been diagnosed with an autoimmune disease or are a healthy volunteer Design: Participants will have a screening visit. This will include: Medical history and physical exam EKG Chest x-ray COVID-19 test. A swab will be put in the participant s nose or the back of their mouth. Blood and urine tests Participants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infection Depending on their group, participants will have 1 to 5 more visits. These will occur over 12 to 18 months. Visits may include: FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine creates pictures of the body. For the scan, they will have a radioactive substance injected into their arm through an IV. Kidney function tests Non-invasive vascular studies test. These tests are similar to what it feels like to have blood pressure checked.
Description: Measures of Immune dysregulation (gene expression changes in immune cells, immune cell subset proportions, serum cytokine and autoantibody levels and repertoire), vasculopathy (changes in vascular function tests (CAVI, Endopat and sphygmocor quantification) and , in some cases, vascular inflammation (as measured by FDG-PET CT) before and after COVID-19.
Measure: Primary Objective: Characterize how COVID-19 modulates systemic inflammation, autoimmunity features, organ damage and vasculopathy in adult and pediatric patients with a previous diagnosis of systemic autoimmunity. Assess how subjects with syste... Time: 36 monthsDescription: Clinical outcomes, as assessed by disease-specific activity/severity measures in response to COVID infection. Response to potential antiviral treatments and/or vaccines that are used for clinical reasons in response to COVID-19 exposure or prevention.
Measure: Understand prevalence and severity of COVID-19 in individuals with autoimmune diseases, and the variables that associate/predict these responses. Time: 36 monthsIL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose
Description: by RT-PCR
Measure: Viral load Time: 7-15 daysMulticenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers
Description: The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
Measure: Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2) Time: at days 0, 21, 42, 90, 180Description: The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination.
Measure: To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo Time: at days 0, 21, 42, 90, 180Description: The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination
Measure: Frequency of confirmed cases of COVID-19 Time: through study completion, an average of 6 monthsDescription: Determination of the level of production of intracellular cytokines by antigen-activated T-lymphocytes
Measure: Changing of antigen-specific cellular immunity level Time: at days 0, 90, 180Description: Frequency of adverse reaction in the seven days following each immunization per age group
Measure: Frequency of adverse events up to seven days after immunization Time: Seven days after each immunizationDescription: Frequency of adverse reaction in the 21 days following each immunization per age group
Measure: Frequency of adverse events up to 21 days after immunization Time: 21 days after each immunizationDescription: Incidence of serious adverse events during the study
Measure: Incidence of serious adverse events during the study Time: throughout the study, an average of 6 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports