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 days