Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug1775 | Hydroxychloroquine Wiki | 0.23 |
drug2916 | Placebo Wiki | 0.21 |
drug1511 | Favipiravir Wiki | 0.20 |
Name (Synonyms) | Correlation | |
---|---|---|
drug2981 | Placebo oral tablet Wiki | 0.11 |
drug3074 | Presatovir Wiki | 0.09 |
drug1776 | Hydroxychloroquine (HCQ) Wiki | 0.08 |
drug4335 | Zinc Wiki | 0.08 |
drug1795 | Hydroxychloroquine Sulfate Wiki | 0.08 |
drug1960 | Interferon Beta-1B Wiki | 0.08 |
drug2176 | Losartan Wiki | 0.08 |
drug274 | Anakinra Wiki | 0.08 |
drug1396 | Enoxaparin Wiki | 0.08 |
drug1620 | Gam-COVID-Vac Wiki | 0.07 |
drug2029 | Ivermectin Wiki | 0.07 |
drug1509 | Famotidine 20 MG Wiki | 0.07 |
drug2977 | Placebo on a 0- and 28-day schedule Wiki | 0.07 |
drug1334 | Ebselen Wiki | 0.07 |
drug2512 | Nasopharyngeal swab Wiki | 0.07 |
drug2837 | Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki | 0.07 |
drug1781 | Hydroxychloroquine + azithromycin Wiki | 0.07 |
drug2779 | PLACEBO Wiki | 0.07 |
drug2321 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.07 |
drug2190 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.07 |
drug4263 | Volatile Organic Compounds analysis Wiki | 0.07 |
drug1467 | Expressive writing Wiki | 0.07 |
drug4405 | blood samples Wiki | 0.07 |
drug1549 | Flow cytometric analysis Wiki | 0.07 |
drug1807 | Hydroxychloroquine Sulfate Tablets Wiki | 0.07 |
drug3746 | Standard of care treatment Wiki | 0.07 |
drug1673 | HB-adMSCs Wiki | 0.07 |
drug1554 | Fluoxetine Wiki | 0.07 |
drug1519 | Favipiravir Placebo Wiki | 0.07 |
drug1459 | Exposure Wiki | 0.07 |
drug3459 | SARS-Cov2 testing Wiki | 0.07 |
drug1799 | Hydroxychloroquine Sulfate 200 MG Wiki | 0.07 |
drug1730 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.07 |
drug2800 | PUL-042 Inhalation Solution Wiki | 0.07 |
drug4013 | Thymalfasin Wiki | 0.07 |
drug2155 | Lopinavir / Ritonavir Wiki | 0.06 |
drug4249 | Vitamin C Wiki | 0.06 |
drug4251 | Vitamin D Wiki | 0.06 |
drug1047 | Convalescent Plasma Wiki | 0.06 |
drug3502 | Saline Wiki | 0.06 |
drug927 | Clazakizumab Wiki | 0.06 |
drug1127 | DAS181 Wiki | 0.06 |
drug4187 | VPM1002 Wiki | 0.05 |
drug4754 | standard therapy Wiki | 0.05 |
drug4719 | self-administered questionnaire Wiki | 0.05 |
drug3740 | Standard of care (SOC) Wiki | 0.05 |
drug492 | BNT162b1 Wiki | 0.05 |
drug4025 | Tocilizumab Wiki | 0.05 |
drug421 | Azithromycin Wiki | 0.05 |
drug3728 | Standard of Care Wiki | 0.05 |
drug2575 | No intervention Wiki | 0.05 |
drug3255 | Racial/Ethnic Frame Wiki | 0.05 |
drug1267 | Drug COVID19-0001-USR Wiki | 0.05 |
drug476 | BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki | 0.05 |
drug928 | Clazakizumab 12.5 mg Wiki | 0.05 |
drug4726 | serology test Wiki | 0.05 |
drug1293 | Dysphagia Handicap Index (DHI) Wiki | 0.05 |
drug1412 | EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki | 0.05 |
drug4008 | Throat swab sample for measuring current infection with SARS-CoV-2 Wiki | 0.05 |
drug2504 | Nasal Swab Wiki | 0.05 |
drug1505 | Facial mask Wiki | 0.05 |
drug325 | Antioxidation Therapy Wiki | 0.05 |
drug46 | 21% Ethanol plus essential oils Wiki | 0.05 |
drug1951 | Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs Wiki | 0.05 |
drug3673 | Sofusbuvir + Daclastavir 60 mg Wiki | 0.05 |
drug4305 | Whole Exome Sequencing Wiki | 0.05 |
drug2564 | Nitric Oxide-Releasing Drug Wiki | 0.05 |
drug1830 | Hyperbaric Oxygen Therapy Wiki | 0.05 |
drug2189 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.05 |
drug3598 | Serum SARs COV 2 IGg screening in health care workers Wiki | 0.05 |
drug2441 | Mucodentol Wiki | 0.05 |
drug2863 | Performance of the test antigenic and test RT-PCR Wiki | 0.05 |
drug1803 | Hydroxychloroquine Sulfate 600 mg once a day Wiki | 0.05 |
drug1815 | Hydroxychloroquine plus Nitazoxanide Wiki | 0.05 |
drug1051 | Convalescent Plasma 2 Units Wiki | 0.05 |
drug4091 | Treatment with Dexmedetomidine Wiki | 0.05 |
drug3652 | Snorkel-based improvised personal protective equipment Wiki | 0.05 |
drug2201 | Low nitrite/NDMA meals Wiki | 0.05 |
drug1215 | Dietary Intervention Wiki | 0.05 |
drug1434 | Examine the impact of COVID-19 during pregnancy Wiki | 0.05 |
drug908 | Chloroquine analog (GNS651) Wiki | 0.05 |
drug1224 | Diffusing capacity of carbon monoxide Wiki | 0.05 |
drug4260 | VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki | 0.05 |
drug3184 | Quantitative analysis of anti-SARS-CoV-2-antibodies Wiki | 0.05 |
drug1954 | Inspiratory training device Wiki | 0.05 |
drug3077 | Presence of specific anti-SARS-CoV-2 antibodies Wiki | 0.05 |
drug4454 | decisions of limitations and stop processing Wiki | 0.05 |
drug1283 | Duodenal biopsy Wiki | 0.05 |
drug2456 | MySafeRx Inspire Flex Wiki | 0.05 |
drug2571 | No Messaging Wiki | 0.05 |
drug961 | Cognitive testing Wiki | 0.05 |
drug1699 | Health warning leaflet Wiki | 0.05 |
drug1477 | EyeQue Insight Wiki | 0.05 |
drug51 | 2: Usual practice + SYMBICORT RAPIHALER Wiki | 0.05 |
drug4142 | Umbilical cord derived mesenchymal stem cells Wiki | 0.05 |
drug1686 | HOME-CoV rule implementation Wiki | 0.05 |
drug3402 | Ruconest Wiki | 0.05 |
drug1603 | GO2 PEEP MOUTHPIECE Wiki | 0.05 |
drug3040 | Povidone-Iodine Wiki | 0.05 |
drug1494 | FSD201 Wiki | 0.05 |
drug2457 | MySafeRx Inspire Plus Wiki | 0.05 |
drug1668 | Guided online support program Wiki | 0.05 |
drug4199 | Vancomycin Wiki | 0.05 |
drug4562 | lung ultrasound (LUS) Wiki | 0.05 |
drug2539 | Next generation Sequencing (NGS) analysis Wiki | 0.05 |
drug2293 | Matched Placebo Hydroxychloroquine Wiki | 0.05 |
drug4798 | vaccine BCG Wiki | 0.05 |
drug2702 | Online instruction Wiki | 0.05 |
drug2370 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.05 |
drug4680 | pulse oximeter Wiki | 0.05 |
drug495 | BNT162c2 Wiki | 0.05 |
drug3856 | T3 solution for injection Wiki | 0.05 |
drug2856 | Penn Microbiome Therapy - 001 Wiki | 0.05 |
drug2559 | Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki | 0.05 |
drug2508 | NasoVAX Wiki | 0.05 |
drug4646 | peripheral blood draw Wiki | 0.05 |
drug4430 | collection of mucosal lining fluid Wiki | 0.05 |
drug4681 | qRT-PCR and serology Wiki | 0.05 |
drug1231 | Digoxin Wiki | 0.05 |
drug1264 | Doxycyclin Wiki | 0.05 |
drug2938 | Placebo Daclatasvir 60 mg Wiki | 0.05 |
drug3665 | Sofosbuvir + Daclatasvir 120 mg Wiki | 0.05 |
drug2900 | Physical exercise Wiki | 0.05 |
drug383 | Atazanavir and Dexamethasone Wiki | 0.05 |
drug1514 | Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine Wiki | 0.05 |
drug2243 | MPT0B640 Wiki | 0.05 |
drug4131 | Ulinastatin Wiki | 0.05 |
drug1759 | Huaier Granule Wiki | 0.05 |
drug2596 | Non-Anchoring Strategy Control Wiki | 0.05 |
drug354 | Ascorbic Acid Wiki | 0.05 |
drug1417 | Escin Wiki | 0.05 |
drug3251 | RUTI® vaccine Wiki | 0.05 |
drug1252 | Doctor Spot Wiki | 0.05 |
drug698 | CGB-S-100 Wiki | 0.05 |
drug4257 | Vitamins Wiki | 0.05 |
drug2247 | MRI (heart, brain, lungs, kidney) Wiki | 0.05 |
drug40 | 1: discontinuation of RAS blocker therapy Wiki | 0.05 |
drug2997 | Placebo: Hydroxychloroquine Wiki | 0.05 |
drug1709 | Hemanext One Wiki | 0.05 |
drug1684 | HLX70 Wiki | 0.05 |
drug1779 | Hydroxychloroquine + Metabolic cofactor supplementation Wiki | 0.05 |
drug2637 | Nutrition Wiki | 0.05 |
drug251 | Alisporivir Wiki | 0.05 |
drug1457 | Expiratory training device Wiki | 0.05 |
drug2468 | NA-831 and Atazanavir Wiki | 0.05 |
drug1489 | FLOW intervention Wiki | 0.05 |
drug840 | Canine odor detection of Volatile Organic Compounds Wiki | 0.05 |
drug1688 | HPV vaccine, Gardasil 9 Wiki | 0.05 |
drug1675 | HCQ & AZ Wiki | 0.05 |
drug123 | ARBOX Wiki | 0.05 |
drug1388 | Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 Wiki | 0.05 |
drug1871 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.05 |
drug1540 | Fit test Wiki | 0.05 |
drug4395 | biological samples collection Wiki | 0.05 |
drug1802 | Hydroxychloroquine Sulfate 400 mg twice a day Wiki | 0.05 |
drug3769 | Standard-titer Convalescent COVID-19 plasma (CCP2) Wiki | 0.05 |
drug3063 | Prediction Market Wiki | 0.05 |
drug1478 | F-652 Wiki | 0.05 |
drug1400 | Enoxaparin Higher Dose Wiki | 0.05 |
drug2686 | Omnibiotic AAD Wiki | 0.05 |
drug935 | Clinical examination Wiki | 0.05 |
drug1793 | Hydroxychloroquine Pre-Exposure Prophylaxis Wiki | 0.05 |
drug4811 | washed microbiota transplantation Wiki | 0.05 |
drug2215 | Lung Function Test Wiki | 0.05 |
drug35 | 18F-αvβ6-BP Wiki | 0.05 |
drug72 | 6 minute walk test Wiki | 0.05 |
drug1178 | Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki | 0.05 |
drug3781 | Sterile Normal Saline for Intravenous Use Wiki | 0.05 |
drug1367 | Emapalumab Wiki | 0.05 |
drug1498 | FTX-6058 oral capsule(s) / Midazolam Syrup Wiki | 0.05 |
drug1813 | Hydroxychloroquine combined with Azithromycin Wiki | 0.05 |
drug3372 | Rintatolimod Wiki | 0.05 |
drug491 | BNT162a1 Wiki | 0.05 |
drug871 | Centricyte 1000 Wiki | 0.05 |
drug1741 | High-titer Convalescent COVID-19 Plasma (CCP1) Wiki | 0.05 |
drug161 | AWARD advice Wiki | 0.05 |
drug1924 | Indomethacin Wiki | 0.05 |
drug2007 | Intravenous saline injection (Placebo) Wiki | 0.05 |
drug3786 | Stool collection or fecal swab Wiki | 0.05 |
drug730 | COVID 19 serology Wiki | 0.05 |
drug4746 | standard concomitant therapy Wiki | 0.05 |
drug899 | Chinese Herbal Medicine Wiki | 0.05 |
drug1655 | Group C:Active principle oropharyngeal spray + Placebo taken PO Wiki | 0.05 |
drug481 | BM-Allo.MSC Wiki | 0.05 |
drug1423 | Estradiol patch Wiki | 0.05 |
drug1452 | Experimental Group Wiki | 0.05 |
drug2246 | MRI Wiki | 0.05 |
drug3272 | Rapid molecular test Wiki | 0.05 |
drug2120 | Leukapheresis Wiki | 0.05 |
drug1360 | Electronic Health Record Review Wiki | 0.05 |
drug2612 | Non-invasive ventilatory support Wiki | 0.05 |
drug4716 | saliva sample Wiki | 0.05 |
drug2867 | Peripheral Blood Wiki | 0.05 |
drug3200 | Questionnaire with precaution information Wiki | 0.05 |
drug1623 | Ganovo+ritonavir+/-Interferon nebulization Wiki | 0.05 |
drug744 | COVID-19 Diagnostic and Assessment Tests Wiki | 0.05 |
drug2648 | OP-101 Wiki | 0.05 |
drug1386 | Endothelial damage and angiogenic biomarkers Wiki | 0.05 |
drug2889 | Phone interviews Wiki | 0.05 |
drug355 | Ascorbic Acid and Zinc Gluconate Wiki | 0.05 |
drug2937 | Placebo Daclatasvir 120 Wiki | 0.05 |
drug1796 | Hydroxychloroquine Sulfate (HCQ) Wiki | 0.05 |
drug2104 | Lactoferrin (Apolactoferrin) Wiki | 0.05 |
drug348 | ArtemiC Wiki | 0.05 |
drug1520 | Favipiravir and Hydroxychloroquine Wiki | 0.05 |
drug2390 | Mindfulness based intervention Wiki | 0.05 |
drug3270 | Rapid detection test Wiki | 0.05 |
drug1274 | Drug: NA-831 Wiki | 0.05 |
drug1700 | Health-related quality of life Wiki | 0.05 |
drug1150 | Daily placebo Wiki | 0.05 |
drug2735 | Outpatient MRI Wiki | 0.05 |
drug3197 | Questionnaire for evaluation of confinement on deviant sexual fantasies Wiki | 0.05 |
drug4781 | thoracic computed tomography scan Wiki | 0.05 |
drug1376 | Emphasis of Academic Researchers Involvement Wiki | 0.05 |
drug2473 | NG Biotech Wiki | 0.05 |
drug1567 | Follow-up of patients with COVID-19 Wiki | 0.05 |
drug4226 | Videofluoroscopy Wiki | 0.05 |
drug4009 | Thrombin Generation Assay (TGA) Wiki | 0.05 |
drug4148 | Unfractionated heparin nebulized Wiki | 0.05 |
drug3763 | Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki | 0.05 |
drug2079 | LAMP Wiki | 0.05 |
drug4138 | Umbilical Cord Lining Stem Cells (ULSC) Wiki | 0.05 |
drug1418 | Esflurbiprofen hydrogel patch 165 mg (EFHP) Wiki | 0.05 |
drug3377 | Risk of MERS infection Wiki | 0.05 |
drug2972 | Placebo of Hydroxychloroquine Wiki | 0.05 |
drug1982 | Internet-connected computer tablet Wiki | 0.05 |
drug77 | A $10 Survey Incentive Wiki | 0.05 |
drug1808 | Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki | 0.05 |
drug1729 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.05 |
drug1573 | Formulation without Active Drug Wiki | 0.05 |
drug4577 | metenkefalin + tridecactide Wiki | 0.05 |
drug410 | Avdoralimab Wiki | 0.05 |
drug1556 | Fluvirin Wiki | 0.05 |
drug4788 | tracheostomy Wiki | 0.05 |
drug1652 | Group A: oropharygeal spray and immunostimulant Wiki | 0.05 |
drug4664 | prayer Wiki | 0.05 |
drug4556 | lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki | 0.05 |
drug2054 | JNJ-53718678 250 mg Wiki | 0.05 |
drug924 | Cimetidine Wiki | 0.05 |
drug1542 | Fixed Anchoring Strategy Wiki | 0.05 |
drug1691 | Halo Placebo Wiki | 0.05 |
drug4621 | normal saline Wiki | 0.05 |
drug3905 | Tap water Wiki | 0.05 |
drug1151 | Danoprevir+Ritonavir Wiki | 0.05 |
drug1414 | Ergoferon Wiki | 0.05 |
drug1087 | Cost-Benefit Frame Wiki | 0.05 |
drug4274 | WHO recommendations (waiting condition) Wiki | 0.05 |
drug1714 | Heparin - Therapeutic dosage Wiki | 0.05 |
drug1487 | FFP2 Wiki | 0.05 |
drug4400 | blood collection via fingerprick Wiki | 0.05 |
drug3835 | Surveys Wiki | 0.05 |
drug1146 | Daclatasvir 60 mg Wiki | 0.05 |
drug639 | Breath biopsy sampling using the ReCIVA Breath Sampler Wiki | 0.05 |
drug1188 | Desferal 500 MG Injection Wiki | 0.05 |
drug4307 | Whole exome sequencing Wiki | 0.05 |
drug1165 | Data collection from medical files Wiki | 0.05 |
drug4429 | collection of biological samples Wiki | 0.05 |
drug4331 | Zanubrutinib Wiki | 0.05 |
drug1383 | Endoscopic intervention Wiki | 0.05 |
drug1128 | DAS181 COVID-19 Wiki | 0.05 |
drug432 | BACMUNE (MV130) Wiki | 0.05 |
drug78 | A $20 Survey Incentive Wiki | 0.05 |
drug1380 | Emtricitabine/tenofovir disoproxil Wiki | 0.05 |
drug2974 | Placebo of NICOTINE Transdermal patch Wiki | 0.05 |
drug3247 | RT-qPCR test Wiki | 0.05 |
drug2100 | Laboratory tests Wiki | 0.05 |
drug1764 | Human biological samples Wiki | 0.05 |
drug896 | Chest MRI Wiki | 0.05 |
drug4011 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.05 |
drug3025 | Polymorphism of the HSD3B1 Wiki | 0.05 |
drug2930 | Placebo 0.20 mg + 2.00 mg/kg Wiki | 0.05 |
drug609 | Blood sample for serology to measure past infection with SARS-CoV-2 Wiki | 0.05 |
drug1466 | Expression of receptors and activating proteases Wiki | 0.05 |
drug1873 | IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki | 0.05 |
drug1943 | Inhaled Supplemental Oxygen Wiki | 0.05 |
drug753 | COVID-19 Pneumonia Wiki | 0.05 |
drug390 | Atovaquone/Azithromycin Wiki | 0.05 |
drug1698 | Health supplements Wiki | 0.05 |
drug1785 | Hydroxychloroquine , Sofosbuvir, daclatasvir Wiki | 0.05 |
drug1213 | Dialyzable Leukocyte Extract Wiki | 0.05 |
drug156 | AVIGAN 200 mg Film Tablets Wiki | 0.05 |
drug666 | Budesonide dry powder inhaler Wiki | 0.05 |
drug2992 | Placebo- 2.00 mg/kg Wiki | 0.05 |
drug4750 | standard operating procedures Wiki | 0.05 |
drug4583 | mobile internet survey on self-test Wiki | 0.05 |
drug3784 | Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection Wiki | 0.05 |
drug2167 | Lopinavir/ Ritonavir Wiki | 0.05 |
drug3819 | Surge capacity Wiki | 0.05 |
drug2507 | Naso pharyngeal swab Wiki | 0.05 |
drug1536 | Filtration Test Wiki | 0.05 |
drug3976 | The control group will not receive hydroxychloroquine Wiki | 0.05 |
drug2127 | Liberase Enzyme (Roche) Wiki | 0.05 |
drug1744 | Home Pulse Oximetry Monitoring Wiki | 0.05 |
drug4023 | To assess for development of IgG antibodies against SARS-CoV2 Wiki | 0.05 |
drug4579 | methylprednisolone therapy Wiki | 0.05 |
drug4616 | non-contact magnetically-controlled capsule endoscopy Wiki | 0.05 |
drug23 | 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse Wiki | 0.05 |
drug1537 | Fingerstick Wiki | 0.05 |
drug1091 | CovX Wiki | 0.05 |
drug1235 | Dipyridamole 100 Milligram(mg) Wiki | 0.05 |
drug3309 | Rehabilitation Wiki | 0.05 |
drug4593 | multipeptide cocktail Wiki | 0.05 |
drug1515 | Favipiravir (3600 mg + 1600 mg) Wiki | 0.05 |
drug1525 | Fenofibrate Wiki | 0.05 |
drug1270 | Drug: GS-5734 - 2.00 mg/kg Wiki | 0.05 |
drug4457 | diagnostic tests for COVID-19 infection Wiki | 0.05 |
drug1513 | Favipiravir (3200 mg + 1200 mg) combined with Azithromycin Wiki | 0.05 |
drug3266 | Ranitidine Wiki | 0.05 |
drug2164 | Lopinavir and ritonavir Wiki | 0.05 |
drug4491 | fingertip tests for POC assays Wiki | 0.05 |
drug2282 | Manremyc Wiki | 0.05 |
drug844 | Cannabis, Medical Wiki | 0.05 |
drug1599 | GLS-1200 Wiki | 0.05 |
drug1690 | Halo Oral Spray Wiki | 0.05 |
drug4442 | convalescent plasma application to SARS-CoV-2 infected patients Wiki | 0.05 |
drug3996 | There is no intervention in this study Wiki | 0.05 |
drug2990 | Placebo- 0.20 mg/kg Wiki | 0.05 |
drug4691 | quetionnary Wiki | 0.05 |
drug3211 | Quidel Sofia SARS Antigen FIA Wiki | 0.05 |
drug3114 | Prophylactic/Intermediate Dose Enoxaparin Wiki | 0.05 |
drug2423 | Monalizumab Wiki | 0.05 |
drug4521 | identify SARS-CoV-2 infection by serology Wiki | 0.05 |
drug1506 | Family Nurture Intervention (FNI) Wiki | 0.05 |
drug2730 | Oseltamivir 75mg Wiki | 0.05 |
drug3616 | Sildenafil Wiki | 0.05 |
drug1426 | Etoposide Wiki | 0.05 |
drug2052 | JNJ-53718678 125 mg Wiki | 0.05 |
drug162 | AWARD plus COVID-specific advice Wiki | 0.05 |
drug521 | Baseline and during hospitalization blood samples Wiki | 0.05 |
drug2941 | Placebo Group Wiki | 0.05 |
drug1216 | Dietary Supplement containing resistant starch Wiki | 0.05 |
drug2784 | POOL RT-PCR Wiki | 0.05 |
drug1508 | Famotidine Wiki | 0.05 |
drug4311 | Women receiving extra remembering by healthcare Wiki | 0.05 |
drug3041 | Povidone-Iodine (PVP-I) Wiki | 0.05 |
drug2163 | Lopinavir and Ritonavir Tablets Wiki | 0.05 |
drug4539 | intubation Wiki | 0.05 |
drug2687 | On-Line Survey Wiki | 0.05 |
drug4544 | laboratory biomarkers Wiki | 0.05 |
drug1050 | Convalescent Plasma 1 Unit Wiki | 0.05 |
drug1674 | HCQ Wiki | 0.05 |
drug1550 | Flow cytometry Wiki | 0.05 |
drug3138 | Psychological and Behaviour Change Support Wiki | 0.05 |
drug1685 | HLX71 Wiki | 0.05 |
drug2326 | Melatonin 2mg Wiki | 0.05 |
drug1758 | Hospitalized Patients for COVID-19 Infection Wiki | 0.05 |
drug2285 | Maraviroc 300 mg Wiki | 0.05 |
drug1687 | HOPE intervention Wiki | 0.05 |
drug3075 | Presatovir placebo Wiki | 0.05 |
drug2469 | NA-831and Dexamethasone Wiki | 0.05 |
drug2031 | Ivermectin + Doxycycline Wiki | 0.05 |
drug3711 | Standard Plasma (FFP) Wiki | 0.05 |
drug1553 | Flucelvax Wiki | 0.05 |
drug4794 | unfractionated heparin Wiki | 0.05 |
drug1677 | HCQ+AZT Wiki | 0.05 |
drug4386 | azithromycin Wiki | 0.05 |
drug2950 | Placebo Sofosbuvir/Daclatasvir 120 Wiki | 0.05 |
drug4167 | Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki | 0.05 |
drug2537 | New screening strategy Wiki | 0.05 |
drug1343 | Education sessions Wiki | 0.05 |
drug2113 | Learning running subcuticular sutures on the Gamified Educational Network Wiki | 0.05 |
drug1512 | Favipiravir (3200 mg + 1200 mg) Wiki | 0.05 |
drug4789 | traditional communication tools Wiki | 0.05 |
drug986 | Combined ART/hydroxychloroquine Wiki | 0.05 |
drug4221 | Video based aerobic exercise Wiki | 0.05 |
drug1766 | Human milk donors Wiki | 0.05 |
drug816 | CYNK-001 Wiki | 0.05 |
drug3447 | SARS-CoV-2 vaccine (inactivated) Wiki | 0.05 |
drug567 | Biological samples specific to research Wiki | 0.05 |
drug4513 | hydroxychloroquine placebo Wiki | 0.05 |
drug926 | Clarithromycin Wiki | 0.05 |
drug3572 | Sensbiosys Wiki | 0.05 |
drug3339 | ResCure™ Wiki | 0.05 |
drug3825 | Surgical facial mask Wiki | 0.05 |
drug2932 | Placebo 250 cc 24 hours continuous infusion for 15 days Wiki | 0.05 |
drug905 | Chloroquine Diphosphate Wiki | 0.05 |
drug2876 | Personal protective equipment Wiki | 0.05 |
drug1528 | Fibreoptic Endoscopic Evaluation of Swallowing (FEES) Wiki | 0.05 |
drug2237 | MFS Wiki | 0.05 |
drug2558 | Nitric Oxide Wiki | 0.05 |
drug3517 | Saliva sample Wiki | 0.05 |
drug4205 | VenaSeal™ Closure System Wiki | 0.05 |
drug1621 | Gam-COVID-Vac Lyo Wiki | 0.05 |
drug727 | COVID 19 Self-Questionnaire Wiki | 0.05 |
drug1625 | Gargle/Mouthwash Wiki | 0.05 |
drug6 | 0.12% Chlorhexidine Gluconate Wiki | 0.05 |
drug1145 | Daclatasvir 120 mg Wiki | 0.05 |
drug967 | Colchicine Tablets Wiki | 0.05 |
drug2660 | Observational Study Wiki | 0.05 |
drug1385 | Endoscopic procedure Wiki | 0.05 |
drug3688 | Sputum analysis Wiki | 0.05 |
drug2105 | Lambda 180 mcg S.C Wiki | 0.05 |
drug426 | Azithromycin 500Mg Oral Tablet Wiki | 0.05 |
drug3400 | Routine standard of care Wiki | 0.05 |
drug4436 | congenital malformation Wiki | 0.05 |
drug3483 | SNG001 Wiki | 0.05 |
drug1640 | Glucose tablets Wiki | 0.05 |
drug4602 | nasopharyngeal and throat swab Wiki | 0.05 |
drug3981 | The standard of care Wiki | 0.05 |
drug1204 | Diagnostic Laboratory Biomarker Analysis Wiki | 0.05 |
drug739 | COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support Wiki | 0.05 |
drug3331 | Remote controlled exercise Wiki | 0.05 |
drug621 | Bolus placebo Wiki | 0.05 |
drug1453 | Experimental drug Wiki | 0.05 |
drug1762 | Human Coach first, then Virtual Assistant Wiki | 0.05 |
drug2510 | Nasopharyngeal Swab Wiki | 0.05 |
drug522 | Baseline blood sample Wiki | 0.05 |
drug1129 | DAS181 OL Wiki | 0.05 |
drug4232 | Virtual Assistant first, then Human Coach Wiki | 0.05 |
drug2674 | Olfaction testing Wiki | 0.05 |
drug4659 | plasma hyperimmune Wiki | 0.05 |
drug2872 | Personal Protective Testing Booth Wiki | 0.05 |
drug1676 | HCQ & AZ vs HCQ+SIR Wiki | 0.05 |
drug3933 | Telephone follow-up Wiki | 0.05 |
drug1174 | Deep Breathing training Wiki | 0.05 |
drug4795 | urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic Wiki | 0.05 |
drug4600 | nasal pharyngeal (NP) swab samples Wiki | 0.05 |
drug557 | BioMedomics COVID-19 IgM-IgG Rapid Test Wiki | 0.05 |
drug4683 | quality of live assessment Wiki | 0.05 |
drug1568 | Follow-up visit Wiki | 0.05 |
drug4409 | blood test for SARS-COV2 serology Wiki | 0.05 |
drug4089 | Treatment for COVID-19 Wiki | 0.05 |
drug4093 | Triazavirin (Riamilovir) Wiki | 0.05 |
drug1770 | Humor/Salience Wiki | 0.05 |
drug1790 | Hydroxychloroquine Only Product in Oral Dose Form Wiki | 0.05 |
drug782 | COVID-19 treatments Wiki | 0.05 |
drug1604 | GPs reports of potential patient safety incidents, non-COVID-19 related Wiki | 0.05 |
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Name (Synonyms) | Correlation | |
---|---|---|
D003141 | Communicable Diseases NIH | 0.65 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.31 |
D018352 | Coronavirus Infections NIH | 0.27 |
Name (Synonyms) | Correlation | |
---|---|---|
D012141 | Respiratory Tract Infections NIH | 0.18 |
D014777 | Virus Diseases NIH | 0.17 |
D003333 | Coronaviridae Infections NIH | 0.11 |
D012327 | RNA Virus Infections NIH | 0.10 |
D003428 | Cross Infection NIH | 0.09 |
D018357 | Respiratory Syncytial Virus Infections NIH | 0.09 |
D000163 | Acquired Immunodeficiency Syndrome NIH | 0.07 |
D030341 | Nidovirales Infections NIH | 0.07 |
D021821 | Communicable Diseases, Emerging NIH | 0.07 |
D058345 | Asymptomatic Infections NIH | 0.07 |
D009410 | Nerve Degeneration NIH | 0.07 |
D004066 | Digestive System Diseases NIH | 0.05 |
D004408 | Dysgeusia NIH | 0.05 |
D018184 | Paramyxoviridae Infections NIH | 0.05 |
D005767 | Gastrointestinal Diseases NIH | 0.05 |
D014808 | Vitamin D Deficiency NIH | 0.05 |
D011014 | Pneumonia NIH | 0.05 |
D030361 | Papillomavirus Infections NIH | 0.05 |
D006685 | Hoarseness NIH | 0.05 |
D000071074 | Neonatal Sepsis NIH | 0.05 |
D000070627 | Chronic Traumatic Encephalopathy NIH | 0.05 |
D001997 | Bronchopulmonary Dysplasia NIH | 0.05 |
D055732 | Pulmonary Aspergillosis NIH | 0.05 |
D008589 | Meningococcal Infections NIH | 0.05 |
D008595 | Menorrhagia NIH | 0.05 |
D006929 | Hyperaldosteronism NIH | 0.05 |
D001228 | Aspergillosis NIH | 0.05 |
D001229 | Aspergillosis, Allergic Bronchopulmonary NIH | 0.05 |
D011488 | Protein Deficiency NIH | 0.05 |
D054559 | Hyperphosphatemia NIH | 0.05 |
D028361 | Mitochondrial Diseases NIH | 0.05 |
D055154 | Dysphonia NIH | 0.05 |
D004314 | Down Syndrome NIH | 0.05 |
D015163 | Superinfection NIH | 0.05 |
D011645 | Puerperal Infection NIH | 0.05 |
D011649 | Pulmonary Alveolar Proteinosis NIH | 0.05 |
D063806 | Myalgia NIH | 0.05 |
D066087 | Perinatal Death NIH | 0.05 |
D005879 | Tourette Syndrome NIH | 0.05 |
D014832 | Voice Disorders NIH | 0.05 |
D003384 | Coxsackievirus Infections NIH | 0.05 |
D004660 | Encephalitis NIH | 0.05 |
D004761 | Enterocolitis, Pseudomembranous NIH | 0.05 |
D000309 | Adrenal Insufficiency NIH | 0.05 |
D007008 | Hypokalemia NIH | 0.05 |
D006560 | Herpes Labialis NIH | 0.05 |
D055501 | Macrophage Activation Syndrome NIH | 0.05 |
D063130 | Maternal Death NIH | 0.05 |
D007251 | Influenza, Human NIH | 0.04 |
D006331 | Heart Diseases NIH | 0.04 |
D008173 | Lung Diseases, Obstructive NIH | 0.04 |
D011024 | Pneumonia, Viral NIH | 0.04 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.04 |
D012140 | Respiratory Tract Diseases NIH | 0.04 |
D007676 | Kidney Failure, Chronic NIH | 0.04 |
D003327 | Coronary Disease NIH | 0.04 |
D015658 | HIV Infections NIH | 0.04 |
D016638 | Critical Illness NIH | 0.03 |
D019965 | Neurocognitive Disorders NIH | 0.03 |
D008585 | Meningitis, Meningococcal NIH | 0.03 |
D008581 | Meningitis, Mening NIH | 0.03 |
D000075902 | Clinical Deterioration NIH | 0.03 |
D014552 | Urinary Tract Infections NIH | 0.03 |
D009181 | Mycoses NIH | 0.03 |
D009101 | Multiple Myeloma NIH | 0.03 |
D003015 | Clostridium Infections NIH | 0.03 |
D000013 | Congenital Abnormalities NIH | 0.03 |
D009220 | Myositis NIH | 0.03 |
D016470 | Bacteremia NIH | 0.03 |
D001424 | Bacterial Infections NIH | 0.03 |
D000073296 | Noncommunicable Diseases NIH | 0.03 |
D004696 | Endocarditis NIH | 0.03 |
D017250 | Caliciviridae Infections NIH | 0.03 |
D001714 | Bipolar Disorder NIH | 0.03 |
D054219 | Neoplasms, Plasma Cell NIH | 0.03 |
D013577 | Syndrome NIH | 0.03 |
D004417 | Dyspnea NIH | 0.03 |
D011251 | Pregnancy Complications, Infectious NIH | 0.03 |
D009080 | Mucocutaneous Lymph Node Syndrome NIH | 0.03 |
D000690 | Amyotrophic Lateral Sclerosis NIH | 0.03 |
D012640 | Seizures NIH | 0.03 |
D058070 | Asymptomatic Diseases NIH | 0.03 |
D016472 | Motor Neuron Disease NIH | 0.03 |
D003139 | Common Cold NIH | 0.03 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.03 |
D002318 | Cardiovascular Diseases NIH | 0.02 |
D020141 | Hemostatic Disorders NIH | 0.02 |
D001778 | Blood Coagulation Disorders NIH | 0.02 |
D004630 | Emergencies NIH | 0.02 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
D055371 | Acute Lung Injury NIH | 0.02 |
D003643 | Death, NIH | 0.02 |
D004211 | Disseminated Intravascular Coagulation NIH | 0.02 |
D009164 | Mycobacterium Infections NIH | 0.02 |
D000755 | Anemia, Sickle Cell NIH | 0.02 |
D001289 | Attention Deficit Disorder with Hyperactivity NIH | 0.02 |
D000257 | Adenoviridae Infections NIH | 0.02 |
D006470 | Hemorrhage NIH | 0.02 |
D015535 | Arthritis, Psoriatic NIH | 0.02 |
D009369 | Neoplasms, NIH | 0.02 |
D004194 | Disease NIH | 0.02 |
D012120 | Respiration Disorders NIH | 0.02 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
D005356 | Fibromyalgia NIH | 0.02 |
D007153 | Immunologic Deficiency Syndromes NIH | 0.02 |
D004198 | Disease Susceptibility NIH | 0.02 |
D001927 | Brain Diseases NIH | 0.02 |
D000857 | Olfaction Disorders NIH | 0.02 |
D009362 | Neoplasm Metastasis NIH | 0.02 |
D014115 | Toxemia NIH | 0.02 |
D018450 | Disease Progression NIH | 0.02 |
D003680 | Deglutition Disorders NIH | 0.02 |
D007154 | Immune System Diseases NIH | 0.02 |
D011565 | Psoriasis NIH | 0.02 |
D008171 | Lung Diseases, NIH | 0.02 |
D055370 | Lung Injury NIH | 0.02 |
D000066553 | Problem Behavior NIH | 0.02 |
D018805 | Sepsis NIH | 0.02 |
D019337 | Hematologic Neoplasms NIH | 0.02 |
D000070642 | Brain Injuries, Traumatic NIH | 0.02 |
D050177 | Overweight NIH | 0.02 |
D009205 | Myocarditis NIH | 0.02 |
D011665 | Pulmonary Valve Insufficiency NIH | 0.02 |
D010300 | Parkinsonian NIH | 0.02 |
D015212 | Inflammatory Bowel Diseases NIH | 0.02 |
D003324 | Coronary Artery Disease NIH | 0.02 |
D003550 | Cystic Fibrosis NIH | 0.02 |
D011248 | Pregnancy Complications NIH | 0.01 |
D003424 | Crohn Disease NIH | 0.01 |
D008175 | Lung Neoplasms NIH | 0.01 |
D001930 | Brain Injuries, NIH | 0.01 |
D059350 | Chronic Pain NIH | 0.01 |
D017563 | Lung Diseases, Interstitial NIH | 0.01 |
D001172 | Arthritis, Rheumatoid NIH | 0.01 |
D007674 | Kidney Diseases NIH | 0.01 |
D011658 | Pulmonary Fibrosis NIH | 0.01 |
D053120 | Respiratory Aspiration NIH | 0.01 |
D020521 | Stroke NIH | 0.01 |
D005355 | Fibrosis NIH | 0.01 |
D009103 | Multiple Sclerosis NIH | 0.01 |
D012598 | Scoliosi NIH | 0.01 |
D001168 | Arthritis NIH | 0.01 |
D006973 | Hypertension NIH | 0.01 |
D000860 | Hypoxia NIH | 0.01 |
D040921 | Stress Disorders, Traumatic NIH | 0.01 |
D007249 | Inflammation NIH | 0.01 |
D014947 | Wounds and Injuries NIH | 0.01 |
D013313 | Stress Disorders, Post-Traumatic NIH | 0.01 |
Name (Synonyms) | Correlation | |
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HP:0011947 | Respiratory tract infection HPO | 0.18 |
HP:0002180 | Neurodegeneration HPO | 0.07 |
HP:0100512 | Low levels of vitamin D HPO | 0.05 |
Name (Synonyms) | Correlation | |
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HP:0002090 | Pneumonia HPO | 0.05 |
HP:0002905 | Hyperphosphatemia HPO | 0.05 |
HP:0003811 | Neonatal death HPO | 0.05 |
HP:0002900 | Hypokalemia HPO | 0.05 |
HP:0000846 | Adrenal insufficiency HPO | 0.05 |
HP:0001618 | Dysphonia HPO | 0.05 |
HP:0001621 | Weak voice HPO | 0.05 |
HP:0000132 | Menorrhagia HPO | 0.05 |
HP:0003326 | Myalgia HPO | 0.05 |
HP:0002383 | Encephalitis HPO | 0.05 |
HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.05 |
HP:0040187 | Neonatal sepsis HPO | 0.05 |
HP:0000859 | Hyperaldosteronism HPO | 0.05 |
HP:0001609 | Hoarse voice HPO | 0.05 |
HP:0011024 | Abnormality of the gastrointestinal tract HPO | 0.04 |
HP:0006536 | Pulmonary obstruction HPO | 0.04 |
HP:0006510 | Chronic pulmonary obstruction HPO | 0.04 |
HP:0001287 | Meningitis HPO | 0.03 |
HP:0100584 | Endocarditis HPO | 0.03 |
HP:0100754 | Mania HPO | 0.03 |
HP:0100614 | Myositis HPO | 0.03 |
HP:0006775 | Multiple myeloma HPO | 0.03 |
HP:0002098 | Respiratory distress HPO | 0.03 |
HP:0006802 | Abnormal anterior horn cell morphology HPO | 0.03 |
HP:0007354 | Amyotrophic lateral sclerosis HPO | 0.03 |
HP:0001928 | Abnormality of coagulation HPO | 0.02 |
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.02 |
HP:0005521 | Disseminated intravascular coagulation HPO | 0.02 |
HP:0001250 | Seizure HPO | 0.02 |
HP:0007018 | Attention deficit hyperactivity disorder HPO | 0.02 |
HP:0002664 | Neoplasm HPO | 0.02 |
HP:0000458 | Anosmia HPO | 0.02 |
HP:0002721 | Immunodeficiency HPO | 0.02 |
HP:0001298 | Encephalopathy HPO | 0.02 |
HP:0003765 | Psoriasiform dermatitis HPO | 0.02 |
HP:0002015 | Dysphagia HPO | 0.02 |
HP:0002088 | Abnormal lung morphology HPO | 0.02 |
HP:0100806 | Sepsis HPO | 0.02 |
HP:0000708 | Behavioral abnormality HPO | 0.02 |
HP:0002037 | Inflammation of the large intestine HPO | 0.02 |
HP:0001677 | Coronary artery atherosclerosis HPO | 0.02 |
HP:0012819 | Myocarditis HPO | 0.02 |
HP:0010444 | Pulmonary insufficiency HPO | 0.02 |
HP:0100280 | Crohn's disease HPO | 0.01 |
HP:0100526 | Neoplasm of the lung HPO | 0.01 |
HP:0012532 | Chronic pain HPO | 0.01 |
HP:0006515 | Interstitial pneumonitis HPO | 0.01 |
HP:0001370 | Rheumatoid arthritis HPO | 0.01 |
HP:0001909 | Leukemia HPO | 0.01 |
HP:0000077 | Abnormality of the kidney HPO | 0.01 |
HP:0002206 | Pulmonary fibrosis HPO | 0.01 |
HP:0001297 | Stroke HPO | 0.01 |
HP:0001369 | Arthritis HPO | 0.01 |
HP:0000822 | Hypertension HPO | 0.01 |
HP:0012418 | Hypoxemia HPO | 0.01 |
Navigate: Correlations HPO
There are 450 clinical trials
The principal objective is to determine the impact of phenelzine on the activation phenotype of T cells and myeloid cells during SARS-CoV2 infection
Description: evaluate the levels of the activation of T cells and myeloid cells after phenelzine exposure by the levels of the % of DR+ CD38+ T cells and CD14+dim CD16+ monocytes.
Measure: levels of lymphocytes T DR + CD38 + and of monocytes CD14 dim + CD16 +. Time: through study completion, an average of 1 yearDescription: evaluate the levels of the expression of immune checkpoints on T cells by flow cytometry
Measure: level of immune checkpoints Time: through study completion, an average of 1 yearDescription: evaluate the modification of functional capacities of T cells by cytokines production, and proliferation, after mitogenic and antigen recall stimulations including SARS-CoV-2 antigens
Measure: cytokine production and proliferation Time: through study completion, an average of 1 yearDescription: assess if there is an impact of phenelzine on the activation levels of neutrophils
Measure: levels of neutrophils Time: through study completion, an average of 1 yearDescription: Determine if the immune responses in obese patients (a strong risk factor for severe Covid19) can be modulated in the same way compared with lean patients
Measure: level of immune responses in obese patients Time: through study completion, an average of 1 yearDescription: Determine if the immune responses can be modulated in the same way in men and in women (men being affected by more severe disease)
Measure: level of immune responses for men and women Time: through study completion, an average of 1 yearDetermine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.
Description: COVID19-0001-USR 1% nebulized pathway changes viral load of SARS-COV-2 virus (COVID19) in the upper and lower airways if started during the initial phase of infection
Measure: Change on viral load results from baseline after using COVID19-0001-USR via nebulization Time: Treatment Period of 7 daysThe purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.
Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.
Measure: Time to clinical worsening Time: RCT (approximately 15 days)Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.
Measure: clinical deterioration on a Likert-type scale (1-6) Time: RCT (approximately 15 days)Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.
Measure: clinical deterioration measured by number of days Time: RCT (approximately 15 days)Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.
Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe) Time: RCT (approximately 15 days)Background: - Increased clinical attention has been paid to the evaluation and management of bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases (such as Severe Acute Respiratory Syndrome [SARS] and new strains of influenza). However, evaluation and treatment data for these illnesses are often limited because human infections to date have been relatively limited. Further knowledge about diseases of bioterrorism concern and emerging infectious diseases may lead to more effective forms of therapy to prevent disease-related illnesses and deaths. Objectives: - To apply standardized, documented, and carefully monitored evaluation and treatment methods for bioterrorism- and biodefense-related illnesses and emerging infectious diseases at the National Institutes of Health Clinical Center. Eligibility: - Individuals at least 2 years of age who have confirmed or suspected infection by a biodefense or bioterrorism agent, or an emerging infectious disease agent. - Individuals at least 2 years of age who have confirmed or suspected exposure to a biodefense or bioterrorism agent, an emerging infectious disease agent, or who have close exposure to an individual who is suspected of being infected with one of these agents. - Health care workers who are involved in medical treatment of the abovementioned infected or exposed individuals. Design: - All eligible persons will have an initial screening evaluation to determine the circumstances of possible infectious exposure (e.g., where, when, and how exposed), current medical condition and medical care given, and any aspects of medical history that might be relevant to the exposure. - Participants may be seen in an outpatient clinic or in the Special Clinical Studies Unit (SCSU) at the National Institutes of Health (NIH). The NIH SCSU is a hospital ward specially designed to minimize the risk of spreading infection to others. - Upon admission, participants will provide blood and urine samples, have an electrocardiogram to measure heart activity, and have specific tests or procedures associated with the particular infectious agent. - Participants who develop illnesses will be treated with the standard of care for known diseases or with experimental measures, depending on the nature of the illness. Separate consent may be required for these treatments. - Participants will remain on this study for at least 1 year following the period of active evaluation and treatment. Participants may be asked to come to the NIH outpatient clinic on a periodic basis for medical evaluations and blood tests, and may be asked to keep a diary card to record any unusual signs or symptoms of possible infection.
Description: Determination of sustained absence of disease-specific symptoms and signs.
Measure: Symptoms and signs Time: 1 yearThe study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.
Description: The presence of Influenza A or Influenza B virus.
Measure: Detection of Respiratory Viruses Time: Specimens will be taken within 5 days of the appearance of symptoms.Background: - Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development. Objectives: - To collect samples and data from individuals who have been exposed to or have contracted viral infections. Eligibility: - Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases. - Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate. Design: - Participants will be pre-screened to determine if they meet the eligibility criteria for the trial. - If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies. - Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing. - Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection. - Treatment is not offered under this study.
Description: January 2031
Measure: Sample collection, analysis of immune function, or review of tissue bx or clinical rpts from outside labs in designated pop. w/ viral, suspected, or recovered from a viral infection or a close contact of people w/or suspected to have a viral inf... Time: open-endedCurrently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.
Description: Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.
Measure: Viral clearance Time: 5-10 daysDescription: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life
Measure: Pharmacokinetics of Oseltamivir Time: Day 0 and Day 9Description: Time to viral clearance on a throat swab, assessed by RT PCR. The time to no detectable influenza virus by culture for the throat swab. Change in viral load (log10 copies/mL) over time for all virological samples (lower limit of detection: 1000 copies/mL) Viral susceptibility of cultured influenza virus to antiviral drugs at baseline and post treatment, assessed by genotypical and phenotypical analyses
Measure: Viral end points Time: 5-10 daysDescription: Time to fever clearance In hospital mortality and mortality by follow up Time to death Time to trans cutaneous O2 saturation of ≥ 95% on room air Clinical course: pneumothorax, encephalitis/encephalopathy Number of days in hospital Number of days ventilated
Measure: Clinical Efficacy Endpoints Time: 5-10 daysDescription: Documented serious adverse events (SAEs) and relationships to oseltamivir AEs leading to drug withdrawal Grade 3 & 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir Skin rashes of any grade Changes in haematological and biochemical parameters over time
Measure: Safety Endpoints Time: 5-10 daysHuman papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina, and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have been proven to be highly effective in preventing the acquisition of HPV infection and the genital precancerous lesions caused by it. However, we do not know yet if a previously infected individual, once vaccinated, would be less infective to her or his sexual partner. We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination (TRAP-HPV) study to answer this question. It will include 500 sexually active couples* (total of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It will be a randomized placebo-controlled, double-blinded intervention trial. Study participants will be followed up to 12 months. Behavioural and biological data will be collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment. The results of this trial will be invaluable in informing policies regarding vaccination of women and men.
Description: Reduction in HPV type concordance (for the four target types) will be the main outcome evaluable as per the above group contrasts. These comparisons will be done with due attention to the enrolment virological status of the individuals. For instance, it is expected that a Avaxim-treated woman who is positive for HPV 6 in the oral specimen but negative for this type in the vaginal specimen may derive benefit if her partner receives Gardasil, even if he is HPV-6 positive in the penile sample. The assumption is that protection via vaccination is pan-mucosal, via transudation of neutralizing antibodies; this protection may mediate transmission.
Measure: The primary outcome will be the reduction of HPV DNA positivity for the target HPV vaccine types (i.e., HPVs 6, 11, 16, and 18) in multiple anatomic sites in the placebo-treated sexual partners of persons who received Gardasil. Time: At months 2, 4, 6, 9 and 12.Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually emerge and require new investigations to understand pathogen biology and pathogenesis in the host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health and the economy are also increasing. Current alerts sent out by the Ministry of Health (about the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely reflect advances in science, which have allowed novel pathogens to be identified. Because of its geography, Singapore is vulnerable to new pathogens through importation or the global travel of its citizens. Hence we must be ever ready to meet unexpected challenges anytime. On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force which has in place many plans that can be activated should there be a large-scale epidemic. What is missing thus far is a program that will enable us to perform scientific studies in the setting of an epidemic. Hence in this study, we will, in collaboration with the Program in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii) characterize viruses (not necessarily novel but emerging and re-emerging) that are raising concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize immune responses to such viruses in healthcare workers as well as patients (those affected by these viruses and those exposed to the affected). The techniques that will be used will be those not routinely available in a hospital's service labs. Some patients will remain undiagnosable with the best available technology. Since new laboratory tools that can detect previously undiagnosed pathogens may become available in the future, the study also aims to archive specimens from patients whose illnesses remain undiagnosed.
Description: Clinical data collection through case records, and interview of patients or next-of-kin or friend in the event information is unavailable or incompletely documented in the case records. Sample collection will be performed according to the following frequency: First day of enrolment: blood draw (by weight) not more than 20ml, nasal (and/or nasopharyngeal ) and/or throat swab, stool and urine sample. On days 2, 3, 5, 7, 10, 14 and 28: blood (by weight) not more than 10 ml, nasal (and/or nasopharyngeal l) and/or throat swab, stool and urine sample. On D28, blood (by weight) not more than 20ml, will be drawn as most immune response changes manifest by then. If available, urine and stool sample will be collected. If the subject is intubated, endotracheal aspirate will replace nasal and throat swab. Sample collection for research will be done at the same time as samples for clinical testing as far as possible, to minimize patient discomfort.
Measure: Detecting of Novel Pathogens Time: Day 1 - Day 28 of recruitmentThe primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.
Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Measure: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5 Time: Baseline to Day 5Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Measure: Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5 Time: Baseline to Day 5Description: The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.
Measure: Rate of Unplanned Medical Encounters Time: Up to Day 28The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.
Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Measure: Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9 Time: Baseline; Day 9Description: A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: Primary RSV lower respiratory tract infection (LRTI) Secondary bacterial LRTI LRTI due to unusual pathogens Lower respiratory tract complication of unknown etiology
Measure: Percentage of Participants Who Developed a Lower Respiratory Tract Complication Time: Up to Day 28Description: Participants were considered to have an event if either condition is met: Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or; Participant dies prior to or on Day 28
Measure: Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality Time: Up to Day 28The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).
Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.
Measure: Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9 Time: Baseline to Day 9The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.
The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.
Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Measure: Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7 Time: Up to 7 daysDescription: FEV1 is defined as forced expiratory volume in the first second.
Measure: Percent Change From Study Baseline in FEV1% Predicted Value Time: Baseline; Day 28This study aimed to analysis the characteristics of MERS transmission and the effect of our institutional personal protective equipment on the controlling the MERS at a tertiary Korean Hospital.
The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management. This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.
The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.
Description: Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
Measure: Time to Alleviation of All ARVI Symptoms. Time: 14 days of observation.Description: Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).
Measure: Time to Normalization of Body Temperature. Time: 14 days of observation.Description: Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.
Measure: Time to Alleviation of Flu-like Nonspecific Symptoms. Time: 14 days of observation.Description: Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.
Measure: Time to Alleviation of Respiratory Symptoms. Time: 14 days of observation.Description: Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
Measure: Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6. Time: On days 2-6 of the observation period.Description: Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.
Measure: ARVI Severity. Time: On days 2-6 of the observation period.Description: Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).
Measure: Percentage of Recovered Patients. Time: On days 2-6 of the observation period.Description: Based on patient diary data. The number of intakes of prescribed antipyretics.
Measure: Rates of Antipyretics Use Per Patient. Time: On days 1- 5 of the treatment period.Description: Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).
Measure: Percentage of Patients With Worsening of Illness. Time: 14 days of observation peiod.Non 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 in this study is to establish a list of host cellular proteins that mediate norovirus infection. Norovirus is one of the most common pathogens attributed to diarrheal diseases from unsafe food. It is also the primary cause of mortality among young children and adults in foodborne infections. Norovirus is not just a foodborne burden. In a recent meta-analysis, norovirus accounts for nearly one-fifth of all causes of (including person-to-person transmission) acute gastroenteritis in both sporadic and outbreak settings and affects all age groups. Undoubtedly, norovirus is of paramount public health concern in both developed and developing countries. Research efforts to better understand norovirus pathobiology will be necessary for targeted intervention. From Middle East respiratory syndrome coronavirus to Zika virus, efforts to identify host factors important for mediating virus infection has always been a research priority. Such information will shed light on potential therapeutic targets in antiviral intervention. Norovirus virus-host interaction studies have been hampered by the lack of a robust cell culture model in the past 20 years. In 2016, norovirus has finally been successfully cultivated in a stem cell-derived three-dimensional human gut-like structure called enteroid or mini-gut. In this study, intestinal stem cells will be isolated from duodenal biopsies collected from participants, followed by differentiation into mini-guts. Genome-wide genetic screening for host essential and restrictive factors will be performed on infected mini-guts by knockout CRISPR and gain-of-function CRISPR SAM, respectively. Shortlisted candidates will undergo preliminary functional validation in cell lines. These data will provide insights into potential therapeutic targets against norovirus infection.
Description: Viability of enteroids as determined by microscopy
Measure: Establishment of human intestinal stem cell-derived enteroids Time: An average of three monthsThe purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).
Description: RSV viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by the RSV viral load as measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Measure: Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5 Time: Baseline through Day 5Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure: RSV Viral Load and Change from Baseline Over Time Time: Baseline through Day 21Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.
Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14 Time: Baseline through Days 3, 8 and 14Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.
Measure: Time to Undetectable RSV Viral Load Time: Up to 21 daysDescription: Proportion of participants with undetectable RSV viral load will be reported.
Measure: Proportion of Participants with Undetectable RSV Viral Load at each timepoint Time: Up to 21 daysDescription: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).
Measure: Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Time: Up to 21 daysDescription: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).
Measure: Severity of RSV Disease Assessed by PRESORS Time: Up to 21 daysDescription: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.
Measure: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Time: Baseline up to 21 daysDescription: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.
Measure: Change from Baseline in Clinician PRESORS Scores Time: Baseline up to 21 daysDescription: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.
Measure: Time to Resolution of RSV Symptoms Time: Up to 21 daysDescription: Time to improvement based on general questions on overall health will be reported.
Measure: Time to Improvement on Overall Health Time: Up to 21 daysDescription: Proportion of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.
Measure: Proportion of Participants with Improvement or Worsening of RSV Disease Time: Up to 21 daysDescription: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.
Measure: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) Time: Up to 21 daysDescription: Proportion of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.
Measure: Proportion of Participants with Vital Sign Abnormalities Time: Up to 28 daysDescription: Proportion of participants with abnormal body temperature will be reported.
Measure: Proportion of Participants with Abnormal Body Temperature as Measured by the Parent(s)/Caregiver(s) Time: Up to 28 daysDescription: Proportion of participants who require (re)hospitalization during treatment and follow-up will be reported.
Measure: Proportion of Participants who Require (re)Hospitalization During Treatment and Follow-up Time: Up to 21 daysDescription: Time return to age-adjusted normal values for vital signs (heart rate, respiratory rate, and/or blood oxygen) for participants with risk factors for severe RSV Disease will be recorded.
Measure: Time Return to Age-Adjusted Normal Values for vital signs (Heart Rate, Respiratory Rate, and/or Blood Oxygen) for Participants with Risk Factors for Severe RSV Disease Time: Up to 21 daysDescription: Time to discharge (from initial admission and from initiation of treatment) will be recorded for Cohort 1 only.
Measure: Cohort 1: Time to Discharge Time: Up to 21 daysDescription: Proportion of participants who require to be admitted to the ICU will be reported for Cohort 1 only.
Measure: Cohort 1: Proportion of Participants who Require to be Admitted to Intensive Care Unit (ICU) Time: Up to 21 daysDescription: In the event that a participant requires ICU, admission, the duration of need for ICU stay will be reported for Cohort 1 only.
Measure: Cohort 1: Duration of ICU Stay Time: Up to 21 daysDescription: Proportion of participants who require supplemental oxygen will be reported for Cohort 1 only.
Measure: Cohort 1: Proportion Participants who Require Supplemental Oxygen Time: Up to 21 daysDescription: Duration of the oxygen supplementation in participants requiring will be reported for Cohort 1 only.
Measure: Cohort 1: Duration of Supplemental Oxygen Time: Up to 21 daysDescription: Proportion of participants who require non-invasive ventilator support (for example [e.g], continuous positive airway pressure) status will be reported for Cohort 1 only.
Measure: Cohort 1: Proportion of Participants who Require Non-invasive Ventilator Support Time: Up to 21 daysDescription: Proportion of participants who require invasive ventilator support (e.g, endotracheal-mechanical ventilation) will be reported for Cohort 1 only.
Measure: Cohort 1: Proportion of Participants who Require Invasive Mechanical Ventilation Support Time: Up to 21 daysDescription: Duration of non-invasive ventilator support (e.g, continuous positive airway pressure) to deliver oxygen will be measured for Cohort 1 only.
Measure: Cohort 1: Duration of Non-invasive Ventilator Support Time: Up to 21 daysDescription: Duration of invasive ventilator support (e.g, endotracheal-mechanical ventilation) to deliver oxygen will be measured for Cohort 1 only.
Measure: Cohort 1: Duration of Invasive Ventilator Support Time: Up to 21 daysDescription: Proportion of participants who need (defined by <50% of normal oral intake) hydration and/or feeding by IV administration or nasogastric tube will be reported for Cohort 1 only.
Measure: Cohort 1: Proportion of Participants who Need Hydration and/or Feeding by Intravenously (IV) Administration or Nasogastric Tube Time: Up to 21 daysDescription: Time to clinical stability is defined as the time from initiation of study treatment until the time at which the following criteria are met: Time to return to age-adjusted normal values for otherwise healthy and pre-RSV infection status for participants with risk factor for severe RSV disease (heart rate, respiratory rate, blood oxygen level), no more oxygen supplementation or otherwise healthy participants and with risk factor(s) for severe RSV disease and no more intravenously (IV)/nasogastric tube feeding/hydration) in otherwise healthy participants or return to pre-RSV status of IV/nasogastric tube feeding/hydration in participants with risk factor for severe RSV disease for Cohort 1 only.
Measure: Cohort 1: Time to Clinical Stability with Clinical Stability Evaluated by the Investigator Time: Up to 21 daysDescription: Time from initiation of study treatment until SpO2 >=92 percentage (%) and SpO2 >= 95% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms will be reported for Cohort 1 only.
Measure: Cohort 1: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) >= 92% and SpO2 >= 95% on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms Time: Up to 21 daysDescription: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measure: Percentage of Participants with Adverse Events Time: Up to 28 daysDescription: Percentage of participants with abnormal laboratory (serum chemistry, hematology and urinalysis) findings will be reported.
Measure: Percentage of Participants with Abnormal Laboratory Findings Time: Up to 28 daysDescription: Percentage of participants with abnormal ECGs findings will be reported.
Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings Time: Up to 21 daysDescription: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.
Measure: Plasma Concentrations of JNJ-53718678 Time: Days 1 and 3Description: Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.
Measure: Medical Resource Utilization Time: Up to 28 daysDescription: Acceptability and palatability of the JNJ-53718678 formulation will be assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing.
Measure: Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s) Time: Day 8Description: Number of participants with changes in the RSV F-gene compared with baseline sequences will be assessed by sequencing of the viral genome.
Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences Time: Up to 21 daysThis study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.
Description: Removal of all oxygen support (with stable SpO2)
Measure: Percent of subjects who Return to Room Air (RTRA) (main study) Time: by Day 28Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.
Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.
Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. Time: within 6 weeks (42 days)Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group
Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group Time: 4 weeks (28 days) post-deliveryDescription: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.
Measure: Incidence of chorioamnionitis Time: prior to deliveryDescription: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.
Measure: Incidence of endometritis Time: within 42 days post-deliveryDescription: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).
Measure: Incidence of other infections Time: within 42 days post-deliveryDescription: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.
Measure: Incidence of use of subsequent maternal antibiotic therapy Time: after randomization to 42 days post-deliveryDescription: Time from drug administration until initial discharge after delivery (time may vary by site).
Measure: Maternal initial hospital length of stay Time: within 42 days post-deliveryDescription: Maternal readmissions within 42 days of delivery
Measure: Incidence of maternal readmissions Time: within 42 days post-deliveryDescription: Maternal admission to special care units
Measure: Incidence of maternal admission to special care units Time: within 42 days post-deliveryDescription: Maternal unscheduled visit for care
Measure: Incidence of maternal unscheduled visit for care Time: within 42 days post-deliveryDescription: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.
Measure: Incidence of maternal GI symptoms Time: within 42 days post-deliveryDescription: Maternal death due to sepsis using the Global Network algorithm for cause of death
Measure: Incidence of maternal death due to sepsis Time: within 42 days post-deliveryDescription: Incidence of other neonatal infections.
Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection) Time: within 42 days post-deliveryDescription: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).
Measure: Neonatal initial hospital length of stay Time: within 28 days of deliveryDescription: Neonatal readmissions within 42 days of delivery
Measure: Incidence of neonatal readmissions Time: within 42 days of deliveryDescription: Neonatal admission to special care units
Measure: Incidence of neonatal admission to special care units Time: within 28 days of deliveryDescription: Neonatal unscheduled visit for care
Measure: Incidence of neonatal unscheduled visit for care Time: within 42 days post-deliveryDescription: Neonatal death due to sepsis using the Global Network algorithm for causes of death
Measure: Incidence of neonatal death due to sepsis Time: within 28 days of deliveryDescription: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.
Measure: Incidence of pyloric stenosis within 42 days of delivery Time: within 42 days of deliveryIn the general population, increased WBCC and neutrophil count are widely used as markers for infection during inflammatory states 1. However, 32% of geriatric patients with an infection do not develop an increase in WBCC 2. The hypothesis is that with inflammation, geriatric patients have a misadapted response of the immune system (IS) 3. Our recent retrospective study 4 has shown that total and differential WBCC were not correlated with infection in a geriatric hospitalized population. Therefore, WBCC does not seem to be a reliable marker for infection in geriatric hospitalized patients. The neutrophil/lymphocyte ratio, and CRP, seem to be better markers. the aim of the study to investigate this hypothesis prospectively and assess the role of aging and chronic diseases (such as cardiovascular diseases (CVD) and risk factors (CVRF) 5, cytomegalovirus (CMV) infection 6, periodontitis 7, onychomycosis 8 ) in this process and assess the role of a geriatric assessment. To assess the usefulness of WBCC in the diagnosis of infection in geriatric patients and to address the contribution of ongoing chronic co-morbidities and age to WBCC-kinetics during an acute inflammatory syndrome, young and geriatric hospitalized patients with an inflammatory syndrome with and without infection will be compared
Description: observation of WBCC is correlated with infection by older patient
Measure: Usefulness of white blood cell count (WBCC) during infection in geriatric patient Time: 1.5 yearsThis 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 yearsThis is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
Description: The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 24 hours: If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved Ileus/megacolon either noted as resolved by any provider documentation or not noted WBC<15,000 cells/uL Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 24 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD)) Lactate ≤2.2 mmol/L (if measured by clinical care team) No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin) Temperature <38.5 °C and ≥35.6°C < 8 bowel movements per day and < 600 mL unformed stool (if volume recorded) Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria
Measure: Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products. Time: 7 DaysDescription: All-cause mortality at 30- and 60-days following last FMT Colectomy or diverting ileostomy within 30 days after last FMT Cumulative days of hospitalization from enrollment until 30 days after FMT Cumulative days in intensive care unit from enrollment until 30 days after last FMT Bacteremia from enrollment until 30 days after last FMT Repeat hospital admission within 60 days of discharge from index hospitalization
Measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0 Time: 180 DaysFoods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.
Description: Species count in fecal sample
Measure: Gut microbiome species richness Time: 1 DayDescription: Measurement of blood lipids
Measure: Lipids Time: 3 daysDescription: Measurement of blood glucose
Measure: Glucose Time: 11 daysDescription: Record of sleep pattern using a wearable device (i.e. fitness watch)
Measure: Sleep Time: 10 daysDescription: Record of physical activity using a wearable device (i.e. fitness watch)
Measure: Physical activity Time: 10 daysDescription: Record of hunger and appetite patterns using a digital app
Measure: Hunger and appetite assessment Time: 10 daysDescription: C-peptide
Measure: Glucose metabolism Time: 3 daysDescription: Weighed food log
Measure: Dietary assessment Time: 10 daysDescription: Weight (kg)
Measure: Anthropometry Time: 1 dayDescription: Height (cm)
Measure: Anthropometry Time: 1 dayDescription: Hip and waist circumference (cm)
Measure: Anthropometry Time: 1 dayDescription: Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)
Measure: Metabolomics by NMR analysis Time: 1 dayDescription: Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.
Measure: Dietary assessment Time: 1 monthDescription: Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.
Measure: Covid-19 symptom assessment Time: 6 monthsDescription: Self-reported in-app question on daily frequency of adherence (categorical)
Measure: Adherence (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on hunger levels (categorical)
Measure: Hunger (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on weight (lbs)
Measure: Weight (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app Bristol Stool chart questoin (categorical)
Measure: Bristol Stool Category (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on bowel frequency
Measure: Bowel Frequency (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on energy levels (categorical)
Measure: Energy (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on alertness (categorical)
Measure: Alertness (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on stress (categorical)
Measure: Stress (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on mood (categorical)
Measure: Mood (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)Description: Self-reported in-app question on daily frequency of activity (categorical)
Measure: Activity (in sub-cohort) Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.
Description: The proportion of participants who develop RSV LRTI through Visit Day 28 per the Endpoint Adjudication Committee (EAC) assessment will be reported.
Measure: Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Time: Up to Day 28Description: The proportion of participants who develop RSV-associated LRTC through Visit Day 28 per the EAC's assessment will be reported.
Measure: Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC) Time: Up to Day 28Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measure: Number of Participants with Adverse Events (AEs) Time: Up to 49 daysDescription: Percentage of participants with abnormal clinical laboratory findings will be reported.
Measure: Percentage of Participants with Abnormal Clinical Laboratory Findings Time: Up to 49 daysDescription: Percentage of participants with abnormal ECGs findings will be reported.
Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings Time: Up to 49 daysDescription: Percentage of participants with abnormal vital signs findings will be reported.
Measure: Percentage of Participants with Abnormal Vital Signs Findings Time: Up to 49 daysDescription: The proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, (all-cause mortality) will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality) Time: Up to 49 daysDescription: Proportion of participants progressing to death (all-cause mortality), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Proportion of participants progressing to death (all-cause mortality) will be reported.
Measure: Proportion of Participants Progressing to Death (All-cause Mortality) Time: Up to 1 yearDescription: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) will be reported.
Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Time: Up to 49 daysDescription: Number of supplemental O2 free days will be reported.
Measure: Number of Supplemental Oxygen (O2) Free Days Through Day 28 Time: Through Day 28Description: Incidence of supplemental oxygen requirement in participants will be reported.
Measure: Incidence of Supplemental Oxygen Requirement Time: Up to 28 daysDescription: Duration of supplemental oxygen requirement in participants will be reported.
Measure: Duration of Supplemental Oxygen Time: Up to 28 daysDescription: Change from baseline in respiratory rate as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Respiratory Rate Time: Baseline up to 49 daysDescription: Change from baseline in heart rate as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Heart Rate Time: Baseline up to 49 daysDescription: Change from baseline in SpO2 as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Time: Baseline up to 49 daysDescription: Change from baseline in body temperature as measured by the investigator during scheduled visits will be reported.
Measure: Change from Baseline in Body Temperature Time: Baseline up to 49 daysDescription: Proportion of participants hospitalized (of participants who were not hospitalized at baseline) will be reported.
Measure: Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline) Time: Up to 1 yearDescription: Proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) will be reported.
Measure: Proportion of Participants Re-hospitalized Time: Up to 1 yearDescription: Total length of hospital stay (time in hospital from first dosing) will be reported.
Measure: Total Length of Hospital Stay Time: Up to 49 daysDescription: Total time in the ICU (time in ICU from first dosing) will be reported.
Measure: Total Time in the Intensive Care Unit (ICU) Time: Up to 49 daysDescription: Incidence of Grade 3 and Grade 4 AEs will be assessed by system organ class where Grade 3: Severe and Grade 4: Life-threatening.
Measure: Incidence of Grade 3 and Grade 4 Adverse Events (AEs) Time: Up to 49 daysDescription: Incidence of respiratory AEs will be reported.
Measure: Incidence of Respiratory AEs Time: Up to 49 daysDescription: Incidence of thoracic-related AEs will be reported.
Measure: Incidence of Thoracic-related AEs Time: Up to 49 daysDescription: Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Measure: Incidence of Antibiotic use in Participants who Develop and in Those who do not Develop RSV LRTI or RSV-Associated LRTC per the EAC's Assessment Time: Up to 49 daysDescription: Time to resolution of symptoms, assessed through an instrument for participant-reported symptoms (RiiQ Symptom Scale) will be reported.
Measure: Time to Resolution of Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Time: Up to 49 daysDescription: Change from baseline in severity of symptoms reported by participants in the RiiQ symptom scale through Day 28 will be reported.
Measure: Change from Baseline in Severity of Symptoms Reported by Participants in the RiiQ Symptom Scale Through Day 28 Time: Baseline up to Day 28Description: Time to resolution of respiratory illness, through the PGI-S Scale, will be reported.
Measure: Time to Resolution of Respiratory Illness as Assessed by Patient Global Impression of Severity (PGI-S) Scale Time: Up to 49 daysDescription: Change from baseline in PGI-H scale through Day 28 will be reported.
Measure: Change from Baseline in Patient Global Impression of Health (PGI-H) Scale Through Day 28 Time: Baseline up to Day 28Description: Change from baseline in PGI-C scale through Day 28 will be reported.
Measure: Change from Baseline in Patient Global Impression of Change (PGI-C) Scale Through Day 28 Time: Baseline up to Day 28Description: AUC (0-24h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose.
Measure: Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-53718678 Time: Up to 24 hours postdose (on Days 1 and 8)Description: Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
Measure: Trough Plasma Concentration (Ctrough) of JNJ-53718678 Time: Predose on Days 1 and 8Description: Cmax is defined as the maximum observed plasma concentration of JNJ-53718678 in the dosing interval.
Measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 Time: Day 1Description: The potential association of plasma concentration-time data of JNJ-53718678 with antiviral activity (RSV viral kinetics) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Antiviral Activity Time: Up to 49 daysDescription: The potential association of plasma concentration-time data of JNJ-53718678 with selected safety (including AEs and laboratory abnormalities) parameters will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Safety Parameters Time: Up to 49 daysDescription: The potential association of plasma concentration-time data of JNJ-53718678 with clinical outcomes (proportion of participants developing LRTI) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Clinical Outcomes Time: Up to 49 daysDescription: RSV viral load and change from baseline over time will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in the mid-turbinate nasal swab specimens.
Measure: RSV Viral Load and Change from Baseline Over Time Time: Baseline up to Day 28Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.
Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 8, 11, 15, 22 and 28 Time: Baseline up to Days 8, 11, 15, 22 and 28Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.
Measure: Time to Undetectable RSV Viral Load Time: Up to 49 daysDescription: Proportion of participants with undetectable RSV viral load at each time point throughout the study will be reported.
Measure: Proportion of Participants with Undetectable RSV Viral Load at Each Timepoint Time: Up to 49 daysDescription: Change from baseline for the HRQOL assessment as assessed through the EQ-5D-5L through Day 28 will be reported.
Measure: Change from Baseline for the Health-related Quality of Life (HRQOL) as Assessed by 5-level EuroQol 5-Dimension (EQ-5D-5L) Through Day 28 Time: Baseline up to Day 28Description: Change from baseline for the HRQOL assessment as assessed through RiiQ impact scales through Day 28 will be reported.
Measure: Change from Baseline for the HRQOL as Assessed by RiiQ Impact Scales Through Day 28 Time: Baseline up to Day 28Description: Change from baseline in the RSV F gene sequence will be reported.
Measure: Change from Baseline in the RSV F Gene Sequence Time: Baseline up to 49 daysIn this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.
Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomizationDescription: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 14 days after randomizationDescription: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Measure: The difference of PaO2/FiO2 between two groups Time: 7 days after randomizationDescription: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Measure: Lower Sequential Organ Failure Assessment (SOFA) score Time: 7 days after randomizationDescription: Percentage of patients requiring Mechanical ventilation support
Measure: Mechanical ventilation support Time: 7 days after randomizationDescription: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Measure: The difference of PaO2/FiO2 between two groups Time: 14 days after randomizationDescription: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Measure: Lower Sequential Organ Failure Assessment (SOFA) score Time: 14 days after randomizationDescription: Percentage of patients requiring Mechanical ventilation support
Measure: Mechanical ventilation support Time: 14 days after randomizationDescription: Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
Measure: Clearance of noval coronavirus Time: 14 days after randomizationDescription: All-cause mortality
Measure: All-cause mortality Time: 30 days after randomizationGut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.
Description: Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following): (1) Respiratory distress,respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%;(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following): (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.
Measure: Number of participants with improvement from severe type to common type Time: 2 weeksThe study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .
Description: Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.
Measure: The rate of virus inhibition Time: Day 0, 2, 4, 7, 10, 14 and 21Description: Body temperature will be followed everyday during time frame.
Measure: The disease prorogation-temperature Time: Day 0 till day 21Description: Respiratory rate will be followed everyday during time frame.
Measure: The disease prorogation-respiratory function 1 Time: Day 0 till day 21Description: Oxygen saturation of blood will be followed everyday during time frame.
Measure: The disease prorogation-respiratory function 2 Time: Day 0 till day 21Description: Chest imaging will be taken at each time point.
Measure: The disease prorogation-respiratory function 3 Time: Day 0, 4, 7, 10, 14 and 21Description: Blood pressure and heart rate will be followed everyday during time frame.
Measure: Patients health condition-routine test Time: Day 0 till day 21Description: Liver function will be assessed as AST, ALT and TBIL at each time point.
Measure: Patients health condition-liver function Time: Day 0, 4, 7, 10, 14 and 21Description: Kidney function will be assessed as eGFR and creatine clearance rate at each time point.
Measure: Patients health condition-kidney function Time: Day 0, 4, 7, 10, 14 and 21Description: Blood routine and myocardial enzyme will be measured at each time point.
Measure: Patients health condition-other blood routine test Time: Day 0, 4, 7, 10, 14 and 21Description: Flow cytometry classification and counting and cytokines will be measured at each time point.
Measure: Patients health condition-blood routine test Time: Day 0, 4, 7, 10, 14 and 21The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1,2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.
Description: after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system
Measure: positive number diagnosed by national guideline in the evaluated population Time: 5 monthsDescription: after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores
Measure: distribution map of evaluated people Time: 5 monthDescription: after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.
Measure: Effect of medical guidance by designated feedback questionnaire Time: 5 monthDescription: after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion.
Measure: mental scale of relief the mental anxiety and avoid unnecessary outpatient Time: 5 monthInfectious 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 study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.
Description: Percentage
Measure: The cure rate of 2019-nCoV. Time: 6 monthsDescription: Percentage
Measure: The improvement rate of 2019-nCoV. Time: 6 monthsDescription: Days
Measure: Duration of fever Time: 2 weeksDescription: Days
Measure: Duration of respiratory symptoms Time: 2 weeksDescription: Days
Measure: Duration of hospitalization Time: 2 weeksA 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, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells (DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine (LV-SMENP) will be investigated.
Description: A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Clinical improvement based on the 7-point scale Time: 28 days after randomizationDescription: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measure: Lower Murray lung injury score Time: 7 days after randomizationDescription: Number of deaths during study follow-up
Measure: 28-day mortality Time: Measured from Day 0 through Day 28Description: Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Measure: Duration of mechanical ventilation Time: Measured from Day 0 through Day 28Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Measure: Duration of hospitalization Time: Measured from Day 0 through Day 28Description: Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Measure: Proportion of patients with negative RT-PCR results Time: 7 and 14 days after randomizationDescription: Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measure: Proportion of patients in each category of the 7-point scale Time: 7,14 and 28 days after randomizationDescription: Proportion of patients with different inflammation factors in normalization range.
Measure: Proportion of patients with normalized inflammation factors Time: 7 and 14 days after randomizationDescription: Frequency of vaccine/CTL Events
Measure: Frequency of vaccine/CTL Events Time: Measured from Day 0 through Day 28Description: Frequency of Serious vaccine/CTL Events
Measure: Frequency of Serious vaccine/CTL Events Time: Measured from Day 0 through Day 28The 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.
Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.
Description: Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.
Measure: The SARS-CoV-2 infection of neonates born to mothers with COVID-19 Time: within 7days after the admissionDescription: The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.
Measure: The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19 Time: Infants ( ≥35 weeks)are at 6 months after birth;Infants(< 35weeks) are at a corrected age of 6 months.Description: The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).
Measure: The small for gestational age newborns in the neonates born to mothers with COVID-19 Time: at birthDescription: The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days
Measure: The preterm delivery of neonates born to mothers with COVID-19 Time: at birthDescription: Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese
Measure: The disease severity of neonates with COVID-19 Time: through study completion, estimated an average of 2 weeksSince 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 monthThe 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 daysThe 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 daysEvaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
Measure: Rate of composite adverse outcomes Time: 14 daysDescription: Clinical recovery was defined as 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).
Measure: Time to recovery Time: 14 daysDescription: Rate of no fever
Measure: Rate of no fever Time: 14 daysDescription: Rate of no cough
Measure: Rate of no cough Time: 14 daysDescription: Rate of no dyspnea
Measure: Rate of no dyspnea Time: 14 daysDescription: Rate of no requiring supplemental oxygen
Measure: Rate of no requiring supplemental oxygen Time: 14 daysDescription: Rate of undetectable New coronavirus pathogen nucleic acid
Measure: Rate of undetectable New coronavirus pathogen nucleic acid Time: 14 daysDescription: Rate of mechanical ventilation
Measure: Rate of mechanical ventilation Time: 14 daysDescription: Rate of ICU admission
Measure: Rate of ICU admission Time: 14 daysDescription: Rate of serious adverse event
Measure: Rate of serious adverse event Time: 14 daysThis is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Description: Percent of subjects who have returned to room air
Measure: Percent of subjects who have returned to room air Time: 7 daysDescription: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
Measure: Percent change of subjects return to baseline oxygen requirement Time: 7 daysThe epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.
Description: Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.
Measure: Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff Time: 3 monthsDescription: "Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient."
Measure: Identification of risk factors for seroconversion Time: 3 monthsDescription: "Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet. The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies."
Measure: Quantify the proportion of asymptomatic infections among staff who have seroconverted Time: 3 monthsDescription: "Description of symptomatic infections Clinical manifestations associated with seroconversion. On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "
Measure: " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome " Time: 3 monthsIn 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 monthStudy 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 daysThis 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 Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.
Measure: Change in PROMIS Dyspnea Functional Limitations Time: baseline, 10 daysDescription: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. 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 PROMIS Dyspnea Severity Time: baseline, 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 daysThis 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 Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.
Measure: Change in PROMIS Dyspnea Functional Limitations Time: 10 daysDescription: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. 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 PROMIS Dyspnea Severity 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 daysThousands 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 daysAdults who have tested positive for SARS-CoV-2 infection and who do not require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome
Description: To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection and, 2) who do not require supplemental oxygen (Ordinal Scale for Clinical Improvement 3 or less) at the time of enrollment. The primary endpoint is the difference in the proportion of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
Measure: Severity of COVID-19 Time: 28 daysDescription: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy
Measure: SARS-CoV-2 infection Time: 28 daysDescription: To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
Measure: Severity of COVID-19 over 14 days Time: 14 daysDescription: To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score. The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening.
Measure: Severity of COVID-19 symptoms Time: 28 daysDescription: The requirement for ICU admission within 28 days from the start of the experimental therapy.
Measure: ICU admission Time: 28 daysDescription: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
Measure: Mechanical Ventilation Time: 28 daysDescription: All cause mortality at 28 days from the start of experimental therapy
Measure: Mortality Time: 28 daysSubjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.
Description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.
Measure: Severity of COVID-19 Time: 28 daysDescription: Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit
Measure: Incidence of SARS-CoV-2 infection Time: 28 daysDescription: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit
Measure: Incidence of SARS-CoV-2 infection Time: 14 daysDescription: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.
Measure: Severity of COVID-19 Time: 14 daysDescription: The requirement for ICU admission within 28 days from the start of experimental therapy.
Measure: ICU admission Time: 28 daysDescription: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.
Measure: Mechanical ventilation Time: 28 daysDescription: All cause mortality at 28 days from the start of experimental therapy.
Measure: Mortality Time: 28 daysIn 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 daysCorona virus is known as covid 19 And is transmitted through droplet infection
Description: The number of pregnant women who have awareness about the disease
Measure: The number of pregnant women who know the exact symptoms of the disease Time: Within one monthCollection 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)Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives. - First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll. - Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation. - Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population. The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).
The COVID-19 outbreak and spread throughout the world now constitutes a global public health emergency. Direct contact between doctors and patients in daily practice bears potential risk of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.
Description: Maneuvarability of the remote control MCE system
Measure: Technical success Time: During the procedureDescription: Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
Measure: Clinical success Time: During the procedureDescription: Adverse events during and after the procedure
Measure: Adverse events Time: During and within 2 weeks after the procedureSARS-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 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 randomizationCoronavirus (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 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 daysThis is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.
Description: Number patients developing severe infection or death
Measure: Number patients developing severe infection or death Time: within 28 daysThe primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.
As shown by the data available, hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system to the presence of the virus, is considered to represent one of the most important negative prognostic factor in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The objective of this study is to investigate new possibilities to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.
Description: Defined as the proportion of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
Measure: Treatment success Time: Up to Day 15Description: Measured in days
Measure: Time to mechanical ventilation Time: Date of randomization to date of mechanical ventilationDescription: Measured in total score
Measure: Change from baseline in Modified Early Warning system score Time: Baseline, Day 15Description: Measured in percent (%)
Measure: Change from baseline in resting peripheral capillary oxygen saturation (SpO2) Time: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15Description: Measured in percent (%)
Measure: Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) Time: Baseline, Day 15Description: Measured in local units
Measure: Change of pH in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of oxygen tension (pO2) in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of potassium in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of sodium in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of chloride in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of lactic acid in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of hemoglobin in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in l/min
Measure: Change from baseline in oxygen supplementation Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Measure: Change of findings of high-resolution computed tomography (CT) scan of the chest Time: Screening, Day 15Description: Measured in local units
Measure: Change from baseline in Ferritin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in lactate dehydrogenase (LDH) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in D-dimers Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in White Blood Cells with differential counts Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Red Blood Counts Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Hemoglobin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Platelet count Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Fibrinogen Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Complement factors C3/C4 Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Prothrombin time Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Cardiac troponin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in aspartate aminotransferase (AST) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in alanine aminotransferase (ALT) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in total bilirubin levels Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in C-Reactive Protein Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Creatinine Time: Baseline, Days 4, 7, 10, 13 and 15Description: Confirmation of death
Measure: Overall survival Time: Weeks 6 and 10Description: Measured in days
Measure: Time to hospital discharge Time: Weeks 6 and 10This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.
COVID-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 monthsA randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
Description: Dichotomous categorical variable measured by "yes" or "no" responses
Measure: COVID-19 disease diagnosis Time: Change from Baseline COVID-19 disease diagnosis at 8 weeksDescription: Dichotomous categorical variable measured by "slight" or "severe" responses
Measure: COVID-19 disease symptoms severity Time: Change from Baseline COVID-19 disease symptoms severity at 8 weeksDescription: Polytomous categorical variable measured by adverse effects responses
Measure: Adverse effects Time: Change from Baseline adverse effects at 8 weeksAn 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 days7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population. 8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa . 12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks. 13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.
Description: The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.
Measure: COVID-19 App-based platform Time: 6 monthsDescription: To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.
Measure: COVID-19 infection Time: 6 monthsThis 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 treatmentCoronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death. Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR. It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors. It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.
Description: Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19
Measure: Coinfections Time: during ICU stay, up to 28 daysDescription: it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance)
Measure: Respiratory dysfunction requiring mechanical ventilation Time: during ICU stay, up to 28 daysDescription: the SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: during ICU stay, up to 28 daysDescription: APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%.
Measure: SAPS II score Time: at admissionDescription: The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained
Measure: Disseminated Intravascular Coagulation (DIC) score Time: during ICU stay, up to 28 daysDescription: measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality.
Measure: Short Form 36 Time: at 9 months +/- 3 months after ICU stayDescription: The scale allows to detect anxiety and depression using 14 items rated from 0-3. Measuring the long-term impact of confirmed COVID-19 infection
Measure: Hospital anxiety and depression scale (HADS) Time: at 9 months +/- 3 months after ICU stayDescription: 22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection
Measure: Impact of Event Scale - revised (IES-R) Time: at 9 months +/- 3 months after ICU stayDescription: Question the stressful experience or event, followed by 20 multiple-choice questions. Measuring the long-term impact of confirmed COVID-19 infection
Measure: Post-traumatic stress disorder Checklist version DSM-5 (PSL-5) Time: at 9 months +/- 3 months after ICU stayDescription: The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection
Measure: Modified Medical Research Council (MMRC) Dyspnea Scale Time: at 9 months +/- 3 months after ICU stayDescription: Evolution of viral clearance in nasal and depp PCR during ICU
Measure: Viral clearance Time: through study completion, an average of 28 daysThis 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 yearsSince December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic. In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients. As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers. The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo. Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:
Description: An infection by SARS-CoV-2 is defined by either: a positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR a positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR a seroconversion to SARS-CoV-2 after randomization.
Measure: Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs) Time: Up to 2.5 monthsDescription: Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.
Measure: Evaluation of the occurrence of adverse events in each arm, Time: Up to 2.5 monthsDescription: Number of treatment discontinuations in each arm
Measure: Evaluation of the discontinuation rates of the investigational drug in each arm, Time: Up to 2 monthsDescription: Treatment adherence rate will be assessed by: measurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection the count of returned drugs at each visit.
Measure: Evaluation of the adherence of participants to study drug, Time: Up to 2 monthsDescription: Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm. Symptomatic infection is defined as : a positive specific RT-PCR on a respiratory or non respiratory sample OR a thoracic CT scan with imaging abnormalities consistent with COVID-19. These investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.
Measure: Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm, Time: Up to 2.5 monthsDescription: Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm. Asymptomatic infection is defined as : a positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up OR as seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up
Measure: Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm Time: Up to 2.5 monthsDescription: Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as : a positive specific RT-PCR on a respiratory sample OR a thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency > 30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 and/or lung infiltrates >50% (1).
Measure: Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm. Time: Up to 2.5 monthsDescription: Safety. Electrocardiogram (ECG)
Measure: corrected QT interval (ms) Time: At baseline, at D2 (only for COVIDAXIS 1) and every week up to 2 months.COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19. We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. The study is funded and leaded by The Ministry of Health, Vietnam.
Description: Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat/nose swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat/nose swabs.
Measure: Viral clearance time Time: Up to 56 days post randomizationDescription: The time since randomization to discharge between study groups
Measure: Lengh of hospital stay Time: Up to 56 days post randomizationDescription: The number of ventilator free days over the first 28 days of treatment
Measure: Ventilator free days Time: first 28 daysDescription: The number of oxygene free days over the first 28 days of treatment
Measure: Oxygene free days Time: first 28 daysDescription: The time to (all-cause) death following over the first 7, 10, 14, 28 and 56 days since randomization
Measure: Time to death Time: first 7, 10, 14, 28 and 56 days since randomizationDescription: The rates of serious adverse events, rates of grade 3 or 4 adverse events
Measure: Adverse events Time: Over the first 28 days (due to the prolonged half-life of Chloroquine)Description: Time since randomization to the first defervescence day
Measure: fever clearance time Time: Up to 56 days post randomizationDescription: WHO Ordinal outcome scale for COVID-19
Measure: Ordinal outcome scale Time: Up to 56 days post randomizationDescription: Development of ARDS defined by the Kigali criteria
Measure: Development of ARDS Time: Up to 56 days post randomizationThis 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 enrolmentSince December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death. Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19. It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.
The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clínical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points. Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.
Description: number of new cases divided by number of persons-time at risk
Measure: Incidence rate of new COVID-19 cases in both arms Time: From day 14 after start of treatment up to the end of follow-up: week 27Description: percentage of cases of COVID 19
Measure: Prevalence of COVID-19 cases in both arms Time: 27 weeks after the beginning of the studyDescription: Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death
Measure: Mortality rate secondary to COVID-19 cases in both groups Time: 27 weeks after the beginning of the studyDescription: percentage of patients who need admission in an ICU due to COVID 19 infection
Measure: Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups Time: 27 weeks after the beginning of the studyDescription: Presence and type of adverse events at this point.
Measure: Adverse events Time: 12 weeks after the start of treatmentDescription: Proportion of participants that drop out of study
Measure: Adverse events Time: 27 weeks after the beginning of the studyWe hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.
Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.
Measure: Time (in days) to clinical improvement within 30 days after randomization Time: within 30 daysThe coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.
Description: From blood samples: protein levels, whole genome sequence, transcriptomic analysis data. From upper respiratory samples: protein levels, virus transcriptomic analysis data. From stool: microbiota analysis data. From urine: protein level.
Measure: COVID-19 desease description Time: Inclusion visit (Day 1)Description: From blood samples: protein levels.
Measure: COVID-19 desease description Time: Day 30 to 90ORCHID 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 randomizationIn order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.
Description: Rate of COVID-19 positive conversion on weekly nasopharyngeal (NP) sampling
Measure: Rate of COVID-19 positive conversion Time: 7 weeksDescription: Time-to-first clinical event consisting of a persistent change for any of the following: One positive NP sample Common clinical symptoms of COVID-19 infection including fever, cough, and shortness of breath Less common signs and symptoms of COVID-19 infection including headache, muscle pain, abdominal pain, sputum production, and sore throat
Measure: Time-to-first clinical event Time: 7 weeksDescription: Time-to-first clinical worsening event consisting of any of the following: Hospitalization for COVID-19 infection Intensive care unit admission for COVID-19 infection All cause death
Measure: Time-to-first clinical worsening event Time: 7 weeksDesynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. The main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.
Description: To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy
Measure: Fraction of healthcare workers infected with SARS-CoV-2 Time: 90 daysDescription: To compare the infection rate of hospitalized patients versus healthcare workers
Measure: Fraction of healthcare workers with COVID-19 Time: 90 daysDescription: Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired.
Measure: Number of patients infected in the hospital Time: 90 daysDescription: To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection.
Measure: Development of SARS-CoV2 specific antibody repertoire Time: 18 monthsA prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of a chloroquine analog (GNS561), an anti PD-1 (nivolumab), an anti-NKG2A (monalizumab), an anti-C5aR (avdoralimab) and an anti-interleukine-6 receptor (tocilizumab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: - COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-PD1 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1:1). - COHORT 2 (moderate/severe symptoms): GNS561 vs anti-IL6 vs anti-C5aR vs standard of care (randomization ratio 1:1:1:1).
Description: 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.
Measure: 28-day survival rate Time: 28 days from randomizationDescription: Time to clinical improvement defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale (WHO-ISARIC) or live discharge from the hospital, whichever comes first.
Measure: Time to clinical improvement Time: 28 days from randomizationDescription: Clinical status will be assessed using a 7-point ordinal scale : Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Clinical status Time: Day 7, Day 14, Day 28Description: Mean change in clinical status from baseline will be assessed using a 7-point ordinal scale.
Measure: Mean change in clinical status from baseline to days Time: Day 7, Day 14, Day 28Description: Overall survival will be defined by the time from date of randomization until date of death, regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Measure: Overall survival Time: 3 months (i.e. at the the time of last patient last visit)Description: The length of stay in Intensive Care Unit (from the date of admission in the Unit to the date of discharge).
Measure: Length of stay in Intensive Care Unit Time: 3 months (i.e. at the the time of last patient last visit)Description: The duration of mechanical ventilation or high flow oxygen devices (from the date of intubation to the stop date of mechanical ventilation or high flow oxygen)
Measure: Duration of mechanical ventilation or high flow oxygen devices Time: 3 months (i.e. at the the time of last patient last visit)Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)
Measure: Duration of hospitalization Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in neutrophils count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Treatment-Emergent Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, New Safety Issues described using the NCI-CTC AE classification v5. Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: 3 months (i.e. at the the time of last patient last visit)Description: Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.
Measure: Cost-Effectiveness Analyses (CEA) Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in lymphocytes count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in platelets count (G/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in hemoglobin count (g/dL)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in CRP count (mg/L)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)Description: Changes from baseline in pro-inflammatory cytokine (IL6)
Measure: Biological parameters Time: 3 months (i.e. at the the time of last patient last visit)This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy Time: 12 weeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or Progression of Symptomatic Days Time: 12 weeksDescription: Assess the symptom response to study therapy as measured by the survey in the EDC
Measure: Assess the safety of Quintuple Therapy Time: 12 weeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via pulse Time: 12 weeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via oxygen saturation Time: 12 weeksDescription: EKG response from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via EKG Time: 12 weeksDescription: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Measure: Assess Tolerability of Quintuple Therapy Time: 12 weeksHealthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.
Description: assessed by: No symptoms Mild symptoms: general malaise, fever, cough, myalgia, asthenia. Moderate symptoms: mild symptoms plus shortness of breath, Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation
Measure: Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19) Time: 12 weeksThis is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
Measure: Prevention of COVID-19 symptoms as recorded in a daily diary Time: 24 weeksDescription: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.
Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events Time: 24 weeksThis is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin
Description: 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 - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: World Health Organization (WHO) ordinal scale measured at 14 days after enrollment Time: Day 14Description: 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 - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: WHO ordinal scale measured at 28 days after enrollment Time: Day 28In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the health care system is not recommended by the Danish Health Authorities. Here, Health Authorities in other countries have different recommendations for the use of facial masks. Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge. SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets - or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person. Facial masks are expected to protect against viral infection in two ways; 1. By reducing the risk of getting the virus in via the mouth or nose via respiratory droplets or aerosol 2. By reducing the transfer from virus-contaminated hands to the mouth or nose Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection. All participants will follow authority recommendations and be randomized to either wear facial masks or not. The participants will be screened for antibodies at study start and study end. They will perform swab-test if they experience symptoms during the study as well as the end of study.
Description: Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or
Measure: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: Time: 1 monthDescription: Component 2 of primary endpoint: Antibody test; Development of positive SARS-CoV-2 antibody test (IgM and/or IgG) during the study period and/or
Measure: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: Time: 1 monthDescription: Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility
Measure: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: Time: 1 monthDescription: Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus
Measure: Positive oropharyngeal/nasal swab (PCR); Time: 1 monthDescription: SAR-CoV-2, Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus
Measure: Positive oropharyngeal/nasal swab (PCR); Time: 1 monthDescription: Returned swabs
Measure: Difference between the two study groups Time: 1 monthDescription: Psychological aspects of face mask wearing in the community
Measure: Discribtion of the face mask users psycological aspects of wearing face masks Time: 1 monthDescription: Cost-effectiveness analyses on the use of surgical face masks
Measure: Costs associated with wearing vs not wearing face masks Time: 1 monthDescription: Preference for self-conducted home swab vs. healthcare conducted swab at hospital or similar
Measure: Differences in the participants preferences Time: 1 monthDescription: Symptoms of COVID-19
Measure: Difference between the two study groups Time: 1 monthDescription: Self-assessed compliance with health authority guideline on hygiene
Measure: Difference between the two study groups with stratification between subgroups (age, gender, occupation, comorbidities) Time: 1 monthDescription: Willingness to wear face masks in the future
Measure: Discribtion of the face mask users willingness to wear face masks Time: 1 monthDescription: Healthcare diagnosed COVID-19 or identified SARS-CoV-2 infection as assessed by number of participants with antibodies against SARS-CoV-2, and/or positive maso/pharyngeal swab (PCR), mortality associated with COVID-19 and all cause mortality
Measure: Healthcare diagnosed COVID-19 between study groups Time: 1 monthDescription: Presence of bacteria: Mycoplasma pneumonia, Haemophilus influenza and Legionella pneumophila (to be obtained from registries when made available)
Measure: Hospital based diagnostics of bacteria between the two study groups Time: 1 monthDescription: Frequency of infected house-hold members between the two groups
Measure: Infection in the household between the two study groups Time: 1 monthDescription: Frequency of sick leave between the two groups (to be obtained from registries when made available)
Measure: Sick leave among participants beteeen the two study groups Time: 1 monthDescription: Predictors of primary outcome or its components
Measure: Predictors of primary outcome; age, gender, size of household, comorbidities, medications, social factors, occupation, mask compliance, compliance to general SARS-CoV-2 recommendations, hours outside home) Time: 1 monthThis is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.
Description: Measure the proportion of subjects with either swab positive COVID-19 or presentation of clinical symptoms as measured by fatigue with either fever >37.2 (oral)and/or a persistent cough.
Measure: Prevention Study: Measure the effect of NORS on the prevention of COVID-19 infection among health care professionals at risk of exposure to COVID-19 Time: 14 daysDescription: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.
Measure: Treatment Sub Study: Measure the efficacy of NORS at reducing the progression of COVID- 19 Time: 21 daysDescription: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.
Measure: Prevention Study: Measure the effect of NORS on the prevention of progression of COVID- 19 Time: 21 daysDescription: Measure the tolerability of the NORS treatments as determined by number of adverse events, pain, discomfort or discontinuations of treatment.
Measure: Prevention Study: Measure the tolerability of NORS treatments Time: 21 daysDescription: Measure the median number of days to negative conversion of SARS-CoV-2 RT-PCR from a nasopharyngeal swabs.
Measure: Treatment Sub Study: Measure the virucidal effect of NORS Treatments Time: 21 daysDescription: Determine the time to clinical recovery in participants with COVID-19 by measuring the median number of days from enrollment to discharge (if admitted), or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air).
Measure: Treatment Sub Study: Determine effect of NORS on the speed of clinical recovery Time: 21 daysDescription: Measure the reduction clinical symptoms in participants with COVID- 19 by the magnitude of the change in Modified Jackson Cold Score Diary Score (5-unit change is a substantial clinical benefit).
Measure: Treatment Sub Study: Determine the reduction in clinical symptoms Time: 21 daysDescription: Measure the proportion of participants that have a positive sero-conversion for SARS-CoV-2
Measure: Treatment & Sub Study: Determine positive sero-conversion for SARS-CoV-2 Time: 21 daysThe spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.
Description: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms
Measure: Rates of return visits to the ED Time: 28 daysDescription: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require hospitalization during their COVID-19 course
Measure: Inpatient hospitalizations required Time: 28 daysDescription: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require intubation during their COVID-19 course
Measure: Rates of intubation Time: 28 daysDescription: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to die of any cause within 28 days of their initial ED visit
Measure: Rates of mortality Time: 28 daysCOVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).
Description: Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.
Measure: the composite rate of adverse outcomes Time: day 7Description: The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission. It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.
Measure: The rate of hospitalization Time: 24 hoursThis study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.
Description: COVID-19 serology testing
Measure: Virology Cure Rate Time: 10 daysDescription: Measure incidence of diarrhea, vomiting, nausea and constipation
Measure: Incidence of GI adverse events Time: 47 daysDescription: 12-Lead ECG daily if QTc >500 msec
Measure: Cardiac Toxicity Time: 10 daysDescription: Measure blood counts
Measure: Changes in WBC w Diff, B cells, T cells, NK cells Time: 10 daysDescription: Measure changes in plasma cytokines throughout course of infection
Measure: Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a Time: 10 daysOur aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.
Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8
Measure: Change of baseline total sequential organ failure assessment (SOFA) score Time: Visit study day 8Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8
Measure: Improvement of lung involvement measurements Time: Visit study day 8Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8
Measure: Increase of pO2/FiO2 ratio Time: Visit Study Day 8Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of sequential organ failure assessment (SOFA) score Time: Day 28Description: Mortality on day 28
Measure: Rate of Mortality Time: Day 28Description: Mortality on day 90
Measure: Rate of Mortality Time: Day 90Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Cytokine stimulation Time: Screening, Day 4Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Gene expression Time: Screening, Day 4Description: Change of serum/plasma proteins between days 0 and 4
Measure: Serum/plasma proteins Time: Screening, Day 4Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation
Measure: Classification of the immune function Time: ScreeningSince December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Description: Mortality at day 28
Measure: Mortality at day 28 Time: day 28Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measure: severe complications Time: up to day 28Description: Delay in imaging in hours
Measure: Imaging Time: day 1Description: delay in microbiological diagnosis in hours
Measure: Delay in Microbiological diagnosis Time: day 1Description: Antiviral therapy Yes / no
Measure: Antiviral therapy Time: up to day 28Description: Antibiotic therapy Yes / No
Measure: Antibiotic therapy Time: day 28Description: Covid-19 treatments Yes / No
Measure: Covid-19 treatments Time: up to day 28Description: number
Measure: Patients receiving renal replacement therapy Time: up to day 28Description: number
Measure: Patients receiving mechanical ventilation Time: up to day 28Description: Patient alive at day 28 : yes / No
Measure: Vital status Time: day 28The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
Description: Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
Measure: Mechanical ventilation Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysDescription: Number of subjects transferred from non-ICU bed to an ICU bed
Measure: ICU transfer Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysDescription: Number of days requiring oxygen therapy
Measure: Oxygen therapy Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysThe overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of ventilator utilization at day 14 Time: 14 daysDescription: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.
Measure: WHO progression scale ≤ 5 Time: 4 daysDescription: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14 Time: 14 daysDescription: Proportion of patients with a decrease of WHO score of at least 1 point at day 4
Measure: Decrease of at least one point in WHO progression scale score Time: 4 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10.
Measure: WHO progression scale Time: 7 and 14 daysDescription: Overall survival.
Measure: Survival Time: 14, 28 and 90 daysDescription: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.
Measure: Respiratory acidosis Time: 4 daysDescription: Evolution of PaO2/FiO2 ratio.
Measure: PaO2/FiO2 ratio Time: day 1 to day 14Description: Time to oxygen supply independency.
Measure: Time to oxygen supply independency Time: 14 daysDescription: Duration of hospitalization.
Measure: Duration of hospitalization Time: 90 daysDescription: Time to negative viral excretion.
Measure: Time to negative viral excretion Time: 90 daysDescription: Time to ICU discharge.
Measure: Time to ICU discharge Time: 90 daysDescription: Time to hospital discharge.
Measure: Time to hospital discharge Time: 90 daysThis Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
Measure: Hours to recovery Time: 42 daysDescription: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications
Measure: Time fever resolution Time: 42 daysA novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.
Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.
Description: The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.
Measure: Number of antibodies against coronaviruses isolated and identified from patient samples Time: Up to 12 months after collection visitThis is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
Description: Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
Measure: Proportion of patients with onset of severe acute respiratory syndrome (SARS) Time: 7 days after randomizationDescription: Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
Measure: Mortality rate Time: after randomization, up to 28 daysDescription: Proportion of participants in need and duration of intensive care support after randomization
Measure: Number of participants in need of intensive care support Time: during and after intervention, up to 28 daysDescription: Viral load change in blood and oropharyngeal swab samples
Measure: Viral concentration Time: After randomization, up to 7 daysDescription: Incidence of serious adverse events during and after treatment
Measure: Cumulative incidence of serious adverse events Time: During and after intervention, up to 28 daysDescription: Incidence of grade 3 and 4 adverse events during and after treatment
Measure: Cumulative incidence of grade 3 and 4 adverse events Time: During and after intervention, up to 28 daysDescription: proportion of discontinuation or temporary suspension of treatment (for any reason)
Measure: Proportion of patients with discontinued treatment Time: after randomization, up to 28 daysDescription: proportion of patients with increased levels of troponin I
Measure: Incidence of cardiac lesions Time: after randomization, up to 120 daysDescription: proportion and magnitude of QTcF interval increases higher than 500ms
Measure: Incidence of cardiac disfunctions Time: after randomization, up to 120 daysDescription: Changes measured on day 120 will be compared to baseline, through spirometry.
Measure: Change in respiratory capacity Time: Day 120 after randomizationThe purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.
Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.
Measure: Time to clinical worsening Time: RCT (approximately 15 days)Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.
Measure: clinical deterioration on a Likert-type scale (1-6) Time: RCT (approximately 15 days)Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.
Measure: clinical deterioration measured by number of days Time: RCT (approximately 15 days)Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.
Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe) Time: RCT (approximately 15 days)This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.
Description: Hospitalization for a COVID-19 related admission during the first month of follow up. Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event.
Measure: Rates of hospitalization for a COVID-19 related complication Time: One month from the start of treatmentDescription: Time to clinical recovery will be defined by a return to normal body temperature (97-99 degrees F) as reported by the patient, and resolution of major presenting symptoms (myalgia, cough, shortness of breath, and GI symptoms) maintained for 72 hours. Patients will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via a pre-specified questionnaire. Patients will continue to be followed for an additional 3 months by electronic medical record review.
Measure: Time to clinical recovery (TTCR) Time: One month from the start of treatmentDescription: This score will be evaluated using a subjective self-reporting questionnaire around 8 symptoms, which include: shortness of breath at rest or exertion, fatigue, myalgia/muscle aces, fever, cough, headache, GI symptoms, inability to taste or smell. Subjects will rate each of their symptoms on an ordinal scale as follows: absent (0), mild (1), moderate (2), or severe (3). These symptom ratings will be added to define the symptom severity score with a possible score range of 0-24 points. Subjects will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via this pre-specified questionnaire. Patients will continue to be followed for an additional 3 months via EHR review.
Measure: Symptom Severity Score Time: One month from the start of treatmentThis is a multi-centre population-based follow-up study for all 504 patients with laboratory-confirmed COVID-19. This study establishes a standardized and structured clinical database to provide complete and multidimensional clinical diagnosis and treatment data of novel coronavirus pneumonia, which also support future epidemiological, infectious disease study and patients' prognosis, by collecting clinical data and the related data of patients with novel coronavirus pneumonia in Southern Zhejiang province.
Description: sum score of SF 36 form in each time frame
Measure: 36-Item Short Form Survey Instrument (SF-36) Time: one month, three month, six month and one year after discharge, minimum scoreDescription: laboratory result
Measure: Lymphocyte value Time: one month, three month, six month and one year after dischargeDescription: laboratory result
Measure: Neutrophil value Time: one month, three month, six month and one year after dischargeDescription: laboratory result
Measure: DDI value Time: one month, three month, six month and one year after dischargeDescription: collect the number of applying ACEIs/ARBs medication and calculate the proportion
Measure: the proportion of applying ACEIs/ARBs medication Time: from the date of hospital admission to the day of hospital dischargeDescription: clinical symptoms
Measure: number of clinical symptoms after hospital discharge Time: one month, three month, six month and one year after dischargeThe purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.
Description: Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day
Measure: Symptom Reduction Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6
Measure: Symptom Resolution: Fever Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe
Measure: Symptom Resolution: Cough Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities
Measure: Symptom Resolution: Shortness of Breath Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale: 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measure: Symptom Resolution: Fatigue Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.
Measure: Symptom Resolution: Muscle/body aches Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.
Measure: Symptom Resolution: Headache Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.
Measure: Symptom Resolution: New loss of taste Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.
Measure: Symptom Resolution: New loss of smell Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .
Measure: Symptom Resolution: Congestion/ runny nose Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.
Measure: Symptom Resolution: Nausea Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.
Measure: Symptom Resolution: Vomiting Time: 28 daysDescription: The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.
Measure: Symptom Resolution: Diarrhea Time: 28 daysDescription: Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.
Measure: Day 5 Symptoms Time: 5 daysDescription: Differences in hospitalization events between the study arms
Measure: Hospitalizations Time: 28 daysDescription: Differences in severity of symptoms between study arms
Measure: Severity of Symptoms Time: 28 daysDescription: Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms
Measure: Adjunctive Medications Time: 28 daysDescription: Differences in number of patients in study arms who experienced side effects from the supplements.
Measure: Supplementation Side Effects Time: 28 daysIt appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit. The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments. A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units. Patients will be randomly allocated 1:1 to either nivolumab or SoC.
Description: the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first
Measure: Time to clinical improvement Time: day 14Description: according to CTC AE-4.03
Measure: Incidence of grade 3-4 adverse events Time: day 28Description: range, from 0 (healthy) to 10 (death)
Measure: World Health Organisation (WHO) progression scale Time: day 4, 7 and 14Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.
Description: Compare rates of intubation between treatment and control groups
Measure: Decrease incidence of intubation by 30% or greater Time: one monthDescription: Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups
Measure: Decrease renal injury Time: one month- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. - Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. - Interim analysis will be permitted as described in the statistical section 8. - The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Description: Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Measure: For patients hospitalized for COVID-19 but not intubated Time: 7 DaysDescription: Mortality rate at 30 days from starting treatment for patients with COVID-19
Measure: Primary objective for patients with COVID-19 already intubated Time: 30 DaysDescription: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
Measure: Duration of hospitalization Time: 60 DaysDescription: The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
Measure: Duration of mechanical ventilation Time: 60 DaysDescription: The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.
Measure: Time to symptoms resolution Time: 60 DaysDescription: Overall survival will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
Measure: Overall survival Time: 60 DaysWe will evaluate low-dose pyridostigmine as add-on therapy to best medical care in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and its related Coronavirus Disease 2019 (COVID-19) who require hospitalization. Our hypothesis is that, in comparison to the placebo, pyridostigmine will reduce in at least 10% a composite outcome [death; mechanical ventilation; >2 point-increase in the SOFA score) by day 28. We will also evaluate interleukin (IL)-6 kinetics during the first 14 days of in-hospital stay. It is estimated that 25-33% of patients hospitalized for COVID-19 are admitted to intensive care units (ICU) for severe hypoxemia. The reported mortality in those with severe disease ranges between 38% and 49%. So far, there is no pharmacological therapeutic (or else) strategy known to reduce morbidity and mortality in these patients. Mortality in COVID-19 appears to be mediated not necessarily by the direct effect of the infection, but by the disproportionate inflammatory response of the host. Pyridostigmine is an old drug that, by inhibiting acetylcholine-esterase, the enzymatic machinery that degrades acetylcholine (ACh), results in increased ACh bioavailability. ACh, in turn, ligates to nicotinic-alpha7 receptors in macrophages and T cells, resulting in reduced overactivation of these immune cells. In experimental murine sepsis, this family of drugs has resulted in reduced inflammation and mortality. Human evidence is scarce for severe inflammatory conditions. However, recent evidence from our group and others indicates that pyridostigmine has an immunomodulatory effect in people living with HIV, resulting in elevation of CD4+ T cell counts, decreased immune activation, and reduction in inflammatory mediators. Altogether, this suggests that ACh-esterase inhibitors may act as immunomodulators during viral infections, potentially reducing the inflammatory cascade (the so-called "cytokine storm") observed in critically ill COVID-19 patients. At the proposed dose (60mg/d), the rate of minor adverse events is less than 5% with no reported serious adverse effects. From that perspective, we consider that pyridostigmine can function as an immuno-modulator and reduce morbidity and mortality in COVID-19-stricken patients, with the added value of a safe pharmacological profile. Moreover, as an old drug, re-purposing it for a novel indication may be a simpler, more efficient approach than developing a novel one from the ground up.
Description: Composite of death, Need for mechanical ventilation, or an increase of 2 or more points in the SOFA score
Measure: Critical condition or death Time: 28 daysDescription: Kinetics of circulating IL-6
Measure: IL-6 Time: 14 days in-hospital, hospital discharge, or deathIn this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 80 patients will be enrolled and randomly assigned in a 1:1:1 ratio to three study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a 1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU site will serve as the central data management site for other centers who undertake this protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60 patients at outside sites are expected to enroll.
Description: Number of patients who remain alive at time point.
Measure: Patient Survival Time: 28 daysDescription: Number of patients who remain alive at end of study.
Measure: Patient Survival Time: 60 daysThe COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.
Description: Analysis of all-cause death in relation with clinical patient profile
Measure: Death rate Time: Through study completion, an average of 4 weeksDescription: Correlation between clinical patient profile and transfer need to intensive care unit
Measure: Transfer to intensive care unit Time: Through study completion, an average of 4 weeksDescription: Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile
Measure: Ventilation analysis Time: Through study completion, an average of 4 weeksDescription: Description of clinical and biological patient profile leading to a worse prognosis
Measure: Construction of a predictive score for COVID-19 severe form Time: Through study completion, an average of 4 weeksThe Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo
Description: The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.
Measure: To assess the impact of hydroxychloroquine and azithromycin on the prevention of SARS-CoV-2 contamination in hospital workers exposed to 40 days of treatment. Time: 3 monthsDescription: Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR
Measure: Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR Time: 40 daysDescription: number of seroconversion by serology between Day 0 and Day 40.
Measure: Reducing seroconversion for SARS-CoV-2 without any clinical sign Time: 3 monthsDescription: number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths
Measure: Evaluation of drug tolerance in the study Time: 40 daysDescription: Number of work stoppages over the period
Measure: Evaluation on work stopping of hospital workers Time: 40 daysDescription: Plasmatic concentrations of treatments
Measure: Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine Time: 40 daysDescription: number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments
Measure: Incidence of cardiologic events Time: 40 daysThis is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.
Description: No evidence of SARS-CoV-2 infection at or before study day 28
Measure: Proportion of participants with no evidence of SARS-CoV-2 infection Time: Up to 28 daysDescription: Resolution of SARS-CoV-2 infection in the upper respiratory tract
Measure: Time (days) to no detection of SARS-CoV-2 in two upper respiratory samples Time: Up to 14 daysEvaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
Description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen min without supplemental oxygen
Measure: Rate of composite adverse outcomes Time: Within 10 days after administrationDescription: Clinical recovery was defined as 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 ≥ 30 breaths per min without supplemental oxygen).
Measure: Time to recovery Time: Within 10 days after administrationTranslational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics. The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.
Description: Investigate the epidemiology of the infection in an asymptomatic population including both healthy individuals at high risk of infection and oncological patients by assessing the seroprevalence of IgG and IgM antibodies against the SARS-CoV-2
Measure: epidemiology Time: 12 monthsDescription: IgG and IgM antibodies evaluation over time
Measure: Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation Time: 12 monthsDescription: Make a comparison between different serological investigation methods and rapid molecular methods becoming available
Measure: methods comparison Time: 24 monthsDescription: To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity
Measure: correlation between biochemical and coagulative factors with SARS-CoV-2 positivity. Time: 24 monthsDescription: Building a phylogenetic map of an epidemic Italian macro-region
Measure: phylogenetic map Time: 24 monthsDescription: Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19
Measure: interactions between the virus and host cells Time: 24 monthsIntensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.
The purpose of the study is to evaluate an effectiveness of the drug Dalargin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.
Description: Estimated by Polymerase chain reaction (PCR)
Measure: The change of viral load in patients with SARS-COVID-19. Time: Upon patient inclusion in the study, after 96 hours and on the 10day;Description: Assessed through the entire patient participation in the study
Measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS) Time: up to 10 daysDescription: The number of days a patient is hospitalized
Measure: Duration of hospitalization Time: up to 10 daysDescription: Early mortality from all causes will be estimated
Measure: The frequency of early mortality Time: up to 30 daysDescription: Late mortality from all causes will be estimated
Measure: The frequency of late mortality Time: up to 90 daysDescription: Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: Death; Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; Hospitalization extended, on non-invasive ventilation; Hospitalization is extended, needs additional oxygen; Hospitalization is extended, additional oxygen is not required; Discharged.
Measure: Clinical status at the time of completion of participation in the study Time: an average of 10 daysThe overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab 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 Eculizumab will receive standard of care. Outcomes of Eculizumab-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 intubation, events considered are intubation or death
Measure: Survival without needs of intubation at day 14 Time: 14 daysDescription: Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score
Measure: Change in organ failure at day 3 Time: 3 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: Intubation free survival at day 14 Time: Day 14Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at days 4, 7 and 14 Time: 4, 7 and 14 daysDescription: Overall survival
Measure: Survival at 14, 28 and 90 days Time: 14, 28 and 90 daysDescription: Time between inclusion and hospital discharge
Measure: Time to discharge Time: 90 daysDescription: Time between inclusion and oxygen supply independency
Measure: Time to oxygen supply independency Time: 90 daysDescription: Time between inclusion and negative viral excretion
Measure: Time to negative viral excretion Time: 90 daysDescription: Incidence of secondary infections (acquired pneumonia)
Measure: Incidence of secondary infections Time: 90 daysDescription: Vasopressor-free survival
Measure: Vasopressor-free survival Time: 90 daysDescription: Ventilator-free survival
Measure: Ventilator-free survival Time: 90 daysDescription: Number of ventilator-free days alive up to day 28
Measure: 28-day ventilator-free days Time: 28 daysDescription: Incidence of dialysis (renal replacement therapy)
Measure: Incidence of dialysis Time: 90 daysDescription: PaO2/FiO2 ratio
Measure: PaO2/FiO2 ratio Time: days 4, 7, 14Description: Number of patients with arterial blood pH of <7.25, with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
Measure: Rate of respiratory acidosis at day 4 Time: 4 daysDescription: Time to ICU discharge
Measure: Time to ICU discharge Time: 90 daysThis study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.
Description: Number of patients developing signs and symptoms of Covid-19 or other infections
Measure: Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group Time: 12 monthsDescription: Number of patients developing Covid-19 infection
Measure: Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group Time: 12 monthsDescription: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action
Measure: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action Time: 12 monthsDescription: Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposure
Measure: Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients Time: 6 monthsA prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.
Description: To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals
Measure: Risk categorization of healthcare workers Time: 9 monthsDescription: To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.
Measure: COVID-19 infection rate among health care workers Time: 9 monthsDescription: To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.
Measure: Risk factors for COVID-19 among health care workers Time: 9 monthsDescription: To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.
Measure: Adherence of health care workers to infection prevention Time: 9 monthsDescription: To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.
Measure: Validity of the available rapid serological test for detecting COVID-19 virus infection Time: 9 monthsDescription: To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.
Measure: Clinical spectrum of COVID-19 Time: 9 monthsDescription: To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals
Measure: Effectiveness of infection prevention in the health care facility Time: 9 monthsDescription: To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals
Measure: Emergency infection prevention and control needs Time: 9 monthsDescription: To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.
Measure: Isolation rate and emergency health care worker replacement needs Time: 9 monthsDescription: To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.
Measure: Rate of seroconversion Time: 9 monthsThis study is a phase II, parallel, prospective, randomized, double-blind, placebo controlled trial. The present study will aim to address the efficacy and safety of acute administration of triiodothyronine on ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO.
Description: The primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. The primary objective will be measured as percentage of patients successfully weaned after 30 days of follow-up.
Measure: Assessment of weaning from cardiorespiratory support Time: 30 daysDescription: Hemodynamic status will be assessed by continuous blood pressure measurements (systolic BP in mmHg)
Measure: Assessment of hemodynamic status Time: 30 daysDescription: Hemodynamic status will be assessed by continuous blood pressure measurements (diastolic BP in mmHg)
Measure: Assessment of hemodynamic status Time: 30 daysDescription: Hemodynamic status will be assessed by continuous blood pressure measurements (mean BP in mmHg)
Measure: Assessment of hemodynamic status Time: 30 daysDescription: Hemodynamic status will be assessed by the number of participants with use of inotropic and vasoactive drugs
Measure: Assessment of hemodynamic status Time: 30 daysDescription: Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of oxygen in mmHg)
Measure: Assessment of pulmonary function Time: 30 daysDescription: Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of carbon dioxide in mmHg)
Measure: Assessment of pulmonary function Time: 30 daysDescription: Pulmonary function will be assessed by arterial measurement of lactate levels (in mmol/L)
Measure: Assessment of pulmonary function Time: 30 daysDescription: Hepatic function will be assessed by laboratory measurements in blood. Changes in aspartate aminotransferase (AST in IU/L) will be measured.
Measure: Assessment of hepatic function Time: 30 daysDescription: Hepatic function will be assessed by laboratory measurements in blood. Changes in alanine aminotransferase (ALT in IU/L) will be measured.
Measure: Assessment of hepatic function Time: 30 daysDescription: Hepatic function will be assessed by laboratory measurements in blood. Changes in gamma-glutamyl transpeptidase (γ-GT in IU/L) will be measured.
Measure: Assessment of hepatic function Time: 30 daysDescription: Hepatic function will be assessed by laboratory measurements in blood. Changes in bilirubin in mg/dL will be measured.
Measure: Assessment of hepatic function Time: 30 daysDescription: Hepatic function will be assessed by laboratory measurements in blood. Changes in fibrinogen in mg/dL will be measured.
Measure: Assessment of hepatic function Time: 30 daysDescription: Hepatic function will be assessed by laboratory measurements in blood. Changes in d-dimers in ng/ml will be measured.
Measure: Assessment of hepatic function Time: 30 daysDescription: Urine volume during 24 hours (in ml) will be recorded.
Measure: Assessment of renal function Time: 30 daysDescription: Changes in urea (in mg/dL) will be recorded.
Measure: Assessment of renal function Time: 30 daysDescription: Changes in uric acid (in mg/dL) will be recorded.
Measure: Assessment of renal function Time: 30 daysDescription: Changes in creatinine (in mg/dL) will be recorded.
Measure: Assessment of renal function Time: 30 daysDescription: Echocardiographic assessment of cardiac left ventricular ejection fraction (LVEF, %)
Measure: Assessment of cardiac function Time: 30 daysDescription: Measurements of cardiac troponin I (in μg/L) will be used to assess myocardial injury
Measure: Assessment of cardiac injury Time: 30 daysDescription: COVID-19 infection will be assessed by inflammatory indices in blood (white blood cells in number per μL)
Measure: Assessment of the course of COVID-19 infection Time: 30 daysDescription: COVID-19 infection will be assessed by inflammatory indices in blood (CRP in mg/L)
Measure: Assessment of the course of COVID-19 infection Time: 30 daysDescription: COVID-19 infection will be assessed by inflammatory indices in blood (erythrocyte sedimentation rate in mm/hr)
Measure: Assessment of the course of COVID-19 infection Time: 30 daysDescription: COVID-19 infection will be assessed by temperature monitoring (in degrees Celsius)
Measure: Assessment of the course of COVID-19 infection Time: 30 daysDescription: COVID-19 infection will be assessed by time needed (in days) for the patient to become negative in COVID-19
Measure: Assessment of the course of COVID-19 infection Time: 30 daysDescription: Number of participants with major (death, cardiac Arrest, electromechanical dissociation, pulmonary embolism, new myocardial infarction, stroke, pulmonary edema, cardiogenic shock and hypotension, septic shock, pulmonary embolism, serious bleeding) events be recorded during the follow up period
Measure: Assessment of clinical outcome and safety Time: 30 daysDescription: Number of participants with minor (myocarditis, Venous Thromboembolism, left Ventricular mural thrombus, renal failure, hepatic failure, stress ulcers, minor bleeding, paroxysmal supraventricular tachycardia and atrial fibrillation, rhythm disturbances) events will be recorded during the follow up period
Measure: Assessment of clinical outcome and safety Time: 30 daysThe goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic tests, like Coris Bioconcept Ag Respi-strip COVID-19 test, and LAMP-based molecular tests) in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support.
Description: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test
Measure: Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result Time: 1 yearDescription: Accuracy refers to the amount of agreement between the results of the rapid tests and a clinical diagnosis of COVID-19
Measure: Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis Time: 1 yearDescription: Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician
Measure: Self-test interpretation of result vs expert clinical image interpretation of result Time: 1 yearDescription: Subjects will complete a survey to rate the testing procedure for ease of use and convenience. The survey will ask subjects to rate the ease of use on a scale from 1 (easiest procedure to complete and understand) to 10 (most complicated and confusing procedure)
Measure: Ease of self-testing procedure Time: 1 yearThe main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo.
The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.
Description: Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
Measure: Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine. Time: Day 30Description: Overall survival time in days from inclusion.
Measure: Overall survival of patients on Dexmedetomidine Time: Day 30Description: The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.
Measure: Daily analgesic effect of Dexmedetomidine Time: Day 30Description: Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.
Measure: Other sedative pharmacological agents Time: Day 30Description: Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation
Measure: Average dosage required for Dexmedetomidine to achieve mild to moderate sedation Time: Day 30COVID-19 ( known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. The picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%. Its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition. In such a context, healthcare professionals assigned to COVID units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences. We would therefore like to describe, using validated tools, the emotional evolution of the care workers at the Limoges University Hospital and the Esquirol University Hospital faced with this new pandemic infection. An initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy
Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measure: anxiety Time: 7 days,Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measure: anxiety Time: 15 days,Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measure: anxiety Time: 1 monthDescription: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measure: anxiety Time: 3 monthThe AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.
Description: Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.
Measure: Documentation of natural course and the therapeutic landscape of patients with COVID-19. Time: 2 yearsThis is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.
Description: The percentage of HM patients with COVID-19 who died.
Measure: To evaluate mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.
Measure: To evaluate potential predictive biochemical parameters of mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.
Measure: To evaluate potential predictive HM-related parameters of mortality. Time: At 2 months from study initiationDescription: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality
Measure: To evaluate COVID severity as predictive parameter of mortality. Time: At 2 months from study initiationDescription: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)
Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity Time: At 6 months from study initiationDescription: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.
Measure: Definition of complete clinical picture of COVID-19 in HM Time: At 2 months from study initiationDescription: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.
Measure: Evolution of HM Time: At 2 months from study initiationDescription: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).
Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics Time: At 2 months from study initiationThere is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.
Description: Number of confirmed (positive CRP) symptomatic infections in each treatment group
Measure: SARS-CoV 2 infection rate Time: up to 12 weeksCoronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.
Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
Measure: Fibrosis Time: 12 monthsDescription: Decreased functional capacity on ergospirometers
Measure: Ergospirometers Time: 12 monthesThe Nancy Cov-H-AKI: study is a prospective, non-randomized, monocenter study performed in patients hospitalised for either the severe or the critical form of Covid-19. The main objective of the Nancy Cov-H-AKI study is to evaluate the association of variations (from inclusion to 72H post-inclusion) of 5 blood-based cardio-vascular-renal biomarkers selected a priori, cardiac (NT-proBNP), coagulation (D-dimers), related to the renin angiotensin aldosterone system (ACE2) and renal (Penkid, and NGAL) with the appearance of acute kidney injury KDIGO grade 1 or higher OR cardiac injury in patients hospitalised for either the severe or the critical form of Covid-19
Description: Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 2).
Measure: Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection Time: From inclusion to hospital discharge, an average of 21 daysDescription: Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 1)
Measure: Troponin greater than 99th percentile during hospitalization for Covid-19 infection Time: From inclusion to hospital discharge, an average of 21 daysDescription: Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) ((with Outcome 3 )
Measure: AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori) Time: From inclusion to hospital discharge, an average of 21 daysDescription: Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) (with Outcome 3)
Measure: Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) Time: From inclusion to hospital discharge, an average of 21 daysDescription: AKI KDIGO grade 1 in hospitalisation
Measure: AKI KDIGO grade 1 or higher Time: From inclusion to hospital discharge, an average of 21 daysDescription: Association with troponin elevation >99th percentile during hospitalisation
Measure: Association with troponin elevation >99th Time: From inclusion to hospital discharge, an average of 21 daysDescription: Association with elevation of serum creatinine >30% during hospitalisation
Measure: Association with elevation of serum creatinine >30% Time: From inclusion to hospital discharge, an average of 21 daysDescription: With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital
Measure: With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) Time: 3 months after discharge from hospitalDescription: Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital
Measure: The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital Time: From inclusion to three months after discharge from hospitalDescription: Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital
Measure: The occurrence of death from any cause during hospitalisation and three months after discharge from hospital Time: From inclusion to three months after discharge from hospitalContext: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.
Description: To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.
Measure: Antibody status in HCW Time: 4 monthsDescription: To determine how many are actively infected with or without showing symptoms.
Measure: Active virus carriers in HCW Time: 4 monthsDescription: To determine how many employees are in their incubation period during study time.
Measure: Incubation time Time: 4 monthsDescription: To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population.
Measure: Background incidence rate Time: 4 monthsDescription: To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees.
Measure: Occupation associated infection risk Time: 4 monthsTo assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals
Description: health care workers who have positive IGg in seum
Measure: Number of IGg seropositive health care workers Time: single measurement from each person collected over 2 monthsDescription: to know positive IGg persons and IGg negative persons to understand risk factors
Measure: Differentiation between low risk and high risk HCWs Time: 2 months through out duration of studyThis is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
Description: Overall mortality within 60 days
Measure: Overall Mortality within 60 days Time: sixty days from infusion of plasmaDescription: length of admission for COVID
Measure: Length of ICU stay during current admission for COVID Time: Length of admission for COVID through study follow-up period, an average of 60 daysA novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures. Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth. It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.
Description: Number of women who are positive for SARS-CoV-2
Measure: Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman Time: at deliveryDescription: Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications
Measure: Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications Time: 2 months after deliveryDescription: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: vaginal, anal, amniotic fluid and in the newborn: nasopharyngeal swabs, gastric aspiration, anal swab.
Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy Time: at deliveryDescription: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: milk and stool samples and in the newborn: nasopharyngeal swabs, urine and stool.
Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy Time: 5 days after deliveryDescription: Evaluation of gestational age at SARSCoV-2 infection by performing serology on monthly collected serum samples (samples collected for routine management of pregnancy).
Measure: Assessment of susceptibility to infection during the 3 trimesters of pregnancy Time: 5 days after deliveryDescription: Study of the methods of confinement by investigation
Measure: Evaluation of the confinement on the risk of exposure to the virus during pregnancy . Time: 5 days after deliveryDescription: A biobank will be carried out, including the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn
Measure: collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy. Time: 5 days after deliveryDescription: Risk factors in uninfected women
Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease. Time: at deliveryDescription: Risk factors in infected and symptomatic women.
Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease. Time: at deliveryDescription: risk factors in newborns
Measure: Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease. Time: at deliveryThis is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.
Description: Number of cases with serological/virological diagnosis for SARS-Co-2 infection
Measure: Incidence of SARS-CoV-2 infection Time: 24 monthsDescription: Number of cases of symptomatic SARS-CoV-2 infection
Measure: Incidence of COVID-19 Time: 24 monthsDescription: Number of cases of hospitalization due to symptomatic SARS-Co-2 infection
Measure: Incidence of hospitalization due to COVID-19 Time: 24 yearsDescription: Level of neutralizing antibodies in participants with SARS-Co-2 infection
Measure: Level of neutralizing antibodies Time: 24 monthsDescription: Positive serology for SARS-Co-2 infection at baseline
Measure: Previous SARS-CoV-2 infection Time: 6 monthsDescription: Number of a new SARS-CoV-2 infection in an individual with a proven previous infection
Measure: Incidence of SARS-CoV-2 reinfection Time: 24 monthsDescription: Number of COVID-19 cases requiring mechanical ventilation
Measure: Incidence of COVID-19 cases requiring mechanical ventilation Time: 24 monthsDescription: Number of deaths due to COVID-19
Measure: Incidence of deaths due to COVID-19 Time: 24 monthsDescription: Number and description of sequels attributed to COVID-19
Measure: Incidence of sequels after COVID-19 Time: 24 monthsStudy of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response. The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1
Description: Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.
Measure: Level of IFN-gamma after a non-specific stimulation of T lymphocytes Time: 6 monthsThe purpose of this study is to provide weekly data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.
Description: serology
Measure: Seroconversion against SARS-CoV2 in children Time: at inclusionDescription: Serology, measure of Ab in children
Measure: Protective immunity Time: at inclusionDescription: Serology in children
Measure: Measure of Ab antiN and Ab anti-S1/2 Time: at inclusionDescription: Serology in children
Measure: Neutralization activity Time: at inclusionDescription: in children, qualitative and quantitative measure , in nasopharynx, saliva and stool
Measure: Positive qPCR in children Time: at inclusionDescription: in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum
Measure: correlation between different Ab and qPCR and neutralization activity Time: at inclusionDescription: Serology, measure of Ab in PCR positive children
Measure: Protective immunity Time: Day 7Description: Serology, measure of Ab in PCR positive children
Measure: Protective immunity Time: Day 15Description: Serology, measure of Ab in PCR positive children
Measure: Protective immunity Time: Day 30Description: Serology, measure of Ab in PCR positive children
Measure: Protective immunity Time: At 6 monthsDescription: Serology, measure of Ab in PCR positive children
Measure: Protective immunity Time: At 12 monthsDescription: Sars-Cov2 PCR in PCR positive children
Measure: duration of viral carriage in stool, saliva and or nasopharynx Time: until 30 days post onsetDescription: Serology in PCR positive children
Measure: correlation between antibody profile and viral clearance Time: until 30 days post onsetDescription: Immune cells in positive PCR children
Measure: Ab profile and memory of immunity Time: At Day 7Description: Immune cells in positive PCR children
Measure: Ab profile and memory of immunity Time: At Day 15Description: Immune cells in positive PCR children
Measure: Ab profile and memory of immunity Time: At Day 30Description: Immune cells in positive PCR children
Measure: Ab profile and memory of immunity Time: At 6 monthsDescription: Immune cells in positive PCR children
Measure: Ab profile and memory of immunity Time: At 12 monthsDescription: Serology and qPCR in positive PCR children
Measure: Transmission to other family members Time: Until 30 daysDescription: Clinical examination and questioning in positive PCR children
Measure: Presence of COVID-19 Symptom Time: Until 12 months of follow-upDescription: Ancillary study: Serology in parents
Measure: seroconversion against SARS-CoV2 in parents Time: at inclusionDescription: Ancillary study: Serology in parents
Measure: Measure of Ab antiN and Ab anti-S1 and neutralization activity Time: at inclusionDescription: Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva
Measure: Positive qPCR in parents Time: at inclusionDescription: Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum
Measure: correlation between different Ab and qPCR Time: at inclusionDescription: Ancillary study: Serology in PCR positive parents
Measure: correlation between antibody profile and viral clearance Time: until 30 days post onsetDescription: Ancillary study: Immune cells in positive PCR parents
Measure: Ab profile and memory of immunity Time: at Day 7Description: Ancillary study: Immune cells in positive PCR parents
Measure: Ab profile and memory of immunity Time: at Day 15Description: Ancillary study: Immune cells in positive PCR parents
Measure: Ab profile and memory of immunity Time: at Day 30Description: Ancillary study: Immune cells in positive PCR parents
Measure: Ab profile and memory of immunity Time: at 6 monthsDescription: Ancillary study: Immune cells in positive PCR parents
Measure: Ab profile and memory of immunity Time: at 12 monthsDescription: Serology and qPCR in positive PCR parents
Measure: Transmission to other family members Time: Until 30 daysInflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 monthsDescription: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 monthsDescription: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 monthsDescription: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 monthsThe COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold. Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19. Treatments currently being investigated include: - Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS; - Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists. We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease. Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are - Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors). - Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities. This in order to: - To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD. - To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.
Description: Participants as those with the emergency ICD-10 (international classification of diseases, 10th revision) code of U07.1 which was assigned to the disease diagnosis of COVID-19.
Measure: Identification of serious COVID-19 infections Time: From 2020/01/01 to 2020/06/30This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 60 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).
Description: Proportion of participants with an occurrence of death
Measure: Death Time: From inclusion (day0) to day 14Description: Proportion of deaths, overall and by cause, in each group
Measure: Death and causes of death Time: From inclusion (day0) to day 28Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR
Measure: Haematological markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia
Measure: Biochemical markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Evolution of Inflammatory markers in each group : PCT, CRP
Measure: Inflammatory markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Evolution of immunological markers in each group : B ans T Cells phenotypic profiles
Measure: Immunological markers evolution Time: from inclusion (day 0) to day 7 and day 14Description: Number and proportion of grade 1,2,3,4 adverse events in each group
Measure: Adverse events Time: from inclusion (day 0) to day 14Description: Number and proportion of grade 1,2,3,4 adverse events in each group
Measure: Adverse reactions Time: from inclusion (day 0) to day 14Description: Plasma concentration of the study drugs at D7
Measure: Plasma concentration Time: day 7Description: Acceptability of the treatment by participant will be assessed with an interview
Measure: Acceptability of the treatment Time: from inclusion (day 0) to day 10This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.
Description: An 8 point ordinal scale will be used to assess pulmonary status consisting of the following values: 8= Death; 7= Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min); 6= Intubation and mechanical ventilation; 5= Non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4= Oxygen by mask or nasal prongs; 3= Hospitalization without oxygen supplementation; 2= Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skilled nursing facility (+/- supplemental oxygen); 1= Discharged to home without supplemental oxygen
Measure: Change in pulmonary status Time: baseline, through study completion, an average of 45 daysDescription: number of events
Measure: Incidence of serious adverse events Time: baseline, through study completion, an average of 45 daysDescription: When calculating days of hospitalization, re-hospitalization or death occurring in the first 28 days should result in zero ascribed to time out of the hospital prior to readmission.
Measure: Length of hospitalization Time: From date of enrollment until the date of extubation, assessed study completion, an average of 45 daysDescription: Reintubations or death within 28 days will result in zero ascribed time off ventilator prior to reintubation
Measure: Ventilator free days Time: baseline, through study completion, an average of 45 daysIn the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.
Description: The primary study endpoint is the ratio of patients who will develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered achieving the primary endpoint.
Measure: The ratio of patients who will develop serious respiratory failure (SRF) Time: Visit study day 14Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment Time: Visit study day 14Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of SOFA score in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of peripheral mononuclear blood cells' (PBMCs) functionality of enrolled subjects will be compared between days 1 and 7
Measure: Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7
Measure: Change of plasma inflammatory mediators levels between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Mortality on day 30
Measure: Rate of Mortality Time: Visit study day 30Description: Mortality on day 90
Measure: Rate of Mortality Time: Visit study day 90Description: Transcriptional, proteomic and metabolomic change will be compared between days 1 and 7
Measure: Change of gene expression between days 1 nad 7 Time: days 1 and 7The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.
Description: Score ranges 1-7 Death; Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized
Measure: Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation Time: 7 days from enrolmentDescription: Days from the date of enrolment to the date of discharge
Measure: Duration of hospitalisation (days) Time: 30 days from enrolmentDescription: Number of deaths
Measure: Death Time: 30 days from enrolmentDescription: Time to become afebrile for a minimum period of 48 hours, without antipyretics
Measure: Time to become afebrile (days) Time: 30 days from enrolmentDescription: Days from enrolment to non-invasive mechanical ventilation
Measure: Time to non-invasive mechanical ventilation (days) Time: 30 days from enrolmentDescription: Days from enrolment to invasive mechanical ventilation
Measure: Time to invasive mechanical ventilation (days) Time: 30 days from enrolmentDescription: Days from enrolment to supplementary oxygen therapy withdrawal
Measure: Time to independence from supplementary oxygen therapy (days) Time: 30 days from enrolmentDescription: Scale ranges 1-7: Death Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles. Hospitalized with oxygen supplement Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID) Hospitalized, without oxygen supplement and without the need for continued medical care Not hospitalized
Measure: Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation Time: 14 days from enrolmentDescription: Number of adverse events and number of patients with adverse events
Measure: Incidence of serious and non-serious adverse events. Time: 30 days after enrolmentDescription: Number of adverse reactions that requires discontinuation of any drug in the study
Measure: Discontinuation due to adverse reactions Time: 30 days after enrolmentThe objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.
Description: Identification of COVID-19 infection from chest X-ray analysis
Measure: Identification of COVID-19 Time: Through study completion, an average of 2 monthsTrial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.
Description: the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis
Measure: Cumulative incidence of ventilator-associated lower respiratory tract infection Time: from day 3 of mechanical ventilation to extubation or day 28 post-intubation.Description: incidence of ventilator-associated tracheobronchitis
Measure: Cumulative incidence of ventilator-associated tracheobronchitis Time: from day 3 of mechanical ventilation to extubation or day 28 post intubationDescription: incidence of ventilator-associated pneumonia
Measure: Cumulative incidence of ventilator-associated pneumonia Time: from Day 3 of mechanical ventilation to extubation or day 28 post intubation.Description: incidence of ICU-acquired bacteremia
Measure: the cumulative incidence of ICU acquired bacteremia diagnosed Time: from ICU admission to extubation or Day 28.Description: death in the ICU
Measure: ICU mortality Time: at day 28Description: death
Measure: Mortality Time: at day 28Description: number of days Under mechanical ventilation
Measure: the duration of mechanical ventilation Time: from the start of mechanical ventilation to extubation or day 28 post intubationDescription: number of days in the ICU
Measure: Length of stay in Intensive Care Unit Time: from admission to ICU until extubation or Day 28This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.
Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.
Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing Time: One yearDescription: To validate the methods used to sequence samples
Measure: Validation of Sequencing Methods Time: One yearBased on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
Description: increasing inflammatory status
Measure: CRPxN/R ratio change Time: 2 weeksDescription: including change in fever or O2 Saturation
Measure: Clinical deterioration by the WHO definition Time: 2 weeksDescription: change in RT-PCR
Measure: PCR Viral Load Time: 2 weeksDescription: change in CT involvement
Measure: CT severity involvement index Time: 2weeksDescription: change in LDH
Measure: LDH change Time: 2 weeksIn this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.
Description: The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.
Measure: Modified WHO Ordinal Scale (MOS) score Time: Day 14Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.
Description: Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.
Measure: Change of neurodegeneration markers level Time: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.
Measure: 7-day length of invasive mechanical ventilation (MV) Time: Up to 7 daysDescription: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: 30-day mortality rate Time: Up to 30-day after randomizationDescription: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of intensive care (ICU) transfer Time: Up to 2 yearsDescription: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of invasive mechanical ventilation Time: Up to 2 yearsDescription: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.
Measure: Rate of tracheostomy Time: Up to 2 yearsDescription: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test
Measure: Length of ICU stay Time: Up to 2 yearsSpectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood. The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.
Description: Searching for presence or absence of abnormal acquired thrombophilic condition as antibodies, hemostasis disturbances. Presence or absence of thrombophilic markers in the blood
Measure: Biological acquired thrombophilia Time: 1 dayDescription: Dosing transcriptomic interferon signature in a blood sample. Presence or absence of interferon in the blood
Measure: Overexpression of interferon type I Time: 1 dayThis is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.
Description: This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.
Measure: Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality. Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.
Measure: Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score. Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.Description: The higher the SOFA score the increased likelihood of organ failure.
Measure: Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: A prolonged length of time in ICU increases mortality.
Measure: Difference in patient outcomes - Length of stay in ICU. Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: A prolonged length of time with ventilator support increases mortality.
Measure: Difference in patient outcomes - Length of ventilator support Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysDescription: A prolonged length of time with vasopressor support increases recovery time.
Measure: Difference in patient outcomes - length of vasopressor support Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 daysThere is an urgent need to understand the outcomes of COVID-19 infected patients regarding the thromboembolic venous disease. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients, improving their clinical care. Interventions are needed to reduce both the incidence and severity of COVID-19. Although it shares characteristics with other similar viruses that also arose in outbreaks, the physiological mechanisms of the virus and its responses on the host are not yet fully known. There are indications that the clinical picture of this disease is in a procoagulant state, with possible increase in episodes of thromboembolic disease. This study aims to analyze the influence of COVID-19 on the incidence of deep vein thrombosis (DVT) in lower and upper limbs, and the variation in the clinical presentation of COVID-19, as well as to provide new evidence applicable to the clinical management of these patients and the establishment of prognostic factors that help early take therapeutic decisions. To this end, an observational, multicenter, national cohorts study will be carried out, sponsored by the Spanish Society of Angiology and Vascular Surgery (SEACV) and the Spanish Chapter of Phlebology and Linfology through its Vascular Research Network (RIV), which will collect demographic variables, comorability, concomitant treatment, analytical status and complementary and ultrasound diagnostic tests, parameters of clinical evolution, therapeutic and complications and mortality to 30 days. All national centers you wish to participate through a secure server that will be accessed through the SEACV and CEFyL website. The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.
Description: Incidence of Deep Venous Disease events in patients with COVID-19 infection
Measure: Deep Venous Disease Incidence Time: 30 daysDescription: 30-days mortality in COVID-19 infection patients with a Deep Venous Disease event
Measure: 30-days mortality Time: 30 daysDescription: Rate of ICU admission in COVID-19 infection patients with a Deep Venous Disease event
Measure: ICU admission Time: 30 daysDescription: Type of anticoagulant treatment in COVID-19 infection patients with a Deep Venous Disease event
Measure: Anticoagulant treatment Time: 30daysUntil the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.
Description: Incidence of COVID-19 cases confirmed or probable in the study population
Measure: Primary outcome Time: From date of randomization to 360 day of the studyDescription: Incidence of severe or critical infection in COVID-19 cases
Measure: Secondary outcome Time: From date to diagnosis to 1 month afterDescription: Lethality of the infection in both groups
Measure: Secondary outcome Time: From date to diagnosis to 1 month afterDescription: Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination
Measure: Secondary outcome Time: From date of randomization to 7 day of the studyDescription: Prevalence of SARS-Cov-2 infection
Measure: Secondary outcome Time: At baseline evaluationThe aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure. The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.
Background: People who get infected with COVID-19 have an unpredictable risk to worsen and die. This makes it hard to decide who can quarantine at home and who should be treated at a hospital. Researchers think the risk may be related to how a person s B and T cells respond to the virus. B and T cells are the major components of a person s immune response. B and T cells responding to the virus with a favorable pattern may lead to recovery, and this favorable pattern may be helpful to establish. If people in a vaccine trial get this same favorable pattern when responding to a vaccine, this may be a useful early signal that the vaccine will be successful. Objective: To examine how immune cells respond to COVID-19 infection. Eligibility: Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or had COVID-19 in the past. Also, healthy donors with no suspected COVID-19 infection Design: Participants will be screened with medical record review. Participants will be tested with a research assay to determine who was infected with COVID-19 and who was not. This test will be used to understand research results, not to advise patients. Participants with active infection must be isolated, usually in a hospital. Other participants may give blood samples at NIH or at their local doctor s office or lab. Participants may give blood samples up to three times a week for a total of ten times, and may also give blood samples after starting a vaccine trial. Participants will be contacted by phone or email every 2 months for up to 2 years.
Description: characterize immune response in patients with active or prior COVID-19 infection
Measure: Characterize immune response Time: OngoingDescription: determine if the B- or T-cell arm of the immune response is more active in responding to COVID-19 infection
Measure: B- and T-cell arm immune response Time: OngoingDescription: determine if there is a correlation between the pattern of immune response to COVID-19 and outcome in patients with acute or resolved infection
Measure: Immune response and outcome Time: OngoingThis is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.
Description: Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
Measure: Vertical transmission Time: 96 hours from birthDescription: Presence of IgG in umbilical cord
Measure: Neonatal protection due to maternal antibodies Time: 24 weeks of gestation to birthDescription: Respiratory distress, hypothermia, poor feeding and others
Measure: Increase risk of neonatal morbidity Time: up to 30 days of lifeACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.
Description: To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.
Measure: Development of population-based models of disease risk Time: Up to 10 yearsDescription: To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.
Measure: Relation between disease burden and geolocation Time: Up to 10 yearsDescription: To specifically identify medications and regimens that address disease symptoms
Measure: Effect of medications on symptoms of COVID19 Time: Up to 10 yearsDescription: To specifically identify medications and regimens that treat and reduce disease severity.
Measure: Effect of medications on disease severity of COVID19 Time: Up to 10 yearsDescription: To identify regional variations in disease incidence and outcomes.
Measure: Rate of COVID19 infection and disease outcomes Time: Up to 10 yearsDescription: To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.
Measure: Effect of COVID19 on health outcomes Time: Up to 10 yearsDescription: To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.
Measure: Long-term follow up and recontact Time: Up to 10 yearsIn this study Investigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.
Description: Serum CRP (measured in mg/dl) will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response
Measure: Change in C-reactive protein (CRP) level Time: Up to 3 daysNational multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer
Description: Mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative).
Measure: Mortality of cancer patients under active anticancer treatment Time: 28 days after the date of the diagnostic procedureDescription: Overall survival will be defined as the time from the date of the first diagnostic procedure (either diagnostic test or chest imaging) to the date of death due to any cause.
Measure: Overall survival Time: 6 months (i.e. at the the time of last patient last visit)Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)
Measure: Hospitalizations Time: 28 days after the date of the diagnostic procedureDescription: Cause of death, related or not to the COVID-19
Measure: Death Time: 6 months (i.e. at the the time of last patient last visit)Description: Associated complications described by their type
Measure: Complications Time: 28 days after the date of the diagnostic procedureDescription: proportion of hospitalizations
Measure: Hospitalizations Time: 28 days after the date of the diagnostic procedureDescription: To describe accurately patients' characteristics in terms of demographics
Measure: Patients' characteristics Time: At the date of the diagnostic procedureDescription: To describe accurately patients' characteristics in type of tumor
Measure: Patients' characteristics Time: At the date of the diagnostic procedureDescription: To describe accurately patients' characteristics in type of anticancer treatment,
Measure: Patients' characteristics Time: At the date of the diagnostic procedureDescription: To describe accurately patients' characteristics in terms of comorbidities
Measure: Patients' characteristics Time: At the date of the diagnostic procedureBackground Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER. Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions. Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care. Study design Prospective observational cohort study in selected European countries. Study population Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers: Tier 0 (Clinical data collection only) - Clinical data will be collected but no biological samples will be obtained for research purposes. Summary of the illness episode and outcome, including a selection of risk factors and comorbidities and medications. Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points. Tier 2 (Clinical data an extended biological sampling). Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission. Study Duration Scheduled 2 years and based on COVID-19 dynamics. Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.
Description: The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.
Measure: Median days alive and out of the hospital Time: 30 daysDescription: Cardiovascular outcomes such as progression of COVID-19, mortality (general and cardiovascular), acute myocardial infarction, stroke / TIA, new heart failure or worsening of pre-existing HF, myocarditis, pericarditis, arrhythmias requiring treatment, phenomena thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure. All events will be reported according to CTCAE 4.0
Measure: Number of participants with adverse cardiovascular outcomes and new worsening heart failure Time: 30 daysDescription: Evaluate levels of biomarkers [troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics].
Measure: Cardiovascular biomarkers related to COVID-19 Time: up to 30 daysThis study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 6 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 6 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 6 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 6 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 6 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 6 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysThis study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.
Description: Study the prognostic factors of the clinical course of patients on Day 15 under treatment with remdesivir. Clinical progress will be categorized using a 7-point ordinal scale.
Measure: Clinical course on Day 15. Time: 15 daysDescription: Explore the prognostic factors of the clinical course of patients on Day 3
Measure: Clinical course on Day 3. Time: 3 daysDescription: Explore the prognostic factors of the clinical course of patients on Day 8
Measure: Clinical course on Day 8 Time: 8 daysDescription: Explore the prognostic factors of the clinical course of patients on Day11
Measure: Clinical course on Day 11. Time: 11 daysDescription: Explore the prognostic factors of the clinical course of patients on D29.
Measure: Clinical course on Day 29. Time: 29 daysDescription: Duration of treatment with remdesivir
Measure: Duration of treatment Time: 29 daysDescription: PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; Glasgow score; creatinine.
Measure: Sepsis-related Organ Failure Assessment score Time: Day 3, 8, 11, 15 and 29Description: Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir
Measure: Duration without mechanical ventilation Time: 29 daysDescription: Mortality at 29 days after initiation of treatment with remdesivir.
Measure: Mortality Time: 29 daysDescription: Evaluate the safety of the treatment with cumulative incidence of grade 3 and 4 adverse events (AEs).
Measure: cumulative incidence of grade 3 and 4 adverse events (AEs). Time: 29 daysThe aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.
Description: The Borg scale is a scale scored between 0-10, indicating the severity of dyspnea. 0 indicates no shortness of breath, 10 indicates severe shortness of breath
Measure: Dyspnea Time: Baseline, up to 4 weeksDescription: Chest expansion was evaluated by measuring the difference between the maximum inspiration and maximum expiration from the level of xsphoid processus of the patients.
Measure: Chest expansion Time: Baseline, up to 4 weeksDescription: Fatigue severity scale is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome
Measure: Fatigue severity Time: Baseline, up to 4 weeksDescription: Patients were instructed and asked to give a score between 0-10 with 0 equating to no pain, 10 indicating severe pain
Measure: Visual Analog Scale for pain Time: Baseline, up to 4 weeksDescription: The HAD scale is a short self administered questionnaire used to screen for anxiety and depression. The questionnaire consists of 14 items, seven each measuring anxiety and seven to measure depression. According to research literature, the cut-off point for elevated anxiety and depression as measured by the HAD scale is eight
Measure: Hospital anxiety and depression scale Time: Baseline, up to 4 weeksDescribe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.
Description: Self assessment on the SEFI (Self-Evaluation of Food Intake) scale at one month after hospital discharge: 0 corresponds to the worsen score (no ingesta) and 10 corresponds to the best (same ingesta than before the disease)
Measure: Evaluation of food intake at 1 month after discharge from hospital for COVID Time: one month after hospital dischargeDescription: Self-reported weight in kilograms, or in the absence of self-reported variations before the disease, during hospitalisation, at hospital discharge, one month after hospital discharge
Measure: Weight variation during the infection Time: one month after hospital dischargeDescription: Effect of these factors (anorexia, dysgeusia, Ear Nose and Throat pain, swallowing disorders, intestinal transit disorders...) on SEFI and weight
Measure: Clinical signs limiting food intake Time: one month after hospital dischargeDescription: Effect of these factors (supply difficulties, disease-related food disgust, limiting food habits or prior diet, hydration difficulties, need for help) on SEFI and weight
Measure: Factors limiting food intake Time: one month after hospital dischargeDescription: Effect of nutritional strategy and interventions that were implemented (nutritional advice, adapted meals, oral nutritional supplementation, enteral and parenteral nutrition during hospitalisation and one month after hospital discharge) on SEFI and weight
Measure: Implemented nutritional strategy Time: one month after hospital dischargeDescription: Effect of pre-existing chronic disorders (pulmonary, chronic inflammatory bowel disease, cardio-vascular disease, diabetes, obesity, cognitive disorders, immunodepression, cancer, inflammatory joint disorder) on SEFI and weight
Measure: Pre-existing chronic disorders Time: one month after hospital dischargeDescription: Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital
Measure: Covid-19 repercussions Time: one month after hospital dischargeThis original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers
Description: Proportion of patients with modification of the treatments administered
Measure: To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy Time: up to 6 monthsDescription: Proportion of patients with change in the rate of treatment administration
Measure: To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy Time: up to 6 monthsDescription: Proportion of patients with change in the number of cures administered
Measure: To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy Time: up to 6 monthsDescription: Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)
Measure: To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy Time: up to 6 monthsDescription: Score of questionnaires of Perceived Stress Scale [0-40 points]
Measure: Evaluate the perceived stress on cancer patients treated in unit day of hospital Time: up to 6 monthsDescription: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]
Measure: Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital Time: up to 6 monthsDescription: Score of questionnaires of sleep disorders (ISI scale, 0-28 points)
Measure: Evaluate the sleep disorders on cancer patients treated in unit day of hospital Time: up to 6 monthsDescription: Score of questionnaires of quality of life (FACT-G scale)
Measure: Evaluate the quality of life on cancer patients treated in unit day of hospital Time: up to 6 monthsDescription: Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)
Measure: Evaluate the cognitive complaints on cancer patients treated in unit day of hospital Time: up to 6 monthsDescription: Score of questionnaires of Perceived Stress Scale [0-40 points]
Measure: Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) Time: up to 3 monthsDescription: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]
Measure: Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) Time: up to 3 monthsDescription: Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)
Measure: Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) Time: up to 3 monthsDescription: Score of questionnaires of feeling of personal effectiveness (0-30 points)
Measure: Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness) Time: up to 3 monthsPhase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.
Description: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).
Measure: Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). Time: 30 days after enrollmentDescription: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.
Measure: Efficacy: Any of the following analytical data after 72h of randomization. Time: Day +21 after randomizationDescription: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.
Measure: Efficacy: Proportion of patients who develop analytical alterations. Time: Day +21 after randomization.Description: Proportion of patients requiring treatment with Tocilizumab Sarilumab, Anakimra or other IL-6 or IL-1 antagonists, or corticosteroids at doses of methylprednisolone greater than 2 mg / Kg / day (or equivalent) and / or any investigational medication.
Measure: Efficacy: Proportion of patients requiring treatment. Time: Until day 21.Prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.
Description: Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)
Measure: Rate of elevated creatine kinase in hyperacute phase Time: 1 weekDescription: Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Rate of elevated creatine kinase Time: 24 monthsDescription: Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)
Measure: Rate of two-peak elevation of creatine kinase during acute phase Time: 30 daysDescription: Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up
Measure: Rate of myositis-specific antibodies Time: 24 monthsDescription: Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up
Measure: Rate of antimyocardial antibodies Time: 24 monthsDescription: Level of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) assessed by the area under the curve (AUC)
Measure: Area under the curve (AUC) of elevated creatine kinase Time: 24 monthsDescription: Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Peak-levels of elevated creatine kinase Time: 24 monthsDescription: Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)
Measure: Peak-levels of troponin Time: 30 daysDescription: Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)
Measure: Peak-levels of urine myoglobin Time: 30 daysDescription: Muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Rate of muscle hyperechogenicity Time: 24 monthsDescription: Peak-muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)
Measure: Peak-muscle hyperechogenicity Time: 24 monthsThe aims of this study is to define the genetic bases of COVID-19 related disease heterogeneity in frail population, to carry out a retrospective study on individuals w/wo symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis and on the presence of genetic profiling and to explore the therapeutic potential of the modulation of ACE2 expression.
Description: BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is immunochromatography based. The test card contains colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. When 10 microL of test sample is added to the sample well of the test cassette, the sample will move forward along the test card via capillary action. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the anti-human IgM antibody immobilized on the membrane, forming a red M line and indicating a positive result for the IgM antibody. If the sample contains IgG antibodies, the same thing happens, forming a red G line and indicating a positive result for the IgG antibody. If neither antibody is present, a negative result is displayed.
Measure: Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis. Time: 6 monthsDescription: By an in silico analysis, we found 2 missense variants in ACE2 gene annotated at residues 82 (rs766996587) and 355 (rs961360700) involved in PPIs with MAF<0.01. Variants in other residues of the ACE2 may affect protein structure and/or activity/localization, influence the binding of the spike protein and thus the virus ability to enter the respiratory tract.In light of its relevance in cell entry, pharmacological approaches aimed at modulating ACE2 expression, through the modulation of SIRT1 activity in the lung or by selective oligo antisense treatment, should help in counteracting COVID-19 infection. Annotated SNPs evaluation of the TMPRSS2 gene showed 4 exonic common polymorphisms (MAF>1%); of these, rs12329760 is a missense variant in the SRCR domain mediating PPI and ligand binding. Common SNPs are at the 3'UTR, possibly involved in regulating mRNA stability and several rare variants mapped in exons encoding the peptidase domain, potentially affecting protein activity.
Measure: ACE2 expression in patients with COVID-19 infection Time: 6 monthsPurpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Description: Presence or absence of IgG antibodies to SARS-CoV2
Measure: Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. Time: at enrollmentDescription: swab for presence of SARS-CoV-2 virus
Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. Time: at enrollmentA prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.
Description: In patients recovering from COVID-19 disease: Characterise using summary statistics the prevalence and severity of organ volume change and damage to heart, kidneys and liver
Measure: Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver) Time: 12 MonthsDescription: In patients recovering from COVID-19 disease: To characterise using summary statistics the prevalence and severity of organ volume change and damage in lung, pancreas and spleen
Measure: Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen) Time: 12 MonthsDescription: In patients recovering from COVID-19 disease: Characterise liver damage as assessed by liver volume in liters, iron corrected T1 (cT1) in milliseconds, liver fat content as %, liver T2star in milliseconds (a correlate of liver iron content)
Measure: Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star Time: 6 MonthsDescription: In patients recovering from COVID-19 disease: Characterise heart and spleen damage as assessed by liver volume in liters as well as kidney, liver and pancreas damage as assessed by volume in liters, iron corrected T1 (cT1) in milliseconds, fat infiltration as %, T2star in milliseconds (a correlate of liver iron content).
Measure: Change from Baseline in organ-specific biomarkers characterising organ volume change in the heart and spleen along with organ volume and damage in the kidney, liver and pancreas assessed by volume, iron corrected T1 (cT1) and fat infiltration Time: 12 MonthsDescription: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by Dyspnea-12. Each question is assigned a value between: none, mild, moderate and severe and is used to assess breathing characteristics.
Measure: Change in patient reported outcome measured by the Dyspnea-12 questionnaire Time: 12 MonthsDescription: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the St. George's Respiratory questionnaire. Each section comprises of questions in various formats allowing to assess which aspects of the illness cause the participant the most problems in daily life.
Measure: Change in patient reported outcome measured by the St. George's Respiratory questionnaire (SGRQ) Time: 12 MonthsDescription: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the EQ-5D-5L questionnaire. Two main sections provide the opportunity to capture statements best describing a participant's daily health and a scale form 0 to 100 capturing self-reported health stats. (100 being the best health imaginable and vice versa)
Measure: Change in patient reported outcome measured by the EQ-5D-5L questionnaire Time: 12 MonthsDescription: In patients recovering from COVID-19 disease: Difference from Baseline in degree of change in liver MR-derived biomarkers with and without known genetic variants associated with liver disease (e.g., PNPLA3) using a paired t-test (or non-parametric alternative)
Measure: Degree of change in liver MR-derived biomarkers Time: 12 MonthsTo compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.
Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.
Description: Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm
Measure: Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period Time: From date of randomization until study completion 12 weeks after treatment initiationDescription: To assess the presence or absence of side effects from HCQ treatment.
Measure: Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationDescription: Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.
Measure: Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationDescription: Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.
Measure: Clinical disease severity in confirmed SARS-CoV-2 participants Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationDescription: Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).
Measure: Incidence of any acute respiratory infection Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationThe main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2
Description: Anti-SARS-COV2 S protein IgG ELISA
Measure: Number of people with detectable antibodies to SARS-COV2 Time: 1 yearDescription: SARS-COV2 PCR
Measure: Number of people with detectable SARS-COV2 nucleic acid Time: 1 yearDescription: Anti-SARS-COV2 S protein IgG ELISA
Measure: Number of people with detectable antibodies to SARS-COV2 Time: 2 yearsDescription: Anti-SARS-COV2 S protein IgG ELISA
Measure: Number of people with detectable antibodies to SARS-COV2 Time: 3 yearsDescription: Anti-SARS-COV2 S protein IgG ELISA
Measure: Number of people with detectable antibodies to SARS-COV2 Time: 4 yearsDescription: Anti-SARS-COV2 S protein IgG ELISA
Measure: Number of people with detectable antibodies to SARS-COV2 Time: 5 yearsDescription: SARS-COV2 PCR
Measure: Number of people with detectable SARS-COV2 nucleic acid Time: 2 yearsDescription: SARS-COV2 PCR
Measure: Number of people with detectable SARS-COV2 nucleic acid Time: 3 yearsDescription: SARS-COV2 PCR
Measure: Number of people with detectable SARS-COV2 nucleic acid Time: 4 yearsDescription: SARS-COV2 PCR
Measure: Number of people with detectable SARS-COV2 nucleic acid Time: 5 yearsVitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.
Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19. Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children.. Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective
Description: Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.
Measure: Characteristics and outcomes of acute respiratory infections due to COVID-19 in children. Time: Baseline-Day 60Description: Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.
Measure: Clinical risk factors of acute respiratory infection due to COVID-19 in children. Time: Baseline-day 60Description: Immunological (Absolute lymphocyte/monocyte counts (mm3) and Immunoglobin level (mg/dL) response measures, will be summarized with mean, standard deviation, median and range.
Measure: Immunologic response to acute respiratory infection due to COVID-19 in children. Time: Baseline-day 60Description: The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.
Measure: Duration of viral shedding and evolution in children longitudinally. Time: Baseline-Day 60The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.
COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.
Description: To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status.
Measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH) Time: At baselineDescription: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.
Measure: Clinical outcomes of symptomatic COVID-19 in PLWH Time: At Day 28Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.
Measure: Clinical outcomes of symptomatic COVID-19 in PLWH Time: At Month 3Description: To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.
Measure: Seroprevalence of COVID-19 in all parent study participants Time: Through study completion, an average of one yearThis study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
Description: Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection
Measure: detection of viral infection using serology and viral-RNA detection kits Time: 1 dayDescription: Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval
Measure: Temporal trend of antibodies in blood Time: 1 monthThis is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.
Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.
Measure: Cohort A: Percentage of COVID-19 exposed healthcare workers treated with hydroxychloroquine with a positive COVID-19 test. Time: At enrollment completion outcome 1 will be analyzed.Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.
Measure: Cohort B: Percentage of COVID-19 exposed high-risk individuals treated with hydroxychloroquine with a positive COVID-19 test. Time: At enrollment completion outcome 2 will be analyzed.An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection
Description: The time of onset of improvement in the patient's clinical condition will be measured following the clinical objective and subjective signs and radiological indicators.
Measure: Time to onset of change in the patient's clinical condition Time: 21 dayDescription: At every examination/evaluation, all AEs, whether noticed by investigators and their associates in the trial, or spontaneously reported by the subjects, or given as answer to direct question, must be evaluated by the investigator and reported on case report forms for AE. AE will be recorded in the e-CRF. Three-degree scale will be used for assessment of AE's severity: mild, moderate, severe.
Measure: Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE Time: 21 dayDescription: To monitor the period of patient's hospitalization
Measure: Length of in-hospital stay Time: 21 dayDescription: To monitor the survival rate during the hospitalization
Measure: Survival rate Time: 21 dayDescription: To monitor the intubation frequency during the hospitalization
Measure: Intubation rate Time: 21 dayDescription: To monitor the levels of proinflammatory markers during the hospitalization (IL-6)
Measure: Proinflammatory markers levels Time: 21 dayThe study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator. The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.
This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.
Description: Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.
Measure: Transfer to ICU Time: Days 0 - 60Description: Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.
Measure: 28 day mortality Time: Days 0 - 60Description: Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.
Measure: Cumulative incidence of serious adverse events Time: Days 0 - 60Description: Will be done by collecting respiratory tract swabs and testing for SARS-CoV-2 positivity.
Measure: Rates and duration of SARS-CoV-2 Time: Days 0, 7, 14, and 21Description: Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.
Measure: Serum of plasma antibody titer to SARS-CoV-2 Time: Days 0, 7, 14, and 28Description: Blood will be collected and analyzed for cellular and humoral response.
Measure: Cellular and humoral immune response Time: Days 0, 7, 14, 28Description: All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.
Measure: Supplemental oxygen free days Time: Days 0-28Description: All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.
Measure: Ventilator free days Time: Days 0 - 28Description: All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.
Measure: ICU free days Time: Days 0 - 28Description: The patient will be evaluated throughout their enrollment in the study. The score will be evaluated to see if the score improved or worsened throughout their admission.
Measure: Sequential organ failure assessment score Time: days 0, 1, 4, 7, 14, 21, 28Description: Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.
Measure: Need for vasopressors Time: Days 0 - 60Description: Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.
Measure: Need for renal replacement therapy Time: Days 0 - 60Description: Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.
Measure: Need for extracorporeal membrane oxygenation (ECMO) Time: Days 0 - 60Description: Will be calculated from the date the patient entered the hospital until they were discharged.
Measure: Hospital length of stay (LOS) Time: Days 0-60Description: Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.
Measure: ICU LOS Time: days 0 - 60Description: All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.
Measure: Grade 3 or 4 Adverse Events (AEs) Time: days 0 - 60Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug better than recombinant human ACE2 Mahmoud ELkazzaz1 1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt. _____________________________________________________________________________________________ _______________________________________________________________________ B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular physiology and pathology, and is currently clinically evaluated to treat acute lung failure. Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis, B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. In vitro, recombinant B38-CAP protein catalyzed the conversion of angiotensin II to angiotensin 1-7, as well as other known ACE2 target peptides. Treatment with B38-CAP suppressed angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis in mice. Moreover, B38-CAP inhibited pressure overload-induced pathological hypertrophy, myocardial fibrosis, and cardiac dysfunction in mice. A study demonestrated that the bacterial B38-CAP as an ACE2-like carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein drugs for hypertension and heart failure. On the other hand, Treatment with recombinant human ACE2 protein (rhACE2), which is devoid of its membrane-anchored domain thus soluble, has been demonstrated to exhibit beneficial effects in various animal models including heart failure, acute lung injury, and diabetic nephropathy, and so forth. rhACE2 is currently tested in the clinic to treat ARDS and COVID-19 infected patients . Using cell cultures and organoids, researchers from the Karolinska Institutet in Sweden and the University of British Columbia (UBC) in Canada, showed that by adding a genetically modified variant of ACE2, called human recombinant soluble angiotensin-converting enzyme 2 (hrsACE2), COVID-19 was prevented from entering cells.The paper, published in Cell, shows that hrsACE2 had a dose dependent effect of viral growth of SARS-CoV-2 and was able to reduce it by a factor of 1,000 to 5,000 in cell cultures. Despite its beneficial effects, rhACE2 is a glycosylated protein and thus its preparation requires time- and cost-consuming protein expression system with mammalian or insect cells, which may not be advantageous in drug development and medical economy Although it had been reported that an immune response is associated with the chronic infusion of rhACE2 resulting in the degradation of rhACE226, this was not observed for B38-CAP; there were no antibodies against B38-CAP detectable in the serum of mice infused with B38-CAP for 2 weeks.B38-CAP is easily prepared with E. coli expression system and is cost effective. with therapeutic efficacy and less toxicity in mouse heart failure model. Implantation of B38-CAP-filled osmotic mini-pumps significantly suppressed Ang II-induced hypertension in conscious mice .without affecting the heart rate. These results indicate that B38-CAP antagonizes the vasopressor effect of Ang II. So the principle investigator expects and suggests that treating with cloned Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug better than recombinant human ACE2 in addition to brsACE2, expected to lure the virus to attach itself to the copy instead of the actual cells… It distracts the virus from infecting the cells to the same degree and should lead to a reduction in the growth of the virus in the lungs and other organs. A study showed that recombinant B38-CAP protein downregulates Ang II levels in mice and antagonizes Ang II-induced hypertension, pathological cardiac hypertrophy, and myocardial fibrosis. We also show beneficial effects of B38-CAP on the pathology of pressure overload-induced heart failure in mice without overt toxicities.Finally the principal investigator expect that treatment with ACE2-like enzyme in bacteria B38-CAP may be do the same mechanism of rhACE2 in inhibiting COVID -19 and the other suggested mechanism is that injection of ACE2-like enzyme of bacteria B38-CAP in human body may down regulate human ACE2 which is the real receptor of COVID -19 and in the same time it will be resistant to COVID- spike protein because there seems a difference in substrate specificity between two enzymes. Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.
Description: Compare the time course of body temperature (fever) between two groups over time.
Measure: Time course of body temperature (fever) Time: 14 daysDescription: Compare viral load between two groups over time.
Measure: Viral load over time Time: 14 daysDescription: PaO2/FiO2 ratio
Measure: P/F ratio over time Time: 14 daysDescription: SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.
Measure: Sequential organ failure assessment score(SOFA score) over time Time: 14 daysDescription: Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Measure: Image examination of chest over time Time: 14 daysThis study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions. It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.
Description: Self-managed questionnaire on functional status, anxiety, pain and independence in daily living; The EuroQoL includes a five item scale and a visual analog scale from 0-100 in order to quantify perception of current health. The five item scale includes ordinary scores from 0-5. Lower numbers equal less problems and better quality of life. For the visual analog scale a higher number represents a better health status perceived.
Measure: Health-related quality of life; EuroQoL (EQ-5D-5L) Time: 01.04.2020 - 30.05.2021Description: 6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.
Measure: 6-minute walk test Time: 01.04.2020 - 30.05.2021Description: Measures the handgrip strength and is associated with sarcopenia, mortality and independence in life (e.g. for older individuals and patients after or with critical illness)
Measure: Jamar dynamometer Time: 01.04.2020 - 30.05.2021Description: Self-administered questionnaire on anxiety and depression after hospitalization; bot, anxiety and depression is quantified by an ordinal scale from 0-3, respectively. The lower the number the less signs of depression or anxiety are present.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: 01.04.2020 - 30.05.2021Description: Questionnaire on avoidance, intrusion and arousal (or overreaction) in order to identify potential risk for post-traumatic stress. The Scale includes 22 questions ordinally scored from "not at all" to " very frequent" with four scores. The scores are transformed into numbers (0,1,3,5). The values are put in a formula resulting in a single value.A value below zero indicates no risk of post-traumatic stress disorder (PTSD) is present. Values equal or higher than zero indicate the risk of a PTSD
Measure: revised Impact of Event Scale (IES-R) Time: 01.04.2020 - 30.05.2020Description: Questionnaire on the nutritional condition of the patient. It includes 16 questions and 2 measures. Points range from 0-30; A score <17 indicates malnutirtion, a score from 17-23.5 indicates a risk of malnutrition and scores between 24-30 indicate normal nutritional behaviour.
Measure: Mini-Nutritional Assessment (MNA) Time: 01.04.2020 - 30.05.2021Description: Measures the lung function (bedside screening)
Measure: Spirometry (bed-side) Time: 01.04.2020 - 30.05.2021Description: This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.
Measure: Post-Covid Functional Scale (PCFS) Time: 01.04.2020 - 30.05.2021Description: Quantifies and stratifies the perception of dyspnoea with a score ranging from 0-4. The higher the value the more frequent and more severe is the perception of dyspnoea during daily life activities.
Measure: modified Medical Research Council Dyspnoea Scale (mMRC Dyspnoea) Time: 01.04.2020 - 30.05.2021This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
Description: Time it takes to identify eligible donors whom are willing to donate
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time from consent to infusion
Measure: Plasma Recipient Time: Measured evey 24 hours up to 30 daysDescription: Survival
Measure: Plasma Recipient Time: Measured in days with 30 day from discharge follow-upDescription: Time until plasma is donated
Measure: Plasma Donor Time: Measured every 24 hours up to 1 yearDescription: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Morbidity reduction
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Reduced Length of Stay in hospital
Measure: Plasma Recipient Time: Measured every 24 hours until patient discharged from hospital up to 1 yearDescription: Reduced Length of Stay on Advance Respiratory Support
Measure: Plasma Recipient Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 yearThe new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
Description: Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.
Measure: Initial biological profile of children and adults with COVID-19 infection Time: Day 0Description: measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.
Measure: Initial immunological profile of children and adults with COVID-19 infection Time: Day 0Description: Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection
Measure: Clinical worsening Time: Within 21 days following inclusionDescription: measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening
Measure: Evolution of the immunological profile of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation
Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 Time: Day 0Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 Time: Day 0Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation
Measure: titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19 Time: Day 0Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening
Measure: titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19 Time: Within 21 days following inclusionDescription: Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.
Measure: Genetic profile of adults with COVID-19 infection Time: Day 0Description: Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening
Measure: Genetic profile of adults with COVID-19 infection Time: Within 21 days following inclusionThis is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.
Description: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Measure: Administration of 18F-αvβ6-BP Time: baselineDescription: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Measure: Administration of 18F-αvβ6-BP Time: 3 monthsDescription: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Measure: Administration of 18F-αvβ6-BP Time: 6 monthsDescription: Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage Time: baselineDescription: Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage Time: 3 monthsDescription: Uptake of 18F-αvβ6-BP in lung damage will be measured by PET
Measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage Time: 6 monthsDescription: Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.
Measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT. Time: baselineDescription: Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.
Measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT. Time: 3 monthsDescription: Uptake of 18F-αvβ6-BP in lung measured by PET will be compared to lung damage as indicated on CT.
Measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT. Time: 6 monthsThis project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date. This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.
Description: whether the subject is hospitalized for COVID-19 symptoms
Measure: Hospitalizations Time: 2 monthsDescription: whether the subject is intubated for COVID-19 symptoms
Measure: Intubation Time: 2 monthsDescription: whether the subject dies of COVID-19 symptoms
Measure: Death Time: 2 monthsDescription: depression
Measure: PHQ-9 score for depressive symptoms, Time: 2 monthsDescription: anxiety
Measure: generalized anxiety Disorder-7 scale Time: 2 monthsA multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia
Description: Frequency of confirmed SARS CoV2 infection
Measure: SARS CoV2 infection Time: At 2 months of follow-upDescription: Any COVID-19 related symptoms (cough, fever, headache, vomiting, nausea, dyspnea, diarrhea, smell disorder,conjunctivitis, dizziness)
Measure: COVID-19 symptoms description Time: At 2 months of follow-upDescription: Any adverse event or serious adverse event
Measure: Adverse Events Time: each month up to 2 monthsThe purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
Description: The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.
Measure: Progression of respiratory failure or death Time: 14 daysThe study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.
Description: Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between patients who improve and patients who get worse during their hospitalisation for COVID-19 infection
Measure: Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions Time: 1 dayDescription: Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the start and the discharge to the hospital in patients infecting and recovering from COVID-19.
Measure: Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition Time: 2 weeksDescription: Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the hospitalisation period and a post-hospitalisation follow-up consultation in patients infected by COVID-19 and recovered.
Measure: Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods Time: 4 monthsThe SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied. In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients. The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease. Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.
Description: Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data using the unique identification number in the 2 databases. This cross-checking of files will allow an almost exhaustive epidemiological analysis in 2 well identified populations.
Measure: Covid attack rate Time: During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiationMain goal: To generate information on the efficacy and safety of Dialyzable Leukocyte Extract (DLE) as an aid in the treatment of patients with acute respiratory infection (suspected or confirmed cases of COVID-19). Primary goal: To generate information on the efficacy of DLE as an aid in symptomatic treatment, by reducing the signs and symptoms of acute respiratory infection (suspected/confirmed cases of COVID-19). Secondary goals: 1. To evaluate clinical deterioration and respiratory alarm data. 2. To evaluate the duration of the clinical picture. 3. To explore cytokine changes associated with the therapeutic effect induced by DLE. 4. To obtain data on the safety of DLE as an aid in the symptomatic treatment of acute respiratory infection (suspected/confirmed cases of COVID-19). 5. To generate information to validate the contingency scale to assess the severity of acute respiratory disease (suspected/confirmed cases of COVID-19). Justification The systemic inflammatory response has been recognized as being responsible for COVID-19 complications. Immunomodulation strategies to control it are currently being considered, including the use of systemic steroids to down-regulate the systemic inflammatory response, the use of human immunoglobulin and even chloroquine given its anti-inflammatory and antiviral qualities; however, none of these treatments has been sufficiently studied or has shown any significant change in the clinical course of infected patients. Due to the importance of the COVID-19 pandemic and in the absence of specific treatment, it is important to implement new treatments that allow modulating the immune response, and one strategy may be the addition of DLE to symptomatic and supportive treatment. Hypotheses by goals. 1. The addition of DLE to the symptomatic treatment could decrease the severity of the clinical outcome (signs and symptoms) in individuals with an acute respiratory infection (cases suspected/confirmed by COVID-19). 2. The addition of DLE to the symptomatic treatment could decrease the clinical deterioration due to the acute respiratory infectious process (suspected/confirmed cases of COVID-19). 3. The addition of DLE to the symptomatic treatment could decrease the duration of the clinical outcome (suspected/confirmed cases of COVID-19).
Description: Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19" at the end of treatment concerning the baseline value. The clinical effect will be daily evaluated with the patient's diary in the cell app. Minimum value 0, Maximum value 32 points. Higher scores mean worse outcome.
Measure: Change in the score of the "Contingency scale to assess the severity of acute respiratory disease in cases suspected/confirmed by COVID-19" Time: 35 daysDescription: Defined as the presence of signs and symptoms related with respiratory alarm symptoms. The respiratory alarm data will be daily evaluated with the patient's diary in the cell app.
Measure: Clinical deterioration Time: 35 daysDescription: Defined as the number of days with any of the symptoms mentioned in contingency table during the visits and follow-up through the patient's diary in the cell app.
Measure: Duration of the clinical status Time: 35 daysDescription: Defined as the changes in the total concentration of the serum cytokines IL-6, TNF-α and type I and II Interferons due to DLE treatment.
Measure: Cytokine concentration Time: 35 daysThis prospective phase I/IIa trial studies the side effects of rintatolimod and Intron A (IFNa) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
Description: This refers to the frequency of grade 3 or 4 AEs considered to be possibly, probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0).
Measure: Incidence of adverse events (AEs) Time: Up to 30 days post treatment intiationDescription: will be evaluated based on quantitative polymerase chain reaction PCR
Measure: Kinetics of viral load in nasopharyngeal swabs Time: Up to 30 days post treatment initiationDescription: Will be analyzed using quantitative polymerase chain reaction (PCR).
Measure: Kinetics of viral load in the peripheral blood and nasopharyngeal swabs Time: During the course of treatment up to day 30Description: The circulatory inflammatory mediators include C-reactive protein (CRP), cytokines, chemokines, interferons.
Measure: Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood Time: During the course of treatment up to day 30Description: The binary endpoint of 30-day mortality will be analyzed using a logistic regression model.
Measure: 30-day mortality Time: At 30 days post treatment initiationDescription: Rate of hospitalization due to infection
Measure: Hospitalization due to infection Time: Up to 30 days post treatment initiationDescription: Will be tested in nasopharyngeal swabs and blood cells of patients
Measure: Determine known mediators of antiviral immunity Time: UP to 30 days post treatment initiationDescription: ARDS will be defined by Berlin criteria
Measure: acute respiratory distress syndrome (ARDS) Time: Up to 30 days post treatment initiationDescription: Need for mechanical ventilation
Measure: respiratory failure requiring mechanical ventilation Time: up to 30 days post treatment initiationThe trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.
Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administrationDescription: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administrationDescription: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationThe purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.
Description: Patient reported change
Measure: Patient reported main complaint Time: 24 hoursDescription: Patient reported change
Measure: Patient reported main complaint Time: 48 hoursDescription: Patient reported change
Measure: Patient reported main complaint Time: 3 monthsDescription: Patient reported change
Measure: Patient reported main complaint Time: 12 monthsDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 24 hoursDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 48 hoursDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 3 monthsDescription: Patient interview notes as written by clinicians.
Measure: Conduct qualitative analyses of data Time: 12 monthsIn this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.
Description: Number of participants alive at day 28.
Measure: Patient Survival Time: 28 daysDescription: Number of participants alive at day 60, end of study.
Measure: Patient Survival Time: 60 daysAgent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2. Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events. Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy. Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2. Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities. Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19. Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19. Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.
Description: patient will be assessed using a scoring table for changes in clinical signs
Measure: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of = 2 Maintained for 24 Hours in comparison to routine treatment Time: 24 hoursDescription: Adverse events caused by the study drug will be assessed
Measure: Percentage of participants with definite or probable drug related adverse events Time: 14 daysA weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.
Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year
Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting Time: 1 yearDescription: Patient/parent reported positive tests for COVID19
Measure: Number of children/adults tested positive for COVID19 Time: 1 yearDescription: Patient/parent reported admissions in hospital because of COVID19
Measure: Number of children/adults admitted in hospital because of COVID19 Time: 1 yearDescription: Patient/parent reported effect of COVID19 on daily activities
Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children Time: 1 yearThe primary objective of this study is to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress.
Description: Respiratory failure-free survival rate 28 is defined as the proportion of patients who have not had respiratory failure nor died <= 28 days from randomization.
Measure: Respiratory failure-free survival rate at day 28 Time: 28 DaysDescription: This scale evaluates the safety and efficacy of investigational therapeutic agents in combination with care for the treatment of hospitalized participants suffering from COVID-19 infections on a scale of scores from 0 to 8, with higher scores indicating higher level of severity of the disease. (0 = No clinical or virological evidence of disease, and 8 = Death)
Measure: Change from Baseline to Day 14 in WHO - 8 Point Ordinal Scale Time: Up to 28 DaysObservational, cross-sectional, multi-center, multi-wave survey, assessing characteristics and predictors of physical and mental health as well as health behaviors during COVID-19 pandemic, targeting the general population (children, adolescents and adults).
Description: Primary outcome in the wave 1 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms, and World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).
Measure: Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Primary outcome in the wave 2 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks six months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).
Measure: Mental health symptoms, well-being change from last 2 weeks before the pandemic to last 2 weeks 6 months after WHO declares pandemic over COVID-19 pandemic Time: wave 2 - change from before to 6 months after pandemicDescription: Primary outcome in the wave 3 survey, conducted during the COVID-19 pandemic, will be mean change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms and World Health Organization (WHO)-5 well-being in the last 2 weeks 12 months after the COVID-19 pandemic ended, compared to the last 2 weeks of "regular life" before the COVID-19 outbreak. For WHO-5 the raw score ranges from 0 (absence of well-being) to 25 (maximal well-being).
Measure: Mental health symptoms change, well-being change from last 2 weeks before the pandemic to last 2 weeks 12 months after WHO declares pandemic over COVID-19 pandemic Time: wave 3 - change from before to 12 months after pandemic (after the pandemic outbreak has been declared from WHO, and until the pandemic outbreak has been declared conlucded by WHO)Description: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 2 - change from before to 6 months after pandemicDescription: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 2 - change from before to 6 months after pandemicDescription: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 2 - change from before to 6 months after pandemicDescription: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in alcohol abuse, as change in units used from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 3 - change from before to 12 months after pandemicDescription: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in cigarettes use, as change in number of cigarettes per day from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 3 - change from before to 12 months after pandemicDescription: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic
Measure: Change in grams of cannabinoids smoked from last 2 weeks before the pandemic to last 2 weeks during pandemic Time: wave 3 - change from before to 12 months after pandemicDescription: Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100. Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100. Time: wave 2 - change from before to 6 months after pandemicDescription: Change in general physical health, self-rated, on a VAS scale from 0 to 100.
Measure: Change in general physical health, self-rated, on a VAS scale from 0 to 100. Time: wave 3 - change from before to 12 months after pandemicDescription: Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100. Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100. Time: wave 2 - change from before to 6 months after pandemicDescription: Change in general mental health, self-rated, on a VAS scale from 0 to 100.
Measure: Change in general mental health, self-rated, on a VAS scale from 0 to 100. Time: wave 3 - change from before to 12 months after pandemicDescription: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100. Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100. Time: wave 2 - change from before to 6 months after pandemicDescription: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100.
Measure: Change in easiness of access to care, self-rated a on a VAS scale from 0 to 100. Time: wave 3 - change from before to 12 months after pandemicDescription: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100. Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100. Time: wave 2 - change from before to 6 months after pandemicDescription: Change in medication adherence, self-rated a on a VAS scale from 0 to 100.
Measure: Change in medication adherence, self-rated a on a VAS scale from 0 to 100. Time: wave 3 - change from before to 12 months after pandemicDescription: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100. Time: wave 1 - change from last 2 weeks before pandemic to the following from April 26th 2020 on, until the pandemic will be over as declared by WHO (we estimate between October 2020 and April 2021)Description: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100. Time: wave 2 - change from before to 6 months after pandemicDescription: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100.
Measure: Change in functioning in self-care, school/work, social, and family, self-rated a on a VAS scale from 0 to 100. Time: wave 3 - change from before to 12 months after pandemicPreparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to: 1. To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19 2. To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
Description: efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
Measure: Efficacy of COVID19 hyper immunoglobulins for patients Time: 2 weeksDescription: efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
Measure: Efficacy of COVID19 hyper immunoglobulins for high risk groups Time: 1 monthDescription: overall percentage of adverse events as hemolysis and anaphylaxis ,headache and other complains that occur during 72 hours of following infusion of anti-SARS-CoV-2 hyper immunoglobulins will be assessed by 1-vital sign 2-hemolysis by LDH and bilirubin level
Measure: Safety of anti-SARS-CoV-2 hyper immunoglobulins assessed by percentage of adverse events Time: 72 hoursIt has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities. This was attributed to: 1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells, 2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression, 3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival. However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection. Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms. Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction. EMA remains prudent about this assertion In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations. It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection.
Description: Describe medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions on existing pathology, drugs administrated symptom onset and when, hospitalisation. Each questions have a multiple choice.
Measure: Describe medications used prior to admission associated with worse infection in COVID-19 patients in France. Time: At inclusion dayDescription: Quantify medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions: existing pathology, drugs administrated symptoms onset and when, hospitalisation. Each questions have a multiple choice.
Measure: Quantify medications used prior to admission associated with worse infection in COVID-19 patients in France. Time: At inclusion dayDescription: Describe patient characteristics thanks to the same questionnaire.
Measure: Describe other patient characteristics with worse infection in COVID-19 patients in France. Time: At inclusion dayDescription: Quantify patient characteristics thanks to the same questionnaire.
Measure: Quantify other patient characteristics with worse infection in COVID-19 patients in France. Time: At inclusion dayThe Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The case-control study is described here (the cross-sectional study is described in a separate ClinicalTrials.gov record).
Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances
Measure: Presence or absence of olfactory and taste disturbances in study participants Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infectionDescription: The relationship between case & control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.
Measure: Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19/within the past 2 weeks of answering the questionnaire (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)
Measure: Clinical manifestations of study participants Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)
Measure: Other pre-existing health conditions Time: BaselineDescription: PPV reflects the probability that the presence of olfactory and taste disturbances will have a positive diagnosis of COVID-19. This is derived from dividing the number of patients with olfactory & taste disturbances with COVID-19 infection over the total number of patients with olfactory and taste disturbances, and multiplying by 100%
Measure: Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection Time: BaselineDescription: NPV reflects the probability that the absence of olfactory and taste disturbances will have a negative diagnosis of COVID-19. This is derived from dividing the number of patients without olfactory & taste disturbances and without COVID-19 infection over the total number of patients with no olfactory and taste disturbances, and multiplying by 100%
Measure: Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection Time: BaselineDescription: The percentage of true positives, i.e. the proportion of patients with olfactory and taste disorders with COVID-19 infection. This can be calculated by dividing the number of subjects with olfactory & taste disturbances who have COVID-19 infection with the number of patients with olfactory & taste disturbances, and multiplying by 100%
Measure: Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection Time: BaselineDescription: The percentage of true negatives, i.e. the proportion of patients without olfactory and taste disorders who do not have COVID-19 infection. This can be calculated by dividing the number of subjects without olfactory & taste disturbances who do not have COVID-19 infection with the number of patients without olfactory & taste disturbances, and multiplying by 100%
Measure: Specificity of olfactory and taste disturbances in predicting COVID-19 infection Time: BaselineWe will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy
Description: Genetic susceptibility to COVID-19
Measure: Mutations leading to increase susceptibility to SARS-COV-2 infection Time: 12 monthsThe purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.
Description: Safety will be defined by the incidence of any infusion associated adverse events as assessed by treating physician
Measure: Incidence of any infusion associated adverse events Time: 60 DaysDescription: Safety will be defined by the incidence of severe adverse events as assessed by treating physician
Measure: Incidence of Severe Adverse Events Time: 60 DaysDescription: Measured at day 60 or at hospital discharge, whichever comes first.
Measure: All Cause Mortality Time: 60 DaysDescription: Number of participants that are alive at 60 days post first infusion follow up
Measure: Survival Rate Time: 60 DaysDescription: Measure IL-6, TNF-alpha from serum of blood samples
Measure: Cytokine Levels Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28Description: D-dimer from serum of blood samples methodology using blood samples or nose / throat swab
Measure: D-dimer Levels Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28Description: CRP from serum of blood samples
Measure: C-reactive protein Levels Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28Description: Viral load by real time RT methodology using blood samples or nose / throat swab
Measure: Quantification of the COVID-19 Time: Day 0, Day 4, Day 8Description: Improved organ failure within 30 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs using Sequential Organ Failure Assessment (SOFA) score.
Measure: Improved Organ Failure Time: Day 30Description: Chest imaging changes for 30 days compare to placebo: 1) Ground-glass opacity, - 2) Local patchy shadowing, 3) Bilateral patchy shadowing, and 4) Interstitial abnormalities.
Measure: Chest Imaging Changes Time: Day o, Day 30COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related
Description: in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
Measure: in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma Time: 1 yearDescription: safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)
Measure: safety of the use of convalescent plasma drom COVID 19 donors Time: 1 yearDescription: any cause of mortality during these periods
Measure: Mortality at 30 days, 90 days, 6 months and 1 year Time: 1 yearDescription: based on results from this trial comparing with official information
Measure: in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports Time: through study completion, an average of 1 yearDescription: number of days of hospitalization in high complexity facilities after convalescent plasma use
Measure: Number of days of hospitalization in high complexity facilities after convalescent plasma use Time: 1 yearDescription: number of days of hospitalization in intensive care unit after convalescent plasma use
Measure: Number of days of hospitalization in intensive care unit after convalescent plasma use Time: 1 yearDescription: number of days of mechanical ventilatory support in patients after convalescent plasma use
Measure: Number of days of mechanical ventilatory support in patients after convalescent plasma use Time: 1 yearDescription: total number of days of mechanical ventilatory support
Measure: Total number of days of mechanical ventilatory support Time: 1 yearDescription: total number of hospitalization days in patients treated with convalescent plasma
Measure: Total number of hospitalization days in patients treated with convalescent plasma Time: 1 yearDescription: total number of hospitalization days in patients after treatment with convalescent plasma
Measure: Number of hospitalization days in patients after treatment with convalescent plasma Time: 1 yearDescription: Viral load measuring
Measure: Viral load measuring Time: 14 daysDescription: COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies
Measure: Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies) Time: day 1 of hospitalizationDescription: negativization of COVID 19 load since convalescent plasma use
Measure: Negativization of COVID 19 load since convalescent plasma use Time: 14 daysDescription: negativization of COVID 19 load since hospitalization
Measure: Negativization of COVID 19 load since hospitalization Time: 14 daysDescription: negativization of COVID 19 load since first reported symptoms COVID-19 related
Measure: Negativization of COVID 19 load since first reported symptoms COVID-19 related Time: 14 daysDescription: Interferon Gamma measurement from donor
Measure: Donor Interferon Gamma profile characterization Time: 1 dayDescription: Granulocyte Macrophage Colony Stimulating Factor measurement from donor
Measure: Donor Granulocyte Macrophage Colony Stimulating Factor characterization Time: 1 dayDescription: Tumor Necrosis Factor Alfa measurement from donor
Measure: Donor Tumor Necrosis Factor Alfa characterization Time: 1 dayDescription: Interleukin -1 beta measurement from donor
Measure: Donor Interleukin -1 beta characterization Time: 1 dayDescription: Interleukin -2 measurement from donor
Measure: Donor Interleukin-2 characterization Time: 1 dayDescription: Interleukin -4 measurement from donor
Measure: Donor Interleukin-4 characterization Time: 1 dayDescription: Interleukin -6 measurement from donor
Measure: Donor Interleukin-6 characterization Time: 1 dayDescription: Interleukin -8 measurement from donor
Measure: Donor Interleukin-8 characterization Time: 1 dayDescription: Interleukin -10 measurement from donor
Measure: Donor Interleukin-10 characterization Time: 1 dayDescription: Interferon Gamma measurement from receptor
Measure: Receptor Interferon Gamma profile characterization Time: 1 dayDescription: Granulocyte Macrophage Colony Stimulating Factor measurement from receptor
Measure: Receptor Granulocyte Macrophage Colony Stimulating Factor characterization Time: 1 dayDescription: Tumor Necrosis Factor Alfa measurement from receptor
Measure: receptor Tumor Necrosis Factor Alfa characterization Time: 1 dayDescription: Interleukin -1 beta measurement from receptor
Measure: receptor Interleukin -1 beta characterization Time: 1 dayDescription: Interleukin -2 measurement from receptor
Measure: Receptor Interleukin-2 characterization Time: 1 dayDescription: Interleukin -4 measurement from receptor
Measure: Receptor Interleukin-4 characterization Time: 1 dayDescription: Interleukin -6 measurement from receptor
Measure: Receptor Interleukin-6 characterization Time: 1 dayDescription: Interleukin -8 measurement from receptor
Measure: Receptor Interleukin-8 characterization Time: 1 dayDescription: Interleukin -10 measurement from receptor
Measure: Receptor Interleukin-10 characterization Time: 1 dayPassive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma - or "hyperimmune" plasma was one of the most widespread and effective anti-infective treatments in the pre-antibiotic era and one of the founding pillars of immunology, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions. To date, there are not proven etiological therapies for SARS-CoV-2 infection, the agent responsible for the disease called Covid-19. Among those subjected to clinical studies during the current epidemic in China, hyperimmune plasma appears to be one of the most rational and promising. The objective of this study will be to evaluate the efficacy and safety of the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy) according to clinical practice in patients with severe Covid-19 infection, compared to patients with severe Covid-19 infection treated only with standard therapy.
Description: Statistically significant reduction (P <0.05) of mortality in the group of patients treated with hyperimmune plasma vs patients treated with standard therapy.
Measure: decrease in mortality Time: 30 daysDescription: Statistically significant increase (P <0.05) of lymphocyte levels after 7 and 14 days after the start of treatment with hyperimmune plasma (treated group), compared to the control group.
Measure: lymphocytes Time: 7 and 14 daysDescription: Statistically significant reduction (P <0.05) of plasma levels of reactive protein C (expressed as mg/L), 7 and 14 days after the start of treatment with hyperimmune plasma vs standard therapy (group control)
Measure: PCR levels vs control Time: 7 and 14 daysDescription: Statistically significant reduction (P <0.05) of plasma levels of reactive protein C (expressed as mg/L), 7 and 14 days after the start of treatment with hyperimmune plasma vs the same patients before the beginning of the treatment
Measure: PCR levels vs before treatment Time: 7 and 14 daysDescription: Significant Correlation (P<0.05) between hyperimmune plasma antibody levels and clinical improvement time (expressed in days)
Measure: AB levels and clinical improvement Time: 30 daysDescription: Statistically significant reduction (P <0.05) of plasma levels of IL-6 (expressed as pg/mL) and TNF-alpha (expressed as pg/mL), 7 and 14 days after the start of treatment with hyperimmune plasma vs standard therapy (group control)
Measure: Inflammatory cytokines vs controls Time: 7 and 14 daysDescription: Statistically significant reduction (P <0.05) of plasma levels of IL-6 (expressed as pg/mL) and TNF-alpha (expressed as pg/mL), 7 and 14 days after the start of treatment with hyperimmune plasma vs the same patients before the beginning of the treatment
Measure: Inflammatory cytokines vs before treatment Time: 7 and 14 daysSNG001 is an inhaled drug that contains a antiviral protein called interferon beta (IFN-β). IFN-β in produced in the lungs during viral lung infections. It has been shown that older people and people with some chronic diseases have an IFN-β deficiency. Many viruses inhibit IFN-β as part of their strategy to evade the immune system. Addition of IFN-β in vitro protects lung cells from viral infection. IFN-β protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2, the virus that causes COVID-19). SNG001 is an inhaled formulation of interferon beta-1a it is currently in Phase II clinical trials for COPD patients. Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving >200 asthma and COPD patients. These trials have shown that SNG001 has: - been well tolerated during virus infections - enhanced antiviral activity in the lungs (measured in sputum and blood samples) - provided significant lung function benefit over placebo in asthma in two Phase II trials. Synairgen believes SNG001 could help prevent worsening or accelerate recovery of severe lower respiratory tract illness in COVID-19 patients. Patients who are in hospital or non-hospitalised but are a high risk groups (e.g. elderly or diabetics) will be invited to take part in the trial. The patient would receive either SNG001 or placebo once daily for 14 days. The severity of the patients condition would be recorded on a scale developed by the World Health Organisation and the patient would be asked questions about their breathlessness, cough and sputum every day, as well as assess their general medical condition and safety. The study will start as a Pilot phase where 100 patients will be randomised in the hospital setting and a 120 patients randomised in the home setting. Once each of the Pilot phases are complete, a Pivotal phase will be conducted. It is estimated that the size of each of the Pivotal phases (hospital and home) will be around 100 to 300 patients per arm. The actual number will be determined after the data review at the end of each of the Pilot phases. If SNG001 proves to be beneficial it would be a major breakthrough for the treatment of COVID-19.
Description: Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period - minimum of 0 (patient is well) to a maximum of 8 (death)
Measure: Ordinal Scale for Clinical Improvement Time: Day 1 to Days 15 and 28Description: Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present at time of enrolment
Measure: Progression to pneumonia (hospital setting only) Time: Day 2 to Day 28Description: Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at time of enrolment
Measure: Progression to pneumonia (hospital setting only) Time: Day 1 to Day 28Description: Time to clinical improvement
Measure: Time to clinical improvement (hospital setting only) Time: Time to hospital discharge OR Time to NEWS2 of ≤ 2 maintained for 24 hoursDescription: NEWS2 assessment of acute-illness severity on a scale of 0 ( being well) up to 24 (requiring emergency response)
Measure: National Early Warning Score 2 (NEWS2) assessment of acute-illness severity (hospital setting only) Time: Day 1 to Day 28Description: Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)
Measure: Changes in daily breathlessness, cough and sputum scale (BCSS) Time: Day 1 to Day 28Description: Looking at blood pressure measured in mmHg
Measure: Safety and tolerability - blood pressure II. Viral load Time: Day 1 to Day 28Description: Looking at heart rate measured in beats per minute
Measure: Safety and tolerability - heart rate II. Viral load Time: Day 1 to Day 28Description: Looking at temperature measured in degrees Celsius
Measure: Safety and tolerability - temperature II. Viral load Time: Day 1 to Day 28Description: Looking at respiratory rate measure in breaths per minute
Measure: Safety and tolerability - respiratory rate II. Viral load Time: Day 1 to Day 28Description: Looking at oxygen levels measured in a %
Measure: Safety and tolerability - oxygen saturation II. Viral load Time: Day 1 to Day 28Description: Looking at adverse events (numbers and terms)
Measure: Safety and tolerability - adverse events II. Viral load Time: Day 1 to Day 28Description: Looking at concomitant medications given during treatment
Measure: Safety and tolerability - concomitant medications II. Viral load Time: Day 1 to Day 28Description: Temperature ≤37.8 °C AND COVID-19 symptoms (breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and taste, rhinorrhoea and anorexia) all rated as absent or mild
Measure: Time to clinical improvement (home setting only) Time: Day 1 to Day 28Description: Time to improvement of COVID-19 symptoms (fever, breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and/or taste, rhinorrhoea and anorexia)
Measure: Time to improvement of COVID-19 symptoms (home setting only). Time: Day 1 to Day 28Description: Time to self-reported recover
Measure: Time to self-reported recovery (home setting only) Time: Day 2 to Day 16Description: Self-reported daily rating of overall feeling of wellness
Measure: Self-reported daily rating of overall feeling of wellness (home setting only). Time: Day 1 to Day 28Description: Quality of life measured using EQ-5D-5L
Measure: Quality of life measured using EQ-5D-5L (home setting only). Time: Day 1 to Day 28Description: Time to virus clearance and viral load
Measure: Virus clearance/load (if samples are available) Time: Day 1 to Day 28Description: Blood and sputum biomarkers
Measure: Blood and sputum biomarkers (if samples are available). Time: Day 1 to Day 28Description: Contact with health services
Measure: Contact with health services (home setting only Time: Day 1 to Day 28Description: Consumption of antibiotics
Measure: Consumption of antibiotics (home setting only Time: Day 1 to Day 28In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.
Description: We measure functional score of comorbidities
Measure: To evaluate the relative contributions of comorbidities on intra-hospitalized death Time: 1 monthDescription: We measure Functional Independence Measure scale
Measure: To evaluate the relative contributions of functional characteristics on intra-hospitalized death Time: 1 monthDescription: We describe the role fo geriatric syndrome such as delirium, falls
Measure: To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes Time: 1 monthSarilumab is an anti-interleukin-6 human monoclonal antibody, such as tocilizumab, which is administered subcutaneously every two weeks for the treatment of moderate to severe active rheumatoid arthritis in adult patients. Despite the effectiveness reported for tocilizumab in the recently published experiences, the need to rapidly find alternative therapies to manage the complications of Covid-19 infection remains extremely high. The lack of clinical experience on the usage of sarilumab in such patients prevents the possibility of adopting early access programs for using commercially available sarilumab (prefilled syringe) packs in patients with severe Covid-19 pneumonia. The present study is aimed to generate a rapid, still robustly documented, evidence on the potential clinical efficacy and tolerability of a further IL-6R antagonist in Covid-19 pneumonia.
Description: Clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as ≥30% decrease in oxygen requirement compared to baseline (as defined as the ratio of O2 flow through the Venturi mask).
Measure: Proportion of patients who show an improvement of the respiratory function Time: 6 weeksDescription: Evaluation of the time to resolution of fever, defined as body temperature ≤36.6°C axilla, ≤37.8°C rectal or tympanic for at least 48 hours without antipyretics in patients with fever at baseline.
Measure: Evaluation of the time to resolution of fever Time: 6 weeksDescription: Evaluation of the viral load on blood and sputum for COVID-19
Measure: Evaluation of the viral load on blood and sputum for COVID-19 Time: Before administration of sarilumab, 48 hours and 96 hours after administrationDescription: Evaluation of the plasma concentration of GM-CSF
Measure: Evaluation of the plasma concentration of GM-CSF Time: Pre-treatment and 96 and 120 hours post-treatmentDescription: Evaluation of the plasma concentration of Il-6
Measure: Evaluation of the plasma concentration of Il-6 Time: Pre-treatment and 96 and 120 hours post-treatmentDescription: Evaluation of the plasma concentration of TNF-α
Measure: Evaluation of the plasma concentration of TNF-α Time: Pre-treatment and 96 and 120 hours post-treatmentDescription: Evaluation of the rate of progression of WBC fraction of immature granulocytes - IG - (absolute count).
Measure: Evaluation of the rate of progression of White Blood Cell (WBC) fraction Time: 96 and 120 hours post-treatmentIntroduction: The SARS-Cov-2 outbreak in France and the concomitant massive increase in the number of cases requiring hospital management create a major risk of COVID-19 infection for hospital staff. In addition to nosocomial transmission, the health care workers (HCWs), defined as persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials, are also exposed to community transmission. Whether HCWs acquire infection at work or in the community is important to adapt protection measures. A few studies investigated COVID-19 infection among medical and nursing personnel. However, none have analyzed all categories of hospital staff. As of April 9, 2020, a total of 9,282 US HCWs with confirmed COVID-19 had been reported to CDC (US), however description of occupational activities was not available. Therefore, limited information is available about COVID-19 infection among HCWs. Thus, the objectives of the sdudy are to estimate the incidence of symptomatic SARS-CoV-2 infection in HCWs in five university hospitals (including geriatric hospitals) of the great Paris area and to estimate both nosocomial and community risk factors. Method: A prospective and retrospective cohort study that includes all hospital staff (including medical and nursing personnel, health care managers, laboratory, radiology, reception staffs, stretcher-bearers, etc.) working in different departments of five university hospitals (acute medical centers and geriatric hospitals) in the great Paris area (9 000 HCWs). Incidence of symptomatic SARS-CoV-2 infection will be estimated with its 95%CI. Individual and contextual risk factors will be analyzed using multilevel multivariate logistic regression modelling to account for clustering and confounding. Conclusion This study should make it possible to better characterize SARS-Cov-2 contamination of HCWs and to estimate the share of nosocomial transmission.
Description: The primary endpoint will be the occurrence of confirmed (RT-PCR or work stopping) SARS-CoV-2 infection.
Measure: SARS-COV-2 infection Time: At inclusionDescription: The primary endpoint will be the occurrence of confirmed (RT-PCR or work stopping) SARS-CoV-2 infection.
Measure: SARS-COV-2 infection Time: Up to 3 monthsDescription: Individual factors collected by a self-questionnaire
Measure: Individual factors Time: At inclusionDescription: Individual factors collected by a self-questionnaire
Measure: Individual factors Time: Up to 3 monthsDescription: Weekly consumption of masks and hydroalcoholic solution
Measure: Hospital ward level Time: Up to 3 monthsIn December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.
Description: Maneuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction.
Measure: Maneuverability score Time: During the procedureDescription: GET was defined as the time time taken for the endoscopist to complete the gastric examination to his or her satisfaction
Measure: Gastric examination time(GET) Time: During the procedureDescription: The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient
Measure: the comfort and acceptability of patients Time: After the procedure(within 5 days)Description: Diagnosis based on the data of nc- MCE by two endoscopist
Measure: diagnostic yield Time: after the procedure(within 5 days)Description: Adverse events during and after the procedure
Measure: Adverse events Time: During and within 2 weeks after the procedureDescription: Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus
Measure: Clinical success Time: During the procedureThe PROTECT open-label randomised basket trial will assess the effectiveness of hydroxychloroquine (HCQ) as chemoprophylaxis against COVID-19 in multiple vulnerable populations in the United Kingdom.
Description: The primary outcome for PROTECT is the time to confirmed COVID-19 infection from the date of randomisation. This will be captured via linkage with PHE or by direct reporting by sites.
Measure: Time to confirmed diagnosis of COVID-19 Time: To study completion, average 6 monthsDescription: Death from any cause
Measure: All-cause mortality Time: To study completion, average 6 monthsDescription: Severity will be assessed by requirement for hospitalisation, HDU/ICU admission or death and Length of inpatient stay.
Measure: Severity of COVID-19 disease Time: To study completion, average 6 monthsDescription: Acute respiratory distress syndrome, viral pneumonitis, myocarditis/myocardial injury, acute kidney injury.
Measure: Incidence of COVID-19 complications Time: To study completion, average 6 monthsTo evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images
Description: patient dies from ARDS
Measure: Mortality rate Time: two weeksDescription: time to recovery
Measure: Duration of severe symptoms Time: two weeksThis project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
Description: Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection
Measure: Serious adverse events in convalescent plasma treated patients Time: From baseline (enrolment) to 24 hours follow-upDescription: Change in SARS-CoV2 quantitative in nasopharyngeal swab
Measure: Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28Description: Transfer to ICU
Measure: Transfer to ICU Time: at Baseline (admission to Covid-ward) until day 28Description: in-hospital death
Measure: in-hospital death Time: at Baseline (admission to Covid-ward) until day 28Description: Change in SARS-CoV2 quantitative in plasma
Measure: Virologic clearance in plasma of convalescent plasma treated patients Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28Description: Duration of hospitalisation
Measure: Time to discharge from hospital after enrolment Time: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)Description: Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)
Measure: Humoral immune response Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment
Measure: Proportion of patients with a positive SARS-CoV-2 PCR Time: 7 days post-treatmentDescription: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab
Measure: Mean viral load Time: Baseline and on days 4, 7, 14 and 21Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial
Measure: Fever and cough progression Time: Up to and including day 21Description: Proportion of participants with positive IgG at day 21
Measure: Seroconversion at day 21 Time: Up to and including day 21Description: Proportion of drug-related adverse events
Measure: Proportion of drug-related adverse events Time: 7 days post treatmentDescription: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay
Measure: Levels of IgG, IgM and IgA Time: Up to and including day 28Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry
Measure: Frequency of innate immune cells Time: Up to and including day 7Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry
Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells Time: Up to and including day 7Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)
Measure: Results from cytokine Human Magnetic 30-Plex Panel Time: Up to and including day 28The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).
Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances
Measure: Presence or absence of olfactory and taste disturbances in COVID-19 patients Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)
Measure: Prevalence of olfactory disturbances in COVID-19 patients Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: Percentage of COVID-19 patients experiencing taste disturbances
Measure: Prevalence of taste disturbances in COVID-19 patients Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19 (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)
Measure: Clinical manifestations of study participants Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)
Measure: Other pre-existing health conditions Time: Prior to diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste before their diagnosis of COVID-19 infection
Measure: Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection Time: Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of diagnosis of COVID-19 infection
Measure: Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection Time: Within 2 weeks preceding the diagnosis of COVID-19 infectionDescription: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of answering questionnaire survey
Measure: Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey Time: Up to 6 monthsA prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.
Description: Percentage of patients with discharge to ICU.
Measure: Cases with discharge to ICU. Time: 30-daysDescription: Percentage of patients with home discharge.
Measure: Patients with home discharge. Time: 30-daysDescription: Percentage of deaths.
Measure: Mortality. Time: 30-daysDescription: Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
Measure: Treatment safety assessed by number of adverse events. Time: 30-daysDescription: Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
Measure: New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients. Time: 30-daysDescription: Percentage of patients with negative PCR for SARS-CoV-2.
Measure: Patients with negative PCR result for SARS-CoV-2 infection. Time: 30-daysBackground: In December 2019, patients with pneumonia secondary to a new subtype of Coronavirus (COVID-19) were identified in China. In a few weeks the virus spread and cases started practically all over the world. In February 2020, the WHO declared a pandemic. Severe symptoms have been found in patients mainly with comorbidities and over 50 years of age. At this time there is no proven therapeutic alternative. In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results. So far there is no standard of treatment and clinical trials are needed to find effective treatment alternatives. Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients. Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule. Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day. Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed. If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned. Outcomes: The primary outcome will be discharge from hospital for improvement. The safety outcomes will be requirement of mechanical intubation, septic shock or death. Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.
Description: Days from admission as a suspected case of COVID with hospitalization criteria until discharge
Measure: Mean days of hospital stay Time: Three monthsDescription: Respiratory deterioration defined by respiratory rate > 25 per minute, requirement of high oxygen supply (FiO2 > 80% ) to maintain oxygen saturation > 90 %, invasive mechanical ventilation or dead.
Measure: Rate of Respiratory deterioration, requirement of invasive mechanical ventilation or dead Time: Three monthsDescription: Daily delta of oxygenation index during the hospitalization
Measure: Mean of oxygenation index delta Time: Three monthsDescription: Mean time to viral negativization of RT-qPCR SARS-CoV-2. Pre Specified time: 5, 14, 21 and 28 days after the first positive PCR.
Measure: Mean time to viral PCR negativization Time: 5, 14, 21 and 28 days after the first positive PCRThe most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.
Description: Increase in plasma D-dimer level compared with baseline at enrollment.
Measure: Change in D-dimer Time: baseline, up to approximately 28 days after last study drug administrationDescription: Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.
Measure: Global composite rank score Time: up to approximately 28 days after last study drug administrationInvivoscribe, Inc. and its wholly owned subsidiary LabPMM, LLC are collecting peripheral blood specimens from patients with suspected SARS-CoV-2 viral infections. These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC. Specimens meeting this research protocol's inclusion criteria may be evaluated with various molecular techniques in order to identify nucleic acid sequences, antibodies, and/or antigens with the potential of being used to develop novel SARS-CoV-2 detection methods and COVID- 19 treatments and/or prevention methods (e.g. drug or vaccine development).
Description: This research protocol describes the collection and analysis of peripheral blood samples to: Identify nucleic acid sequences that may be used aide in the development of SARSCoV- 2 detection methods. Identify antibodies that may be used aide in the development of SARS-CoV-2 detection methods. Identify antigens that may be used aide in the development of SARS-CoV-2 detection methods. Identify nucleic acid sequences that may be used aide in the development of COVID- 19 treatments and/or vaccines. Identify antibodies that may be used aide in the development of COVID-19 treatments and/or vaccines. Identify antigens that may be used aide in the development of COVID-19 treatments and/or vaccines.
Measure: Identification of nucleic acid sequencing, antibodies and antigens to be used in detection methods or treatments and/or vaccines Time: 2 yearsPurpose of Study • The purpose of this study to evaluate, the effectiveness of convalescent plasma in combatting the symptoms and effects of the coronavirus disease, COVID-19. Beyond supportive care, there are no proven treatment options for COVID-19.
Description: % patients who survived
Measure: Survival Rate Time: At 28 DaysThe study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
Description: efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
Measure: Severity Category Time: 12 daysDescription: efficacy of CsA in combination with standard treatment in reducing mortality
Measure: Mortality Rate Time: through study completion, an average of 6 weeksDescription: efficacy of CsA in combination with standard treatment in reducing days in hospital
Measure: Number of Days in hospital Time: through study completion, an average of 6 weeksDescription: efficacy of CsA in combination with standard treatment in reducing days in ICU beds
Measure: Number of days in ICU beds Time: through study completion, an average of 6 weeksDescription: efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Measure: Fio2 Needs Time: through study completion, an average of 6 weeksDescription: safety and tolerability of cyclosporine vs standard treatment administration
Measure: Adverse events rate Time: through study completion, an average of 6 weeksDescription: change from baseline in C reactive protein levels
Measure: Change in CRP Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in ferritin levels
Measure: Change in ferritin Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in LDH levels
Measure: Change in LDH Time: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: change from baseline in Creatin phosphokinase levels
Measure: Change in CPK Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in D Dimer levels
Measure: Change in D Dimer Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in IL-6 levels
Measure: Change in IL-6 Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: change from baseline in KL-6 levels
Measure: Change in KL-6 Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: COVID19 Viral load determination
Measure: Change in Viral Load Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: Specific IgG and IgM determination
Measure: Change specific antibodies Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease. The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training. In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient. Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic. In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient. In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause. Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality. And a new applicability in the pulmonary recruitment by PEEP titration has been presented. The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.
Description: In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), > 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.
Measure: LUS applicability with COVID 19 Time: 10 monthsDescription: Comparison between Xray / CT scan exam and LUS
Measure: Radiographic correlation (chest Xray and tomodensitometry) Time: 10 monthsDescription: according to LUS score, ventilatory mode and parameters, medical history and bood analysis results
Measure: LUS Mortality prediction Time: 10 monthsDescription: comparison of LUS score depending of the position used for performing LUS
Measure: Prediction of Prone position response Time: 10 monthsThis is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using ResCure™ Time: 12 WeeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or progression of symptomatic days Time: 12 WeeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of ResCure™ via pulse Time: 12 WeeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of ResCure™ via oxygen saturation Time: 12 WeeksDescription: EKG from baseline to 12 weeks
Measure: Assess the safety of ResCure™ via EKG Time: 12 WeeksDescription: Assess Adverse Events and Serious Adverse Events due to ResCure™
Measure: Assess Tolerability of ResCure™ Time: 12 WeeksSelective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
Description: All cause mortality at Day 60
Measure: Mortality at Day 60 Time: 60 days post treatmentDescription: Dialysis Dependency at Day 60
Measure: Dialysis Dependency Time: 60 days post treatmentDescription: Ventilation free survival at Day 28
Measure: Ventilation at Day 28 Time: 28 days post treatmentDescription: Dialysis Dependency at Day 28
Measure: Dialysis Dependency Time: 28 days post treatmentDescription: All cause mortality at Day 28
Measure: Mortality at Day 28 Time: 28 days post treatmentDescription: Change from baseline in urine output
Measure: Urinary output change Time: 10 days of treatmentDescription: Change from baseline in PO2/FiO2
Measure: P02/FiO2 change Time: 10 days of treatmentDescription: Assessment of SAEs, AE and UADEs
Measure: Safety Assessments Time: 10 days of treatmentDescription: Assessment of device performance
Measure: SCD Integrity Time: 10 days of treatmentThis is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.
Description: Incidence of AEs within 30 days of randomization.
Measure: Incidence of AEs Time: 30 daysDescription: Mortality within 30 days of randomization.
Measure: Mortality Time: 30 daysDescription: Cause of death within 30 days of randomization
Measure: Death Time: 30 daysDescription: Number of ventilator-free days within 60 days of randomization.
Measure: Number of ventilator-free days Time: 60 daysDescription: Time from randomization to an improvement of one category using the ordinal scale. The ordinal scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, limitation on activities Not hospitalized, no limitations on activities
Measure: Improvement of one category Time: 30 daysDescription: Change in the 7-point ordinal scale from baseline. The ordinal scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, limitation on activities Not hospitalized, no limitations on activities
Measure: 7-point ordinal scale Time: 30 daysDescription: Change in NEWS from baseline. The following 7 clinical parameters will be assessed: Respiration rate Oxygen saturation Any supplemental oxygen Temperature Systolic blood pressure Heart rate Level of consciousness Measurements within normal ranges are assigned a 0. If the measurement in each category is substantially above or below the normal range, it is given a +1, +2, or +3. The more far off than normal, the bigger the number (in each category). A higher number indicates worse outcome. Each category can be 0-3, except for supplemental oxygen which is only 0-2. The highest value a patient can get is 20.
Measure: NEWS Time: 30 daysDescription: Time from randomization to discharge or to a NEWS of ≤ 2 maintained for 24 hours, whichever occurs first.
Measure: NEWS of ≤ 2 Time: 30 daysDescription: Change from baseline in Sequential Organ Failure Assessment (SOFA) score on days 8, 15, 22, and 29. System Score for each category is 0-4 with 28 is the maximum score for worst outcome. The following categories are: Respiration Coagulation Liver Cardiovascular Central Nervous System Renal
Measure: Sequential Organ Failure Assessment (SOFA) Time: days 8, 15, 22, and 29Description: Number of days requiring oxygen.
Measure: Oxygen Time: 30 daysDescription: Duration of hospitalization from randomization.
Measure: Hospitalization Time: 30 daysDescription: Incidence of SAEs within 30 days of randomization
Measure: Incidence of SAEs Time: 30 daysThe COVID-19 pandemic is a global emergency threatening to take millions of lives in the United States and around the world. There is no current vaccine strategy against COVID-19 infection caused by a novel coronavirus named SARS-CoV-2. Studies with a related coronavirus called SARS-CoV-1 that caused the SARS outbreak in 2003 indicated that memory CD8+ T cells recognizing viral epitopes persisted for more than 6 years post infection while neutralizing antibodies and memory B cells were short-lived and were undetectable after a short period of time (Tang et al., 2011; Peng et al., 2006; Channappanavar et al., 2014). Thus, including viral epitopes that are recognized by memory CD8+ T cells is imperative for vaccines that can provide long-term immunity against SARS-CoV-2. In this study, blood samples from COVID-19 patients who have recovered from the infection will be used to identify the viral epitopes recognized by their memory CD8+ T cells. This will be accomplished using a genome-wide, high-throughput screening technology developed at Harvard Medical School (Kula et al., 2019) and licensed by the study sponsor, TScan Therapeutics. A 24,000-member library that tiles across all ~100 viral isolates of SARS-CoV-2 that have been sequenced so far has already been synthesized at TScan. Blood samples from convalescent patients are urgently needed to identify T cell receptors and immunogenic viral epitopes on SARS-CoV-2. It is the hope that these data will inform development of a vaccine with the potential for long-lasting protection against SARS-CoV-2.
Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
Description: This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) Time: Day 1 to Day 8Description: This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline Time: Day 1 to Day 8Description: Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4 Time: Day 4Description: This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline on day 4 Time: Day 4Description: Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following pO2/FiO2 less than 150 Need for mechanical or non-mechanical ventilation (CPAP)
Measure: Range of development of severe respiratory failure Time: Day 1 to Day 14Description: Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.
Measure: Range of hospital readmission until day 14 Time: Day 1 to Day 14Description: Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8
Measure: Change of viral load in respiratory secretions from baseline on day 8 Time: Day 1 to Day 8Description: Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of function of monocytes at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th1 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th2 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum human beta defensin-2 (hBD-2) between days 1 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of the IL-10/TNFα ratio between days 1 and 8 Time: Day 1 to Day 8In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.
Description: Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission
Measure: Asymptomatic COVID-19 positive pregnant women Time: Through completion of the study, an average of 1 yearDescription: Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission
Measure: Asymptomatic Hispanic COVID-19 positive pregnant women Time: Through completion of the study, an average of 1 yearDescription: Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms
Measure: Follow up of asymptomatic COVID-19 positive pregnant women Time: Through completion of the study, an average of 1 yearDescription: Prevalence of COVID-19 positive newborns from infected mothers
Measure: COVID-19 positive newborns Time: Through completion of the study, an average of 1 yearDescription: Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19
Measure: Severe COVID-19 disease in pregnant women Time: Through completion of the study, an average of 1 yearCoronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection. In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.
Description: It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection
Measure: The survey that was taken by telephone calls Time: Day 0Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.
Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Measure: Number of secondary cases of SARS-CoV2 infection among residents at six days Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Measure: Number of secondary cases of SARS-CoV2 infection among residents at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.
Measure: Number of secondary cases of SARS-CoV2 infection among residents at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable
Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at six days Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable
Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable
Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous qualitative variable (1: Death 0: Survival)
Measure: Mortality Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period
Measure: Compliance with treatment Time: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administeredDescription: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.
Measure: Symptoms of SARS-CoV-2 infection at six days Time: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.
Measure: Symptoms of SARS-CoV-2 infection at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.
Measure: Symptoms of SARS-CoV-2 infection at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection
Measure: Hospitalization Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors
Measure: Adverse events at six days Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors
Measure: Adverse events at 14 days Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquineDescription: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors
Measure: Adverse events at 28 days Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquineThe objective of this study is to assess the long-term outcomes after hospital admission with Covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and socioeconomic outcomes.
Description: Expert evaluation
Measure: Imaging of the lungs Time: 3 months after dischargeDescription: Expert evaluation
Measure: Imaging of the lungs Time: 12 months after dischargeDescription: Liter
Measure: Pulmonary function tests Time: 3 months after dischargeDescription: Liter
Measure: Pulmonary function tests Time: 12 months after dischargeDescription: Walking distance (meters) and change in oxygen saturation.
Measure: Six-minute walk test Time: Performed 3 months after dischargeDescription: Walking distance (meters) and change in oxygen saturation.
Measure: Six-minute walk test Time: Performed 12 months after dischargeDescription: 0-100 scale. The lower the score, the more disability.
Measure: Short Form-36 (SF-36) questionnaire Time: 3 months after dischargeDescription: 0-100 scale. The lower the score, the more disability.
Measure: Short Form-36 (SF-36) questionnaire Time: 12 months after dischargeDescription: 10-50 score. The higher the score, the more fatigue
Measure: Fatigue Assessment Score Time: 3 months after dischargeDescription: 10-50 score. The higher the score, the more fatigue
Measure: Fatigue Assessment Score Time: 12 months after dischargeDescription: 0-30. The lower the score, the more cognitive impairment
Measure: Cognitive sore (MOCA) Time: 3 months after dischargeDescription: 0-30. The lower the score, the more cognitive impairment
Measure: Cognitive sore (MOCA) Time: 12 months after dischargeDescription: 0-21. The higher the score, the more risk of anxiety or depression.
Measure: Hospital anxiety and Depression score (HADS) Time: 3 months after dischargeDescription: 0-21. The higher the score, the more risk of anxiety or depression.
Measure: Hospital anxiety and Depression score (HADS) Time: 12 months after dischargeDescription: Any pre-COVID-19 comorbidity and treatment with immmunosuppressants will be registered.
Measure: Comorbidities Time: 12 months after dischargeDescription: Change in outcomes between discharge and follow-up visits will be evaluated
Measure: Blood sample at routine follow up. Time: 3 months after dischargeDescription: Change in outcomes between discharge and follow-up visits will be evaluated
Measure: Blood sample at routine follow up. Time: 12 months after dischargeDescription: Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.
Measure: Biobanking of blood Time: 3 months after dischargeDescription: Knowledge regarding COVID19 is drastically evolving. Biobanking makes it possible to investigate blood samples in the future corresponding to ongoing evidence.
Measure: Biobanking of blood Time: 12 months after dischargeThe COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)
Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease Time: Measuring during 28-day period since randomization (Intention to treat analysis)Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)
Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization Time: Measuring during 14-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.
Measure: Time to clinical improvement Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;
Measure: Time to clinical failure Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with hospitalization for any cause
Measure: Hospitalization for any cause Time: Measuring during 28-day period since randomizationDescription: Evaluation of adverse events evaluated as associated to any of study arms
Measure: Proportion of participants who presented with adverse events Time: Measuring during 28-day period since randomizationDescription: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.
Measure: Time to improvement on respiratory scale symptoms Time: Measuring during 28-day period since randomizationThere is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.
Description: defined as the time from first dose of polyphenol extract to hospital discharge
Measure: Time to hospital discharge Time: Throughout the Study (Day 0 to Day 28)Description: proportion
Measure: 28-day all-cause mortality Time: Throughout the Study (Day 0 to Day 28)Description: proportion
Measure: invasive ventilation on day 28 Time: Throughout the Study (Day 0 to Day 28)Description: mean difference
Measure: Difference in Pro and antiinflammatory citoquine levels Time: day 1-14Description: proportion
Measure: Negativization of COVID-PCR at day 14 Time: day 14This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19
Description: The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding stratified log-rank test (to account for the "early" versus "late" time from symptom onset randomization strata). Non detectable defined as "a viral load below the limit of quantification
Measure: Virologic Efficacy Time: 28 daysDescription: Measure the safety and tolerability of EIDD-2801 by estimating in the randomization arm the probability of 1) any adverse events (AEs) leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AE (not already present at baseline), and 4) study drug-related new grade 3 or higher AE. The cumulative probability of each safety and each tolerability endpoint (4 endpoints) by using the Kaplan-Meier approach and stratified log-rank test.
Measure: Number of Participants with any Adverse Events (AEs) as Assessed by Kaplan Meier Approach Time: 28 daysDescription: Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs by using the Kaplan-Meier approach and stratified log-rank test.
Measure: Number of Participants With any Adverse Events (AEs), Grade 2 or higher as Assessed by Kaplan Meier Approach Time: 28 daysHospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.
Description: Incidence rate of IPC-defined HOCIs, measured as incidence rate of recorded cases per week per 100 inpatients, during each phase of the study based on case report forms.
Measure: Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs) Time: 6 monthsDescription: Identification of nosocomial transmission using sequencing data in potential HOCIs in whom this was not identified by pre-sequencing IPC evaluation, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
Measure: Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing Time: 6 monthsDescription: Incidence rate of IPC-defined hospital outbreaks, defined as cases of hospital transmission linked by location and with intervals between diagnoses of no greater than 2 weeks (relevant data extracted from case report forms), measured as incidence rate of outbreak events per week per 100 inpatients during each phase of the study.
Measure: Incidence rates of IPC-defined hospital outbreaks Time: 6 monthsDescription: Incidence rate of IPC+sequencing-defined hospital outbreaks, defined by retrospective review of all available sequencing and epidemiological data for identification of transmission clusters and measured as outbreak events per week per 100 inpatients during each phase of the study.
Measure: Incidence rates of IPC+sequencing-defined hospital outbreaks Time: 6 monthsDescription: Changes to IPC actions implemented following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
Measure: Changes to IPC actions following viral sequence reports Time: 6 monthsDescription: Changes to IPC actions that would ideally have been implemented (given unlimited resources) following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
Measure: Recommended changes to IPC actions following viral sequence report - not implemented Time: 6 monthsDescription: Health economic benefit of standard and rapid sequencing reports to IPC measured using bespoke health economic case report data comparison between baseline, standard and rapid sequencing phases.
Measure: Health economic benefit to IPC of standard vs rapid sequencing reports Time: 6 monthsDescription: Number of HCW days off work measured from sampling these data points on case report forms at all study phases.
Measure: Impact of both standard and rapid sequencing reports on number of HCW days off work Time: 6 monthsThis is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease
Description: Negative PCR of SARS-CoV-2 and the absence of clinical manifestations of COVID-19 infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.
Measure: Polymerase chain reaction (PCR) Time: 4 weeks after randomizationDescription: Time to clinical symptoms of a respiratory infection with positive PCR SARS-CoV-2
Measure: Time to symptoms Time: 14 days after last contactDescription: Time to detect positive SARS-CoV-2 PCR
Measure: Time to positive PCR Time: 14 days after last contactDescription: The number of asymptomatic cases of SARS-CoV-2 infection
Measure: Number of cases Time: 14 days after last contactDescription: The number of mild, moderate and severe forms of the disease COVID-19 with Bromhexine hydrochloride
Measure: Case severity Time: 14 days after last contactDescription: Evaluation of adverse events
Measure: Drug tolerance Time: 14 days after last contactObservational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.
Description: Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.
Measure: Description of the characteristics of patients Time: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeksSeroepidemiological Study of SARS-CoV-2 Infection in Population Subgroups in the State of São Paulo
Description: IgM and IgG antibodies against SARS-CoV-2
Measure: Prevalence of antibodies against SARS-CoV-2 through serological testing Time: 1 monthDescription: Positive RT-PCR test result for SARS-CoV-2
Measure: Frequency of participants with a positive RT-PCR test result for SARS-CoV-2 Time: 1 monthThis clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.
This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.
Description: The primary endpoint of this trial is the survival on day 21. The primary endpoint, as a dichotomous composite of survival (yes/no) and no longer fulfilling criteria of severe COVID-19, will be analyzed according their classification. Specifically, categorical variables will be analyzed by means of absolute and relative frequencies, and all continuous variables will be described using arithmetic mean, standard deviation, median, quartiles. Also, geometric means, variance and 95% confidence intervals (CI), will be calculated for all pharmacokinetics parameters.
Measure: Survival Time: Day 21Description: The primary endpoint of this trial is the survival on day 35.
Measure: Survival Time: Day 35Description: The primary endpoint of this trial is the survival on day 60.
Measure: Survival Time: Day 60Description: The secondary endpoint of this trial is that no longer fulfilling criteria of severe COVID-19 within 21 days after inclusion. This will be assessed on the basis of respiratory rate and ventilation support.
Measure: Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease Time: Day 21To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%. Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.
Description: Flow cytometry measurement of the percentage of circulating Th1 lymphocytes
Measure: Percentage of circulating Th1 lymphocytes Time: Until the end of the study, about 12 months.Description: Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11
Measure: Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11 Time: Until the end of the study, about 12 months.It still unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes, including the timing of maternal viral exposure by gestational age, the effects of parity, age, host immune responses, coexisting medical and obstetrical conditions and the effects of treatment regimens. While further information is gathered, based on the existing evidence from other infections causing pneumonia, pregnant women should be considered to be at high risk for developing severe infection during the current COVID-19 epidemic. Results from clinical trials with HCQ in nonpregnant adults may not be directly extrapolated to pregnant women given the special features of the pregnancy status. Thus, clinical research is urgently needed to improve the care and reduce the risk of poor pregnancy outcomes of women in this and in future epidemics.
Description: Number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start
Measure: Number of PCR confirmed cases among pregnant women Time: 21 days after interventionThe SARS-CoV-2 pandemic and resulting COVID-19 disease causes a substantial burden on healthcare systems. Little is known about how the infection spreads within healthcare. In order to design control strategies, knowledge of the presence of viral nucleic acid and whether an immune response to the virus has been mounted is needed. The purpose of this study is to determine whether personnel and patients/clients in healthcare in Region Stockholm have a currrent SARS-CoV-2 infection or have had an infection. This information will be used to understand how the infection spreads in healthcare, to explore the association with sick-leave among personnel, and to plan high-quality and safe care. Healthcare providers and organizations participating in the study from the greater Stockholm region include the following: Karolinska University Laboratory, Karolinska University Hospital; Intensive Care Unit, Karolinska University Hospital; SciLifeLab; KTH Royal Institute of Technology; Roo Home Healthcare Services (Roo Hemtjänst och Vård); Health Care Services Stockholm County (SLSO); Region Stockholm; Southern Hospital (Södersjukhuset); Danderyd Hospital; Capio St Göran Hospital; Södertälje Hospital; Tiohundra AB; Ersta Hospital, Sweden; and St Eriks Eye Hospital (St Eriks Ögonsjukhus).
Description: Ongoing and past SARS-CoV-2 infection, measured in throat samples (current infection) and serum (past infection, antibodies to SARS-CoV-2) evaluated in relation to age, gender, sickleave, address, workplace, sampling date, work tasks (for healthcare personnel) and evaluated in relation to date of hospitalization, diagnoses, and interventions for patients and healthcare clients.
Measure: SARS-CoV-2 infection Time: Throat and blood samples are taken one time at enrollment. Other background characteristics are determined using linkages to healthcare employment databases up to two months after enrollment.Description: Sequencing will be completed on the positive samples to determine is the virus isolate is the same. This can provide information on the spread of the infection in population.
Measure: SARS-CoV-2 sequencing Time: Sequencing will be completed in a later phase of the study, after enrollment is complete and within 1 year.The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
Description: Comparing the influence of the intervention on the Survival rate.
Measure: Survival rate. Time: up to 8 weeks.Description: For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.
Measure: Rate of disease remission. Time: up to 4 weeks.Description: Comparing the influence of the intervention on the PCR negative results.
Measure: The number of patients with PCR negative results. Time: up to 4 weeks.Description: Recording the changes from severe to moderate or mild and the time taken.
Measure: Mean change in the disease severity (clinical assessment). Time: up to 4 weeks.Description: Recording the changes in blood pressure mmHg.
Measure: Mean change in blood pressure. Time: up to 4 weeks.Description: Recording the changes in heart rate in beat/second.
Measure: Mean change in heart beats. Time: up to 4 weeks.Description: Recording the changes in body temperature in Celsius.
Measure: Mean change in body temperature. Time: up to 4 weeks.Description: Recording the changes in the respiratory rate in breath/minute.
Measure: Mean change in body respiratory rate. Time: up to 4 weeks.Description: Recording the changes in arterial oxygen saturation in mmHg.
Measure: Mean change in oxygen saturation. Time: up to 4 weeks.Description: Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).
Measure: Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio). Time: up to 4 weeks.Description: Recording the changes in complete blood picture (CBC) in cells per liter.
Measure: Mean change in complete blood picture (CBC). Time: up to 4 weeks.Description: Recording the changes in C reactive protein (CRP) in mg/L.
Measure: Mean change in C reactive protein (CRP). Time: up to 4 weeks.Description: Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.
Measure: Mean change in erythrocyte sedimentation rate (ESR). Time: up to 4 weeks.Description: Recording the changes in D-dimer in ng/mL.
Measure: Mean change in D-dimer. Time: up to 4 weeks.Description: Recording the changes in ferritin in ng/mL.
Measure: Mean change in ferritin. Time: up to 4 weeks.Description: Recording the changes in liver Albumin in g/L.
Measure: Mean change in liver Albumin. Time: up to 4 weeks.Description: Recording the changes in total and direct Bilirubin in mg/dL.
Measure: Mean change in total and direct Bilirubin. Time: up to 4 weeks.Description: Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).
Measure: Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ). Time: up to 4 weeks.Description: Recording the changes in aspartate aminotransferase (AST) in IU/L.
Measure: Mean change in aspartate aminotransferase (AST). Time: up to 4 weeks.Description: Recording the changes in Alanine Aminotransferase (ALT) in IU/L.
Measure: Mean change in Alanine Aminotransferase (ALT). Time: up to 4 weeks.Description: Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.
Measure: Mean change in Blood Urea Nitrogen (BUN). Time: up to 4 weeks.Description: Recording the changes in Serum Creatinine in mg/dL.
Measure: Mean change in Serum Creatinine. Time: up to 4 weeks.Description: Recording the changes in Serum Creatinine in ml/min.
Measure: Mean change in Serum Creatinine clearance. Time: up to 4 weeks.Description: Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.
Measure: Mean change in Glomerular filtration rate (GFR ). Time: up to 4 weeks.Description: Recording the changes in interleukin-1 (IL-1) in pg/ml.
Measure: The mean change in serum interleukin-1 (IL-1). Time: up to 4 weeks.Description: Recording the changes in interleukin-6 (IL-6) in pg/ml.
Measure: The mean change in serum interleukin-6 (IL-6). Time: up to 4 weeks.Description: Recording the changes in interleukin-10 (IL-10) in pg/ml.
Measure: The mean change in serum interleukin-10 (IL-10). Time: up to 4 weeks.Description: Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.
Measure: The mean change in serum tumor necrosis factor-alpha (TNF alpha). Time: up to 4 weeks.Description: Recording the changes in immunoglobulin G (IgG) in ng/ml.
Measure: Mean changes in immunoglobulin G (IgG). Time: up to 4 weeks.Description: Recording the changes in immunoglobulin M (IgM) in ng/ml.
Measure: Mean changes in immunoglobulin M (IgM). Time: up to 4 weeks.Description: Recording the changes in PCR viral load in copies/mL.
Measure: The mean change in PCR viral load. Time: up to 4 weeks.Description: Recording the changes in lung CT.
Measure: Mean change in lung CT manifestation. Time: up to 4 weeks.Description: Recording any unexpected Adverse Events of the intervention.
Measure: Nature and severity of Adverse Events. Time: up to 4 weeks.Description: Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.
Measure: Time for lung recovery. Time: up to 8 weeks.Description: Recording the changes the event of missed drug doses.
Measure: The number of missed drug doses among each treatment group. Time: up to 4 weeks.This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
Measure: Identification of requirement of mechanical ventilation Time: 3 weeksDescription: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Measure: Prediction of requirement of mechanical ventilation Time: 3 weeksDescription: Descriptive assessment of clinical parameters and LUS-score over time
Measure: Association of LUS to clinical parameters Time: 3 weeksDescription: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
Measure: Description of findings on LUS Time: 3 weeksAlthough SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15
Description: Patient's clinical state will be evaluated by the proportion of patients able to be weaned of oxygen at D15 after randomization (randomization date is the day where the experimental treatment (i.e. NIVOLUMAB) is administered).
Measure: Patient's clinical state Time: 15 days after randomizationDescription: Proportion of in-coming patients in ICU at D7 and D15 post-randomization
Measure: Readmission Time: 7 days and 15 days after randomizationDescription: Proportion of death at D7 and D15 post-randomization
Measure: Mortality Time: 7 days and 15 days after randomizationDescription: Proportion of patients weaned out of oxygen at D7 post-randomization
Measure: Oxygen flow needs Time: 7 days after randomizationDescription: Mean oxygen flow needed
Measure: Requirement of oxygen Time: 7 days and 15 days after randomizationDescription: Proportion of out-coming patients from hospitalization at D7 and D15 post-randomization
Measure: Discharge from hospital Time: 7 days and 15 days after randomizationDescription: Report of all adverse events linked or not to experimental treatment during the study
Measure: Adverse events Time: Within 15 days post-randomization and 90 days and 6 months after randomizationDescription: Presence or not of nasopharyngeal SARS-CoV-2 determined by PCR response
Measure: Presence of nasopharyngeal SARS-CoV-2 Time: On day 0 before randomization and 15 days after randomizationDescription: Presence or not of nasopharyngeal SARS-CoV-2 Quantified by PCR
Measure: nasopharyngeal SARS-CoV-2 viral charge Time: On day 0 before randomization and 15 days after randomizationDescription: Number of total LT (using immuno-phenotyping) will explore the immune response
Measure: Number of total Lymphocytes T Time: On day 0 before randomization and 15 days after randomizationDescription: Number of CD3+ LT (using immuno-phenotyping) will explore the immune response
Measure: Number of CD3+ Lymphocytes T(lymphocyte subpopulation of CD3+ T cells) Time: On day 0 before randomization and 15 days after randomizationDescription: Number of total CD4+ LT (using immuno-phenotyping) will explore the immune response
Measure: Number of CD4+ Lymphocytes T(lymphocyte subpopulation of CD4+ T cells) Time: On day 0 before randomization and 15 days after randomizationDescription: Evaluation of number of CD8+ LT (using immuno-phenotyping) will explore the immune response
Measure: Number of CD8+ Lymphocytes T(lymphocyte subpopulation of CD8+ T cells) Time: On day 0 before randomization and 15 days after randomizationDescription: Systemic concentration measurement of IL-6 will explore the inflammatory response
Measure: Interleukin 6 (IL-6) Time: On day 0 before randomization and 15 days after randomizationDescription: Systemic concentration measurement of IL-10 will explore the inflammatory response
Measure: Interleukin 10 (IL-10) Time: On day 0 before randomization and 15 days after randomizationDescription: Systemic concentration measurement of TNFα will explore the inflammatory response
Measure: Tumor Necrosis Factor alpha (TNFα ) Time: On day 0 before randomization and 15 days after randomizationDescription: Systemic concentration measurement of IFNγ will explore the inflammatory response
Measure: Interferon gamma (IFNγ) Time: On day 0 before randomization and 15 days after randomizationDescription: Systemic concentration measurement of type I IFN will explore the inflammatory response
Measure: Type I Interferon (type I IFN) Time: On day 0 before randomization and 15 days after randomizationDescription: Evaluation of Tim3 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19
Measure: Tim3 expression Time: On day 0 before randomization and 15 days after randomizationDescription: Evaluation of PD1 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19
Measure: PD1 expression Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of PD-L1 expression on monocytes will explore explore the fundamental research on obesity and COVID-19
Measure: PD-L1 expression Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of HLA-DR expression on monocytes will explore explore the fundamental research on obesity and COVID-19
Measure: Human Leukocyte Antigen - DR isotype gene expression (HLA-DR expression) Time: On day 0 before randomization and 15 days after randomizationDescription: The cytotoxic LT production of IFNγ will explore the fundamental research on obesity and COVID-19
Measure: Production of IFNγ by lymphocytes T Time: On day 0 before randomization and 15 days after randomizationDescription: The cytotoxic LT production of granzyme B will explore the fundamental research on obesity and COVID-19
Measure: Production of granzyme B by lymphocytesT Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of LPS will explore the endotoxemia and perform fundamental research on obesity and COVID-19
Measure: Lipopolysaccharides (LPS) Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of LBP (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19
Measure: LBP(LPS-Binding Protein) Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of sCD14 (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19
Measure: sCD14 Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of High Density Lipoproteins proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19
Measure: High Density Lipoproteins Time: On day 0 before randomization and 15 days after randomizationDescription: Measurement of apolipoprotein proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19
Measure: Apolipoprotein Time: On day 0 before randomization and 15 days after randomizationAccording to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.
Description: Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).
Measure: Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period Time: Day of intervention (1 day)The inflammation is central in COVID-19 infections. Our aim is to evaluate the clinical value of measuring inflammation by using serum protein electrophoresis (SPE). SPE evaluation of inflammation should be able to predict outcome, follow up evolution or treatment efficacy in patients with coronavirus infection and thus anticipate their evolution to severe viral infection and allow an optimal clinical management. SPE inflammation diagnostics will be benchmarked with other diagnostics of inflammation, currently used more routinely.
Description: hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause
Measure: Complications onset Time: Up to 3 weeksDescription: Risk quantification
Measure: Risk value associated with each risk factor as identified at the end of the main study analysis Time: Up to 3 weeksDescription: Correlation between complications onset (as defined by hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause) and individual protein fraction value
Measure: Predictive performance and risk associated with each individual protein fraction Time: Up to 3 weeksDescription: Evolution over time of the serum quantity of each individual protein fraction (6 fractions studied)
Measure: Intra-patient kinetics evolution of the electrophoresis curves Time: Up to 3 weeksDescription: Evolution over time of the serum quantity of each biological risk factor (as defined for the study)
Measure: Intra-patient kinetics evolution of biological risk factors Time: Up to 3 weeksDescription: Central review of each serum protein electrophoresis curve
Measure: Inter-expert reproducibility analysis of electrophoretic inflammatory profiles centrally reviewed Time: After study completion, estimated 10 months after first patient enrolledDescription: Urine samples at admission, every 4 days and at complications onset
Measure: Contribution of urinary electrophoresis inflammation profiles in the interpretation of serum electrophoresis curves Time: Up to 3 weeksDescription: Biobank with serum samples for the implementation, at the end of the study, of a high-resolution capillary electrophoresis technique enabling each serum protein to be viewed individually
Measure: Exploratory biological objective: Definition of a more detailed electrophoretic inflammatory profile Time: After study completion, estimated 10 months after first patient enrolledThe purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.
Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2
Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3. Time: Visit 3 (90 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Time: Visit 4 (135 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Time: Visit 5 (180 +/- 5 days)Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled
Measure: Prevalence of IgG/IgM against SARS-CoV-2 Time: Screening Visit and Visit 3 (90 +/- 5 days)Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit
Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19. Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.
Measure: The impact of new cardiovascular events between the two study groups Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.
Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed
Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
Description: Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.
Measure: Disease severity Time: on day 7Description: Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)
Measure: Time to clinical improvement Time: within 14 days after enrolmentDescription: Proportion of participants alive and not having required invasive or non-invasive ventilation
Measure: Proportion of participants alive and not having required invasive or non-invasive ventilation Time: at 14 days after enrolmentDescription: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)
Measure: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg) Time: within 14 days after enrolmentDescription: Changes in the ordinal WHO scale
Measure: Changes in the ordinal WHO scale Time: from baseline over 14 daysDescription: Length of hospital stay in survivors
Measure: Length of hospital stay in survivors Time: until day 28Description: Proportion of participants progressing to mechanical ventilation
Measure: Proportion of participants progressing to mechanical ventilation Time: on day 7 and day 14Description: Proportion of participants requiring ICU treatment
Measure: Proportion of participants requiring ICU treatment Time: on day 7 and 14Description: Length of ICU stay
Measure: Length of ICU stay Time: until day 28Description: 28 Ventilator-free days
Measure: 28 Ventilator-free days Time: until day 28Description: All-cause mortality
Measure: All-cause mortality Time: time from randomisation to death within four weeksDescription: Changes in biomarker level CRP
Measure: Changes in biomarker level CRP (mg/l) Time: until day 14Description: Changes in biomarker level LDH
Measure: Changes in biomarker level LDH (U/l) Time: until day 14Description: Changes in biomarker level D-Dimer
Measure: Changes in biomarker level D- Dimer (yg/ml) Time: until day 14Description: Changes in biomarker level Ferritin
Measure: Changes in biomarker level Ferritin (ng/ml) Time: until day 14Description: Changes in biomarker level IL-6
Measure: Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml) Time: until day 14Description: Changes in lymphocyte count
Measure: Changes in lymphocyte count (cells per microliter of blood) Time: until day 14Description: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples
Measure: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples Time: time from enrolment to first of 2 negative assays at least 12 hours apartDescription: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins
Measure: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins Time: within 14 daysDescription: Time to defervescence (temperature <38.0°C)
Measure: Time to defervescence (temperature <38.0°C) Time: sustained for at least 48 hoursDescription: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)
Measure: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28 Time: until day 28Description: Duration of supplemental oxygen
Measure: Duration of supplemental oxygen Time: until day 28Description: Peak serum concentration of conestat alfa will be measured
Measure: Change in pharmacokinetics of conestat alfa Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge dateDescription: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)
Measure: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration) Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge dateThis is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
Measure: SARS-CoV-2 Neonatal Infection Time: 7 daysDescription: stillbirths and deaths in the first week of life
Measure: Perinatal mortality Time: 35 weeksDescription: maternal ICU admission due to COVID-19
Measure: ICU maternal admission Time: 35 weeksDescription: Newborn 5 minute Apgar Score < 7
Measure: 5 minute Apgar Score < 7 Time: 1 dayDescription: Delivery between 24 and 36 weeks
Measure: Preterm labour Time: 35 weeksDescription: Preterm premature rupture of the membranes between 24 and 36 weeks
Measure: PPROM Time: 35 weeksDescription: spontaneous pregnancy loss before 24 weeks
Measure: Miscarriage Time: 14 weeksAt the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus. Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells. Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible. The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.
Description: Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19
Measure: Emergency department attendance of hospitalisation related to COVID-19 Time: Day 1 to day 28Description: Evaluate the effect of intervention on body temperature
Measure: Body temperature Time: Day 1 to day 14Description: Evaluate the effect of intervention on blood oxygen level
Measure: Blood oxygen saturation level Time: Day 1 to day 14Description: Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.
Measure: Symptoms as assessed by common cold questionnaire Time: Day 1 to day 14Description: Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.
Measure: Symptoms as assessed by FluPro questionnaire Time: Day 1 to day 14Description: Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load
Measure: Nasal/throat swab SARS-CoV-2 viral load Time: Day 1, 7 and 14Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.
Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Measure: Health-related quality of life. Time: One-year (12 months) after ICU discharge.Description: Length of stay at the ICU.
Measure: Length of stay at the ICU. Time: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).Description: Incidence of all-cause mortality.
Measure: Incidence of all-cause mortality Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Rehospitalization.
Measure: Rehospitalization. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
Measure: Percentage of long-term ventilatory support need. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Percentage of patients requiring any kind of renal replacement therapy.
Measure: Percentage of renal replacement therapy need. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
Measure: Symptoms of anxiety and depression. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).
Measure: Score of functional independence. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.
Measure: Score of cognitive function. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Percentage of major cardiac events.
Measure: Percentage of major cardiac events. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.
Measure: Score of Chronic obstructive pulmonary disease (COPD) Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
Measure: Symptoms of posttraumatic stress disorder Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Measure: Utility score of health-related quality of life at 3, 6, and 9 months. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.Description: The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).
Measure: Score of self-rated health. Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System
Description: Conduct a quantitative fit test and calculate the percentage of participants who pass the test.
Measure: Success Percentage Time: 15 minutesDescription: Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask
Measure: End-tidal CO2 Variation. Description: mmHg. Time: at 0 and 15 minutesDescription: Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask
Measure: Oxygen Pulse Oximetry Variation. Description: mmHg. Time: at 0 and 15 minutes.Description: Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes
Measure: Mask Visibility. Description: Likert Scale. Time: 15 minutesDescription: When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.
Measure: Willingness of usage. Description: Likert Scale. Time: after 15 minutes
Background:
Mitochondrial disease is a rare disorder. It can cause poor growth, developmental delays,
muscle weakness, and other symptoms. The disease is usually inherited. It can be present at
birth or develop later in life. Infection is a major cause of disease and death in people
with this disease. Researchers want to learn more about how infection and the declining
health of people who have this disease may be related to the COVID-19 pandemic. To do this,
researchers will study the DNA of people who become ill with suspected or confirmed
coronavirus. Their DNA will be compared to the DNA of their family members.
Objective:
To learn more about how genes may play a role in how COVID-19 affects people with
mitochondrial disease.
Eligibility:
People age 2 months and older with mitochondrial disease and a suspected or confirmed
diagnosis of COVID-19.
Description: To identify immune signatures that associate with host responses todisease that would allow improved patient stratification and identification of potential therapeutic targets to mitigate the severesymptoms and sequelae of infection in mitochondrial disease.
Measure: We will perform whole blood transcriptomic analysis, humoral response profiling and soluble mediator profiling. Time: Undefined for natural history studyDescription: to stratify severity of illness based on clinical factors (e.g. intensive care status, ventilatory support, clinical laboratory data, radiologyrecords)
Measure: Patient Medical Records for Data Abstraction Time: Undefined for natural history studyDescription: to understand functional status, healthcare resource access and other sociodynamic factors as they affect the mitochondrial disease community.
Measure: Patient centered outcomes data via questionnaires Time: Undefined for natural history studyIntroduction: The SARS Co-2 contagious rate is high (Ro: 2.0-3.0). The infection is aggressive with high pathogenicity. Global confinement impacts all social and economic fields of human activity. Clinical behavior exceeds the capabilities of public health care. With the initial information on the pandemic, it is estimated that 20% of health personnel in direct contact with patients can acquire the disease, despite preventive self-care. The molecular relationship of COVID-19 with the subject's ACE2 protein encourages the virus to enter the host cell, and initiates replication and the immune response, causing an imbalance generating an immunological storm of cytokines, with serious damage to the host. Objective: It is proposed to supply a combined scheme of two compounds by oropharyngeal spray that capture the virus before entering the target cell and orally administer immunomodulatory compounds that regulate the inflammatory response released by the virus, in order to improve the antiviral response. Methodology: A controlled, parallel design, triple blind, phase II clinical trial will be conducted with four study groups to compare the active compounds (oropharyngeal spray and capsule) with placebo. Discussion: With the application of the combined scheme of two compounds, a 75% reduction in infection is expected in health providers in direct contact with COVID patients.
Description: Seroconversion of IgM for COVID-19. Result of positive IgM antibodies: A previously scheduled closure visit will be conducted, the trial product will be interrupted if a case is classified as severe-critical, and clinical follow up will be continued as planned. As protocols by the Health Ministry dictate, cases will be confirmed with a PCR-RT test, for the diagnosis of COVID-19. The result of the test will be requested to document the outcome.
Measure: Seroconversion of IgM for COVID-19. Time: 1 monthDescription: seroconversion of IgG
Measure: Seroconversion of IgG for COVID-19. Time: through study completion, 45 daysThe investigators hypothesize that the intake of Omni-Biotic® 10 AAD can reduce the duration of diarrhea in Covid-19 disease. The investigators further hypothesize that Omni-Biotic® 10 AAD can reduce stool frequency, improve stool consistency, improve other gastrointestinal symptoms of Covid-19, reduce disease duration and severity, reduce intestinal inflammation and can improve dysbiosis. The investigators aim to perform a randomized, double blind, placebo-controlled study using telemedicine in patients with Covid-19 disease.
Description: Duration of diarrhea (defined as days with 3 or more loose stools)
Measure: Diarrhea Time: 30 daysDescription: stool evacuations per days
Measure: Stool frequency Time: 30 daysDescription: Stool consistency according to Bristol stool scale for each evacuation, score 1-7, a higher score means a lower stool consistancy
Measure: Stool consistency Time: 30 daysDescription: presence of anorexia, nausea, vomiting, abdominal pain, bloating (yes/no)
Measure: Gastrointestinal symptoms Time: 30 daysDescription: days patients feel sick, are not able to work or are on sick leave
Measure: Duration of Covid-19 disease Time: 30 daysDescription: mild/moderate/severe
Measure: Severity of Covid-19 disease Time: 30 daysDescription: measured by ELISA
Measure: Stool Calprotectin Time: 30 daysDescription: measured by ELISA
Measure: Stool Zonulin Time: 30 daysDescription: 16S RNA sequencing
Measure: Microbiome composition Time: 30 daysStudy Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Measure: Ordinal Scale of COVID19 Disease Severity at 14 days Time: 14 daysDescription: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Measure: Incidence of Hospitalization Time: 14 daysDescription: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
Measure: Incidence of COVID-19 related Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who expire due to all causes.
Measure: Incidence of all-cause Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal Time: 14 daysDescription: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall symptom severity at 5 and 14 days Time: 5 and 14 daysDescription: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline Time: 14 daysThe present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.
Description: The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.
Measure: Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection Time: through study completion, an average of 1 yearDescription: To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.
Measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval Time: through study completion, an average of 1 yearIn light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel. The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.
Description: 30-day mortality
Measure: Mortality Time: up to 30 daysDescription: In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.
Measure: Level-of-care Time: up to 7 daysDescription: in days
Measure: In-hospital length of stay Time: Up to 30 daysDescription: in hours
Measure: Emergency department length of stay Time: Within 24 hoursDescription: Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.
Measure: Clinical correlation Time: Within 3 daysCovid 19 is a pandemic infection developed in late 2019
Description: The proper knowledge about covid-19
Measure: The number of pregnant women who have knowledge about covid-19 Time: one monthAs dentists begin reopening their practices during a global pandemic, the risk of COVID-19 infection that dentists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. The goal of the proposed study is to understand U.S.-based dentists' health and dental-practice reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These findings could be used to describe the prevalence and incidence of COVID-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
Description: COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen
Measure: COVID-19 probable or confirmed case Time: 18 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.
Measure: Anxiety Time: 12 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.
Measure: Depression Time: 12 monthsDescription: Self-reports of infection control efforts in the respondents' primary dental practices
Measure: Dental practice infection control efforts Time: 12 monthsDescription: Self-reports of personal protective equipment use
Measure: Dentists' use of personal protective equipment Time: 12 monthsSince the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in detecting signs of viral pneumonia has become clear from the literature. However, the increased patient flow creates an additional pressure on CT centers. We believe, the use of chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is not available. Lung MRI may be useful in routing a patient in a difficult epidemiological situation.
Description: Expected number - more than two zones
Measure: Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan Time: Upon completion, up to 1 yearPeople with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.
Description: Duration of clinical symptoms
Measure: Clinical course of SARS-CoV-2 infection in cancer patients. Time: 56 daysDescription: Severity of clinical symptoms
Measure: Clinical course of SARS-CoV-2 infection in cancer patients. Time: 56 daysDescription: Number of patients whose cancer treatment has been impacted by SARS-CoV-2
Measure: Clinical course of SARS-CoV-2 infection in cancer patients. Time: 56 daysDescription: Proportion of samples successfully processed and result obtained, with 95% confidence interval Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)
Measure: Feasibility of SARS-CoV-2 testing with a lateral flow assay. Time: 56 daysEvaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among elderly people. It is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course of the disease. They investigators did not find any study on a COVID + geriatric population reassessing carriage at 1 month even though age seems to be a risk factor for prolonged excretion as suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases. 2020 Apr 9; ciaa351
Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals with ESRD will reduce the rate and severity of infection with COVID-19.
Description: Number of subjects who become infected with COVID-19 over the course of the study
Measure: Reduction in documented infection with COVID-19 Reduction in infection with COVID-19 Time: 6 monthsDescription: Number of subjects who become hospitalized
Measure: Need for hospitalization Time: 6 monthsDescription: If subject becomes hospitalized, what length of time does the subject remain hospitalized
Measure: Hospital length of stay Time: 6 monthsDescription: Number of subjects who are entered into the ICU
Measure: Need for ICU admission Time: 6 monthsDescription: If subject is entered into the ICU, what length of time does the subject remain in the ICU
Measure: ICU length of stay Time: 6 monthsDescription: Number of subjects who require mechanical ventilation
Measure: Need for mechanical ventilation Time: 6 monthsDescription: If mechanical ventilation is required, what length of time the ventilation is required
Measure: Duration of mechanical ventilation Time: 6 monthsDescription: If subject becomes infected with COVID-19, how long does the subject require to recover from the infection
Measure: Recovery time from COVID-19 Time: 6 monthsDescription: Evaluation of whether any comorbidities are changed over the course of treatment (eg., worsening of congestive heart failure)
Measure: Change in any existing comorbidities or occurrence of newly diagnosed disease Time: 6 monthsDescription: Determination of whether there are more or fewer infections other than COVID-19 (other respiratory, urinary tract, cellulitis, etc.)
Measure: Incidence of non-COVID-19 infections Time: 6 monthsDescription: Evaluation of the levels of CD4 and CD8 subjects
Measure: Change in lymphocyte subsets (CD4, CD8) Time: 6 monthsDescription: Number of subjects who die during the course of the study
Measure: Mortality Time: 6 monthsDescription: Number of subjects with mild, moderate, or severe adverse events based on perceived clinical significance of the event
Measure: Treatment-emergent adverse events Time: 6 monthsDescription: Number of subjects with mild, moderate, or severe changes to vital signs based on perceived clinical significance of the event
Measure: Treatment-emergent changes in vital signs Time: 6 monthsDescription: Number of subjects with mild, moderate, or severe laboratory findings based on perceived clinical significance of the event
Measure: Treatment-emergent laboratory parameters Time: 6 monthsThis is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.
Description: number of positive serologies
Measure: positive serologies Time: 12 monthsIn December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
Description: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab after Intervention Initiation.
Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 days following interventionDescription: Viral load variation in the nasopharyngeal swab during treatment.
Measure: Viral load variation in the nasopharyngeal swab. Time: 7 days following intervention.Description: Variation of serum lymphocyte counts during treatment.
Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 days following intervention.Description: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab at the end of follow-up.
Measure: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 after intervention.Description: Proportion of patients with clinical improvement, defined as the time to normalize fever, respiratory rate and oxygen saturation and cough relief at the end of follow-up.
Measure: Proportion of patients with clinical improvement. Time: 7 after intervention.This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.
Description: Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
Measure: Outcome of pregnancy Time: Up to the deliveryDescription: Measure of antibodies in maternal serum at delivery
Measure: Prevalence of positive serology to SARS-CoV-2 at delivery Time: At the deliveryDescription: Measure the ratio of cord blood antibodies on maternal antibodies titers
Measure: Transplacental transfer of antibodies to SARS-CoV-2 Time: At the deliveryDescription: Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy
Measure: To characterize placental alterations related to SARS-CoV-2 infection Time: At the deliveryDescription: Measure of antibodies in cord blood and at the age of 1 month
Measure: To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life Time: Up to 1 month post deliveryDescription: Occurence of infectious disease, neurological development, growth
Measure: Clinical evolution of the children Time: Up to 3 yearsThe aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic . VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the "new corona virus" SARS-CoV 2.
This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.
Description: Comparison of adverse event rates between treatment arms
Measure: Adverse event rates Time: after first dose until day 28 of follow upDescription: comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm
Measure: Efficacy for shortening duration of SAR-CoV2 detection by PCR Time: weekly after treatment until 4th weekDescription: comparison of median duration for total antibody detection in each arm
Measure: Antibody detection rates Time: weekly after treatment until 4th week- This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases. - This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank. The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection. An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP). Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
Description: Decrease of hospital days of safety until discharge
Measure: Duration of hospitalization/Recovery status Time: 2-3 weeksBacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness. Front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees in Ontario.
Description: To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.
Measure: COVID-19 infection Time: 7 monthsDescription: Compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo
Measure: Incidence of hospitalization for COVID-19 Time: 7 monthsDescription: Compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with positive COVID-19 test treated with either VPM1002 or placebo
Measure: Incidence of ICU admission for COVID-19 Time: 7 monthsDescription: Compare the incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measure: Incidence of ARDS Time: 7 monthsDescription: Compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measure: Mechanical ventilation for COVID-19 Time: 7 monthsDescription: To compare the incidence of secondary infection in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measure: Secondary infection in COVID-19 Time: 7 monthsDescription: To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measure: COVID-19-related Mortality Time: 7 monthsDescription: Compare the incidence of deep vein thrombosis, pulmonary embolism, or stroke in participants with positive COVID-19 test treated with either VPM1002 or placebo.
Measure: Incidence of DVT Time: 7 monthsDescription: Compare the incidence of COVID-19 in participants who have received BCG vaccination previously.
Measure: Incidence of COVID-19 in Participants with Past BCG Vaccination Time: 7 monthsDescription: To measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin identified as potential biomarkers of COVID-19 infection using blood samples collected prior to the vaccination and at the end of the 7-month follow-up.
Measure: Measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin as biomarkers of COVID-19 Time: 7 monthsDescription: Adverse events following administration of VPM1002 when used for prevention of COVID-19.
Measure: Adverse events following BCG vaccine Time: 7 monthsDescription: Compare the priming of the innate trained immunity (i.e. induction of Th1 and Th17 responses to unrelated stimuli) to participants administered placebo.
Measure: Innate Trained Immunity Time: 7 monthsNote that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford. The primary objective of this study is to identify clinical and biochemical prognostic markers in adults with virologically confirmed COVID-19 who do not require oxygen supplementation, with a focus on: aiding safe discharge from a healthcare facility (i.e. a high NPV); near-term impact on COVID-19 interventions in resource-limited settings (i.e. simple clinico-demographic variables and biochemical markers for which near-patient / POCTs are commercially available or in late-stage development). The secondary objective of this study is to evaluate the field-based performance of near-patient lateral flow assays for suPAR and IL-6 in adults with non-severe SARS-CoV-2 infection
Description: Identify clinical and biochemical prognostic markers in adults with non-severe COVID-19. This is assessed through the ability of the markers to predict progression to subsequent supplemental oxygen requirement - sensitivity, specificity, NPV, PPV and AUROC, and discrimination (c-index) and calibration (plots of observed probabilities against predicted probabilities) of a prognostic model combining up to four markers.
Measure: Clinical and biochemical prognostic markers Time: 14 daysDescription: To evaluate the field-based performance of near-patient lateral flow assays for suPAR and IL-6 in adults with non-severe SARS-CoV-2 infection. This is assessed through looking at correlation of the near-patient lateral flow assays and the instrumented multi-analyte immunoassaygold standard.
Measure: Evaluate field-based performance of POC Time: 14 daysThis is a bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (COVID-19).
Description: A patient with a saturation of 90% or less despite the use of a reservoir mask without rebreathing with a flow of 7 liters per minute (FiO2 0.6 or higher), will be considered to have severe ARDS. These oximetric criteria have a close correlation with a PaO2 / FiO2 of 100 or less, which defines severe ARDS.
Measure: Proportion of patients developing severe ARDS. Time: 28 daysDescription: Defined as the time (in hours) from the start of the treatment under study to the normalization of temperature, normalization of respiratory rate and SpO2. Axillary temperature < 37.5ºC (oral < 37.2ºC) for 48 hours, without antipyretic treatment. Breathing rate < 24 rpm during the clinical evaluation and at least two consecutive daily evaluations (48 hours). SpO2 > 93% breathing ambient air during clinical assessment and at least two consecutive daily assessments (48 hours).
Measure: Differences in Time to Clinical Improvement Time: 28 daysDescription: The ordinal scale of 7 categories of patient health status ranges from: Death. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, with non-invasive ventilation or high flow oxygen devices. Hospitalized, requiring supplemental oxygen. Hospitalized, not requiring supplemental oxygen. Non-hospitalized, activity limitation. Non-hospitalized, no activity limitation.
Measure: Change in clinical status of subject on a 7-point ordinal scale. Time: 28 daysDescription: Classification according to the WHO toxicity scale
Measure: Proportion of patients developing adverse effects, serious adverse reactions, laboratory or physical examination findings, EKG abnormalities acquired during the trial, death and adverse events leading to early discontinuation of treatment. Time: 28 daysThe purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Description: WHO definition of "influenza-like illness" (ILI) [Fitzner 2018] or confirmed viral/bacterial respiratory infection AND Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
Measure: The rate of "flu-like illness" which includes: Time: 1 yearThe purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.
Description: Decrease from baseline in mean resting SpO2
Measure: Proportion of patients with clinical worsening Time: Day 1 to Day 14Description: Proportion of patients requiring hospitalization
Measure: Maximal severity of COVID-19 after treatment Time: Day 1 to Day 42In a case-series analysis, 9 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent. OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Patient sampling locations will include the nasopharynx and oropharynx. Operating room environmental locations will include areas in the patient care arena such as the anesthesia machine. Samples of each location will be obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet light and other infection control practices that are currently in place, such as utilization of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved vascular care. UV-C light for environmental cleaning is not regulated by the FDA. Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed for S. aureus as a process control. We will characterize the epidemiology of perioperative SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative infection control bundle and to serve as the platform for national dissemination of a perioperative COVID-19 defense strategy.
Description: Sars-CoV-2 transmission event
Measure: Perioperative transmission of SARS-CoV-2 Time: 24 hoursThis is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.
Description: Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.
Measure: To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity Time: 6 DaysDescription: Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control
Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection Time: 2, 4 and 6 daysDescription: Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.
Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection Time: 2, 4 and 6 daysDescription: Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms
Measure: To Measure the efficacy of NONI in prevention of progression of COVID-19 Time: 28 daysDescription: Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 & max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.
Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19 Time: 6 daysDescription: Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.
Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19 Time: 2, 4, 6, 14 and 28 daysDescription: Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.
Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19 Time: 2, 4, 6, 14 and 28 daysDescription: Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance
Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection Time: 14 daysDescription: Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.
Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection Time: 14 daysThis is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.
Description: The impact of the treatment on virological clearance (viral load) post-treatment
Measure: Clearance of viral load Time: 14 daysDescription: This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters
Measure: Safety of the treatment Time: 14 daysThe overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
Description: To assess the infusional toxicity
Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.
Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation
Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)
Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia Time: Day 28Description: To assess the clinical status (on a 7-point WHO ordinal scale)
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the duration of oxygen therapy and/or mechanical ventilation
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the length of stay at the intensive care unit and of hospitalization
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To assess the number of organ failures
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the intensity of the inflammatory response
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the evolution of coagulation parameter
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the presence of Biomarker of lung lesion, repair and scarring
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 28Description: To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To assess the pulmonary function
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).
Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy) Time: Day 90Description: To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations
Measure: To investigate immune modulation Time: Day 28Description: To assess the cytotoxic activity by MLR
Measure: To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro Time: Day 28This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.
Description: Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
Measure: Time to virological cure Time: 14 daysDescription: All adverse events definitely, probably or possibly related to study treatment.
Measure: Safety Time: 28 daysDescription: Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
Measure: Clinical improvement Time: 28 daysDescription: Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours
Measure: Clinical symptoms Time: 28 daysDescription: Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
Measure: Biomarkers Time: 28 daysIvermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Description: Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
Measure: Incidence of severe complications due COVID-19 infection Time: 28 daysDescription: Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%
Measure: Incidence of Severe Acute Respiratory Syndrome Time: 28 daysDescription: Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute
Measure: Incidence of Severe Acute Respiratory Syndrome Time: 28 daysDescription: Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)
Measure: Adverse events Time: 28 daysDescription: Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)
Measure: Adverse events Time: 28 daysDescription: Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)
Measure: Adverse events Time: 28 daysDescription: Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of > 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.
Measure: Adverse events Time: 28 daysDescription: Death of any cause since protocol enrollment
Measure: Overall survival Time: 28 daysAmong the distinctive features of Covid-19, numerous reports have stressed the importance of vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by apoptotic/stimulated cells are reliable markers of vascular damage released upon pro-inflammatory conditions and behave as active participants in the early steps of clot formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial cells.
Coronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The disease is highly infectious, and its main clinical symptoms include fever, dry cough, fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to the severe stage, which is characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction. After China, COVID-19 spread across the world and many governments implemented unprecedented measures like suspension of public transportation, the closing of public spaces, close management of communities, and isolation and care for infected people and suspected cases. The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May 2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle against COVID-19 is still continuing in Malaysia and all over the world. Due to the CMO and CMCO in the country, public and private universities have activated the e-learning mode for classes and as the government ordered, universities are closed and no face-to-face activities allowed. This has forced students of all disciplines including dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning mode. To guarantee the final success for fight against COVID-19, regardless of their education status, students' adherence to these control measures are essential, which is largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP theory. Once the restrictions are eased students have to come back and resume their clinical work in the campus. Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19 and the students preference for online learning.
Description: KAP towards COVID-19 was assessed using validated questionnnaire
Measure: Knowledge, Attitude, Practice of dental students towards COVID-19 Time: 4 monthsDescription: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire
Measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics Time: 4 monthsDescription: Preference towards online learning. was assessed using a standard questionnaire
Measure: Preference towards online learning. Time: 4 monthsThe study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.
Description: COVID-19 infection will be assessed by serological analysis of the presence of IgG anti-Covid-19 antibodies, an a subsequent pharyngeal swab. Symphtoms and possible hospitalization will be considered in clinical response.
Measure: Clinical response to COVID-19 Time: 36 monthsDescription: PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).
Measure: Immunological response to COVID-19 Time: 36 monthsDescription: Genetic variants analysis potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU
Measure: Genetic predisposition to COVID-19 Time: 36 monthsDescription: Microbiota analysis (using 16S rDNA sequencing technology) of residual BAL, pharyngeal swab, plasma and saliva/sputum to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection
Measure: Microbiome-related response to COVID-19 Time: 36 monthsPrimary Objective: - To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR - To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR - To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo
Description: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR (based on central lab test) and signs and symptoms (strict-term) of SARS-CoV-2 infection during the Efficacy assessment period (EAP) Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a RT-qPCR confirmed SARS-CoV-2 infection (either symptomatic or asymptomatic) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants with treatment-emergent adverse events (TEAEs) and severity of TEAEs Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection (broad term) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (strict term) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants who have a positive SARS-CoV-2 RT-qPCR and absence of signs and symptoms (broad term) during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days of symptomatic SARS-CoV-2 infection (strict-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days of symptomatic SARS-CoV-2 infection (broad-term) from the first day of the first sign or symptom until the last day of the last sign or symptom associated with the first positive SARS-CoV-2 RT-PCR that occurs during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Time-weighted average of viral shedding (log10 copies/mL) from the first positive SARS CoV-2 RT-qPCR Nasopharyngeal (NP) swab sample (with an onset during the EAP) until the visit within the window including 22 days after the positive test during the EAP Time: Up to 1 monthDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in Nasopharyngeal (NP) swab samples among individuals with ≥1 RT-qPCR positive that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Area under the curve (AUC) in viral shedding (log10 copies/mL) from the first positive SARS-CoV-2 RT-qPCR NP swab sample until the first confirmed negative test, that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Daily responsibilities including work (employed adults) or school (matriculating students), or family obligations/responsibilities (childcare or eldercare) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Number of days missed for daily responsibilities due to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Incidence of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Severity of symptomatic SARS-CoV-2 infection in seronegative and seropositive participants (based on central lab test) in both the EAP and follow-up periods Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline
Measure: Proportion of baseline seropositive subjects (based on central lab test) with TEAEs and severity of TEAEs Time: Up to 8 monthsDescription: Pharmacokinetic (PK) parameters may include, but are not limited to: - Maximum observed plasma concentration (Cmax) - Cmax/Dose - Time of maximum observed plasma concentration (tmax) - Time of Clast (tlast) - Last measurable plasma concentration (Clast) - Area under plasma concentration-time curve from time 0 to infinity (AUCinf) - AUCinf/Dose - Elimination half-life (t1/2) - Concentration in serum 28 days (C28) after dosing) Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Concentrations of REGN10933 in serum over time and selected PK parameters Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Concentrations of REGN10987 in serum over time and selected PK parameters Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933 over time Time: Up to 8 monthsDescription: Cohort A: SARS-CoV-2 RT-qPCR Negative at Baseline Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987 over time Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants who subsequently develop signs and symptoms (strict-term) of symptomatic SARS-CoV-2 infection during EAP Time: Within 14 and 28 days of a positive RT-qPCRDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants who subsequently develop signs and symptoms (broad-term) of symptomatic SARS-CoV-2 infection during EAP Time: Within 14 and 28 days of a positive RT-qPCRDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of symptomatic SARS CoV-2 infection (strict-term) Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of symptomatic SARS CoV-2 infection (broad-term) Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Time-weighted average change from baseline in viral shedding in NP swab samples until the visit within the window including day 23 Time: Until day 23Description: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Area under the curve (AUC) in viral shedding (log10 copies/mL) in NP swab samples until the first confirmed negative test Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Maximum SARS-CoV-2 RT-qPCR log10 viral copies/mL in NP swab samples Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of medically attended visits in emergency rooms or urgent care centers related to RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants requiring medically attended visits in emergency rooms or urgent care centers related to a RT-qPCR confirmed SARS CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days of hospital and intensive care unit (ICU) stay in participants hospitalized for a RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Daily responsibilities including work (employed adults) or school (matriculating students), or family obligations/responsibilities (childcare or eldercare) Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Number of days missed for daily responsibilities due to a RT-qPCR confirmed SARS-CoV-2 infection Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Proportion of participants with TEAEs and severity of TEAEs Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Incidence of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods Time: Up to 8 monthsDescription: Cohort B: SARS-CoV-2 RT-qPCR Positive at Baseline
Measure: Severity of symptomatic SARS-CoV-2 infection in both the EAP and follow-up periods Time: Up to 8 monthsThis survey is performed to examine if during the Covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics
Description: The conformity of the modalities of the decisions of limitations and therapeutic stops will be evaluated by a composite criterion defined by the simultaneous presence of the 3 main modalities imposed by the Clayes-Leonetti law to achieve a limitation that are : An outside consultant's opinion ( required if no advance directives), the caregiver collegial discussion or adherence to patient advance directives, notification of decision in the medical record
Measure: decisions of limitations and therapeutic stops Time: at the end of patient's hospitalization, an average of one monthDescription: notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT
Measure: Characteristics of the notification of LAT procedure Time: at the end of patient's hospitalization, an average of one monthDescription: number and status of caregivers who participated to the collegial discussion
Measure: Characteristics of the LAT procedure (persons who participated to the collegial discussion) Time: at the end of patient's hospitalization, an average of one monthDescription: formal elements of the consultant's reasoned opinion ( legal term) in the file
Measure: Characteristics of consultant's reasoned opinion for the LAT procedure Time: at the end of patient's hospitalization, an average of one monthDescription: formal elements of advance directives
Measure: Characteristics of the LAT procedure Time: at the end of patient's hospitalization, an average of one monthDescription: number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study
Measure: Characteristics of units Time: day 0Description: measured in year
Measure: Age of physicians Time: Day 0Description: male or female
Measure: gendrer of physicians Time: Day 0Description: Measured in year of experience
Measure: Exparience of physicians Time: Day 0Description: professional status
Measure: Characteristics of physicians Time: Day 0Description: measured in year
Measure: Age of patients Time: day 0Description: comorbidities
Measure: patient's history Time: day 0Description: COVID19 infection (yes or no)
Measure: COVID-19 patient's status Time: day 0Description: hospitalization reason
Measure: Characteristics of hospitalization's patients Time: day 0Description: organ failure
Measure: Characteristics of affected organ Time: day 0Description: severity score
Measure: Characteristics of patients Time: day 0Description: fate
Measure: final patient status Time: day 0Description: family presence or relatives
Measure: patient's environnement Time: day 0This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir with or without Dexamethasone.
Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
Measure: 1. Time (Hours) to recovery Time: [ Time Frame: 36 days ]Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications
Measure: Time fever resolution Time: [ Time Frame: 36 days ]The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.
Description: Incidence of subjects with COVID-19, defined by the presence of: Fever Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction. Positive test for SARS-COV-2 (PCR o serology)
Measure: Incidence of subjects with COVID-19 Time: 60 daysDescription: Incidence of severe COVID-19, defined by CURB > 2 and/or death
Measure: Severity of COVID-19 Time: 60 daysDescription: Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study
Measure: Seroconversion to SARS-CoV-2 Time: 60 daysDescription: Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
Measure: Subjects with symptoms Time: 60 daysDescription: The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19
Measure: Hospital admission due to COVID-19 Time: 60 daysDescription: The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19 • Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.
Measure: Admission to an intensive care unit due to COVID-19 Time: 60 daysDescription: Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
Measure: Elapsed time until hospitalization Time: 60 daysDescription: Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
Measure: Elapsed time until admission into an care unit for COVID-19 Time: 60 daysDescription: Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.
Measure: Elapsed time until death not related to COVID-19 Time: 60 daysThe overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.
Description: Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)
Measure: Acceptance of robotic telehealth system Time: Immediately after completion of triageDescription: Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)
Measure: Willingness to interact with robotic telehealth system Time: Immediately after completion of triageDescription: Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)
Measure: Satisfaction of interacting with a robotic telehealth system Time: Immediately after completion of triageDescription: Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)
Measure: Use of robotic system versus in-person triage Time: Immediately after completion of triageThe purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.
Description: % of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Measure: Documented cumulative incidence of SARS-CoV-2 infection Time: up to 4 monthsDescription: Number of days Documented as sick leave for SARS-CoV-2
Measure: Documented sick leave for SARS-CoV-2 Time: up to 4 months (cumulative)Description: Number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2
Measure: days off work due to the quarantine Time: up to 4 monthsDescription: Number of days in quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive Time: up to 4 monthsDescription: Number of days of self-reported fever (≥38 ºC)
Measure: Fever Time: Up to 4 monthsDescription: Cumulative incidence of self-reported acute respiratory symptoms
Measure: Cumulative incidence of self-reported acute respiratory symptoms Time: up to 4 monthsDescription: Number of days of self-reported acute respiratory symptoms
Measure: Number of days of self-reported acute respiratory symptoms Time: up to 4 monthsDescription: Number of participants with pneumonia confirmed by X-ray
Measure: Incidence of pneumonia Time: up to 4 monthsDescription: Cumulative incidence of death from documented SARS-CoV-2 infection
Measure: Cumulative incidence of death from documented SARS-CoV-2 infection Time: Up to 4 monthsDescription: Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Measure: Incidence of admission to ICU Time: Up to 4 monthsDescription: Number of days admitted to the ICU for documented SARS-CoV-2 infection
Measure: Days in IUC Time: Up to 4 monthsDescription: Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Measure: Incidence of mechanical ventilation Time: Up to 4 monthsDescription: Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Measure: Incidence of hospital admissions Time: Up to 4 monthsDescription: Number of days of hospitalization for documented SARS-CoV-2 infection
Measure: Days of hospitalization Time: Up to 4 monthsDescription: Levels of IgG
Measure: Levels of IgG Time: Up to 4 monthsDescription: Levels of IgM
Measure: Levels of IgM Time: Up to 4 monthsDescription: Levels of SARS-CoV-2 antibodies at the end of the study period
Measure: Levels of SARS-CoV-2 antibodies at the end of the study period Time: Up to 4 monthsDescription: All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection, as they will be collected as part of the associated symptoms
Measure: AEs Time: Up to 4 monthsDescription: All thoseAdverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.
Measure: SAEs Time: Up to 4 mothsThe purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
Description: % positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Measure: Documented cumulative incidence of SARS-CoV-2 infection Time: Up to 4 monthsDescription: Number of days of documented sick leave for SARS-CoV-2
Measure: Sick leave for SARS-CoV-2 Time: Up to 4 monthsDescription: The number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2
Measure: Days off work due to the quarantine Time: Up to 4 monthsDescription: Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive Time: Up to 4 monthsDescription: Number of MD, nursing, personnel management and services, etc.
Measure: Professional category Time: Up to 4 monthsDescription: Number of days of self-reported fever (≥38 ºC)
Measure: Fever Time: Up to 4 monthsDescription: Cumulative incidence of self-reported acute respiratory symptoms
Measure: Incidence of self-reported acute respiratory symptoms Time: Up to 4 monthsDescription: Number of days of self-reported acute respiratory symptoms
Measure: Days of self-reported acute respiratory symptoms Time: Up to 4 monthsDescription: Number of participants with pneumonia confirmed by X-ray
Measure: Incidence of pneumonia Time: Up to 4 monthsDescription: Cumulative incidence of death from documented SARS-CoV-2 infection
Measure: Incidence of death from SARS-CoV-2 infection Time: Up to 4 monthsDescription: Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Measure: Incidence of admissions to Intensive Care Unit (ICU) Time: Up to 4 monthsDescription: Number of days admitted to the ICU for documented SARS-CoV-2 infection
Measure: Days in ICU Time: Up to 4 monthsDescription: Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Measure: Incidence of mechanical ventilation Time: Up to 4 monthsDescription: Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Measure: Incidence of hospital admissions Time: Up to 4 monthsDescription: Number of days of hospitalization for documented SARS-CoV-2 infection
Measure: Days of hospitalization Time: Up to 4 monthsDescription: Incidence of SARS-CoV-2 antibodies at the end of the study period
Measure: Incidence of SARS-CoV-2 antibodies Time: Final visitDescription: Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
Measure: Types of antibodies detected Time: Final visitDescription: Levels of SARS-CoV-2 antibodies at the end of the study period
Measure: Levels of SARS-CoV-2 antibodies Time: Final visitDescription: All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection as part of the associated symptoms.
Measure: AEs Time: Up to 4 monthsDescription: All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.
Measure: SAEs Time: Up to 4 monthsThe research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease. During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods. In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.
Description: Antibiotic prescription modification following the FilmArray results as: No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation
Measure: Therapeutic decision Time: 24 h following the FilmArray resultsIn our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.
Description: Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.
Measure: Numeric Rating Scale for Pain Time: up to 10 weeksDescription: Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: up to 10 weeksDescription: Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.
Measure: SF-12 Health assesment Questionaire Time: up to 10 weeksApproximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.
Description: Transfer factor for carbon monoxide
Measure: TLCO Time: 3-5 days intervals (inpatients)Description: Transfer factor for carbon monoxide
Measure: TLCO Time: 1-6 months (outpatients, follow up)Description: frequency dependence of resistance as measured by oscillometry
Measure: D5-20 Time: 3-5 days intervals (inpatientsDescription: frequency dependence of resistance as measured by oscillometry
Measure: D5-20 Time: 1-6 months (outpatients, follow up)Description: forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
Measure: FEV1/FVC Time: 3-5 days intervals (inpatients)Description: forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
Measure: FEV1/FVC Time: 1-6 months (outpatients, follow up)Description: structured questionnaire
Measure: comorbidities Time: at hospital admission and each follow (every 1-6 months)Description: structured qualitative questionnaire
Measure: clinical symptoms Time: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)Description: validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations)
Measure: St. George's Respiratory Questionnaire total score Time: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
Description: The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
Measure: Hospitalization Rate Time: 10 DaysDescription: The time to symptoms resolution is defined as the time in days from therapies initiation to the first documented symptoms resolution as assessed by a local site. Patients whose symptoms are not resolved, or result in death, or lost follow-up on the designed follow-up date, will be censored on that date.
Measure: Time to symptoms resolution Time: 2 MonthsDescription: Overall survival (OS) will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.
Measure: Overall survival Time: 2 MonthsDescription: Univariate test will be performed in terms of identifying the association between exploratory objective and the hospitalization rate, Mantel-Haenszel test for categorical variables, and t-test or its non-parametric version for the continuous variables based on the normalized of the data.
Measure: Plasma product's cytokine level assessment Time: Day 0Description: Safety assessment will be performed on infusion day for the Treatment group (immediately post infusion), and for all patients on randomization day +3 and +7 days (by telephone, closest business day is acceptable), +2 weeks (+/- 3 days), +4 weeks (+/- 3 days).
Measure: Rates of adverse events associated with convalescent plasma infusion. Time: Day 3 and 7, Weeks 2 and 4Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients will be able to identify their treatments, but study staff will be blinded as to assignment.
Description: Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.
Measure: Change in severity of COVID-19 infection Time: 4 weeksDescription: Number of days with any symptom of anosmia
Measure: Number of days with any symptom of anosmia Time: 4 weeksDescription: Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). VAS scale from 0 to 100, with a higher score indicating a worse outcome.
Measure: Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). Time: 4 weeksDescription: Number of days where rescue medication is required
Measure: Number of days where rescue medication is required Time: 4 weeksPHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.
Description: The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.
Measure: Identification of baseline characteristics which correlate with disease severity Time: Based on clinical need - Up to 1 year follow up.Description: Relationship between changes in markers of inflammation (CRP, D dimer, ferritin, fibrinogen, pro-calcitonin) and pulmonary, renal and cardiac complications post hospitalisation for Covid-19 infection.
Measure: Identification of blood biomarkers which correlate with disease severity Time: Based on clinical need - Up to 1 year follow up.Description: Genomic, proteomic and transcriptomic analysis of blood samples to look for genetic susceptibility to severe disease presentations and to identify new biomarkers that predict disease severity or disease trajectory
Measure: Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations Time: Based on clinical need - Up to 1 year follow up.Description: Incidence of: Interstitial lung disease Pulmonary embolism Pulmonary hypertension as determined by pulmonary artery systolic pressure on echocardiogram or mean pulmonary artery pressure on right heart catheterisation if performed Renal dysfunction (as defined by new persistent impairment of egfr or new sustained protenuria measured using urinary protein-creatinine ratio) Cardiac dysfunction (new LV or RV systolic dysfunction on echocardiogram) Psychological distress as measured using Hospital anxiety and depression scale
Measure: Incidence Time: Based on clinical need - Up to 1 year follow up.Description: Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21
Measure: Change in respiratory symptom scores Time: Based on clinical need - Up to 1 year follow up.Description: Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.
Measure: Change in respiratory symptom scores Time: Based on clinical need - Up to 1 year follow up.Description: Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.
Measure: Change in frailty and quality of life scores Time: Based on clinical need - Up to 1 year follow up.Description: Assessed through the Clinical Frailty Scale: Scores range from 1-9.
Measure: Change in frailty and quality of life scores Time: Based on clinical need - Up to 1 year follow up.Description: D dimer/ fibrinogen and new pulmonary embolism
Measure: Relationship between serum markers and clinical outcomes Time: Based on clinical need - Up to 1 year follow up.Description: Troponin/ BNP and cardiac disease
Measure: Relationship between serum markers and clinical outcomes Time: Based on clinical need - Up to 1 year follow up.Description: Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities
Measure: Relationship between serum markers and clinical outcomes Time: Based on clinical need - Up to 1 year follow up.Description: Changes in health behaviours such as alcohol consumption and tobacco use Mental health and psychological wellbeing Factors affecting compliance with Public Health England guidelines The impact of cultural and religious beliefs on behaviours during the pandemic
Measure: Thematic analysis of semi-structured interviews exploring the following areas: Time: Up to 1 year follow up.This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied
Description: The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.
Measure: Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire Time: 3 monthsDescription: prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied
Measure: Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection Time: 3 monthsThis study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores Time: 6 monthsDescription: Time to non-infectivity as measured by PCR testing
Measure: Efficacy of Treatment by Time to Non-Infectivity Time: 10 daysDescription: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores Time: 6 monthsDescription: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. Time: 6 monthsDescription: Changes in blood parameters measured in a Complete Blood Count (CBC).
Measure: Safety of Dual Therapy as Measured by Complete Blood Count Time: 6 monthsDescription: Changes in blood parameters measured in a Complete Metabolic Panel.
Measure: Safety of Quadruple Therapy as Measured by Complete Blood Count Time: 6 monthsDescription: Changes in serum albumin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin Time: 6 monthsDescription: Changes in serum albumin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin Time: 6 monthsDescription: Changes in serum albumin/globulin ratio
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio Time: 6 monthsDescription: Changes in serum albumin/globulin ratio
Measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio Time: 6 monthsDescription: Changes in serum alkaline phosphatase levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase Time: 6 monthsDescription: Changes in serum alkaline phosphatase levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase Time: 6 monthsDescription: Changes in serum AST levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST Time: 6 monthsDescription: Changes in serum AST levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST Time: 6 monthsDescription: Changes in serum ALT levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT Time: 6 monthsDescription: Changes in serum ALT levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT Time: 6 monthsDescription: Changes in serum BUN/Creatinine Ratio
Measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio Time: 6 monthsDescription: Changes in serum BUN/Creatinine Ratio
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio Time: 6 monthsDescription: Changes in serum Blood Urea Nitrogen levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN Time: 6 monthsDescription: Changes in serum Blood Urea Nitrogen levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN Time: 6 monthsDescription: Changes in serum calcium levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium Time: 6 monthsDescription: Changes in serum calcium levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium Time: 6 monthsDescription: Changes in serum carbon dioxide levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide Time: 6 monthsDescription: Changes in serum carbon dioxide levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide Time: 6 monthsDescription: Changes in serum chloride levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride Time: 6 monthsDescription: Changes in serum chloride levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride Time: 6 monthsDescription: Changes in serum creatinine levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine Time: 6 monthsDescription: Changes in serum creatinine levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine Time: 6 monthsDescription: Changes in serum globulin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin Time: 6 monthsDescription: Changes in serum globulin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin Time: 6 monthsDescription: Changes in blood glucose levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose Time: 6 monthsDescription: Changes in blood glucose levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose Time: 6 monthsDescription: Changes in blood potassium levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium Time: 6 monthsDescription: Changes in blood potassium levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium Time: 6 monthsDescription: Changes in serum total bilirubin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin Time: 6 monthsDescription: Changes in serum total bilirubin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin Time: 6 monthsDescription: Changes in serum total protein levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein Time: 6 monthsDescription: Changes in serum total protein levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein Time: 6 monthsDescription: Presence or absence of treatment related serious adverse events Grade III or higher
Measure: Safety of Dual Therapy as Measured by Treatment Related SAE Time: 6 monthsDescription: Presence or absence of treatment related serious adverse events Grade III or higher
Measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE Time: 6 monthsCan Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people presenting for COVID-19 testing? NBT can be used to detect the substances present in a person's breath. In this study the breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large number of samples from people with COVID-19 (as confirmed by the standard swab test used by the NHS) will enable a breath profile to be produced, ie the substances present in the breath when someone has COVID-19. After the profile has been validated, NBT can be used to test whether or not a person has COVID-19 by seeing if their breath matches the profile. Using this technology for COVID-19 testing has advantages over the current standard test. The sample can be analysed immediately in the clinical setting and the results are available in 5-10 minutes, so if the person tests negative they can go back to their normal life straight away. The current swab test takes around 72 hours for the results to be available, and the person needs to self-isolate during this time in case they test positive, resulting in potentially unnecessary days of work missed and inconvenience. The breath test is non-invasive and is unlikely to cause any discomfort, as the person is only required to breath normally into the device. This study will also review the practicalities of using this test. It is quick and easy to train people in how to carry out the test, so it could potentially easily be rolled out to testing sites.
Description: This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile
Measure: To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms Time: 6 MonthsDescription: This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample using ML. These will be combined to provide a COVID-19 positive profile.
Measure: -To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML). Time: 6 monthsDescription: The patient samples that return COVID-19 negative will be used as controls for identification of VOCs and relative concentrations that are common to all samples.
Measure: To differentiate this unique profile from the patients that are found to be negative for COVID-19 Time: 6 monthsThis research is planned to illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection
Description: The duration from start of treatment to normalization of pyrexia, respiratory rate ,O2 saturation and relief of cough that is maintained for at least 72 hours.
Measure: Time to clinical recovery Time: 14-28 daysDescription: Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Measure: Viral clearance Time: 14 daysDescription: Evaluate the lung extension of pneumonia at day 14
Measure: radiological lung extension Time: 14 daysDescription: incidence and type of adverse events
Measure: drug adverse events Time: 28 daysDescription: number of deaths to total number of patients
Measure: 28 day mortality Time: 28 dayDescription: deteriorated patients who need admission to intensive care unit
Measure: intensive care unit (ICU) admission rate Time: 28 daysDescription: duration from hospitalization to discharge
Measure: Duration of hospital stay Time: 28 daysEvaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.
Description: Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo. Extraction of genomic material will be performed using a QIAgen mini kit (QIAmp viral RNA) validated by the CDC (United States Center for Disease Control and Prevention (https://www.fda.gov/media/134922/download) (CDC-006-00019) Viral load will be quantified with the following detection kits: Commercial Kit: PCR-EUA-CDC-nCoV-IFU. Commercial KIT SENTINEL - STAT-NAT Covid 19B (Berlín). Rational: In mild cases of COVID-19, 50% of the patients eradicated the virus within a period of 3 weeks, 25% eradicated the virus before the 13th day, 75% during the first month and the rest were " late eradicators." This latter subgroup of patients has been associated with severe cases of COVID-19 disease.
Measure: Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th. Time: 7 dayDescription: Consequently, in mild cases, viral eradication will likely occur more frequently during the first to second week of COVID-19 disease; less than 15% could eradicate the virus during the first week of symptom onset. From an epidemiological point of view, increasing the viral eradication rate from less than 15% to more than 35% during the first two weeks of treatment would be clinically relevant.(seven), 14 (fourteen) and 35 (thirty-five) after starting treatment compared to the baseline measurement.
Measure: Comparative decrease of the viral load Time: 3 - 35 daysDescription: Clinical improvement according to the WHO COVID-19 ordinal scale. Minimun 0 (zero), (best), maximum 8 (eight) (worst)
Measure: Clinical improvement Time: 1 - 35 daysDescription: Percentage of pneumonia patients meeting severity criteria.
Measure: Pneumonia patients meeting severity criteria. Time: 1 - 35 daysDescription: Number of days with fever (axillary temperature higher than 37.5°C).
Measure: Number of days with fever Time: 1 - 35 daysDescription: Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.
Measure: Patients requiring mechanical ventilation Time: 1 - 35 daysDescription: Mortality rate.
Measure: Mortality rate. Time: 1- 35 daysDescription: Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).
Measure: Lymphocyte recovery Time: 7 dayDescription: Days of ICU hospitalization.
Measure: ICU hospitalization. Time: 1 - 35 daysDescription: Oxygen saturation (SpO2) > 92% (at ambient FiO2).
Measure: Oxygen saturation Time: 1 - 35 daysDescription: Days of hospitalization
Measure: Days of hospitalization Time: 1 - 35 daysDescription: Respiratory rate per minute (in afebrile state conditions).
Measure: Respiratory rate Time: 1 - 35 daysIn recent months, a new coronavirus, SARS-CoV-2, has been identified as the cause of a serious lung infection named COVID-19 by the World Health Organization. This virus has spread rapidly among the nations of the world and it is the cause of a pandemic and a global health emergency. There is still very little scientific evidence on the virus, however epidemiological data suggest that one of the most frequent comorbidities is diabetes, along with hypertension and heart disease. There is no scientific evidence on the possible effects of this infection on the function of the β cell and on glycemic control. Clinical evidence seems to suggest that COVID-19 infection mostly affects the respiratory system, and an acute worsening of glycemic compensation is not described as generally observed in bacterial pneumonia. However, previous work on acute respiratory syndromes (SARS) caused by similar coronaviruses, had described that the infection has multi-organ involvement related to the expression of the SARS coronavirus receptor, the angiotensin 2 converting enzyme, in different organs, especially at the level of endocrine pancreatic tissue. In the population of this previous work, glucose intolerance and fasting hyperglycaemia have been described and in 37 of 39 diabetic patients examined, a remission of diabetes was observed three years after the infection. It is possible that the coronaviruses responsible for SARS may enter the pancreatic islets using the angiotensin 2 converting enzyme receptor, expressed at the level of the endocrine pancreas, thus causing diabetes. Additionally, previous literature on coronavirus infections (SARS and MERS or Middle-East Respiratory Syndrome) suggested that diabetes could worsen the evolution of the disease. In particular, in case of Middle-East Respiratory Syndrome-CoV infection, diabetic mice had a more prolonged serious illness and a delay in recovery regardless of the viremic titer. This could probably be due to a dysregulation of the immune response, which results in more serious and prolonged lung disease. There are currently no data on pancreatic beta cell function in patients with COVID-19.
Description: Difference in insulin levels during and after COVID-19 infection and compared to patients in the control group
Measure: Serum β - cellular function index insulin levels Time: 12 monthsDescription: Difference in C-peptide levels during and after COVID-19 infection and compared to patients in the control group
Measure: Serum β - cellular function index C-peptide levels Time: 12 monthsDescription: Difference in HOMA-β index during and after COVID-19 infection and compared to patients in the control group
Measure: Serum β - cellular function HOMA-β index Time: 12 monthsDescription: Difference in pro-insulin/insulin ratio during and after COVID-19 infection and compared to patients in the control group
Measure: Serum β - cellular function pro-insulin/insulin ratio Time: 12 monthsDescription: Check for the existence of damage to the beta cell function induced by COVID-19 infection, clinically observable with changes in the secretory response of insulin
Measure: Evaluation of the secretory response of insulin to the arginine stimulation test Time: 12 monthsDescription: Presence of SARS-CoV-2 viral particles in β cells in COVID-19 patient samples
Measure: Viral SARS-CoV-2 particles in β cells Time: 12 monthsDescription: Evidence of impairment of β cell function in the serum of COVID-19 patients
Measure: Percentage of patients with preserved β cells function Time: 12 monthsDescription: Changes in glucose values in COVID-19 patients and healthy volunteers
Measure: Glucose values Time: 12 monthsDescription: Changes in the values of continuous glucose monitoring in both COVID-19 patients and healthy volunteers
Measure: Values of continuous glucose monitoring Time: 12 monthsDescription: Comparison of interleukin 1-β levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker interleukin 1-β Time: 12 monthsDescription: Comparison of interleukin IL-2 levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker interleukin IL-2 Time: 12 monthsDescription: Comparison of interleukin IL-6 levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker interleukin IL-6 Time: 12 monthsDescription: Comparison of interleukin IL-7 levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker interleukin IL-7 Time: 12 monthsDescription: Comparison of interleukin IL-10 levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker interleukin IL-10 Time: 12 monthsDescription: Comparison of interleukin tumor necrosis factor-α levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker tumor necrosis factor-α Time: 12 monthsDescription: Comparison of interferon gamma levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker interferon gamma Time: 12 monthsDescription: Comparison of macrophage inflammatory protein-1β levels in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker macrophage inflammatory protein-1β Time: 12 monthsDescription: Comparison of macrophage inflammatory monocyte chemoattractant protein-1 in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker monocyte chemoattractant protein-1 Time: 12 monthsDescription: Comparison of macrophage inflammatory granulocyte-macrophage colony-stimulating factor in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker granulocyte-macrophage colony-stimulating factor Time: 12 monthsDescription: Comparison of macrophage inflammatory granulocyte colony-stimulating factor in COVID-19 patients compared with healthy subjects
Measure: Changes in the inflammatory marker granulocyte colony-stimulating factor Time: 12 monthsThe objective of the study is to determine the percentage of past SARS-CoV-2 infections in hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in Badalona Serveis Assistencials de Badalona.
Description: Number of participants with past SARS-CoV-2 infection
Measure: Number of participants with past SARS-CoV-2 infection Time: Day 0Description: Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection
Measure: Number of infections in health personnel who have taken voluntary hydroxychloroquine as a prevention strategy for COVID-19 infection Time: Day 0Description: Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19.
Measure: Number of infections in health personnel based on the degree of exposure to patients infected with COVID-19. Time: Day 0Description: Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category.
Measure: Number of infected participants who are active smokers and/or have chronic lung disease and/ or have history of hypertension.Relationship of degree of exposure to participants infected with SARS-CoV-2 admitted to the hospital.Professional category. Time: Day 0Description: Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment.
Measure: Number of participants infected with SARS-CoV-2 that presented symptoms and their grade. Number of participants infected with SARS-CoV-2 who required hospitalization. Number of participants infected with SARS-CoV-2 who received treatment. Time: Day 0Description: Number of family members infected from each participant with SARS-CoV-2 infection
Measure: Number of family members infected from each participant with SARS-CoV-2 infection Time: Day 0A key strategy in the treatment of COVID-19 would be to find an effective antiviral agent that would decrease the peak viral load and, consequently, the associated degree of immunopathological damage that follows this phase. The clinically approved substances considered for this study are used for treatment of other virus diseases, like HIV (atazanavir) and HCV (sofosbuvir and daclatasvir). Severe progression of COVID-19 among patients under treatment for these aforementioned viruses is empirical less common. Besides, the clinical rationale, there are pre-clinical evidence pointing out that patients with COVID-19 could benefit from treatments with atazanavir, sofosbuvir and daclatasvir.
Description: Change in the slope of the SARS-COV 2 log viral load evaluated by nasopharyngeal swab samples assessed at baseline and days 3, 6 and 9 after randomization (isolated antiviral).
Measure: Phase II first step: Change in area under the curve of SARS-COV 2 viral load Time: days 3, 6 and 9 after randomizationDescription: Change in the slope of the SARS-COV 2 log viral load curve evaluated by nasopharyngeal swab samples assessed at baseline and days 3, 6 and 9 after randomization (combined antiviral).
Measure: Phase II second step: Change in area under the curve of SARS-COV 2 viral load Time: days 3, 6 and 9 after randomizationDescription: Number of days without oxygen, non-invasive ventilation/high flow nasal cannula or need for mechanical ventilation in 15 days.
Measure: Phase III: Number of free days from respiratory support Time: 15 daysCoronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.
Description: Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.
Measure: Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women. Time: From the start of the study up until one month prior to study end.Description: Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.
Measure: Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women. Time: From the start of the study up until one month prior to study end.Description: Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.
Measure: Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women. Time: From the start of the study up until one month prior to study end.Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de Paris and in staff working in these centers during COVID-19 epidemic.
Description: Primary objective is to evaluate SARS-COV2 seroprevalence in people hosted and health care workers of 3 centers of Samusocial de Paris where COVID19 epidemics occured
Measure: SARS-COV-2 seroprevalence in 3 centers for homeless and people in social distress Time: 6 monthsDescription: Measure of morbidity in the participating population in the 3 centers
Measure: Morbidity rate Time: 6 monthsDescription: Number of deaths related to Covid-19 during the epidemic in the 3 centers
Measure: Covid-19 related death rate in the 3 centers from March to May 2020 Time: 6 monthsClinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19. Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.
Description: After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs. Data will describe the range of each cell population across participants.
Measure: Cellular immune system profiling Time: Up to 20 daysDescription: Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping. Data will report the antiviral phenotypic characteristics of these cells.
Measure: Innate immune system profiling Time: Up to 100 daysDescription: Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells. These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.
Measure: Expansion of virus-specific innate immune cells Time: Up to 100 daysThe purpose of this epidemiologic study is to estimate the prevalence and incidence of anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also estimate the risk of SARS-CoV-2 exposure in target population.
Description: Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.
Measure: Prevalence of Symptomatic Infection Time: 1 yearDescription: Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.
Measure: Prevalence of Subclinical Infection Time: 1 yearThe purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.
Description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.
Measure: can or can't fell bitterness Time: Immediately after spray testThis study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.
Description: asymptomatic seroconversion for SARS-CoV-2
Measure: Seroconversion Time: 24 weeksDescription: asymptomatic seroconversion for SARS-CoV-2
Measure: Interim analysis - seropositivity at 12 weeks Time: 12 weeksDescription: Sensitivity and specificity of dried blood spot assay compared with venous blood serology
Measure: Dried Blood Spot performance Time: 24 weeksDescription: Sensitivity and specificity of salivary IgA compared with venous blood serology
Measure: Salivary IgA performance Time: 24 weeksDescription: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
Measure: Prevalence of SARS-CoV-2 Time: 24 weeksDescription: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time
Measure: Change in seropositivity Time: 24 weeksDescription: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity
Measure: Change in seroconversion rate Time: 24 weeksThis study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.
Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.
Measure: Difference in Th2 Sputum Markers Time: Day 1Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.
Measure: Other markers of fungal inflammation and allergic reaction in patients with CF Time: Day 1Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.
Measure: Biobanking of specimens Time: Day 1The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.
Measure: Survival without needs of ventilator utilization at day 14 Time: day 14Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at day 7 and 14 Time: day 7 and day 14Description: Overall survival
Measure: Overall survival at 14, 28, 60 and 90 days Time: 14, 28, 60 and 90 daysDescription: Cumulative incidence of discharge alive
Measure: Cumulative incidence of discharge alive at 14 and 28 days Time: 14 and 28 daysDescription: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of mechanical ventilation at day 1 Time: day 1Description: Cumulative incidence of oxygen supply independency
Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days Time: 14 and 28 daysTo detect microbial infection and AMR associated with COVID 19 infection. To correlate risk factors of COVID 19 patients with microbial infections and their effects on disease.
Description: The correlation between microbial infection and COVID 19 infection and their effect on prognosis and disease outcome.
Measure: Microbial infections and antimicrobial resistance (AMR) patterns associated with hospitalized patients with 2019 novel coronavirus disease (COVID 19) Time: baselineThe clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.
Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to Day 30 Follow-up AssessmentDescription: This will be assessed at various time points by clinical laboratory tests and vital signs.
Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities Time: First dose date up to Day 30 Follow-up AssessmentDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 7 daysThere is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.
Description: Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.
Measure: Rate of patients with positive anti-COVID19 serology Time: Day 1Description: Rate of patients with symptomatic or severe (hospitalization) form of infection.
Measure: Rate of patients with symptomatic or severe (hospitalization) form of infection Time: Day 1The pandemic of a new coronavirus SARS-COV-2, which causes COVID-19 disease, has spread rapidly and is a major public health challenge. While the focus is primarily on containing the number of cases and finding alternative therapies, information is still lacking to elucidate the dynamics of viral circulation and to understand the distribution of the infection in the population. The cases reported in Argentina and worldwide could plausibly represent only a small proportion of the number of asymptomatic or poorly symptomatic cases that exist in society. However, the magnitude of this dissociation between symptomatic cases and asymptomatic persons is unknown. Knowing this information is of strategic importance as it will allow the estimation of a community prevalence and the evaluation of the best containment strategy. In fact, although all social distancing measures are now indispensable, the feasibility of prolonging the measure over time is a complex issue and in any case will require population-based information. The best way to approach the estimation of a true population prevalence is to take representative samples from the population and test them periodically. These experiences were carried out in other contexts showing heterogeneous results within the community studied. In Spain, for example, the range of antibodies present in the population varied from 1.1% to 14.2%, also showing that an important part of the population had had contact with the virus without symptoms. Studies in Switzerland and the United States also show similar findings. However, these estimates are not automatically transferable to other settings. The city of Buenos Aires has a particular demographic composition with an important group of the population living in shantytowns (it is estimated that between 7% and 10% of the population lives in shantytowns) and with much heterogeneity among the different communes of the city. In the villas, the incidence rates of COVID-19 infection differ significantly from those present in the group "outside the village". However, there is also an important difference in the incidence rates by commune, even without considering the villas. Thus, it is important to know the sero-epidemiology of antibodies against SARS-COV2 in a representative sample of the city of Buenos Aires. For this purpose, a nationally produced test (COVIDAR IgG) developed by professionals from CONICET and Instituto Leloir will be used. The aim of this initiative is to estimate the true dimension of the COVID-19 epidemic in the City of Buenos Aires, by studying the immunological status of the Buenos Aires population in relation to SARS-Cov2, as well as to observe the evolution of the infection among the population, since this information is essential to guide future public health measures related to the control of COVID-19. To achieve this objective, a comprehensive sero-epidemiological study will be carried out to provide estimates of past SARS-Cov2 infection with sufficient precision to be representative of the sero-epidemiological status of the Buenos Aires city population.
Description: To estimate the prevalence of SARS-Cov2 infection in the city of Buenos Aires, by means of the determination of IGG-type antibodies in a representative and randomized sample of adult residents of the city.
Measure: Prevalence of IGG for COVID-19 Time: 4 monthsThe purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.
Description: metabolite of vitamin D
Measure: Change in total circulating 25(OH)D concentration Time: monthly in COVID-19 negative participants through study completion for 1 yearDescription: metabolite of vitamin D
Measure: Change in total circulating 25(OH)D concentration in COVID-19 positives Time: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participantsDescription: The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.
Measure: Change in SARS-CoV-2 antibody titers Time: every 3 months up to 12 monthsDescription: At baseline, 3, 6, 9 and 12 months, inflammatory cytokines will be measured in participant plasma samples. Cytokines to be measured are Interferon-gamma (IFN-g), Interleukin-1beta (IL-1B), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13, and Tumor Necrosis Factor-alpha (TNFa). Values of these cytokines at baseline will compared to those at 3, 6, 9, and 12 months
Measure: Change in inflammatory cytokine concentration (10 cytokine panel Elisa: Interferon (INF)-gamma, Interleukin (IL)-1beta, IL-2, IL-3, IL-4, IL-6, IL-8, IL-10, IL-13, Tumor Necrosis Factor (TNF)-alpha Time: baseline and every 3 months up to 12 monthsDescription: COVID-19 positive participants or if COVID-19 negatives develop respiratory symptoms will complete this respiratory survey daily for 2 weeks
Measure: Respiratory symptoms Time: daily for 2 weeksDescription: Inventory of signs and symptoms of rhino/sinusitis. These signs include sneezing, running nose, cough, dizziness, fatigue, and sense of smell. Each sign is rated on a scale of 0 to 5, with 0 indicating not problem, for instance 1 indicating mild problem, 4 indicating severe problem and 5 indicating problem as bad as it can be.
Measure: Signs and symptoms of rhino/sinusitis Time: Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positivesDescription: Dietary intake assessment
Measure: NCI Dietary Intake Time: baseline then at 6 and 12 monthsDescription: Survey of participant health problems
Measure: Charlson Comorbidity survey Time: baseline then at 6 and 12 monthsDescription: Assessment of physical activity of each participant
Measure: Paffenberger Physical Activity Assessment Time: Baseline then at 6 and 12 monthsDescription: Each participant will complete the Perceived Stress Scale Questionnaire (PSS) to assess their perceived stress. Assessments are base on a scale of 0 to 4, with 0 indicating "never" and 4 indicating "very often"
Measure: Perceived stress Time: monthly for 1 yearDescription: Each participant will complete the and Pandemic Stress Index Questionnaire (PSI) to assess their perceived stress cause by the pandemic. Assessments are base on a scale of 0 to 6, with 0 indicating "not at all" and 5 indicating "extremely," and 6 indicating "decline to answer."
Measure: Pandemic stress Time: monthly for 1 yearDescription: Personality characteristics of each participant
Measure: NEO-Personality Inventory Time: baseline visitDescription: A health assessment will be completed by each participant monthly for 1year. This health. This is for information on health status only and not for comparative assessment.
Measure: GrassrootsHealth Monthly Health assessment Time: baseline, 6, and 12 monthsIn this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Description: Time to negative RT-PRC result indicating that patient is no longer infective
Measure: Time to Non-Infectivity by RT-PCR Time: 6 monthsDescription: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) Time: 6 monthsDescription: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) Time: 6 monthsDescription: Patients will have serum stored for titer testing to compare antibody levels over time
Measure: Efficacy of Treatment as measured by Titer Time: 6 monthsDescription: Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Measure: Efficacy of Treatment as measured by RT-PCR Time: 10 daysDescription: Blood D-Dimer levels
Measure: Safety of Treatment as Measured by D-Dimer Time: 6 MonthsDescription: Blood Pro-Calcitonin levels
Measure: Safety of Treatment as Measured by Pro-Calcitonin Time: 6 MonthsDescription: Blood CRP levels
Measure: Safety of Treatment as Measured by C-Reactive Protein Time: 6 MonthsDescription: Blood ferritin levels
Measure: Safety of Treatment as Measured by Ferritin Time: 6 MonthsDescription: Blood enzyme levels
Measure: Safety of Treatment as Measured by Liver Enzymes Time: 6 MonthsDescription: CBC
Measure: Safety of Treatment as Measured by Complete Blood Count Time: 6 MonthsDescription: Blood electrolytes
Measure: Safety of Treatment as Measured by Electrolyte Levels Time: 6 MonthsDescription: Presence or absence of Grade 3 or high treatment related adverse events
Measure: Safety of Treatment as Measured by Treatment Related Adverse Events Time: 6 monthsThe objective of this study is to detect the evidence on the immune response following acute SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after infection for both symptomatic and asymptomatic patients.
Description: it's expected to have COVID-19 antibodies within 1month of infection the antibody titre expected to rise the fall to a lower levels
Measure: rising titre of IGg antibodies Time: first monthThe study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
Description: Qualitative method validation: qualitative result of the ELISA (Patient does / does not have immunity) as the gold standard compared to the POC using univariate measures to derive sensitivity and specificity of the POC.
Measure: Qualitative method validation (yes/ no) Time: at baselineDescription: Quantitative method validation: antibody concentration from the ELISA are related to the dichotomous result from POC.
Measure: Quantitative method validation (antibody concentrations) Time: at baselineDescription: Antibody and T cell repertoires and transcriptional profiles of cells will be used to identify potential antibody and T cell clones correlated with COVID-19 protection.
Measure: Immune cell repertoire sequencing Time: at baselineAn International Multi-Centre Randomised Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients Diagnosed with SARS-CoV-2 Infection (COVID-19).
Description: Morbidity
Measure: Proportion of participants alive and not having required new intensive respiratory support (invasive or non-invasive ventilation) or vasopressors/inotropic support in the 28 days after randomisation. Time: 28 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: World Health Organization (WHO) 7-point outcome scale (clinician assessed) Time: 28 daysDescription: All cause mortality
Measure: Mortality Time: 7, 15, 28, and 90 daysDescription: Number of days
Measure: Time to death Time: 90 daysDescription: Number of days
Measure: Length of hospital stay Time: 90 daysDescription: Yes/No
Measure: Receipt of invasive or non-invasive ventilation Time: 28 daysDescription: Number of days
Measure: Length of receipt of invasive or non-invasive ventilation Time: 28 daysDescription: Number of days
Measure: Length of intensive care unit (ICU) stay Time: 90 daysDescription: Yes/No
Measure: Presence of chest infiltrates on chest x-ray (CXR) or CT Time: 3 and 7 daysDescription: Number of days
Measure: Time to defervescence from randomisation Time: 28 daysDescription: C-reactive protein (CRP) and Lactate dehydrogenase (LDH) and D-dimer
Measure: Biomarker levels Time: 28 daysDescription: number of days of use in first 10 days
Measure: Antibiotic use Time: 10 daysDescription: Recording of the following adverse events: Diarrhoea, Nausea, Vomiting, Pancreatitis, QTc prolongation (>500ms) 24 hours, serious allergic reaction or anaphylaxis, transfusion-related acute lung injury, transfusion-associated circulatory overload
Measure: Adverse Events Time: 10 daysDescription: Yes/No
Measure: Serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death in hospital Time: 28 daysDescription: Yes/No - based on the modified Kidney Disease Improving Global Outcomes (KDIGO) criteria; serum creatinine increase by≥ 26.5mol/L within 48 hours OR to ≥1.5 times baseline, known or presumed to have occurred within the prior 7 days
Measure: Acute Kidney Injury (AKI) Time: 28 daysDescription: Confirmed deep vein thrombosis, pulmonary embolus, ischemic cerebrovascular event, acute myocardial infarction or other thrombotic event during index hospitalisation.
Measure: Thrombotic events Time: 28 daysDescription: Proportion of patients with negative SARS-CoV-2 real time - polymerase chain reaction (RT-PCR) at day 3 and day 7 from upper or lower respiratory tract samples.
Measure: Viral clearance Time: 3 and 7 daysThe study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.
Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement
Measure: WHO Ordinal Scale Time: 30 daysDescription: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Measure: Degree of supplemental oxygen Time: 30 daysDescription: Peripheral oxygen saturation measured by pulse oximetry
Measure: Peripheral Oxygen Saturation (SpO2) Time: 30 daysThe study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.
Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement
Measure: WHO Ordinal Scale Time: 30 daysDescription: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Measure: Degree of supplemental oxygen Time: 30 daysDescription: Peripheral oxygen saturation measured by pulse oximetry
Measure: Peripheral Oxygen Saturation (SpO2) Time: 30 daysAs of 27th May 2020, approximately 5.7 million people worldwide are known to have been infected with COVID-19 coronavirus and more than 350,000 have died (1). The severity of this viral disease for an individual is associated with a widespread perturbation of immune, physiological and metabolic parameters (2, 3). These whole body changes could be considered characteristic of a systemic inflammatory response to tissue injury and it has been long recognised that a large and ongoing systemic inflammatory response is associated with the development of multiple organ failure and infective disease (4, 5). One of the cardinal signs of severe COVID-19 infection is a marked systemic inflammatory response (2). This response bears striking similarity to the systemic inflammatory response experienced by patients undergoing major elective surgical resections for cancer (6, 7). Indeed, the systemic inflammatory response and the associated metabolic stress has been most well characterised in major elective surgery, where the relationship between the magnitude of the post-operative systemic inflammatory response and the development of post-operative complications is now well recognised, as is the effect of patient comorbidity on this relationship (8, 9). Such work has informed therapeutic manoeuvres including minimally invasive surgery, pre-operative optimisation (e.g. anaesthesia, nutrition and steroids) and enhanced recovery protocols. The aim of the present study was to examine whether routinely collected clinicopathological characteristics of patients with COVID-19 on admission were informative on the immune and metabolic stress experienced by patients with COVID-19 and whether such characteristics were informative on subsequent outcome.
Description: 30-day mortality and prognostic score
Measure: mortality Time: 30-dayThis study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.
Description: hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection
Measure: hematological findings Time: at time of admissionDescription: proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices
Measure: clinical presentations Time: at time of admissionIt is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia. After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.
Description: Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air
Measure: Time to recovery (free of respiratory failure) Time: Day 28Description: Evaluation of CD4 and CD8 levels
Measure: Lymphopenia Time: Day 14Description: Percentage of subjects still alive
Measure: Survival Time: Day 28Description: Length of time before hospital discharge
Measure: Hospital length of stay Time: Day 28Description: Number of subjects that require high flow oxygen
Measure: Requirement for high flow oxygen supplementation Time: Day 28Description: Number of days that each subject requires high flow oxygen
Measure: Duration of high flow oxygen supplementation Time: Day 28Description: Number of subjects that are admitted to the ICU
Measure: ICU admission Time: Day 28Description: Number of days that each subject remains in the ICU
Measure: ICU length of stay Time: Day 28Description: Number of subjects that require mechanical ventilation
Measure: Mechanical ventilation Time: Day 28Description: Number of days that each subject requires the mechanical ventilation
Measure: Duration of mechanical ventilation Time: Day 28Description: Number of subjects that have decreases or increases in comorbidities existing at time of enrollment
Measure: Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease Time: Day 28Description: Number of subjects who get infections other than COVID-19
Measure: Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.) Time: Day 28Description: Adverse events and serious adverse events experienced by the subjects
Measure: AEs/SAEs Time: Day 60Description: Mild, moderate, or severe changes to vital signs (heart rate, blood pressure, temperature, number of respirations per minute) based on perceived clinical significance of the change
Measure: Changes to vital signs Time: Day 28Description: Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change
Measure: Changes in laboratory parameters Time: Day 28Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
Description: Pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
Measure: Change from baseline to the lowest S/F oxygen ratio Time: 14 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Measure: Change in S/F Ratio Time: 14 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Measure: Percentage change in S/F Ratio Time: 14 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42
Measure: Percentage of participants at each level on the WHO OSCI score Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42
Measure: Percentage of participants with shifts from each level of the WHO OSCI score at baseline Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42
Measure: Percentage of participants remaining at their baseline score on the WHO OSCI (or lower) Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day
Measure: Percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).
Measure: The time in days spent at each participant's worst reported WHO OSCI score (excluding death). Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.
Measure: Intubation and mechanical-ventilation free survival Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause
Measure: Overall survival Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy
Measure: Number of days requiring oxygen therapy Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C
Measure: Number of days with pyrexia Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
Measure: Maximum daily temperature Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels
Measure: SpO2 level Time: 42 daysDescription: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.
Measure: Time to discharge Time: 42 daysDescription: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.
Measure: Time to oxygen saturation (SpO2) ≥94% Time: 42 daysDescription: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.
Measure: Time to recovery Time: 42 daysDescription: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness and relationship to treatment
Measure: Number of participants experiencing AEs by seriousness and relationship to treatment Time: 42 daysDescription: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters
Measure: Incidence of clinically significant abnormal lab parameters Time: 42 daysThis randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.
Description: Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.
Measure: Arterial Oxygenation Time: One hour after sildenafil administrationDescription: Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.
Measure: Arterial Oxygenation Time: Daily until the end of follow-up (up to 15 days after randomisation)Description: Mean difference in the alveolo-arterial gradient between study groups.
Measure: Alveolo-arterial gradient Time: One hour after sildenafil administrationDescription: Mean difference in the alveolo-arterial gradient between study groups.
Measure: Alveolo-arterial gradient Time: Daily until the end of follow-up (up to 15 days after randomisation)Description: Proportion of patients requiring admission to an intensive care unit in each study group
Measure: Intensive care unit admission Time: Up to two weeks after randomisationDescription: Proportion of patients requiring noninvasive mechanical ventilation o high-flow nasal cannula unit in each study group
Measure: Noninvasive Mechanical Ventilation or Requirement of High-Flow Nasal Cannula Time: Up to two weeks after randomisationDescription: Proportion of patients requiring invasive mechanical ventilation in each study group
Measure: Invasive mechanical ventilation Time: Up to two weeks after randomisationDescription: Proportion of patients that survived COVID19 in each study group
Measure: Survival Time: Up to two weeks after randomisationDescription: Adverse events attributable to sildenafil use.
Measure: Adverse events Time: Up to two weeks after randomisationThis study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib.
Description: Assessment of AUCinf for acalabrutinib and ACP-5862 (metabolite of acalabrutinib) following administration of capsule with and without rabeprazole.
Measure: Area under plasma concentration-time curve from time zero to infinity (AUCinf) Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2Description: Assessment of AUClast for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.
Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2Description: Assessment of Cmax for acalabrutinib and ACP-5862 following administration of capsule with and without rabeprazole.
Measure: Maximum observed plasma concentration (Cmax) Time: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day 1, and 24 hours post-dose on Day 2Description: Assessment of the safety and tolerability of acalabrutinib capsule when administered with COCA-COLA and rabeprazole.
Measure: Number of participants with adverse events and serious adverse events Time: From screening until Follow-up visit (Upto 5 to 6 Weeks)The use of nanomaterials in facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with important characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer shows virucidal activity in several types of viruses, including other coronavirus serotypes, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2. The effectiveness of respirators will also be attributed to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Pilot Randomized Clinical Trial with reduced sample and ii) Controlled Randomized Clinical Trial (RCT). This RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The pilot trial will be conducted initially with a group of fifty participants (n = 25 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) of a Hospital. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating centers and will be accompanied by eight consecutive shifts (each shift lasting 6 to 12 hours, followed by approximately 36 hours of rest). Participants will be accompanied during 21 days, and will be assessed at baseline (T0), at the end of the 10th day (T1) and at the end of the 21st day (T2). The respirators will be assessed after the end of the 1st hospital shift for morphological characterization (virus quantity and inactivation).
Description: Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)
Measure: Incidence of laboratory-confirmed COVID-19 Time: 21 daysDescription: Electron microscopy technique will be used, to identify if there is viruses present (through its direct visualization and morphological recognition) and they are inactive. This assessment will occur after the end of the first hospital shift.
Measure: Ability of the filtering element to inactivate the SARS-Cov-2 Time: 24 hoursDescription: 11-point Likert scale ranging from -5 ("extremely unsatisfied"), 0 ("neutral"), to 5 ("completely satisfied")
Measure: Usability and comfort of the respirator Time: Assessments at T1 (day 10) and T2 (day 21)Description: quantified based on the activities and procedures performed by the participants. Adherence will be measured by a self-report recorded in a diary, estimating the percentage of use referring to the total workhours.
Measure: Adherence to the use of the Respirator Time: Assessments at the end of the first and second weeks of interventionDescription: Measured by the Job Stress Scale Questionnaire (17 questions composed by 4-point Likert scales)
Measure: Stress Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by the Maslach Burnout Inventory
Measure: Burnout Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by the Six-dimensional short form quality of life questionnaire (SF-6D), with scores ranging from 0 to 1 (in which 0 is equal to the worst health state and 1 is equal to the best health state).
Measure: Self-reported quality of life Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by the Nordic Musculoskeletal Questionnaire, which assess the self-report of musculoskeletal symptoms in the last 12 months and last 7 days. Identification of areas of the body causing musculoskeletal problems in a body map (possible sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet).
Measure: Musculoskeletal discomfort Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Description: Measured by a VAS-scale ranging from 0 to 10, being 0 the worst work ability and 10 the best work ability, considering the present time.
Measure: Work ability Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)Patients confirmed COVID-19 with gastrointestinal manifestations will be included. Characteristics and outcomes will be described for them.
Description: Clinical characteristics of age, sex, comorbidities and symptoms.
Measure: Clinical data questionnaire Time: 2 monthsDescription: Laboratory characters
Measure: Tests such as CBC Time: 2 monthsDescription: Laboratory characters
Measure: liver function test Time: 2 monthsSerological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.
Description: The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies
Measure: Measure of the COVID-19 immunity of the population Time: 1 yearDescription: The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population
Measure: Evaluation of the level of asymptomatic and pauci-symptomatic infections Time: 1 yearPatients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization. Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.
Description: assess different dimensions of quality of life: physical and mentaland social dimensions
Measure: assess quality of life after severe COVID infection Time: measured at 3 months after ICU left.Description: Clinical status of patients and assessment of quality of life. collects crucial elements of care based on doctors' prescriptions
Measure: Quality of life and Clinical status Time: measured at 3 and 6 months after ICU left.Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.
Description: The duration of infection.
Measure: Nature of COVID19 Time: 1 yearsDescription: Costs related to Covid in terms of health resource needs.
Measure: Costs related to COVID-19 Time: 1 yearsDescription: Number of infection recovery for each systemic anti-cancer subgroup.
Measure: Systemic anti-cancer therapy subgroup Time: 1 yearsDescription: Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.
Measure: Laboratory values collected at hospitalization Time: 1 yearsDescription: Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.
Measure: COVID-19 infection in myeloma patient subgroups Time: 1 yearsDescription: Number of frail patients with COVID-19 infection and resolution of it.
Measure: Incidence of COVID-19 infection in frail patients Time: 1 yearsDescription: Number of infection and outcome per country.
Measure: Infection outcome in different countries Time: 1 yearsNon-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 infection in adults.
Description: percentage of patients with non-infectious diseases relating to overall number of patients registered in study
Measure: rate of non-infectious diseases Time: 12 month since a moment of request of medical helpDescription: correlation between number of patients with COVID-19 of various severity and number of pre-existing conditions and their severity among these groups
Measure: severity of COVID-19 depending on pre-existing diseases Time: 12 month since a moment of request of medical helpDescription: Registration of disability or change of disability status
Measure: disability registration / change of disability status Time: 12 month since a moment of request of medical helpDescription: rate of deaths among registered participants
Measure: rate of letal outcomes Time: 12 month since a moment of request of medical helpDescription: correlation between number of deaths and pre-existing diseases
Measure: rate of letal outcomes depending on pre-existing disease Time: 12 month since a moment of request of medical helpSince December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. Cancer patients seem to be at higher risk of infection and evolution to severe forms related to immunosuppression, according to the first published data from Chinese experience. However, the role of confounding factors such as age and smoking habits cannot be independently assessed. Supplementary data from a large retrospective Italian cohort suggest that the proportion of cancer patients with severe form of COVID-19 could be lower than expected. In addition, the proportion of asymptomatic SARS-Cov-2 infected cancer patients is unknown. Based on academic and expert's recommendations, most of cancer units have already modified cancer treatment during the pandemic, in order to limit the number of outpatient visits / inpatient admissions and then reduce or avoid cross infection of COVID-19, although the negative impact on patient's outcome (cancer recurrence or mortality) has not been established. Thus, a large screening for SARS-Cov-2 infection in treated cancer patients could help to: - Define an accurate prevalence of COVID-19 immunization in this population - Aggregate data on the relationship between clinical characteristics in cancer patients and COVID-19 risk. - Provide information about asymptomatic COVID-19 cases. - Organize effectively cancer units to separate infected and non-infected patients. The RT-PCR gold-standard test for COVID-19 on nasal and pharyngeal swabs has limitations, as the test is not universally available, turnaround times can be lengthy, and reported sensitivities vary. It does not provide information about immunization status. Serological assays may be important for understanding the epidemiology of emerging SARS-Cov-2, including the burden and role of asymptomatic infections. Thus, the development of new devices or techniques for accurate diagnosis of SARS-CoV-2 infections, of fast and safe use, that could be spread in the local hospitals and clinics, would be a major advance for identifying and treating patients. In addition, information about the immunization of fragile people, such as cancer patients, could help to plan a safe strategy for anti-cancer treatment schedule and for the end of quarantine.
Description: The rate of prevalence will be defined as the ratio of the number of positive patients to the number of patients tested based on the rapid serological test (presence of IgM and/or IgG).
Measure: To evaluate the prevalence of COVID-19 Time: Day 1Description: The assessment of the perception of the rapid serological test for patient and health care professional will be measured in terms of Pain, simplicity, rapidity and satisfaction, reported on a questionnaire: • Pain: The pain assessment will be performed using a visual analog scale (VAS). The score will be graded between 0 (absence of pain) to 10 (maximum pain) • Simplicity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". • Rapidity: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good". • Satisfaction with care: The assessment of the satisfaction of care will be carried out using a Likert scale with 4 modalities. The score will be graded between "Poor" to "Very Good"
Measure: To evaluate patient's and health care professional's perception about the rapid serological test. Time: Day 1Description: Diagnostic performance: sensibility, specificity, positive and negative predictive values, positive and negative likelihood ratio and area under the ROC curve, will be assessed to evaluate the rate of COVID-19 positive and COVID-19 negative serological rapid test on whole blood compared to the gold-standard RT-PCR on nasal swab.
Measure: To evaluate the concordance of COVID-19 positivity by the rapid serological test compared to the gold-standard RT-PCR on nasal swab for eligible patients Time: Day 1Description: Diagnostic performance: sensibility, specificity, positive and negative predictive values, positive and negative likelihood ratio and area under the ROC curve, will be assessed to evaluate the rate of COVID-19 positive and COVID-19 negative serological rapid test on whole blood compared to an ELISA serological test on whole blood.
Measure: To evaluate the concordance of COVID-19 positivity by the rapid serological test compared to a classic serological test (ELISA method) from whole blood Time: Day 1Description: The rate of patients with at least one positive test among all the methods applied (rapid serological test and/or serological ELISA test and/or RT-PCR and/or ddPCR) will be defined.
Measure: To evaluate the proportion of the patients who will have at least one positive testing among all the methods applied. Time: 6 monthsDescription: The proceedings of additional COVID-19 testing for corresponding patients will be described in terms of: Time interval between the tests Type and results of the subsequent tests
Measure: To evaluate the number of patients who will get at least one new testing after the rapid serological test has been performed. Time: 6 monthsDescription: The clinical and biological characteristics between positive and negative COVID-19 will be compared in term of: Age, gender, BMI, performance status, smoking history, alcohol consumption, medical history and concomitant medication clinical stage, location, type of treatment. blood group, hematology, coagulation parameters and serum clinical chemistry
Measure: To compare the clinical and biological characteristics between positive and negative tested COVID-19 patients Time: 6 monthsDescription: The rate of hospital admission for severe COVID-19 form and death will be assessed.
Measure: To describe the outcome of COVID-19 positive patients Time: 6 monthsDescription: A change on the anti-cancer treatment Schedule induced by the result of COVID-19 test will be defined as : a medical treatment delay decision or a treatment discontinuation decision
Measure: To evaluate the impact of COVID-19 rapid serological test on the anti-cancer treatment schedule Time: 6 monthsThis research aims to investigate the incidence, clinical condition, mode of transmission and laboratory data of women and their babies, who were exposed to COVID-19 infection during pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess periodontal condition and quality of life before and after delivery of women with excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence of congenital syndrome in babies associated with the presumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical examination, being a group with congenital malformations and their respective controls and an interview with the mother was carried out.
Description: Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.
Measure: Periodontal status Time: Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.Description: Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.
Measure: Quality of life of pregnants Time: Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).Description: IgM and IgG serology test for COVID19
Measure: Maternal infection Time: Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.
Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Maximum observed concentration (Cmax) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Terminal phase half-life (t1/2) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC [0-t]) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC from time 0 (predose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Cmax of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Lag time before observation of drug concentrations (Tlag) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Tmax of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-t) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-infinity) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Cmax of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Tlag of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Tmax of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: AUC(0-t) of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: AUC(0-infinity) of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Cmax of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Tlag of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Tmax of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: AUC(0-t) of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: AUC(0-infinity) of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC from time 0 (predose) to 24 hours post dose administration (AUC [0-24]) of gepotidacin after a single 1500 mg dose Time: Up to 24 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC from time 0 (predose) to 48 hours post dose administration (AUC [0-48]) of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC from time 0 (predose) to time tau (AUC[0-tau]) of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after the second dose of 3000 mg gepotidacin (evening dose) Time: From start of evening dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Accumulation ratio for Cmax (RoCmax) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Accumulation ratio for AUC (RoAUC) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose (first dose) in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose (first dose) in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: AEs will be collected.
Measure: Cohort 4: Number of participants with non-serious adverse events (non-SAEs) Time: Up to Day 16Description: SAEs will be collected.
Measure: Cohort 4: Number of participants with serious adverse events (SAEs) Time: Up to Day 16Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 4: Number of participants with abnormal vital signs Time: Up to Day 16Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.
Measure: Cohort 4: Number of participants with abnormal electrocardiogram (ECG) findings Time: Up to Day 16Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 4: Number of participants with abnormal hematology parameters Time: Up to Day 16Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 4: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 16Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 4: Number of participants with abnormal urinalysis findings Time: Up to Day 16Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Cmax of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tlag of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tmax of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose under fed conditions Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-24) of gepotidacin Time: Up to 24 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-48) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Tlag of a gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Apparent volume of distribution (Vz/F) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Apparent oral clearance (CL/F) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Total unchanged drug (Ae total) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-24) of gepotidacin in urine Time: Up to 24 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: AUC(0-48) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Renal clearance of drug (CLr) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Amount of drug excreted in urine in a time interval (Ae[t1-t2]) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 1: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: AEs will be collected.
Measure: Cohort 1: Number of participants with non-SAEs Time: Up to Day 14Description: SAEs will be collected.
Measure: Cohort 1: Number of participants with SAEs Time: Up to Day 14Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 1: Number of participants with abnormal hematology parameters Time: Up to Day 14Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 1: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 14Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 1: Number of participants with abnormal urinalysis findings Time: Up to Day 14Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 1: Number of participants with abnormal vital signs Time: Up to Day 14Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.
Measure: Cohort 1: Number of participants with abnormal ECG findings Time: Up to Day 14Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-24) of gepotidacin Time: Up to 24 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-48) of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: T1/2 of a gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Vz/F of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: CL/F of gepotidacin Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Ae total of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-24) of gepotidacin in urine Time: Up to 24 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: AUC(0-48) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: CLr of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: Ae(t1-t2) of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 2: fe% of gepotidacin in urine Time: Up to 48 hours post dose in each periodDescription: AEs will be collected.
Measure: Cohort 2: Number of participants with non-SAEs Time: Up to Day 20Description: SAEs will be collected.
Measure: Cohort 2: Number of participants with SAEs Time: Up to Day 20Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 2: Number of participants with abnormal hematology parameters Time: Up to Day 20Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 2: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 20Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 2: Number of participants with abnormal urinalysis findings Time: Up to Day 20Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 2: Number of participants with abnormal vital signs Time: Up to Day 20Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.
Measure: Cohort 2: Number of participants with abnormal ECG findings Time: Up to Day 20Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Cmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Tmax of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Tlag of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-tau) of gepotidacin first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Cmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in each PeriodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Tmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: RoCmax of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: RoAUC of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of morning dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose) Time: From start of evening dose up to 48 hours post evening dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Vz/Fof gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: T1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Trough concentration (Cmin) of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: t1/2 of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: Vz/F of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.
Measure: Cohort 3: CL/F of digoxin Time: Up to 96 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Cmin of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: t1/2 of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: Vz/F of midazolam Time: Up to 48 hours post dose in each periodDescription: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.
Measure: Cohort 3: CL/F of midazolam Time: Up to 48 hours post dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Ae total of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-24) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: AUC(0-48) of gepotidacin in urine following two 3000 mg doses (urine) Time: From start of morning dose up to 48 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: fe% of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose in each periodDescription: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 3: CLr of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in each periodDescription: AEs will be collected.
Measure: Cohort 3: Number of participants with non-SAEs Time: Up to Day 30Description: SAEs will be collected.
Measure: Cohort 3: Number of participants with SAEs Time: Up to Day 30Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Cohort 3: Number of participants with abnormal hematology parameters Time: Up to Day 30Description: Blood samples will be collected for the assessment of chemistry parameters.
Measure: Cohort 3: Number of participants with abnormal clinical chemistry parameters Time: Up to Day 30Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Cohort 3: Number of participants with abnormal urinalysis Time: Up to Day 30Description: Number of participants with abnormal vital signs will be assessed.
Measure: Cohort 3: Number of participants with abnormal vital signs Time: Up to Day 30Description: Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG findings will be assessed.
Measure: Cohort 3: Number of participants with abnormal ECG findings Time: Up to Day 30Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: T1/2 of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Vz/F of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CL/F of gepotidacin after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Tlag of gepotidacin after the first dose of 3000 mg (morning dose) Time: Up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Vz/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: t1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae total of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-24) of gepotidacin in urine after a single 1500 mg dose Time: Up to 24 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-48) of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: fe% of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CLr of gepotidacin in urine after a single 1500 mg dose Time: Up to 48 hours post dose in Period 1 and Period 2Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae total of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-24) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 24 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: AUC(0-48) of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 48 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: fe% of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3Description: Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.
Measure: Cohort 4: CLr of gepotidacin in urine following two 3000 mg doses Time: From start of morning dose up to 60 hours post morning dose in Period 3ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
Description: Number of subjects with a DLT event during or within 24 hours after ULSC infusion [Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.]
Measure: Incidence of Dose Limiting Toxicity (DLT) Time: 24 hoursDescription: Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion
Measure: Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE) Time: 1 weekDescription: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up
Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE) Time: 1 monthDescription: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up
Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE) Time: 12 monthsDescription: Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Measure: Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS Time: 1 monthDescription: Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator
Measure: Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio Time: 1 monthDescription: Number of ventilator-free days (VFD) in period of 1 month from study treatment
Measure: Number of ventilator-free days (VFD) Time: 1 monthDescription: Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in Complete Blood Count (CBC) with differential from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of blood glucose (mg/dL) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of sodium (mEq/L) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of potassium (mEq/L) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Changes in levels of alanine transaminase (ALT; U/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Measure: Changes in levels of alanine transaminase (ALT; U/L) from baseline Time: 1 month, 2 months, 3 months, 6 months, and 12 monthsDescription: Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria
Measure: Change in Urinalysis (UA) from baseline Time: 1 monthThe purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.
Description: Proportion of participants who experience treatment-related adverse events (TEAE) ≥ Grade 3 (CTCAE v5.0) during the first 24 hours after infusion of clazakizumab or placebo
Measure: Primary Endpoint Time: 24 hoursDescription: Proportion of participants who need mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) after the first dose of clazakizumab or placebo
Measure: Requirement for mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) Time: 14 daysDescription: Proportion of participants who experience infusion-related reactions during the first 24 hours after infusion of clazakizumab or placebo
Measure: Infusion-related reactions during 24 hours from the time of infusion Time: 24 hoursDescription: Proportion of participants alive at day 28 after the first dose of clazakizumab or placebo
Measure: Patient survival at 28 days Time: 28 daysDescription: Proportion of participants alive at day 60 after the first dose of clazakizumab or placebo
Measure: Patient survival at 60 days Time: 60 daysDescription: Proportion of participants who require an open-label dose of clazakizumab
Measure: Requirement for open-label clazakizumab Time: 14 daysDescription: Number of days in the ICU following the first dose of clazakizumab or placebo
Measure: Time in the intensive care unit (ICU) Time: 60 daysDescription: Number of days in the hospital following the first dose of clazakizumab or placebo
Measure: Time in the hospital Time: 60 daysDescription: Number of days from first dose of clazakizumab or placebo to requiring mechanical ventilation
Measure: Time to mechanical ventilation Time: 60 daysDescription: Difference in WHO Clinical Progression Scale between clazakizumab and placebo
Measure: Clinical status improvement assessed by the World Health Organization (WHO) Clinical Progression Scale at day 14 Time: 14 daysDescription: Difference in WHO Clinical Progression Scale between clazakizumab and placebo
Measure: Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28 Time: 28 daysDescription: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 14 from baseline between clazakizumab or placebo
Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 14 Time: 14 daysDescription: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 28 from baseline between clazakizumab or placebo
Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 28 Time: 28 daysCOVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in a national multicenter cohort.
Description: Death within 3 months after infection (Yes/No).
Measure: Death Time: Up to 3 months after resolutionDescription: Graft loss up to 3 months after infection (Yes/No).
Measure: Graft loss Time: Up to 3 months after resolutionDescription: Composite outcomes: Mechanical ventilation (Yes/No); Need for dialysis (Yes/No); Need for ICU admission during evolution (Yes/No).
Measure: Hospitalization Time: Until discharge date, an average of 1 monthThis is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center. The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
This is a standardized protocol for the rapid, coordinated clinical investigation of severe or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19) will be enrolled. This protocol has been designed to enable data and biological samples to be prospectively collected and shared rapidly in a globally-harmonized sampling schedule. Multiple independent studies can be easily aggregated, tabulated and analyzed across many different settings globally. The protocol is the product of many years of discussion among international investigators from a wide range of scientific and medical. Recruitment under this protocol has been initiated in response to Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral hemorrhagic fever (Ebolavirus) in 2014, Monkeypox & MERS-coronavirus in 2018, Tick-borne encephalitis virus (TBEV) in 2019 and COVID-19 in 2020. Participants may be newly identified through healthcare system or public health access, under quarantine, or in isolation care in outpatient or inpatient settings relevant to the Johns Hopkins University School of Medicine. Other locations may adopt this study concurrently, under a deferred review, or cooperatively. The existence of this protocol would ensure a timely, comprehensive epidemiologic and clinical characterization of the initial cases of COVID-19 in a mounting pandemic. The World Health Organization (WHO) recognized the need for standardized data collection for the epidemiology, immunology and clinical characteristics of these novel pathogens, and established the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) network in 2011. At the core of the protocol are a standardized schedule, structure and content of clinical, laboratory and microbiologic data collection, supplemented by domain-specific components (e.g., acute respiratory infection, viral hemorrhagic fever). The timepoints of this protocol will also be aligned with a separate multi-center institutional review board (IRB) approved protocol to describe patients with emerging infectious diseases that present to military treatment facilities within the United States.
Description: SARS-CoV-2 Reverse transcription polymerase chain reaction (RT-PCR) and viral culture will be performed on prospectively collected samples to determine presence and Ct of viral RNA and presence or absence of cultivable virus in assessing how long virus is shed (in days).
Measure: Duration of viral shedding Time: 3 monthsDescription: Incidence of comorbidities (chronic kidney disease, lung disease, cardiovascular disease, venous thromboembolism) will be determined.
Measure: Incidence of comorbidities Time: 12 monthsDescription: Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.
Measure: Treatment response as assessed by survival Time: 1 monthDescription: Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.
Measure: Treatment response as assessed by survival Time: 3 monthsDescription: Survival rates overall will be determined in assessing the mortality of COVID-19.
Measure: Mortality of COVID-19 Time: 12 monthsDescription: Changes in a lung ultrasound score (LUS) over time will be calculated and evaluated for prediction of disease severity defined by the World Health Organization COVID-19 ordinal scale (clinical status on an ordinal scale from 0 to 8 with higher scores meaning worse outcome).
Measure: Change in lung ultrasound score Time: Baseline and 1 monthDescription: Change in IgM antibody levels in serum will be determined for description of host response.
Measure: Change in immunoglobulin M (IgM) antibody levels in serum Time: Baseline, one month, and every three months up to 12 monthsDescription: Change in IgG antibody levels in serum will be determined for description of host response.
Measure: Change in immunoglobulin G (IgG) antibody levels in serum Time: Baseline, one month, and every three months up to 12 monthsDescription: Change in IgA antibody levels in serum will be determined for description of host response.
Measure: Change in immunoglobulin A (IgA) antibody levels in serum Time: Baseline, one month, and every three months up to 12 monthsThe purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.
Description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.
Measure: can or can't fell bitterness Time: Immediately after spray testThe purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. The research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. It is of great significance to COVID-19 's practical prevention and control.
Description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face. If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.
Measure: can or can't fell bitterness Time: Immediately after spray testPlasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
Description: Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer.
Measure: Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients Time: Up to 12 months after enrollmentDescription: Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates.
Measure: All-cause mortality Time: At day 28 post-CCP infusionDescription: Will be examined to see how this relates to the duration of hospitalization.
Measure: Donor antibody levels Time: Up to 28 days post-CCP infusionDescription: Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group.
Measure: Incidence of adverse events Time: Up to 28 days post-CCP infusionDescription: Will be assessed on a 7-point ordinal scale. The scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring low flow supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration); Not hospitalized
Measure: CCP recipient outcomes Time: Up to 28 days post-CCP infusionDescription: Patient can stay at the hospital for up to 28 days post-CCP infusion
Measure: Duration of hospitalization (days) Time: Up to 28 days post-CCP infusionDescription: Will be assessed on a 7-point ordinal scale.
Measure: Time to clinical improvement (days) Time: Up to 28 days post-CCP infusionThe purpose of this study is to evaluate whether LY3819253 prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19) in facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure. Participants with a high risk of SARS-CoV-2 exposure will receive LY3819253 or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.
Description: Percentage of Participants with SARS-CoV-2 Infection
Measure: Percentage of Participants with SARS-CoV-2 Infection Time: Week 4Description: Percentage of Participants with Moderate or Worse Severity COVID-19
Measure: Percentage of Participants with Moderate or Worse Severity COVID-19 Time: Week 8Description: Percentage of Participants with Mild or Worse Severity COVID-19
Measure: Percentage of Participants with Mild or Worse Severity COVID-19 Time: Week 8Description: Percentage of Participants Who are Hospitalized due to COVID-19
Measure: Percentage of Participants Who are Hospitalized due to COVID-19 Time: Week 8Description: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
Measure: Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death Time: Week 8Description: Percentage of Participants Who Die Due to COVID-19
Measure: Percentage of Participants Who Die Due to COVID-19 Time: Week 8SARS-CoV2 or CoVid19 disease is a newly described pathology linked to a subtype of the coronavirus family identified in China in December 2019. This pathology can present multiple clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms called "Acute Respiratory Distress Syndrome". The elderly population is more at risk for this infection due to the senescence of the immune system, co-morbidities and poly medications. They also often present a greater state of fragility. This study aims to report the epidemiology of the first 50 patients over 90 years of age hospitalized within the CHU Brugmann hospital.
Description: Age, sex, ethnicity
Measure: Demographic data Time: 5 minutesDescription: Smoking, Obesity, Diabetes, Arterial hypertension, Coronary pathology, Cerebrovascular disease, chronic renal failure, chronic obstructive pulmonary disease, Neoplasia, Autoimmune disease, Chronic liver disease
Measure: Comorbidities Time: 5 minutesDescription: CIRS-G quantifies burden of disease in elderly patients (comorbidity scale). Higher scores indicate higher severity (maximum score = 56 points).
Measure: Cumulative Illness Rating Scale-Geriatric (CIRS-G) Time: 5 minutesDescription: Under Chronic corticosteroid therapy or Immunosuppressive therapy
Measure: Treatments Time: 5 minutesDescription: Presence and date of first apparition: Fever, Cough, Dyspnea, Chest pain, Nausea or vomiting, Diarrhea, Fatigue, Anosmia, ageusia, inappetence, Confusion, Fall, Fracture
Measure: Signs and symptoms Time: 5 minutesDescription: Vital signs at hospital admission: Fever
Measure: Fever Time: 5 minutesDescription: Vital signs at hospital admission: Hypoxemia
Measure: Hypoxemia Time: 5 minutesDescription: Vital signs at hospital admission:Tachycardia
Measure: Tachycardia Time: 5 minutesDescription: Vital signs at hospital admission: Hypotension
Measure: Hypotension Time: 5 minutesDescription: Vital signs at hospital admission: Gasometry
Measure: Gasometry Time: 5 minutesDescription: Contact with confirmed covid person before admission, lives in a retirement home with other cases, Initial bacterial or viral co-infection, Bacterial or viral co-infection during the hospital stay
Measure: Infectious data Time: 5 minutesDescription: Blood count at hospital admission or first recorded
Measure: Blood count Time: 5 minutesDescription: Ionogram at hospital admission or first recorded
Measure: Ionogram Time: 5 minutesDescription: Liver function at hospital admission or first recorded
Measure: Liver function Time: 5 minutesDescription: Coagulation at hospital admission or first recorded
Measure: Coagulation Time: 5 minutesDescription: Renal function at hospital admission or first recorded
Measure: Renal function Time: 5 minutesDescription: Albumin at hospital admission or first recorded
Measure: Albumin Time: 5 minutesDescription: CRP at hospital admission or first recorded
Measure: CRP Time: 5 minutesDescription: Fibrinogen at hospital admission or first recorded
Measure: Fibrinogen Time: 5 minutesDescription: D-dimers
Measure: D-dimers at hospital admission or first recorded Time: 5 minutesDescription: NTproBNP at hospital admission or first recorded
Measure: NTproBNP Time: 5 minutesDescription: CK at hospital admission or first recorded
Measure: CK Time: 5 minutesDescription: Troponin at hospital admission or first recorded
Measure: Troponin Time: 5 minutesDescription: Ferritin at hospital admission or first recorded
Measure: Ferritin Time: 5 minutesDescription: Procalcitonin at hospital admission or first recorded
Measure: Procalcitonin Time: 5 minutesDescription: Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins
Measure: Biology - highest rate Time: 5 minutesDescription: Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+
Measure: Biology - lowest rate Time: 5 minutesDescription: Percentage of pulmonary involvement on chest CT scan
Measure: Percentage of pulmonary involvement on chest CT scan Time: 5 minutesDescription: Number of pulmonary lobes affected
Measure: Number of pulmonary lobes affected Time: 5 minutesDescription: Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'
Measure: Type of lesions Time: 5 minutesDescription: Need for oxygenotherapy (yes/no)
Measure: Need for oxygenotherapy Time: 5 minutesDescription: Means of ventilation
Measure: Means of ventilation Time: 5 minutesDescription: Hydroxychloroquine or Azithromycin
Measure: Treatment received Time: 5 minutesDescription: Length of ICU Stay
Measure: Length of ICU Stay Time: 5 minutesDescription: One of the following choices: death, went back home, went back to a retirement home, was placed in a revalidation unit.
Measure: Status at hospital exit Time: 5 minutesDescription: 28-day mortality after PCR / CT scan / diagnosis
Measure: Mortality Time: 5 minutesThere is a considerable variation in the disease behavior in terms of contracting the infection, manifesting none to a range of symptoms and severity of the infection among individuals exposed to or infected with SARS-CoV-2 virus, the causative organism of COVID-19. Although the respiratory system appears to be the primary target of this virus infection, emerging evidences suggests involvement of extra-pulmonary organs including central nervous system. We aim to compare the genetic profile of individuals with vs without COVID-19 after being exposed to infected cases. Additionally, we will assess the cognitive function in covid-19 positive cases with vs. without neurological symptoms at the time of infection and 1-month follow-up using the Montreal Cognitive Assessment (MoCA) questionnaire.
Description: Evaluate variants in the following known COVID-associated genes, ACE2R, IFITM, HLA-B 46, HLA-B 15, Toll Like Receptor and IFN-1, LIST, Perforin and mutations in Chromosome 3p21.31 along with novel genetic variants.
Measure: Genetic variants with vs without COVID-19 Time: 1 dayDescription: Assess the cognitive status at baseline using MoCA survey in patients with vs without neurological symptoms
Measure: Cognitive function at baseline Time: 1 dayDescription: change in the MoCA score from baseline in patients with vs without neurological symptoms
Measure: Change in cognitive function at 1 month Time: 1 monthDescription: compare the genetic variants in patients with no or mild to moderate vs severe symptoms
Measure: Genetic analysis Time: 1 dayThis phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
Description: Percentage of laboratory-confirmed COVID-19 cases
Measure: Incidence of laboratory-confirmed COVID-19 after the second dose Time: 14 days to 6 months after the second doseDescription: Percentage of suspected COVID-19 cases
Measure: Incidence of suspected COVID-19 cases Time: within 14 days to 6 months after the second dose.Description: Percentage of laboratory-confirmed cases (severe, critical, death)
Measure: Incidence of laboratory-confirmed cases (severe, critical and death) Time: within 14 days to 6 months after the second doseDescription: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Measure: Seroconversion rate anti-S antibody IgG titer (ELISA) Time: 14 days after two doses of vaccinationDescription: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Measure: Seroconversion rate anti-S antibody IgG titer (ELISA) Time: 6 months after two doses of vaccinationDescription: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Measure: Seropositive rate of neutralizing antibodies Time: 14 days after two doses of vaccinationDescription: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Measure: Seropositive rate of neutralizing antibodies Time: 6 months after two doses of vaccinationDescription: Number of Local reactions and systemic events
Measure: Local reaction and systemic events Time: 30 minutes to 14 days after each vaccinationDescription: Number of Local reactions and systemic events
Measure: Local reaction and systemic events occurring after the last vaccination Time: 14 days to 28 days following last vaccinationDescription: Number of any SAE occur
Measure: Serious adverse events during study Time: 6 months after the last doseThe McMaster Multi-Regional Hospital Coronavirus Registry (COREG) is a platform that is collecting detailed case data on laboratory confirmed COVID-19 hospital inpatients and outpatients. The COREG platform will provide rapid high-quality evidence to improve the prevention and clinical management of COVID-19 for older adults in Canada, and internationally. The COREG platform will also provide researchers and partners with complete regional level clinical data on COVID-19 cases to inform rapid decision-making and projections, sub-studies, extensions, and linkage for all affected populations.
Description: Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.
Measure: Serious COVID-19 infection Time: through study completion, an average of 1 yearDescription: Defined as persons admitted with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform. We will also conduct sub analyses of hospital acquired COVID-19 also captured in the COREG platform.
Measure: Severe infection (requiring admission) Time: through study completion, an average of 1 yearDescription: Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.
Measure: COVID-19 related death Time: through study completion, an average of 1 yearDescription: Days from admission to discharge.
Measure: Length of stay Time: through study completion, an average of 1 yearDescription: New or increased severity of conditions and syndromes from pre-morbid state.
Measure: Complications Time: through study completion, an average of 1 yearDescription: Rate of intensive interventions during hospital stay.
Measure: Intensive interventions Time: through study completion, an average of 1 yearCOVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.
Description: COVID-19 symptom relief at day 28, and % of COVID-19 symptom relief and its 95% confidence interval (CI) will be calculated using the exact binomial distribution and compared using Fisher's exact test.
Measure: Proportion x 100 = percent of patients with improved COVID-19 symptoms Time: Day 28CT signs that are evocative of lung COVID-19 infections have been extensively described, whereas 18F-FDG-PET signs have not. Our current study aimed to identify specific COVID-19 18F-FDG-PET signs in patients that were (i) suspected to have a lung infection based on 18F-FDG-PET/CT recorded during the COVID-19 outbreak and (ii) whose COVID-19 diagnosis was definitely established or excluded by appropriate viral testing.
Description: Visual analysis of the pulmonary lobes by calculating a extent score for each patient
Measure: Visual analysis of pulmonary lobes Time: 1 dayDescription: Measurement of metabolic activity with SUV max of lung areas with CT abnormalities
Measure: Measurement of metabolic activity Time: 1 dayThis study proposes to evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Description: Measured by respiratory rate >30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ration <300 and received a medical diagnosis of respiratory failure, septic shock or multiple
Measure: Determine the therapeutic efficacy (response rate) of convalescent plasma infusion in patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19). Time: Through study completion, an average of 30 daysDescription: SARS-CoV-2 Ag levels through RT-PCR
Measure: Determine the immunologic effects of convalescent plasma infusion Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: Absolute lymphocyte count (10*3/uL) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: reatinine kinase (mg/dL) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: C-reactive protein (mg/dl) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: D-Dimer (ng/ml FEU) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: Interleukin-6 (pg/ml) Time: Through study completion, an average of 14 daysDescription: Measure normalization of laboratory parameters for risk
Measure: Ferritin (ng/mL) Time: Through study completion, an average of 14 daysUltrasound can reliably detect morphologic changes associated with pneumonia. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of long-term pulmonary complications as consequences of Covid-19 pneumonia.
Description: Comparison of percentage of patients with oxygenation index drop below 300 mmHg during 14 after inclusion between group with and without changes in the ultrasound on admission.
Measure: Relation of changes in ultrasound and progression to respiratory failure Time: Through study completion, an average of 1 year.Description: Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group with signs of pneumonia vs. group without signs of pneumonia in the ultrasound, on the day of admission.
Measure: Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection Time: Through study completion, an average of 1 year.Description: Correlation of the score reflecting severity of ultrasonographic pneumonia signs with oxygen saturation of arterial blood and with oxygen and carbon dioxide partial pressure in repetitive measurements.
Measure: Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure Time: Through study completion, an average of 1 year.Description: Correlation of the score reflecting severity of ultrasonographic pneumonia signs with the volume of lung interstitium affected by pneumonia, measured in high resolution computer tomography scans.
Measure: Sensitivity of ultrasound in detecting interstitial changes in the lungs Time: Through study completion, an average of 1 year.Description: Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group which improved and which did not improve in the score reflecting severity of ultrasonographic pneumonia signs from the measurement on the day of admission to measurement five days later.
Measure: Impact change in severity of ultrasonographic pneumonia signs on severity of COVID-19 infection Time: Through study completion, an average of 1 year.The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine. We will be using a Real Time Polymerase Chain Reaction (RT-PCR) assay collected by a nasopharyngeal (nose) swab. RT-PCR is a real time test that can detect the amount of genetic material of a specific virus.The study is funded by The Miami Center for AIDS Research (CFAR)
Description: SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay
Measure: Number of participants who tested positive with SARS COV-2 Infection Time: month 3Description: SARS COV-2 antibody will be analyzed from blood samples via serological assay
Measure: Number of participants who tested positive with SARS COV-2 antibody Time: month 3There is emerging evidence that patients with SARS-CoV-2 are affected by increased coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to the lung but also involving the kidneys, heart and gut. Thrombin plays a central role in mediating clot forming as well as in mediating inflammation. A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the risk of venous and arterial thrombotic complications. Colchicine is an inexpensive (generic drug), orally administered, and a potent anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance. The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR.
Description: To assess the effect of edoxaban versus no active treatment on the composite endpoint of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-CNS systemic embolism or death at day 25 (+/-3) after randomization.
Measure: Edoxaban vs. no active treatment Time: Baseline to day 25Description: To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.
Measure: Colchicine vs no active treatment Time: Baseline to day 14Description: An intraluminal filling defect on CT scan or MR venography in the IVC or iliac veins.
Measure: Number of patients with asymptomatic proximal deep-vein thrombosis Time: Baseline to day 25Description: Typical symptoms of DVT associated with non-compressible vein segment on ultrasonography or an intra-luminal filling defect on venography, CT venography or MRI venography,located in the inferior vena cava (IVC), the iliac vein, the common femoral vein, the femoral or the popliteal vein.
Measure: Number of patients with symptomatic proximal or distal deep-vein thrombosis Time: Baseline to day 25Description: Typical symptoms of PE associated with an intra-luminal filling defect in (sub) segmental or more proximal branches on spiral computed tomography scan (CT) or computerized tomographic pulmonary angiography (CTPA). a considerable perfusion defect (~ 75% of a segment) with a local normal ventilation result (high probability) during perfusion-ventilation lung scan (PLS, VLS or V/Q scan). an intraluminal filling defect or a sudden cut-off of vessels (~more than 2.5 mm in diameter) on a catheter guided pulmonary angiogram. In case of an inconclusive CTPA, inconclusive V/Q scan or inconclusive angiography demonstration of DVT in the lower extremities e.g. by compression ultrasound or venography will be required
Measure: Number of patient with symptomatic pulmonary embolism or thrombosis Time: Baseline to day 25Description: For the primary analysis, MI endpoint will be defined based on the third universal definition of myocardial infarction with the exception of periprocedural MI after PCI, which will be defined according to the SCAI definition.
Measure: Number of patients with myocardial infarction Time: Baseline to day 25Description: Ischemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by CNS infarction
Measure: Number of patients with non-CNS systemic embolism Time: Baseline to day 25Description: Death will be classified in 5 categories with respect to cause. Thromboembolism, cardiovascular, bleeding, Pulmonary other known cause. In general, all deaths will be assumed to be due to thromboembolism or pulmonary in nature unless another cause is obvious
Measure: Number of deaths Time: Baseline to day 25Description: Need for non-invasive or invasive ventilation
Measure: Ventilation need Time: Baseline to day 25Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19. This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.
Description: To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia
Measure: Urinary levels of renal biomarkers Time: Seven daysDescription: Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia
Measure: Incidence of AKI Time: One monthDescription: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality
Measure: Urinary levels of renal biomarkers and mortality Time: 30 daysDescription: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.
Measure: Urinary levels of renal biomarkers and severity of the disease. Time: 30 daysDescription: Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.
Measure: Risk factors for AKI in severe COVID-19 Time: 30 daysDescription: Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.
Measure: Evolution renal biomarkers Time: 7 daysDescription: Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.
Measure: Evolution of viral load Time: 7 daysDescription: Analyze the complement pathway in urine and compare its evolution over time in patients with and without acute kidney injury and SARS-CoV-2 infection.
Measure: Evolution of complement pathway Time: seven daysDescription: Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.
Measure: Metabolomic profile Time: 7 daysDescription: Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.
Measure: Respiratory changes Time: 30 daysDescription: Stablish the nosocomial infections in subjects with or without AKI
Measure: Nosocomial Infections Time: 30 daysOur hypothesis: Serum Vitamin D (25(OH)D) is significantly lower in severe versus non-severe COVID-19 infections and that this is a function of ethnicity. There is an association between vitamin D status and various cytokines (pro-inflammatory molecules). The primary objective of this research is to provide a snap shot of vitamin D status in patients from the South-East London area by age, sex, ethnicity and BMI and demonstrate ethnic differences in vitamin D status as well as its associations with severe vs non-severe COVID-19 infections. The secondary objective is to determine if there is an association between vitamin D status and various cytokines (pro-inflammatory molecules) and severity of disease.
Description: All vitamin D results performed by the Nutristasis Unit at St. Thomas' since January 2020 (N= ~15000) together with age, weight and height if available, ethnicity and other relevant laboratory markers (Ca, adjusted calcium, PTH, Mg, phosphate, liver and renal profile, Covid-19 screening, CRP, Haematinics, FBC) if they were tested within two weeks of the sample being measured for vitamin D will be acquired. The results of this audit will provide us with a snap shot of vitamin D status in patients from the South-East London area by age, sex, ethnicity and BMI (weight in kg/height2). Correlation analysis will also be undertaken with other laboratory parameters.
Measure: Collecting vitamin D results in patients from the South-East London area together with age, sex, ethnicity and BMI and other relevant laboratory results. Time: January-June 2020Description: All Covid-19 screening results together with vitamin D (nmol/L), ethnicity, age (yrs), weight (m) and height to obtain BMI, length of stay in hospital including ICU in days (if applicable), type of illness, recovered or not (y or no), associated health conditions, CRP, Ferritin, Haematinics, vitamin A and E, procalcitonin, LDH, INR, fibrinogen, FBC, D-dimers, CK, Troponin-T, cytokines, renal function and electrolytes will be collected from patients tested at GSTT NHS Trust. We expect that only a small number of patients who had Covid-19 screening performed would have had vitamin D, cytokines and other markers measured. However, we estimate that we will be able to identify a sufficient number of Covid-19 patients for regression and correlation analysis from this data.
Measure: Collecting Covid-19 screening results together with age, sex, ethnicity and BMI and other relevant laboratory results. Time: March-June 2020This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission
Description: Demographical characteristics will be recorded
Measure: General Characteristics of the infants with respiratory infection at the NICU admission Time: 5 months1.5. Why this clinical study? The prevalence of seropositivity following SARS-CoV 2 infection might have its own potential benefits in terms of predicting the end of pandemic and the validity of herd immunity. It is not clear if SARS-CoV 2 infection would have a long-lasting antibody-mediated immunity, and if the antibodies' persistence is dependent on disease severity.depends on the severity of illness. If evidence is provided about the persistence of antibodies that is reflective of the protective immune response, serodiagnosis will be an important tool to identify individuals with various risk for infection, and those who are in need of receiving the forthcoming vaccines. The here proposed prospective clinical study will test the prevalence of seropositivity following SARS-CoV 2 infection in critically ill patients compared to those who do not require intensive care unit (ICU) admission or invasive ventilation with respect to the IgM and IgG levels.
Description: The measurements are dependent on epitope recognitions for synthetic, adsorbed S proteins
Measure: Changes in the levels of S specific antibodies in severely ill patients compared to mild cases. Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: The measurements are dependent on epitope recognitions for synthetic, adsorbed N proteins
Measure: Changes in the levels of N specific antibodies in severely ill patients compared to mild cases. Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Titers of the S specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions
Measure: S specific binding antibodies of SARS-CoV-2 Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Titers of the N specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions
Measure: N specific binding antibodies of SARS-CoV-2 Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Titers of the neutralizing antibodies directed against S protein of SARS-CoV-2 would be assayed as described in the interventions
Measure: Neutralizing antibodies directed against S protein of SARS-CoV-2 Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: The severity category of critically ill patients would be estimated using an APACHI II score. Minimum score = 0; maximum score = 71.
Measure: The severity category of critically ill Time: Day 0, 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Length of ICU stay from the admission day to the ICU
Measure: Length of ICU Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: Length of hospital stay from the hospital admission day
Measure: Length of hospital stays Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: If the patients alive or dead through a telephone interview.
Measure: Alive status at 28-days Time: For 28 days after the onset of symptoms of SARS-Cov2 infectionDescription: If the patients alive or dead through a telephone interview.
Measure: Alive status at 90-day Time: For 90 days after the onset of symptoms of SARS-Cov2 infectionDescription: To correlate the levels of S neutralizing antibodies in severely ill patients compared to mild cases.
Measure: Correlation between the levels of S neutralizing antibodies and disease severity Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionDescription: To correlate the levels of N neutralizing antibodies in severely ill patients compared to mild cases.
Measure: Correlation between the levels of N neutralizing antibodies and disease severity Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infectionClinical trial to compare sublingual low does thimerosal in adults that have symptoms of SARS-CoV-2 Infection against placebo to show a difference in physical characteristics and viral levels.
Description: Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument
Measure: Mean duration and severity of disease Time: Two daysDescription: AEs will be assessed by the investigator as to severity, duration and relationship to treatment
Measure: Incidence/Safety of Adverse Events Time: Baseline through 10 daysA novel coronavirus, designated corona virus disease 2019 (COVID-19) has resulted in a Pandemic at the time of writing (27th April) the reported number of confirmed cases exceeding 3 million and over 200000 associated deaths. The burden on global critical care has been considerable. As of 24th April there have been 8752 UK critical care admissions with services under considerable strain, and a mortality rate over 50%. Survivors of critical illness will require significant input. This study will perform mixed methods to provide rich data on risk stratification and recovery from critical illness. Recovery from a novel disease requires documenting and the study reports physical and psychological changes following hospital discharge in survivors. In addition qualitative interviews are being conducted with patients who have survived and been discharged from critical care along with their relatives and treating professionals, to better understand their needs during recovery.
Description: Chelsea critical care physical assessment tool
Measure: Physical Time: through study completion , an average of 1 yearDescription: Incremental Shuttle Walk Test (ISWT)
Measure: Physical Time: through study completion , an average of 1 yearDescription: 1- minute Sit to Stand, Grip strength
Measure: Physical Time: through study completion , an average of 1 yearDescription: Short Form Survey on health related quality of life (SF-12). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Higher scores indicate better outcome.
Measure: Health Related Quality of life Time: at 3 monthsDescription: Short Form Survey on health related quality of life (SF-36). Scores can range from 0 to 100 and a higher score indicates better outcome.
Measure: Health Related Quality of life Time: at 1 yearDescription: Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome.
Measure: Psychological Time: through study completion , an average of 1 yearDescription: Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome.
Measure: Psychological Time: through study completion , an average of 1 yearDescription: Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome.
Measure: Psychological Time: through study completion , an average of 1 yearDescription: Post-traumatic stress disorder (PTSD) Trauma Screening (TSQ). A screening tool with 10 items. If 6 items are endorsed then the outcome is 'positive' for PTSD.
Measure: Psychological Time: at 1 yearDescription: escalation to critical care (Yes/No)
Measure: risk stratification Time: through study completion and average of 1 yearDescription: mechanical ventilation (Yes/No)
Measure: risk stratification Time: through study completion and average of 1 yearDescription: critical care stay hospital stay (number of days)
Measure: risk stratification Time: through study completion and average of 1 yearWhile many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.
Description: Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls
Measure: Native myocardial T1 relaxation time Time: 12 weeks post COVID-19 diagnosisDescription: Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging
Measure: FLAIR imaging Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline
Measure: Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline
Measure: Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline
Measure: Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline Time: 12 weeks post COVID-19 diagnosisDescription: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI
Measure: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI Time: 12 weeks post COVID-19 diagnosisDescription: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic
Measure: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic Time: 12-24 weeks post COVID-19 diagnosisThe world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.
Description: Overall duration of the hospitalization from day of admission until the day of discharge or fatality
Measure: Length of hospitalization Time: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Did the patient need a intensive care treatment during the hospitalization (yes/no)
Measure: Need of intensive care Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: Day of admission to ICU until discharge or fatality
Measure: Lenght of the Intensive Care Treatment Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: Percentage of patient died during hospitalization
Measure: Overall mortality Time: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)Description: percentage of patients with 25-hydroxyvitamin D > 50nmol/L (>20ng/mL) at day 7 - The values of calcium, phosphorus, 24-hydroxyvitamin D, 1.25-dihydroxyvitamin D, parathyroid hormone.
Measure: Development of vitamin D levels Time: Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)Description: percentage of patients developing a sepsis
Measure: Development of sepsis Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)Description: We assess every other complications which occurs due to COVID-19
Measure: Complications due to COVID-19 Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)Description: The BP will be assessed daily in mmHg
Measure: Blood pressure (BP) Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: The heart rate will be assessed daily in bpm
Measure: Heart rate Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)Description: The SpO2 will be assessed daily in %
Measure: Peripheral oxygen saturation (SpO2) Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Requirement for oxygen will be assessed daily (yes/no) if yes how many liters per minute
Measure: Percentage of patients who require oxygen Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Breathing frequence will be assessed daily in breaths per minute
Measure: Breathing frequency Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: GCS will be assessed daily 3 to 15 points. It describes the extent of impaired consciousness. 15 points means no impairment, 3 points means severe impairment of consciousness.
Measure: Glasgow Coma Scale (GCS) Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Assessing the history of smoking in pack years (PY). the assessment will be made with the following options for answering Current smoker: Smoking for how many years? Cigarettes per day? Former smoker, how many years smoked? How many cigarettes per day Life-long non-smoker
Measure: Percentage of patients are smokers, former smokers or lifelong non-smokers Time: Assessing of the smoking Status at BasleineDescription: Assessed in No/ Mild/ Moderate /Severe
Measure: Current Symptoms Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Description: Temperature will be assessed daily in degrees celsius
Measure: Temperature Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective 1. Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640 2. Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640
Description: MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 ± 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measure: MTD Time: 28days(+/-2days)Description: Viral load change (log10 viral load assessed by reverse transcription-qPCR)
Measure: Viral load Time: Time Frame: Day 1, 3, 5, 7, 9 and 12Description: Assessed TTCI with WHO clinical progression scale by measuring clinical status daily. TTCI is defined as the time (in days) from initiation of study treatment until a decline of one category on WHO clinical progression scale which ranges from 0 (uninfected; no viral RNA detected) to 10 (death)
Measure: Time to clinical improvement Time: Time Frame: dialy up to Day 10Description: Cmax
Measure: Pharmacokinetic (PK) Time: Day 1,3 and 5.Description: Ctrough
Measure: Pharmacokinetic (PK) Time: Day 1,3 and 5.Description: AUCτ
Measure: Pharmacokinetic (PK) Time: Day 1,3 and 5.It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the effectiveness and safety of the administration to of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.
Description: Development of of the disease according to the definitions of cases found in the guidelines from the Colombian National Institute of Health
Measure: Clinical development of covid-19 disease during the intervention period Time: 8 weeksDescription: Indicate if the patient had positive serological antibodies at the end of the study
Measure: Seroconversion Time: 8 weeksDescription: Need for hospitalization independent of the level of complexity due to covid-19
Measure: Hospitalization requirement Time: 8 weeksDescription: ICU need due to Covid-19
Measure: Intensive Care Unit Requirement Time: 8 weeksDescription: Adverse effect due to medication or placebo
Measure: Safety of the intervention Time: 8 weeksBackground: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.
Description: This study will assess the time to the occurrence of influenza-like illness (ILI) or acute respiratory infection (ARI) in subjects previously COVID+ compared to subjects known as COVID- (controls), more specifically subjects will belong to two subgroups: nursing home residents (65+) and nursing home staff (18-65y). COVID+ is defined as a past SARS-CoV-2 infection.
Measure: Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls Time: up to 8 monthsDescription: Disease severity will be measured by hospitalization and mortality
Measure: Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity. Time: up to 8 monthsSARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.
Description: All-cause mortality at day 28, defined as the comparison of proportions of patients death for any cause at day 28 from randomization.
Measure: All-cause mortality at day 28 Time: Day 28 from randomizationDescription: All-cause mortality at ICU discharge, defined as the comparison of proportions of patients death for any cause at ICU discharge.
Measure: All-cause mortality at ICU discharge Time: from randomization to ICU discharge, censored at day 30Description: All-cause mortality at Hospital discharge, defined as the comparison of proportions of patients death for any cause at hospital discharge
Measure: All-cause mortality at hospital discharge Time: from randomization to ICU discharge, censored at day 90Description: Occurrence of rescue administration of high-dose steroids or immune-modulatory drugs
Measure: Need of rescue administration of high-dose steroids or immune-modulatory drugs Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of new organ dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score ≥3 for the corresponding organ occurring after randomization.
Measure: New organ dysfunction during ICU stay Time: From randomization to ICU discharge, censored at day 28Description: Grade of organ dysfunction during ICU stay, grade of dysfunction is measured with Sequential Organ Failure Assessment (SOFA) score daily from randomization to day 28 or ICU discharge.
Measure: Grade of organ dysfunction during ICU stay Time: From randomization to ICU discharge, censored at day 28Description: Total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered.
Measure: ICU free days at day 28 Time: From randomization to day 28Description: Occurrence of new infections including bacterial infections, fungal infections by Candida, Aspergillus, and viral reactivations including Adenovirus, Herpes Virus e Cytomegalovirus
Measure: Occurrence of new infections Time: from randomization to day 28Description: Total number of days that patient is alive and free of ventilation between randomisation and day 28. Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.
Measure: Ventilation free days at day 28 Time: From randomization to day 28, censored at hospital dischargeDescription: Total number of days that patient is alive and free of vasopressors between randomisation and day 28.
Measure: Vasopressors free-days at day 28 Time: From randomization to day 28, censored at hospital dischargeDescription: Occurrence of switch from non-invasive to invasive mechanical ventilation
Measure: Switch from non-invasive to invasive mechanical ventilation Time: from randomization to ICU discharge, censored at day 28Description: Total number of hours from start of non-invasive to invasive ventilation to switch to invasive ventilation
Measure: Delay from start of non-invasive ventilation to switch to invasive ventilation Time: from randomization to ICU discharge, censored at day 28Description: Adverse events occurred from randomization to day 28. Events that are part of the natural history of the primary disease process or expected complications of critical illness will not be reported as adverse events.
Measure: Occurrence of protocol related adverse events Time: From randomization to day 28Description: Occurrence of objectively confirmed venous thromboembolism, stroke or myocardial infarction
Measure: Occurrence of venous thromboembolism, stroke or myocardial infarction Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of major bleeding defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death)
Measure: Occurrence of major bleeding (safety end point) Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of clinically relevant non-major bleeding defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm2, or 100 cm2, intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.
Measure: Occurrence of clinically relevant non-major bleeding (safety end point) Time: from randomization to ICU discharge, censored at day 28Description: Mean arterial pressure will be measured in millimeters of mercury
Measure: Mean arterial pressure Time: Daily from inclusion until ICU discharge, censored day 28Description: hearth rate will be measured in beats per minute
Measure: hearth rate Time: Daily from inclusion until ICU discharge, censored day 28Description: respiratory rate will be measured in breaths per minute
Measure: respiratory rate Time: Daily from inclusion until ICU discharge, censored day 28Description: diuresis will be measured daily in milliliters of urine output in the previous 24 hours
Measure: diuresis Time: Daily from inclusion until ICU discharge, censored day 28Description: systemic body temperature will be measured in celsius degrees
Measure: systemic body temperature Time: Daily from inclusion until ICU discharge, censored day 28Description: fluid balance will be measured in milliliters of fluids input and output in the previous 24 hours
Measure: fluid balance Time: Daily from inclusion until ICU discharge, censored day 28Description: Haemoglobin will be measured in mg/dl
Measure: Haemoglobin concentration Time: Daily from inclusion to ICU discharge (censored at day 28)Description: platelets count will be measured in U 10^3/mm^3
Measure: platelets count Time: Daily from inclusion to ICU discharge (censored at day 28)Description: white blood cells count will be measured in U per 10^9/L
Measure: white blood cells count Time: Daily from inclusion to ICU discharge (censored at day 28)Description: troponin will be measured in µg/L
Measure: troponin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: coagulative function will be measured with parameters INR, PT, aPTT
Measure: coagulative function Time: Daily from inclusion to ICU discharge (censored at day 28)Description: D-dimer will be measured in µg/ml
Measure: D-dimer Time: Daily from inclusion to ICU discharge (censored at day 28)Description: anti-thrombin will be measured as a percentage
Measure: anti-thrombin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: liver function will be assessed through measurement of AST, ALT in U/L
Measure: Liver function Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Bilirubin will be measured in mg/dL
Measure: Bilirubin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Creatinine will be measured in mg/dL
Measure: Creatinine Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Blood cells count will be measured in Units per x 10^9/L of blood
Measure: Blood cells count Time: daily from inclusion to ICU discharge (censored at day 28)Description: C-reactive protein (CRP) will be measured in mg/dl
Measure: C-reactive protein (CRP) Time: daily from inclusion to ICU discharge (censored at day 28)Description: procalcitonin(PCT) wiull be measured in ng/ml
Measure: procalcitonin(PCT) Time: daily from inclusion to ICU discharge (censored at day 28)Description: interleukin 6 (IL-6) will be measured in pg/ml
Measure: interleukin 6 (IL-6) Time: daily from inclusion to ICU discharge (censored at day 28)Description: Ventilation mode will be cathegorized in spontaneous breathing, invasive or non invasive ventilation
Measure: Ventilation mode Time: Daily from inclusion to ICU discharge (censored at day 28)Description: inspired oxygen fraction will be measured in percentage of oxygen in inspired air
Measure: inspired oxygen fraction Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Gas exchanges will be assessed by measurement of PaO2, PaCO2 in mmHg by arterial blood gas analysis
Measure: Gas exchanges Time: Daily from inclusion to ICU discharge (censored at day 28)Description: lactates will be measured in mMol/L
Measure: lactates Time: Daily from inclusion to ICU discharge (censored at day 28)Description: pH will be measured in pH scale
Measure: pH Time: Daily from inclusion to ICU discharge (censored at day 28)Description: oxygen saturation in blood will be measured in arterial and venous samples in percentage values
Measure: oxygen saturation in blood Time: Daily from inclusion to ICU discharge (censored at day 28)Description: New blood, respiratory and urinary-tract infections will be recorded
Measure: New infections Time: From randomization to day 28Description: Viral reactivation measured by CMV DNA titres will be recorded.
Measure: Viral reactivation Time: From randomization to day 28Description: Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) will be recorded.
Measure: Need of new renal replacement therapy Time: from randomization to day 28Description: Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded
Measure: Adjunctive treatments Time: from randomization to ICU discharge (censored at day 28);Whether university teaching on campus with infection control measures in place is associated with higher risk of COVID-19 than online instruction, is unknown. The investigators will assess this by conducting repeated surveys among students at universities and university colleges in Norway, where some instruction is given in-person, and some is provided online (hybrid model). The investigators will ask about the students' COVID-19 status, and how much in-person and online instruction the students are getting. The investigators will estimate the association between in-person instruction and COVID-19-risk using multivariate regression, controlling for likely confounders. The investigators will also assess whether type of instruction is associated with how satisfied the students are with the instruction the students are offered, their quality of life, and learning outcomes.
Description: Self-reported positive test results
Measure: COVID-19 incidence Time: Through study completion, i.e. 4 months.Description: Self-reported ("Overall, how satisfied are you with life right now?")
Measure: Quality of life Time: Through study completion, i.e. 4 months.Description: Self-reported ("Overall, how satisfied have you been with the teaching you have received in the past 14 days?")
Measure: Satisfaction with teaching Time: Through study completion, i.e. 4 months.Description: Self-reported
Measure: COVID-19 testing incidence Time: Through study completion, i.e. 4 months.Description: Exam results from Common Student System
Measure: Learning outcome Time: End of term, December 2020.The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.
Description: The primary endpoint will be the disease severity on the 7-point WHO Ordinal Scale on day 7. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19
Measure: Disease Severity on the 7-Point WHO Ordinal Scale Time: Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline valueDescription: at least 2 points Ordinal Scale for Clinical Improvement, clinical severity will be assessed.
Measure: Clinical improvement Time: Daily until day 14Description: Admission to ICU with invasive or non-invasive ventilation or death will be assessed.
Measure: Invasive or non-invasive ventilation Time: Daily until day 14.Description: Patients with ALI within 14 days after enrollment, PaO2/FiO2 will be determined daily. This is only relevant for patients with arterial blood gas sampling performed in the ICU or rarely in the medical unit.
Measure: Acute Lung Injury Time: Daily until day 14.This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.
Description: Describe the clinical features of the illness or syndrome and complications, and determinants of severity. Assessment daily for 14 days, then hospital discharge.
Measure: Clinical characterization of coronavirus disease-2019 (COVID-19) Time: 1 yearInvestigators aimed to compare clinical and radiographic markers between SARS-CoV-2 positive and RSV positive infants
Description: Total neonatal intensive care duration, total duration of oxygen supplement
Measure: Oxygen status and evaluation of neonatal intensive care stay Time: 3 monthsThis QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.
Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.
Measure: Change in Testing Throughput After Hexapod Implementation Time: Up to 22 weeksDescription: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.
Measure: Change in Isolation Gowns Utilized After Hexapod Utilization Time: Up to 22 weeksDescription: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.
Measure: Change in Cost per Test After Hexapod Implementation Time: Up to 22 weeksDescription: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.
Measure: Return on Investment Time: Up to 22 weeksDescription: The difference in median shift salaries before and after Hexapod implementation will be calculated.
Measure: Change in Testing Personnel Cost Per Test Time: Up to 22 weeksDescription: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.
Measure: Change in Cost of Isolation Gowns Utilized Time: Up to 22 weeksDescription: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.
Measure: Cost of Additional Consumable Supplies Utilized Time: Up to 22 weeksA randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administered subcutaneously once weekly, for up to two weeks (2 injections at most), in addition to standard supportive care, compared to standard supportive care alone, in a population of COVID-19 infected patients. patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180 mcg S.C + standard care (intervention arm) or standard care only (control arm).
Description: The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19.
Measure: Viral shedding in days since initial diagnosis Time: 21 daysDescription: Rate of treatment-emergent and treatment-related severe adverse events (SAEs)
Measure: Rate of adverse events and severe adverse events Time: 21 days from entryDescription: the time (in hours) from initiation of trial treatment (Lambda or standard care) until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours.
Measure: Time to clinical recovery Time: 72 HoursDescription: Requirement for non-invasive (bipap) or mechanical ventilation
Measure: Rate of non-invasive or mechanical ventilation Time: 28 DaysDescription: length of hospital stay from admission to discharge
Measure: Length of hospital stay Time: 28 DaysDescription: All-cause mortality
Measure: All-cause mortality Time: At day 28 following admission to the hospitalDescription: Rate of undetectable COVID-19 virus levels at different days
Measure: Undetectable COVID-19 virus levels Time: At days 7,14 and 21 from admissionOn March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. Worldwide, the number of confirmed cases continues to rise, leading to significant morbidity and mortality. In the Netherlands, although the incidence is currently low due to social distancing measures, recurrence of infections is expected once measures are going to be lifted. Although individuals of any age can acquire SARS-CoV-2, adults of middle and older age are at highest risk for developing severe COVID-19 disease. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in vulnerable populations are urgently needed. Bacille Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but also induces protection against various respiratory infections, including those with a viral etiology. We hypothesize that BCG vaccination reduces clinically relevant respiratory tract infections requiring medical intervention, including COVID-19, in vulnerable elderly. The objective of this trial is to determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerable elderly. The trial is designed as an adaptive multi-center double-blind randomized placebo-controlled trial. The attempt is to include 5,200 to 7,000 vulnerable elderly, defined as ≥60 years of age being discharged from hospital in the last 6 weeks, or visiting a medical outpatient clinic, thrombosis care services, or chronic renal replacement departments. Patients with contraindications to BCG vaccination as stipulated in the Summary of Product Characteristics (SPC) and patients with a history of COVID-19 will be excluded. Participants will be randomized between intracutaneous administration of BCG vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio.The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection requiring medical intervention, potentially including COVID-19 episodes. The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, acute respiratory infection (ARI; all infections regardless of medical intervention), ARI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.
Description: Clinically relevant relevant respiratory tract infection is composed of clinical symptoms in combination with the need for medical intervention. Exact criteria for clinically relevant respiratory tract infection and COVID-19 are described in the protocol. A blinded adjudication committee will determine the status of the primary endpoints of all participants with a potential primary endpoint, based on information provided in a standardized narrative using data reported by the participant and from GP and hospital medical records when relevant. For detection of ARI, symptoms are checked on a weekly (from week 1-4) or bi-weekly basis (from week 4 onward).
Measure: The trial has an adaptive primary endpoint. Based on predefined objective and quantitative criteria the primary endpoint will be either a clinically relevant respiratory tract infection, or COVID-19. Time: 180 daysDescription: Cumulative incidence of SARS-CoV-2 infection regardless of symptomatology defined as having had COVID-19 as described under primary endpoints above and/or SARS-CoV-2 positive test in real time as part of the test-and-trace program of the Dutch government and/of documented SARS-CoV-2 seroconversion at 6 months. Seroconversion will be defined as antibody-positive at 6 months but negative at baseline.
Measure: Cumulative incidence of SARS-CoV-2 infection (irrespective the presence of symptoms) Time: 180 daysDescription: Defined as either of 1) ARI + microbiological evidence of influenza infection, 2) seroconversion of influenza between enrolment and month 6.
Measure: Influenza infection Time: 180 daysDescription: Meeting the definition stated in the primary outcome. Irrespective of requiring an intervention.
Measure: An acute respiratory tract infection Time: 180 daysDescription: Meeting the definition stated in the primary outcome including the requirement of an intervention.
Measure: Medically attended acute respiratory tract infection Time: 180 daysDescription: Meeting the definition stated in the primary outcome including the need of hospitalization.
Measure: Acute respiratory tract infection related hospital admission Time: 180 daysDescription: Using the Katz Activities of Daily Living (ADL) scale, from A (fully independent) to G (dependent in feeding, continence, transferring, going to toilet, dressing, and bathing)
Measure: Functioning in daily activities Time: 180 daysDescription: Using the EQ5D quality of life instrument, with questions on 4 domains (mobility, self-care, usual activities, pain discomfort) and the percepted health of the participant with 100 meaning the best health you can imagine, and 0 meaning the worst health you can imagine
Measure: Quality of life using the EQ5D quality of life instrument Time: 180 daysDescription: Using the 6-item Lawton Activities of Daily Living questionnaire, with scores ranging from 0 (low function, dependent) to 8 (high function, independent) for women (0 through 5 for men)
Measure: Activities in daily living Time: 180 daysThis study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China. These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). This will be a prospective, single-center observational study involving human subjects. IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH). IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection. To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing. Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time. Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study. Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing. For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test. Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive. All testing will be performed in a two-week window. All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment. We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care. The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum. One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020. The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.
Description: The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.
Measure: Physician Prevalence of COVID-19 serum IgG Time: up to 1 yearDescription: The prevalence of COVID-19 serum IgG in household members (as defined above) of physician participants that are positive at the time the associated physician tested positive.
Measure: Household Member Prevalence of COVID-19 serum IgG Time: up to 1 yearDescription: The differences in prevalence of COVID-19 IgG in physician participants that are deemed to be at minimum, moderate or high risk of COVID-19 exposure.
Measure: Physician Risk of Exposure Time: up to 1 yearDescription: The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.
Measure: Physician and Household Member Transmission Time: up to 1 yearDescription: The correlation between IgG prevalence and previous COVID-19 symptoms - a means of quantifying the presence of asymptomatic carriers amongst the medical staff, an important and heretofore poorly described vector of transmission.
Measure: Asymptomatic Infection Time: 1 yearDescription: The correlation between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.
Measure: PPE Use and Positivity Time: up to 1 yearDescription: The development of COVID19 infections in physicians at our hospital over the test period of 12 months, and its correlation to Covid19_IgG positivity. This will allow us to understand the persistence of the antibody and its potential neutralizing power, over time.
Measure: Antibody Persistence Time: up to 1 yearThe emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.Therefore, present feasibility study of the safety and efficacy of Guduchi Ghan Vati was conducted in asymptomatic patients with COVID-19
Description: Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result
Measure: Virologic clearance Time: 14 daysDescription: Total duration of stay in hospital for complete recovery
Measure: Hospital Stay Time: 14 daysDescription: Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form
Measure: Clinically relevant adverse effects Time: 14 daysDescription: Routine blood tests were performed to assess complete blood counts, blood biochemistry parameters {Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Urea, C-reactive protein (CRP), as well as Albumin} and immunoglobulines.
Measure: Laboratory tests Time: change from baseline to 14 daysAs dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
Description: 2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody
Measure: COVID-19 probable or confirmed case Time: 18 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.
Measure: Anxiety Time: 12 monthsDescription: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.
Measure: Depression Time: 12 monthsDescription: Self-reports of infection control efforts in the respondents' primary dental practices.
Measure: Dental practice infection control efforts Time: 12 monthsDescription: Availability, frequency of use, and frequency of reuse of personal protective equipment
Measure: Personal protective equipment Time: 12 monthsDescription: Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.
Measure: Employment status Time: 12 monthsIn this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.
Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'. Time: 7 monthsDescription: The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'. Time: 7 monthsDescription: The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'. Time: 7 monthsDescription: The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.
Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'. Time: 7 monthsDescription: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/1000 patient days, DDD or DDA of unnecessary AB/1000 patient days, DDD or DDA of inappropriate AB/1000 patient days and DDD or DDA of suboptimal AB/1000 patient days. Used units: g/1000 hospitalized patients days
Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection Time: 7 monthsDescription: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/hospitalization, DDD or DDA of unnecessary AB/hospitalization, DDD or DDA of inappropriate AB/hospitalization and DDD or DDA of suboptimal AB/hospitalization. Used units: g/hospitalization
Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2 Time: 7 monthsDescription: The number of C. Difficile infections in the inpatient setting
Measure: Rate of Clostridioides Difficile infections Time: 7 monthsDescription: median or mean age (number) , comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: median or mean weight (kg), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of comorbidities expressed as mean Charlson Comorbidity Index score, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of chronical pulmonary disease, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in rate of chronical pulmonary disease as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of haematological or solid neoplasia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in rate of haematological or solid neoplasia as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of diabetes mellitus, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in rate of diabetes mellitus as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients with fever (t°>38°c), dyspnea, cough, runny nose, throat pain, thoracic pain, myalgia, fatigue, anosmia, confusion at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: significant difference in rate of patients with presence or not of at least one suggestive symptom of COVID-19 symptomatology, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients rate of patients having received an antibiotic prescription for a suspicion of respiratory tract infection during the 3 weeks before hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics?
Measure: significant difference in rate of patients with recent AB prescription, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients with significant positive respiratory cultures, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the rate of patients having had at least one positive significant respiratory germ culture, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of patients with oxygen suppletion need, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the rate of patients needing oxygen supletion at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean duration of hospitalization on a COVID-ward, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: significant difference in the mean duration of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: significant difference in the rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean SatO2/FiO2 ratio (number ranging from 50-500), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the mean value of oxygen saturation percentage over fractional oxygen percentage, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean/median qSOFA score at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in qSOFA score level at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: Rate of lymphopenia (<1250/mcl), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?
Measure: Is there a significant difference in the rate of lymphopenia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean CRP values (mg/dl) at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of C-reactive protein measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean WBC count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of white blood cell count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean neutrophil count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of neutrophil count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean lymphocyte count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics
Measure: significant difference in the mean value of lymphocyte count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean creatinine (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of creatinine measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean LDH (U/L) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of LDH measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean bilirubin (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of bilirubin measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean ferritin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of ferritin (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean troponin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of troponins (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsDescription: mean D-dimer (ng/ml) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics
Measure: significant difference in the mean value of D-dimers (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics? Time: 7 monthsIn this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric "adult COVID-19" intensive care unit.
Description: Secondary infection will include healthcare associated infections as well as sepsis, and septic shock
Measure: Number of patient with secondary infection Time: 2 weeksDescription: mortality
Measure: Number of patients dying Time: 7-day, 28-day and 60-dayDescription: Description of the variable clinical phenotypes of COVID-19 in adults and children. This include COVID-19 respiratory failure, acute myocarditis and multi system inflammatory syndrome in children (MIS-C)
Measure: Description of clinical phenotypes Time: through study completion, an average of 4 weeksDescription: Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex
Measure: Description of immunological phenotypes Time: through study completion, an average of 4 weeksBackground: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial. Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.
Description: All-cause mortality at 60 days after randomization
Measure: 60-day mortality Time: 60 daysDescription: Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after randomization. For patients ventilated 28 days or longer and for subjects who die, VFD is 0.
Measure: Ventilator-free days Time: 28 daysPart I: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). No more than one subject per day will be enrolled. 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the data safety monitoring board (DSMB) as well as an amendment to the regulatory authorities (Paul-Ehrlich Institute and Ethics Committee) before proceeding to Part II. Part II: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study investigational medicinal product (IMP) (CoVac-1). 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the DSMB whether to proceed to next Part III. Part III: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). The aim of the clinical is to evaluate the safety and immunogenicity of a single use of a SARS-CoV-2-derived multi-peptide vaccine in combination with the toll like receptor (TLR)1/2 ligand XS15 in adults
Description: ECOG (Scale 0-5)
Measure: Safety- Eastern Cooperative Oncology Group (ECOG) Status Time: Day 28Description: temperature (in grade centigrade)
Measure: Safety -Vital Signs 2 Time: Day 28Description: blood pressure/pulse mmHg and bpm Follow-Up Days:Signs/symptoms, as assessed on volunteer's diary and visit
Measure: Safety -Vital Signs 3 Time: Day 28Description: Alkaline phosphatase (AP) Unit: U/l
Measure: Safety-Blood Chemistry and Coagulation 1 Time: Day 28Description: aspartate transaminase (AST/ SGOT) Unit: U/l
Measure: Safety-Blood Chemistry and Coagulation 2 Time: Day 28Description: hemoglobin (Hb) Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing Unit: g/dl
Measure: Safety-Hematology 1 Time: Day 28Description: red blood cells (RBC) Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing Unit: Mio/µl
Measure: Safety-Hematology 2 Time: Day 28Description: platelet count (PLT) Unit: 1000/µl Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing
Measure: Safety-Hematology 3 Time: Day 28Description: white blood cells (WBC) Unit: 1/µl Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.
Measure: Safety-Hematology 4 Time: Day 28Description: 60 ml of heparin blood for immunomonitoring and analysis of peptide specific T-cell response will be analyzed by the Walz lab, KKE Translational Immunologie at the Department of Immunology, Tuebingen (central laboratory). Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit. Unit:Counts
Measure: CoVac-1 specific T-cell response Time: Day 28The Paris Fire Brigade staff have been particularly exposed to COVID-19 due to rescue and care activities for victims at risk in Paris area (where the virus was actively circulating). In addition, when the pandemic began in France, they had to take care of patients before procedures to protect caregivers were implemented. The contamination of young military personnel, whose physical capacity was put into strain at work, raises the question of the consequences of COVID-19 on their physical fitness. At the time, the medium- and long-term evolution of this disease and its possible repercussions on physical fitness are unknown. Moreover, like any soldiers who have been confined, they may present at least a cardio-respiratory deconditioning (sometimes independent of the disease making it difficult to distinguish between a sequelae of the infection or rehabilitation). Based on previous coronavirus epidemics (Sars-Cov 1 and Mers-Cov), it appears that long-term sequelae are possible even in mild forms and can result in an alteration of exertion ability. In the current context and in the absence of national or international recommendations on the return to physical activity, the French Armed Forces Health Service has proposed a simple management plan aiming at: i) allowing mass screening for possible exercise intolerance and targeting at-risk personnel, ii) allowing individualized re-training and iii) guaranteeing that military personnel can carry out their mission without jeopardizing their health.
Description: Aerobic performance will be assessed through a test called VAMEVAL. VAMEVAL consists of running around a track marked out every 50 meters to the rhythm of a soundtrack that accelerates at a rate of 0.5 km/h in 2-minute increments until exhaustion or inability to maintain the pace of the race. The result of the test made on return to work will be compared to the last result on the same test performed before COVID-19 infection.
Measure: Magnitude of the decrease in aerobic performance on return to work Time: Up to 18 monthsA Trial of GC4419 in Patients with Critical Illness due to COVID-19
A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.
Description: Spirometry in Liters
Measure: Lung function Time: 6 months after hospital dischargeDescription: Spirometry in Liters
Measure: Lung function Time: 12 months after hospital dischargeDescription: Diffusing capacity of carbon monoxide (% predicted)
Measure: Lung function Time: 6 months after hospital dischargeDescription: Diffusing capacity of carbon monoxide (% predicted)
Measure: Lung function Time: 12 months after hospital dischargeDescription: 6 min walk test in Meters
Measure: Lung function Time: 6 months after hospital dischargeDescription: 6 min walk test in Meters
Measure: Lung function Time: 12 months after hospital dischargeDescription: Alterations in chest radiography
Measure: Radiological alterations Time: 6 months after hospital dischargeDescription: Alterations in chest radiography
Measure: Radiological alterations Time: 12 months after hospital dischargeDescription: Alterations in thoracic CT scan
Measure: Radiological alterations Time: 6 months after hospital dischargeDescription: Alterations in thoracic CT scan
Measure: Radiological alterations Time: 12 months after hospital dischargeDescription: Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)
Measure: Quality of life alterations Time: 6 months after hospital dischargeDescription: Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)
Measure: Quality of life alterations Time: 12 months after hospital dischargeSince December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019). It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care. Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured. In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection. The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.
Description: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Modified Medical Research Council"
Measure: Identify functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
Measure: Identify functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria
Measure: Identify functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Measure: Identify functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: complaints will be assessed by questionnaire "Modified Medical Research Council"
Measure: description of functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
Measure: description of functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: complaints will be assessed by FRIED criteria
Measure: description of functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Measure: description of functionnal and psychosocial complaints Time: 3 months after last hospitalizationDescription: Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization
Measure: Identify the factors favoring the persistence of complaints Time: 3 months after last hospitalizationDescription: Complaints will be assessed by questionnaire"Modified Medical Research Council"
Measure: Describe functional, neuropsychological and social complaints at a distance Time: 3 months after last hospitalizationDescription: Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"
Measure: Describe functional, neuropsychological and social complaints at a distance Time: 3 months after last hospitalizationDescription: Complaints will be assessed by FRIED criteria
Measure: Describe functional, neuropsychological and social complaints at a distance Time: 3 months after last hospitalizationDescription: Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Measure: Describe functional, neuropsychological and social complaints at a distance Time: 3 months after last hospitalizationDescription: Medical and surgical consultations after discharge will be measured as percentage
Measure: Describe the needs for medical and surgical consultations after discharge from hospital Time: 3 months after last hospitalizationDescription: neuropsychological support, dietetics, social assistance after discharge will be measured as percentage
Measure: Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital. Time: 3 months after last hospitalizationDescription: Describe the factors of inequalities in access to care and study their impact on the occurrence of a SARS-CoV-2 infection, its severity and the occurrence of a functional or psycho-social complaint.
Measure: Describe the factors of inequalities in access to care Time: 3 months after last hospitalizationInfection with covid-19 is associated with respiratory failure, which when related to other etiologies can lead to reduced quality of life, physical, cognitive and mental dysfunction. There is no knowledge of the possible consequences of severe covid-19 infection. Our objective is to describe these repercussions, identifying risk factors and assessing the impact of physical training. At least 100 patients over 18 years of age who survive severe Covid-19 infection will be evaluated. Assessments after 1, 4, 6 and 12 months after hospital discharge. Quality of life, dyspnea, activity of daily living, muscle strength, mental and cognitive dysfunction will be evaluated, as well as pulmonary function test, cardiopulmonary stress test and chest tomography. Return to work, thromboembolic events and mortality up to 12 months will also be monitored. Hospitalization data will be used to identify factors related to quality of life, fatigue and respiratory dysfunction. Predefined risk factors will be evaluated: age, sex, smoking, previous comorbidities index, previous clinical frailty, serum C-reactive protein and leukocyte / lymphocyte ratio in the first 24 hours of hospitalization, time between onset of symptoms and hospitalization, ICU and mechanical ventilation, time on mechanical ventilation, compliance corrected by the ideal weight at the start of mechanical ventilation, driving pressure, tidal volume corrected by the ideal weight and PEEP (positive end expiratory pressure) after 24 hours of intubation in controlled ventilation, tidal volume corrected by the ideal weight after 24 hours of spontaneous ventilation, inspiratory muscle training and pulmonary rehabilitation after hospital discharge.
Description: EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually. Assessment at 6 months after discharge
Measure: Quality of life assessment of a survivor of severe COVID-19 infection 6 months after hospital discharge; Time: 6 months after dischargeTo evaluate the spectrum of comorbidities and complications and its impact on the clinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).
Description: Identifying and management of different co-morbidities and complications of covid-19 infection.
Measure: Identifying different co-morbidities and complications of covid-19 infection. Time: baselineThe data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration. The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19
Description: 8-hour cortisol level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Measure: 8-hour cortisol level in patients with Covid19 pneumonia Time: day 0Description: TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Measure: TSH level in patients with Covid19 pneumonia Time: day 0Background: COVID-19 is an infection caused by a coronavirus. It can affect different parts of the body. For most people, it causes fevers or trouble breathing. Some people can have symptoms long after they recover. Researchers want to learn if there are signs of changes in the nervous system that may be related to COVID-19. Objective: To test the nervous system (the brain and nerves) in people who have had COVID-19 yet still have certain symptoms even after recovering. Eligibility: People age 18 and older who had COVID-19 and still have neurologic symptoms after they recovered from the initial infection. Design: Participants will be screened with a medical record review. Participants will have a neurological exam. They will complete pen-and-paper tests of their memory and thinking. They will complete a smell test with 'scratch-and-sniff' booklets. They will give blood samples. Participants will have magnetic resonance imaging (MRI) of the brain. Soft padding or a coil will be placed around their head. They will lie on a table that slides in and out of the MRI scanner. They will get a contrast dye through an intravenous (IV) catheter. Participants blood pressure, blood flow, skin temperature, sweating, and breathing will be monitored. Participants will have an electrocardiogram to measure heart function. Participants will blow into a mouthpiece for several seconds. Participants will lie on a table that has a motor. The motor tilts the table. Participants will have blood drawn through an IV as the table tilts. Participants will have a lumbar puncture. A small needle will be inserted into the spinal canal to obtain fluid. Participants may repeat some tests 8 weeks to 1 year later.
Description: The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect Covid-19-associated disease.
Measure: MRI brain abnormalities Time: at NIH Clinical Center VisitDescription: Neurologic examination: The number and character of abnormalities associated with both central and peripheral nervous system disease.
Measure: Neurological Examination Time: At NIH Clinical Center VisitDescription: Autonomic testing: The number and character of test results indicating autonomic nervous system disease as evidenced by abnormal heart rate and blood pressure responses during tilt table testing.
Measure: Autonomic Testing Time: At NIH Clinical Center VisitA new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020. The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on. Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic. Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm. Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2. The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia. They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases. Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization. Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.
Cancer patients are considered vulnerable to COVID-19 infection. During the pandemic, cancer patients may need to continue their regular treatment of chemotherapy and / or radiotherapy and therefore must visit a hospital unit. As such, they may be at risk for SARS-CoV-2 infection by means of close contact to other patients and health care workers. Hospitals may implement policies to identify symptomatic subjects and limit their access to the chemotherapy / radiotherapy unit. However, asymptomatic COVID-19 positive patients may escape these filters and potentially be contagious to other patients and their health-related workers that care for other several patients. Therefore, there is a real risk of an outbreak that affects a particularly fragile patient population. Patients and their doctors need to know what is the risk associated to visiting a chemotherapy unit in order to decide if the risk outweighs the benefits of cancer treatment in their particular case. To date, this risk is unknown. The study will test patients and health care workers for COVID-19 infection during the peak of the pandemic in a chemotherapy unit in Mexico in order to determine this risk.
Description: Determination of SARS-CoV-2 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy during the pandemic period.
Measure: SARS-CoV-2 infection rate in patients with solid tumors. Time: From June 2020 to September 2020.Description: Identification of patients with solid tumors receiving chemotherapy and / or radiotherapy in our center during the COVID-19 pandemic to get informed consent.
Measure: Integration of a cohort of patients with solid tumors receiving oncological treatment. Time: 4 monthsDescription: To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 among the cohort of patients with solid tumors through a daily digital survey.
Measure: Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors. Time: 4 monthsDescription: To determine the SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms through a PCR test for SARS-CoV-2.
Measure: SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms. Time: 4 monthsDescription: To determine the SARS-CoV-2 infection rate in asymptomatic patients with solid tumors through a biweekly PCR test for SARS-CoV-2.
Measure: SARS-CoV-2 infection rate in asymptomatic patients with solid tumors. Time: 4 monthsDescription: Determination of demographics, clinical and outcomes of cancer patients infected with SARS-CoV-2.
Measure: Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 . Time: 4 monthsDescription: Identification of healthcare workers that treat patients with solid tumors in the chemotherapy and radiotherapy unit at our center to get informed consent.
Measure: Integration of a cohort of healthcare workers. Time: 4 monthsDescription: To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 between the cohort of healthcare workers through a daily digital survey.
Measure: Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers. Time: 4 monthsDescription: To determine the SARS-CoV-2 infection rate in the cohort of healthcare workers with respiratory symptoms through a PCR test for SARS-CoV-2.
Measure: SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms. Time: 4 monthsDescription: To determine the SARS-CoV-2 infection rate in asymptomatic healthcare workers through a biweekly PCR test for SARS-CoV-2.
Measure: SARS-CoV-2 infection rate in asymptomatic healthcare workers. Time: 4 monthsDescription: Determination of past infection rate in both cohorts (patients with solid tumors and health-related workers) through IgG antibodies detection at the beginning and at the end of the trial.
Measure: Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection. Time: 4 monthsDescription: To create a register of oncological patients with solid tumors diagnosed with COVID-19.
Measure: Register of oncological patients with solid tumors diagnosed with COVID-19. Time: 4 monthsThe goal of this project is to help the state of Minnesota understand why individuals are not getting tested and potentially identify trusted individuals or organizations that could be used in follow-up work to send messages. Investigators focus on the first two issues of unit and item nonresponse, which is not random across the population and thus could lead to nonresponse bias. To do so, investigators are deploying flyers through 10 Twin City area food shelves and potentially through public housing units with information on how to answer an online questionnaire.
Description: Number of participants who received a flyer that mentions a $20 incentive and completed the survey
Measure: Effect of monetary incentives in increasing unit response 1 Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.Description: Number of participants who received a flyer that mentions a $10 incentive and completed the survey.
Measure: Effect of monetary incentives in increasing unit response 2 Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.Description: Number of participants who received a flyer that mentions a government frame and completed the survey
Measure: Effect of a government frame in reducing unit response 1 Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.Description: Number of participants who received a flyer that mentions a research frame and completed the survey.
Measure: Effect of a government frame in reducing unit response 2 Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.Description: Number of participants who received a flyer that mentions a government frame and $20 incentive and completed the survey
Measure: Interactions between monetary incentives and a government frame 1 Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.Description: Number of participants who received a flyer that mentions a government frame and $10 incentive and completed the survey
Measure: Interactions between monetary incentives and a government frame 2 Time: This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.Description: Number of participants who received a flyer that mentions a researcher frame and $20 incentive and completed the survey
Measure: Interactions between monetary incentives and a government frame 3 Time: This outcome will be assessed during the 20-minute Baseline Survey.Description: Number of participants who received a flyer that mentions a researcher frame and $10 incentive and completed the survey
Measure: Interactions between monetary incentives and a government frame 4 Time: This outcome will be assessed during the 20-minute Baseline Survey.Description: Demographic characteristics (e.g. sex, education level, income level, race/ethnicity) of participants who are assigned to each treatment arm and completed the survey.
Measure: Demographic characteristics of participants assigned into each treatment arm Time: This outcome will be assessed during the 20-minute Baseline Survey.Description: Number of survey participants who are randomly assigned to receive each messaging frame that: a) emphasizes the public health benefits of answering the survey questions (cost-benefit frame); b) emphasizes an individual's responsibility to their community (duty frame); c) emphasizes the disproportionate impact of COVID-19 on certain ethnic and racial groups; or d) provides no messaging.
Measure: Effect of various messaging frames in increasing item non-response Time: This outcome will be assessed during the 20-minute Baseline Survey.It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment. Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection
Description: Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors
Measure: describe cancer patients with COVID-19 and their clinical course Time: Almost 1 yearThe current research is a pilot study to determine the feasibility of recruiting and retaining 40 participants diagnosed with COVID-19. The purpose is to observe the early use of fluoxetine (commonly known as Prozac) to reduce the severity of the COVID-19 illness. Fluoxetine is a drug that has been approved by the U.S. Food and Drug Administration (FDA) since 1987 for various mental health disorders.
Description: Measures number of subjects hospitalized for COVID-19 symptoms
Measure: Rate of hospitalization Time: 8 weeksDescription: The 23-item daily symptom checklist measures the presence or absence of COVID-related symptoms (e.g. shortness of breath, fever, chills) and other possible symptoms (e.g. ear pain, vomit, seizures).
Measure: Physical symptoms assessed through daily checklist Time: 8 weeksDescription: Measures number of subjects intubated for COVID-19 symptoms
Measure: Rate of intubation Time: 8 weeksDescription: Measures number of subjects who die from COVID-19 symptoms
Measure: Rate of death Time: 8 weeksDescription: Measured using the 9-item Patient Health Questionnaire (PHQ-9) each item rated on a scale of 0-3, where 0=no depressive symptoms and 3=depressive symptoms present nearly every day. A high score indicates severe depression.
Measure: Depressive symptoms assessed weekly Time: 8 weeksDescription: Measured using the 4-item SPAN assessment rated on a scale from 0-4 where 0=not at all distressing and 4=extremely distressing. A score greater than 5 indicates the presence of PTSD.
Measure: Post traumatic stress disorder symptoms assessed weekly Time: 8 weeksDescription: Measured using the 7-item General Anxiety Disorder Scale (GAD-7) rated from 0-3, where 0=no anxiety symptoms and 3=anxiety symptoms present nearly ever day. A high score indicates severe anxiety.
Measure: Anxiety symptoms assessed weekly Time: 8 weeksDescription: Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.
Measure: Suicidality assessed daily Time: 8 weeksThe purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.
Description: % of anti-covid positive cells
Measure: Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19 Time: 3 monthsThe investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).
Description: RT-PCR on nasopharyngeal is considered as gold standard
Measure: Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus Time: At diagnosisDescription: Number of samples tested in a day for each test
Measure: Practicability to samples Time: At diagnosisDescription: Quantity of premises required for each test
Measure: Practicability to premises Time: At diagnosisDescription: Feasibly Reading and interpretation For each test
Measure: Practicability to interpretation Time: At diagnosisDescription: Render times for each test
Measure: Practicability to render time Time: At diagnosisDescription: Research of IgG by ELISA and RDT
Measure: IgG Antibody detection in saliva Time: At diagnosisDescription: Research of IgM by ELISA and RDT
Measure: IgM Antibody detection in saliva Time: At diagnosisDescription: Research of IgA by ELISA and RDT
Measure: IgA Antibody detection in saliva Time: At diagnosisDescription: Evaluation by questionnaire of the patient tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions are about pain, discomfort, speed of performance)
Measure: Patient tolerance of the salivary self-sampling Time: At diagnosisDescription: Evaluation by questionnaire of the operator tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions is about pain, discomfort, speed of performance)
Measure: Operator tolerance of the salivary self-sampling Time: At diagnosisDescription: Including sampling, transport, technique (consumables, reagents, machine), human resources
Measure: Cost of each approach Time: At diagnosisThis project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.
Description: Prevalence and risk-factors for SARS-CoV-2 infection
Measure: Prevalence and risk-factors for SARS-CoV-2 infection Time: inclusion during 4 monthsDescription: Prevalence and risk-factors for COVID-19
Measure: Prevalence and risk-factors for COVID-19 Time: inclusion during 4 monthsDescription: Durability of IgG positivity/immunity
Measure: Durability of IgG positivity Time: 12 monthsCORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.
Description: Secondary efficacy outcome
Measure: Proportion of participants seroconverting to SARS-CoV-2 (i.e. with test results for antibodies to SARS-CoV-2 transitioning from negative at baseline to positive at follow-up) Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants developing antigen test-positive COVID-19 Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants developing 'probable COVID-19', as adjudged using a validated symptom score Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants developing antigen test-positive influenza Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants reporting symptoms of acute respiratory infection Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Mean MRC dyspnoea score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: Secondary efficacy outcome
Measure: Mean FACIT Fatigue Scale score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: Secondary efficacy outcome
Measure: Mean COVID-19 Recovery Questionnaire score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who experience COVID-19 requiring hospitalisation Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants hospitalised for COVID-19 requiring ventilatory support Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants who experience influenza requiring hospitalisation Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of any cause during participation in the trial Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of acute respiratory infection during participation in the trial Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of COVID-19 during participation in the trial Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: Proportion of participants dying of influenza during participation in the trial • mean end-study 25(OH)D concentrations (sub-set of participants having end-study tests of vitamin D status) Time: Over 6 monthsDescription: Secondary efficacy outcome
Measure: mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) Time: 6 monthsDescription: Secondary safety outcome
Measure: Proportion of participants experiencing known hypercalcaemia Time: Over 6 monthsDescription: Secondary safety outcome
Measure: Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation Time: Over 6 monthsDescription: Secondary safety outcome
Measure: Proportion of participants experiencing a serious adverse event of any cause Time: Over 6 monthsIn December 2019, a cluster of pneumonia cases of unidentified cause emerged in Wuhan,was identified as the culprit of this disease currently being identified as "Coronavirus Disease 2019" (COVID-19) by World Health Organization. Coronavirus was found to not only target the patient's lungs but also multiple organs. Around 2-33% of Coronavirus Disease-19 patients developed gastrointestinal symptoms. Studies have shown that Severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) was found in patient's feces, suggesting that the virus can spread through feces. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes. The investigators are uncertain about the impact of synbiotic on patients with COVID-19. However, a therapeutic strategy aiming at investigating the gut Imicrobiota of patients with COVID-9 who take synbiotic or not, leading to lesser progression to severe disease, less hospital stay and improved quality of life.
Description: Combined symptom score improvement of the first 4 weeks. Symptoms score assessment ranges from 20-80. The higher the score, the worse the symptoms.
Measure: Combined symptom score Time: 4 weeksDescription: Compare the number and severity of symptoms existing by checking the list in symptoms assessment such as cough, shortness of breath, fever and gastrointestinal symptoms like anorexia, nausea, vomiting, abdominal pain, bloating before and during the study
Measure: Clinical improvement Time: 4 weeksDescription: Compare the time to develop antibody against SARS-CoV-2 in both group
Measure: Time to develop antibody against SARS-CoV-2 Time: 16 daysDescription: Improvement of quality of life measured by EQ-5D-5L. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The index can be calculated by deducting the appropriate weights from 1, the value for full health (i.e. state 11111). Each category ranges from 1 to 5. The small the number, the better the health. The EQ-VAS is a vertical visual analogue scale that ranges 0-100 (higher score indicates better imaginable health).
Measure: Quality of life measured by EQ-5D-5L Time: 4 weeksDescription: Improvement of quality of life measured by SF-12. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. There are formulas for transformation of scale scores so that they will range from 0-100. High score in functioning items indicates better functioning while high score in pain items indicates freedom from pain.
Measure: Quality of life measured by SF-12 Time: 4 weeksDescription: Measure the duration of hospital stay in both group
Measure: Duration of hospital stay Time: up to 3 monthsDescription: Compare the time to negative PCR in both group
Measure: Time to negative PCR Time: through study completion, an average of 1 yearDescription: Trend of symptom score, ranges from 26-104. The higher the score, the worse the symptoms.
Measure: Trend of symptom score Time: 4 weeksDescription: Duration of gastrointestinal symptoms such as anorexia, nausea, vomiting, abdominal pain, bloating within 4 week.
Measure: Gastrointestinal symptoms Time: 4 weeksDescription: Changes in fecal bacteria metabolites measured by PCR at different time points
Measure: Changes in fecal bacteria metabolites Time: weeks 2, 4, 5 and 8 months 3, 6, 9 and 12Description: Change in plasma cytokines level at week 2 and week 5 compared with baseline
Measure: Change in plasma cytokines level Time: week 2 and week 5Description: Changes in the gut microbiome (bacteria, virome and fungome) measured by metagenomics at different time points (weeks 1, 2, 3, 4, 5 and months 3, 6, 9 and 12) compared to baseline
Measure: Changes in the gut microbiome Time: weeks 1, 2, 3, 4, 5, 8 and months 3, 6, 9 and 12Description: Number of admission to Intensive Care Unit
Measure: Number of admission to Intensive Care Unit Time: 4 weeksDescription: Number of subjects with home discharge
Measure: Number of subjects with home discharge Time: 4 weeksDescription: Number of mortality
Measure: Number of mortality Time: 4 weeksDescription: Number of days absent from work since admission
Measure: Number of days absent from work Time: 3 monthsDescription: Change in score on Quality of life using EQ-5D-5L and SF-12. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The index can be calculated by deducting the appropriate weights from 1, the value for full health (i.e. state 11111). Each category ranges from 1 to 5. The small the number, the better the health. The EQ-VAS is a vertical visual analogue scale that ranges 0-100 (higher score indicates better imaginable health). While the SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. There are formulas for transformation of scale scores so that they will range from 0-100. High score in functioning items indicates better functioning while high score in pain items indicates freedom from pain.
Measure: Change of quality of life questionnaire Time: week 8, months 3, 6, 9 and 12Description: Number of adverse event
Measure: Number of adverse event Time: 3 monthsThe non-essential and non-urgent follow-up consultations of patients living with HIV were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients during COVID-19 epidemic. This change in care can have an impact on follow-up and access to treatment for PVVIH.
Description: Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at inclusion in the study
Measure: Prevalence of SARS CoV2 infection in PVVIH in Hauts de France Time: InclusionDescription: Determination of the number of patients with microbiologically or clinically-biologically proven SARS CoV2 infection at the end of the study
Measure: Prevalence of SARS CoV2 infection in PVVIH in Hauts de France Time: through study completion, an average of 19 monthsDescription: Percentage of patients who stopped their antiretroviral treatment
Measure: Determine the incidence rate of COVID 19 among PVVIH antiretroviral treatment Time: through study completion, an average of 19 monthsDescription: Reason for discontinuing antiretroviral treatment
Measure: Determine the incidence rate of COVID 19 among PVVIH discontinuing antiretroviral treatment Time: through study completion, an average of 19 monthsDescription: Percentage of patients who stopped all follow-up by an infectious disease specialist
Measure: Determine the incidence rate of COVID 19 among PVVIH who stopped all follow-up Time: through study completion, an average of 19 monthsDescription: Evaluation of the psychological scales HAD on PVVIH
Measure: Psychological consequences of this epidemic among PVVIH : HAD Time: through study completion, an average of 19 monthsDescription: Evaluation of the psychological scales PROQOL-HIV on PVVIH
Measure: Psychological consequences of this epidemic among PVVIH : PROQOL-HIV Time: through study completion, an average of 19 monthsThis study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).
Description: TEAEs in subjects receiving NGM621 compared to placebo
Measure: Treatment emergent adverse events - Part 1 Time: 85 daysDescription: TEAEs in subjects receiving NGM621 compared to placebo
Measure: Treatment emergent adverse events - Part 2 Time: 91 daysDescription: Clnical status (on an 8-point ordinal scale) in NGM621 group versus placebo group
Measure: Clinical status at Day 15 and Day 29 - Part 2 Time: 29 daysThe purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
Description: The RRS is an ordinal scale assessing a participant's clinical status.
Measure: Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Time: Up to Day 8Description: Clinical resolution is defined by free of oxygen supplementation, and free of supplemental feeding, and no medical need for intensive care unit (ICU), and key RSV Signs/Symptoms resolved to absent or mild as per the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Clinician Rated Outcome (ClinRO) Signs/Symptoms questionnaire.
Measure: Percentage of Participants with Clinically Resolved RSV Disease as Assessed by ClinRO Sign/Symptoms Questionnaire Time: Up to Day 8Description: Time from first study dose to resolution of key RSV Signs/symptoms (absent or mild) will be assessed based on parent's/caregiver's PRESORS Observer Rated Outcome (ObsRO) signs/symptoms and supplementation free (oxygen and feeding/hydration).
Measure: Time From First Study Dose to Resolution of key RSV Signs/Symptoms Based on ObsRO Time: Up to Day 21Description: Time from discharge to resolution of key RSV Signs/symptoms will be assessed based on PRESORS ObsRO Sign/Symptoms (only including participants who did not reach resolution before first discharge).
Measure: Time From Discharge to Resolution of key RSV Signs/Symptoms based on ObsRO Sign/Symptoms Questionnaire Time: Up to Day 21Description: Time from first dosing to end of oxygen supplementation will be assessed (only including participants who were receiving oxygen supplementation at the time of first dosing).
Measure: Time From First Dosing to end of Oxygen Supplementation Time: Up to Day 35Description: Number of participants with post-baseline RSV-related complications will be assessed.
Measure: Number of Participants with Post-baseline RSV-Related Complications Time: Up to Day 35Description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Measure: Number of Participants with Adverse Events Time: Up to Day 35Description: Number of participants with abnormalities in Clinical laboratory values (Hematology, Clinical chemistry, and routine urinalysis) will be assessed.
Measure: Number of Participants with Abnormalities in Clinical Laboratory Values Time: Up to Day 35Description: Number of participants with ECG abnormalities will be assessed.
Measure: Number of Participants with Abnormalities in Electrocardiograms (ECG) Time: Up to Day 35Description: Number of participants with vital signs (Temperature, pulse/heart rate, and peripheral capillary oxygen saturation [SpO2]) abnormalities will be assessed.
Measure: Number of Participants with Abnormalities in Vital Signs Time: Up to Day 35Description: Time to resolution of signs/symptoms (absent or mild) of RSV disease as assessed by PRESORS ObsRO signs/symptoms questionnaire.
Measure: Time to Resolution of Signs/symptoms of RSV Disease as Assessed by ObsRO Signs/Symptoms Questionnaire Time: Up to Day 21Description: PRESORS ObsRO Signs/Symptoms Questionnaire Scores will be assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease.
Measure: PRESORS ObsRO Signs/Symptoms Questionnaire Scores Time: Up to Day 21Description: Change from baseline in PRESORS ObsRO Signs/Symptoms questionnaire scores over time will be assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease.
Measure: Change From Baseline in PRESORS ObsRO Signs/Symptoms Questionnaire Scores Over Time Time: Baseline up to Day 21Description: Time to improvement on PRESORS ObsRO GHQ will be assessed. ObsRO GHQ contains questions which are used to record the caregiver's general impression of the child's RSV disease severity, change in RSV disease severity, and overall health status.
Measure: Time to Improvement in ObsRO General Health Questions (GHQ) Time: Up to Day 21Description: Time to resolution of signs/symptoms of RSV disease as assessed by ClinRO signs/symptoms questionnaire will be reported.
Measure: Time to resolution of Signs/Symptoms of RSV Disease as Assessed by ClinRO Signs/Symptoms Questionnaire Time: Up to Day 21Description: PRESORS ClinRO signs/symptoms questionnaire score will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease.
Measure: PRESORS ClinRO Signs/Symptoms Questionnaire Scores Time: Up to Day 21Description: Change from baseline in PRESORS ClinRO signs/symptoms questionnaire scores over time will be assessed.
Measure: Change From Baseline in ClinRO Signs/Symptoms Questionnaire Scores Time: Baseline up to Day 21Description: Percentage of participants with clinically resolved RSV disease based on PRESORS ClinRO signs/symptoms will be assessed.
Measure: Percentage of Participants with Clinically Resolved RSV Disease Based on ClinRO Signs/symptoms Time: Day 2 to 8Description: Change from baseline in ClinRO GHQ score over time will be assessed. ClinRO GHQ contains questions which are used to record the caregiver's general impression of the child's RSV disease severity, change in RSV disease severity, and overall health status.
Measure: Change from Baseline in ClinRO GHQ Score Over Time Time: Baseline up to Day 21Description: Time to hospital discharge from start of dosing will be assessed.
Measure: Time to Hospital Discharge From Start of Dosing Time: Up to Day 35Description: Time to readiness of participants for hospital discharge (as evaluated by the investigator) will be assessed.
Measure: Time to Readiness for Hospital Discharge Time: Up to Day 35Description: Percentage of participants requiring ICU stay will be assessed.
Measure: Percentage of Participants Requiring Intensive Care Unit (ICU) Stay Time: Up to Day 35Description: Duration of requiring ICU stay will be assessed.
Measure: Duration of Requiring ICU Stay Time: Up to Day 35Description: Percentage of participants requiring re-hospitalization for respiratory/other reasons will be assessed.
Measure: Percentage of Participants Requiring Re-hospitalization for Respiratory/other Reasons Time: Up to Day 35Description: Time to end of oxygen supplementation will be assessed.
Measure: Time to end of Oxygen Supplementation Time: Up to Day 35Description: Percentage of participants requiring oxygen supplementation will be assessed.
Measure: Percentage of Participants Requiring Oxygen Supplementation Time: Up to Day 35Description: Duration of oxygen supplementation will be assessed.
Measure: Duration of Oxygen Supplementation Time: Up to Day 35Description: Time to end of supplemental feeding/hydration will be assessed.
Measure: Time to end of Supplemental Feeding/hydration Time: Up to Day 35Description: Percentage of participants requiring hydration and/or feeding by IV administration or nasogastric tube will be assessed.
Measure: Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube Time: Up to Day 35Description: Duration of supplemental feeding/hydration will be assessed.
Measure: Duration of Supplemental Feeding/hydration Time: Up to Day 35Description: Time to end of supplemental oxygen and/or feeding/hydration will be assessed.
Measure: Time to end of Supplemental Oxygen and/or Feeding/hydration Time: Up to Day 35Description: Number of participants with medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.
Measure: Number of Participants with Medical Encounters and Treatments Time: Up to Day 35Description: Number of participants with antibiotic treatment episodes will be assessed.
Measure: Number of Participants with Antibiotic Treatment Episodes Time: Up to Day 35Description: Number of participants with systemic or inhaled corticosteroids and bronchodilators use will be assessed.
Measure: Number of Participants with Systemic or Inhaled Corticosteroids and Bronchodilators use Time: Up to Day 35Description: RSV viral load area under the RSV viral load-time curve [AUC] will be assessed by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.
Measure: RSV Viral Load Area Under the RSV Viral Load-time Curve [AUC]) From Immediately Prior to First Dose of Study Intervention (Baseline) Through Day 3, Day 5, and Day 8 Time: Baseline, Day 3, 5 and Day 8Description: RSV viral load over time will be assessed by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measure: RSV Viral Load Over Time Time: From Baseline to Day 21Description: Change From baseline in RSV viral load over time will be assessed by qRT-PCR assay in the mid-turbinate nasal swabs specimens.
Measure: Change From Baseline in RSV Viral Load Over Time Time: Baseline to Day 21Description: Percentage of participants with undetectable RSV viral load will be assessed.
Measure: Percentage of Participants with Undetectable RSV Viral Load Time: Up to Day 21Description: Number of participants with post-baseline changes in the RSV F-gene compared with baseline sequences will be assessed.
Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences Time: Up to Day 21Description: Plasma concentration of rilematovir will be assessed.
Measure: Plasma Concentration of Rilematovir Time: Post-dose (Day 1) and pre-dose (Day 2)Description: Acceptability and palatability of the rilematovir formulation will be assessed through a questionnaire completed by parent(s)/caregiver(s).
Measure: Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) Time: Day 8A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs & saliva samples).
Description: A positive percent agreement (PPA) of EASYCOV PoC assay will be corroborated with the routine Turkish MOH and FDA approved reference method RT-PCR using nasopharyngeal samples.
Measure: Positive percent agreement (PPA) Time: 1 monthDescription: The performance (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of EASYCOV POC assay will be evaluated compared to the routine Turkish MOH and FDA approved RT-PCR method using nasopharyngeal samples.
Measure: Performance Time: 1 monthThe coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. These patients represent a significant infection risk to the medical staff. According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form. Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection, especially in healthcare workers who are at high risk of infection.
Description: This is the proportion of patients with at least one positive serology between W2 and W19. The time of S19 takes into account a seroconversion delay of 5 weeks in relation to the SARS-CoV2 contamination.
Measure: SARS-COV2 seroconversion between W0 and W19 after randomization Time: Between week 0 and week 19Description: This is the proportion of patients with at least one positive serology between W2 and W16.
Measure: SARS-COV2 seroconversion Time: Week 16Description: Asymptomatic COVID-19 infection is defined as SARS-CoV2 seroconversion at Week 19 without symptoms suggestive of COVID until the end of Week 16 to take in account of the two weeks of incubation period
Measure: Asymptomatic COVID-19 infection proportion at week 14 Time: Week 14Description: documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared before W8 and W16 respectively, and requiring hospitalization or home oxygen therapy, or having resulted in death
Measure: Proportion of severe COVID-19 infection Time: Week 8, Week16The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.
Description: The investigators will analysis total gene expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole transcriptome will be extracted and processed for analysis (about 25000 genes) using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).
Measure: Differential gene expression profile. Time: 3 monthsDescription: The investigators will analysis total miRNA expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole miRNA expression will be extracted and processed for analysis using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).
Measure: Differential miRNA expression profile. Time: 3 monthsDescription: This assay will be done on plasma of patients. The investigators will analysis the different cytokine profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using xMAP (Multi-Analyte Profiling) technology & Luminex 200. The obtained data will be analyzed using statistical software to study the different profile between the selected participants. The obtained data will be also correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).
Measure: Multiplex Cytokine assay Time: 3 monthsGiven the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial. The aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in military health professionals in Tunisia compared to two control groups.
Description: Determine if the use of doxyciciline low dose as preventive treatment decrease the number of cases infected with covid 19 in the active arm compared to the placebo arm. Participants for each randomized treatment arm as compared to placebo.
Measure: decreasing the number of cases infected with covid 19 Time: WEEK 6Description: Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.
Measure: Measurement of the emergence of clincal symptoms of COVID 19 Time: WEEK 6Description: Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized DOXY versus placebo.
Measure: the seroprevalence of SARS- CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving DOXY compared to those receiving placebo. Time: WEEK 6This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.
Description: Based on therapy outcome measures from FEES, VoiS
Measure: Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation). Time: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months) Time: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 monthsDescription: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only. Time: t = day 5, day 10, day 14, day 21 - For in-patients only.Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: Relationship between severity of dysphonia and/or dysphagia with grade of ARDS Time: t = day 0 and 9 monthsDescription: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: Relationship between severity of dysphonia and/or dysphagia with length of intubation Time: t = day 0 and 9 monthsDescription: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measure: Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation Time: t = day 0 and 9 monthsDescription: Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28
Measure: Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months. Time: t = day 0, 1 month and 9 months.Description: Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).
Measure: Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months Time: t = day 0, 1 month and 9 monthsThis is a longitudinal study of the long-term impact of COVID-19 on the lungs. Participants will be followed over a period of up to 4 years and impacts of COVID-19 on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129, pulmonary function tests, exercise capacity, computed tomography imaging and questionnaires.
Description: Measured using 129-Xenon MRI ventilation defect percent
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by VDP. Time: 1 yearDescription: Measured using forced expiratory volume in one second (FEV1)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FEV1. Time: 1 yearDescription: Measured using forced vital capacity (FVC)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FVC. Time: 1 yearDescription: Measured using total lung capacity (TLC)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by TLC. Time: 1 yearDescription: Functional residual capacity (FRC)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FRC. Time: 1 yearDescription: Measured using residual volume (RV)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by RV. Time: 1 yearDescription: Measured using forced oscillation technique (FOT)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FOT. Time: 1 yearDescription: Measured using lung clearance index (LCI)
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by LCI. Time: 1 yearDescription: Measured using Fractional Exhaled Nitric Oxide (FeNO).
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by FeNO. Time: 1 yearDescription: Exercise capacity measured by six-minute walk test
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by exercise capacity. Time: 1 yearDescription: Measured using the baseline dyspnea index questionnaire.
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by baseline dyspnea index questionnaire Time: 1 yearDescription: Measured using the modified medical research council (mMRC) dyspnea scale questionnaire.
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by (mMRC) dyspnea scale questionnaire. Time: 1 yearDescription: Measured using the COPD assessment test (CAT).
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by CAT. Time: 1 yearDescription: Measured using the St. George's respiratory questionnaire (SGRQ).
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by SGRQ. Time: 1 yearDescription: Measured using the International Physical Activity Questionnaire (IPAQ).
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by IPAQ. Time: 1 yearDescription: Measured using blood and sputum eosinophil count.
Measure: Determine long-term respiratory impairment in COVID-19 survivors who did and did not require hospitalization at one year as measured by eosinophil count. Time: 1 yearDescription: Measured using 129-Xenon MRI ventilation defect percent
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by VDP. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using forced expiratory volume in one second (FEV1).
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FEV1. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using forced vital capacity (FVC)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FVC. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using total lung capacity (TLC)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by TLC. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using functional residual capacity (FRC)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FRC. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using residual volume (RV)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by RV. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using forced oscillation technique (FOT).
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FOT. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using lung clearance index (LCI)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by LCI. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using Fractional Exhaled Nitric Oxide (FeNO)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by FeNO. Time: within 3 months post COVID-19 infection recoveryDescription: Exercise capacity measured by six-minute walk test
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by exercise capacity. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using the baseline dyspnea index questionnaire.
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the baseline dyspnea index questionnaire. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using the modified medical research council (mMRC) dyspnea scale questionnaire
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by the mMRC dyspnea scale questionnaire. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using the COPD assessment test (CAT)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by CAT. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using the St. George's respiratory questionnaire (SGRQ)
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by SGRQ. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using the International Physical Activity Questionnaire (IPAQ).
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by IPAQ. Time: within 3 months post COVID-19 infection recoveryDescription: Measured using blood and sputum eosinophil count.
Measure: Determine the clinical, structural, physiologic, and imaging biomarkers within 3 months post COVID-19 infection recovery as measured by eosinophil count.. Time: within 3 months post COVID-19 infection recoveryDescription: Evaluated by assessing different genders.
Measure: Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by sex. Time: up to 4 yearsDescription: Evaluated by assessing different age groups.
Measure: Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by age. Time: up to 4 yearsDescription: Evaluated by assessing smoking history measured in pack-years.
Measure: Determine if COVID-19-induced respiratory impairment and predictors of respiratory impairment differ by smoking history measured in pack-years. Time: up to 4 yearsRandomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.
Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 15 Minutes Time: Baseline, 15 minutesDescription: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 30 Minutes Time: Baseline, 30 MinutesDescription: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 45 Minutes Time: Baseline, 45 MinutesDescription: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva
Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 60 Minutes Time: Baseline, 60 MinutesThe principal objective is to determine the impact of phenelzine on the activation phenotype of T cells and myeloid cells during SARS-CoV2 infection
Description: evaluate the levels of the activation of T cells and myeloid cells after phenelzine exposure by the levels of the % of DR+ CD38+ T cells and CD14+dim CD16+ monocytes.
Measure: levels of lymphocytes T DR + CD38 + and of monocytes CD14 dim + CD16 +. Time: through study completion, an average of 1 yearDescription: evaluate the levels of the expression of immune checkpoints on T cells by flow cytometry
Measure: level of immune checkpoints Time: through study completion, an average of 1 yearDescription: evaluate the modification of functional capacities of T cells by cytokines production, and proliferation, after mitogenic and antigen recall stimulations including SARS-CoV-2 antigens
Measure: cytokine production and proliferation Time: through study completion, an average of 1 yearDescription: assess if there is an impact of phenelzine on the activation levels of neutrophils
Measure: levels of neutrophils Time: through study completion, an average of 1 yearDescription: Determine if the immune responses in obese patients (a strong risk factor for severe Covid19) can be modulated in the same way compared with lean patients
Measure: level of immune responses in obese patients Time: through study completion, an average of 1 yearDescription: Determine if the immune responses can be modulated in the same way in men and in women (men being affected by more severe disease)
Measure: level of immune responses for men and women Time: through study completion, an average of 1 yearIn this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.
Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measure: Mucosal antibodies Time: Day 0Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measure: Mucosal antibodies Time: Day 3 (index cases)Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measure: Mucosal antibodies Time: Day 6 (index cases)Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measure: Mucosal antibodies Time: Day 7 (household contacts)Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measure: Mucosal antibodies Time: Day 14 (household contacts)Description: Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measure: Mucosal antibodies in all participants Time: Day 28Description: SARS-CoV-2 PCR on nasopharyngeal swab and throat swab
Measure: SARS-CoV-2 infection Time: day 0Description: Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.
Measure: Serum antibodies Time: day 28Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measure: Functional antibody assays Time: Day 0Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measure: Functional antibody assays Time: Day 3 (index cases)Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measure: Functional antibody assays Time: Day 6 (index cases)Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measure: Functional antibody assays Time: Day 7 (household contacts)Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measure: Functional antibody assays Time: Day 14 (household contacts)Description: Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measure: Functional antibody assays Time: Day 28This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
Several publications document the occurrence of symptoms that persist or occur late. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients. Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
Description: Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months.
Measure: Clinical description of asthenia Time: At the end od the study, an average of 22 monthsDescription: Frequence of dyspnea between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measure: Clinical description of dyspnea Time: At the end od the study, an average of 22 monthsDescription: Frequence of thoracic disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measure: Clinical description of thoracic disorders Time: At the end od the study, an average of 22 monthsDescription: Frequence of neurological disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measure: Clinical description of neurological disorders Time: At the end od the study, an average of 22 monthsDescription: Frequence of anosmia disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Measure: Clinical description of anosmia Time: At the end od the study, an average of 22 monthsSince 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. With the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. The biological disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease 2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives. Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the management of biological disasters for an overcrowded emergency department should be planned. In the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected COVID-19. This application reduced the exposure time of the first responders and reserve adequate interview quality. However, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. These factors might led to poorer quality of critical care. The investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. This model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. Besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. This study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.
Description: Team Emergency Assessment Measure, minimal score is 0 and the maximal score is 4. Higher score means a better outcome.
Measure: teamwork score Time: immediately after interventionThis is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.
Description: Primary safety outcome Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) Proportion of patients with Treatment-Emergent Serious Adverse Events (TESAEs) Proportion of patients with Treatment-Emergent Adverse Events of Special Interest (TEAESI; infusion related reactions including hypersensitivity/anaphylactic reaction) Proportion of patients with potential effects on the incidence of Antibody-Dependent Enhancement (ADE)
Measure: To evaluate the preliminary safety and tolerability of CT-P59 up to Day 14 of the last enrolled subject Time: Up to Day 14Description: 1. The percentage of patients with positive/negative for quantitative Polymerase Chain Reaction (qPCR) and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 2. Duration (days) of viral shedding in nasopharyngeal swab specimens for qPCR and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 3. Area under the concentration-time curve of viral titers for qPCR and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 4. Actual results and change from baseline for viral shedding in nasopharyngeal swab specimens (titers) for qPCR and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 1. Proportion of patients with clinical recovery
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 2. Proportion of patients requiring supplemental oxygen
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 3. Proportion of patients with intensive care unit transfer
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 4. Proportion of mechanical ventilation
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 5. Proportion of patients with all-cause mortality
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 6. Proportion of patients with hospital admission
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 1. Pharmacokinetic (PK) parameter: Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 2. Pharmacokinetic (PK) parameter: Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 3. Pharmacokinetic (PK) parameter: Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 4. Pharmacokinetic (PK) parameter: Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 5. Pharmacokinetic (PK) parameter: Time to Cmax (Tmax) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 6. Pharmacokinetic (PK) parameter: Terminal half-life (t1/2) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 7. Pharmacokinetic (PK) parameter: Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 8. Pharmacokinetic (PK) parameter: Terminal elimination rate constant (λz) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 9. Pharmacokinetic (PK) parameter: Total body clearance (CL) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 10. Pharmacokinetic (PK) parameter: Volume of distribution during the elimination phase (Vz) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.
Description: Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Measure: Describe the frequency PIIRs Time: 1 dayDescription: Describe the characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Measure: Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection Time: 1 dayDescription: Identified the predictors of PIIRs in order to find warning symptoms
Measure: Predictors of PIIRs Time: 1 dayDetermine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.
Description: COVID19-0001-USR 1% nebulized pathway changes viral load of SARS-COV-2 virus (COVID19) in the upper and lower airways if started during the initial phase of infection
Measure: Change on viral load results from baseline after using COVID19-0001-USR via nebulization Time: Treatment Period of 7 daysThis is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107). Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S. aureus BSI including IE.
The COVID-19 infection primarily manifests itself as a respiratory tract infection, although new evidence indicates that this disease has systemic involvement involving multiple systems including the cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune systems. Recent studies have shown that in its pathophysiology, inflammation and thrombogenesis predominate, especially in the severe forms of COVID-19. Thus, the investigators hypothesized that the use of heparin and tocilizumab could potencially reduce inflammation and thrombogenesis in patients with severe COVID-19 infection, improving patients outcomes and survival.
Description: Proportion of patients with clinical improvement in 30 days, defined by hospital discharge or a reduction of at least 2 points compared to baseline on the ordinal scale recommended by the World Health Organization: Not hospitalized, with no limitations on activities; Not hospitalized, but limited to activities; Hospitalized, with no need for supplemental oxygen; Hospitalized, needing supplemental oxygen; Hospitalized, requiring high flow oxygen therapy, non-invasive mechanical ventilation or both; Hospitalized, requiring ECMO, invasive mechanical ventilation or both; Death.
Measure: Proportion of patients with clinical improvement Time: 30 daysDescription: Number of days in hospital and ICU
Measure: Hospital and ICU length of stay; Time: 30 daysDescription: Rate and Time of invasive mechanical ventilation
Measure: Duration of invasive mechanical ventilation Time: 30 daysDescription: Time of use of vasopressors
Measure: Duration of vasopressor use Time: 30 daysDescription: Renal failure by AKIN criteria in 30 days
Measure: Renal failure by AKIN criteria Time: 30 daysDescription: Myocardial injury; Acute myocardial infarction; Cardiogenic shock; arrhythmias; Myocarditis; Pericarditis; Ventricular dysfunction.
Measure: Incidence of cardiovascular complications Time: 30 daysDescription: Deep vein thrombosis and pulmonary embolism
Measure: Incidence of venous thromboembolism Time: 30 daysDescription: Mortality rate
Measure: Mortality Time: 30, 60 and 90 daysThis is a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate SARS-CoV-2 infected patients and safety during after study drug injection.
Description: Proportion of patient with negative conversion in nasopharyngeal swab specimen based on reverse transcription quantitative polymerase chain reaction(RT-qPCR)or cell culture at each visit.
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 14Description: Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 14Description: Time to clinical recovery
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 14Description: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) Time: Up to Day 28Description: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection
Measure: To evaluate the therapeutic efficacy CT-P59 for Part 2 (Phase III) Time: Up to Day 28Description: Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection.
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients with all-cause mortality
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Time to clinical recovery
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Duration of fever defined as the last day in the patient diary on which the temperature >38°C (100.4°F) is recorded, or a potentially antipyretic drug (acetaminophen or ibuprofen) is taken
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients with hospital admission due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of mechanical ventilation due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients requiring additional prescription medication due to SARS-CoV-2 infection
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture
Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2 Time: Up to Day 14 and 28Description: Proportion of patients reporting Adverse events (AEs, including serious adverse events)
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Proportion of patients reporting Adverse events of special interest (Infusion related reactions, hypersensitivity and anaphylactic reactions)
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Incidence of ADE (Antibody Dependent Enhancement)
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Proportion of patients with anti-drug antibodies Immunogenicity
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Proportion of patients with anti-drug antibodies S evere Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection related signs and symptoms.
Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2 Time: Up to Day 90Description: Viral shedding in nasopharyngeal swab specimen based on RT-qPCR and cell culture
Measure: To evaluate virology for part 1 and part 2 Time: Up to Day 90Description: Genotype and phenotype of SARS-CoV-2 viral isolates
Measure: To evaluate virology for part 1 and part 2 Time: Up to Day 90Description: Viral serology for SARS-CoV-2 antibody
Measure: To evaluate virology for part 1 and part 2 Time: Up to Day 90The aim is to deliver an intervention to promote nurse leadership and decision-making in the hospital setting, by providing them with training for maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.
Description: It will consist of 44 questions for core competencies of infection control and prevention, including 10 constructs of: (1) Identification of infectious disease processes, (2) Surveillance and epidemiologic investigations, (3) Preventing/controlling the transmission of infectious agents, (4) Employee/occupational health, (5) Management and communication planning, (6) Quality/performance improvement and patient safety, and (7) Education and research education, (8) Confidence with training and awareness for identification and implementation for COVID-19 prevention and control strategies, (9) confidence in training and awareness, and (10) satisfaction with workplace support. It is a five-point Likert-type scale (strongly agree - agree - neutral - disagree - strongly disagree). The highest value of the scale is 6 and the lowest value is 1; with 6 points showing strong agreement with the item statement (E.g. Q1. Can you differentiate between other infections and COVID-19).
Measure: Core competencies in nurses for infection control and prevention (Min and Sil 2014) Time: 3 monthsSARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that we call "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response. ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARB, losartan, limits lung injury in murine influenza H7N9 and decreases viral titre and RNA. We have a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARB, losartan) to decrease the mortality of hospitalized COVID-19 patient.
Description: Location within hospital (ICU or wards)
Measure: ICU Admission Time: up to 6 monthsDescription: Sequential Organ Failure Assessment (SOFA) score
Measure: SOFA score Time: 28 daysDescription: Use of inotropic agents and increase(s) of of troponin and/or NT-proBNP from admission level
Measure: Acute cardiac injury Time: 6 monthsDescription: Severe adverse effects of ARBs and mortality
Measure: Severe adverse events Time: 6 monthsThe objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2. It is a case-control study including : - cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system; - controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement); - cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls. Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.
Description: Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places through case-control analyses.
Measure: Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the online questionnaire Time: 1 yearDescription: Proportion of cases reporting likely contamination circumstances in the family environment
Measure: Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the phone interview Time: 1 yearDescription: Proportion of cases reporting likely contamination circumstances in the family environment
Measure: Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the online questionnaire Time: 1 yearDescription: Proportion of cases reporting likely contamination circumstances in the professional environment
Measure: Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the phone interview Time: 1 yearDescription: Proportion of cases reporting likely contamination circumstances in the professional environment
Measure: Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the online questionnaire Time: 1 yearDescription: Proportion of participants reporting adherence to mask-wearing
Measure: Level of adherence to mask-wearing reported in the phone interview Time: 1 yearDescription: Proportion of participants reporting adherence to mask-wearing
Measure: Level of adherence to mask-wearing reported in the online questionnaire Time: 1 yearDescription: Proportion of participants reporting adherence to hand-washing
Measure: Level of adherence to hand-washing in the phone interview Time: 1 yearDescription: Proportion of participants reporting adherence to hand-washing
Measure: Level of adherence to hand-washing in the online questionnaire Time: 1 yearDescription: Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places through case-control analyses.
Measure: Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the phone interview Time: 1 yearThe coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form. Daily active smokers are rare among outpatients or hospitalized COVID-19 patients. Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR). Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).
Description: Defined by scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 14
Measure: The unfavorable outcome on Day 14 Time: Day 14COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV). The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying. There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.
The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines. Camostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.
Description: Proportion of patients hospitalized for COVID-19 deterioration or who died without hospitalization
Measure: Hospitalization for COVID-19 deterioration or death without hospitalization Time: Day 21Description: Number of patients with at least one adverse event
Measure: Adverse events Time: Day 21Description: Number of patients with at least one serious adverse event
Measure: Serious adverse events Time: Day 21Description: Number of patients who discontinued the investigational medication
Measure: Investigational medication discontinuation Time: Day 21Description: Proportion of patients hospitalized for COVID-19 deterioration (reviewed by independent adjudication comitter) or who died without hospitalization
Measure: Hospitalization for COVID-19 deterioration or death without hospitalization, evaluated by independent adjudication comittee Time: Day 21Description: WHO clinical scale: Uninfected - No clinical or virological evidence of infection: 0; Ambulatory - No limitation of activities: 1; Ambulatory - limitation of activities: 2; Hospitalized - no oxygen therapy: 3; Hospitalized - oxygen by mask or nasal prongs: 4; Hospitalized; oxygen by non invasive ventilation or High flow: 5; Intubation and Mechanical ventilation: 6; Mechanical ventilation + additional organ support (pressors, Renal replacement therapy, ECMO):7; Dead: 8
Measure: Clinical improvement using the Word Health Organization (WHO) COVID-19 scale Time: Day 7, 14, 21Description: Proportion of patients admitted to an intensive care unit
Measure: Need for intensive care Time: Day 21Description: Number of days alive without hospitalization up to day 21
Measure: Duration of hospitalization Time: Day 21Description: Proportion of patients with initiation of invasive mechanical ventilation
Measure: Need for invasive mechanical ventilation for severe COVID-19 Time: Day 21Description: Proportion of patients with initiation of oxygen therapy
Measure: Need for oxygen therapy for COVID-19 Time: Day 21Description: Proportion of patients alive at day 90
Measure: Overall survival Time: Day 90Description: Number of days alive without symptoms at day 21
Measure: Duration of symptoms Time: Day 21Description: By Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) on nasal swab and droplet quantification of SARS-CoV2 ribonucleic acid-emia (RNAemia)
Measure: SARS-CoV-2 virological assessment Time: Day 7, 14, 21Description: SARS-CoV2 antibodies quantification in blood
Measure: SARS-CoV-2 serological assessment Time: Day 7, 14, 21 and 90Description: Peripheral blood lymphocyte phenotyping with telomere length measurement
Measure: Peripheral blood lymphocyte phenotyping Time: Day 1, 14, 90Description: Acute kidney failure defined as at least serum creatinine increase of 0.3mg/dl or 1.5-1.9 times baseline and/or oliguria < 0.5ml/kg/h
Measure: Acute kidney failure Time: Day 21Description: estimated glomerular filtration rate
Measure: Renal function Time: Day 7, 14 and 21Description: Uricemia in mmol/L or mg/dL
Measure: Concentration of urea in blood Time: Day 7, 14 and 21Description: Kaliemia in mmol/L
Measure: Concentration of potassium in blood Time: Day 7, 14 and 21Description: Liver transaminases dosage on blood sample
Measure: Liver function Time: Day 7, 14 and 21Description: Gamma-glutamyl transferase (gamma-GT) dosage on blood sample
Measure: Liver function (2) Time: Day 7, 14 and 21Description: Biobanking of blood samples for predictive biomarker assessment
Measure: Biobanking for biomarker assessment Time: Day 1, 7, 14, 21, 90A randomized, parallel-group treatment, quadruple masked, two-arm study to assess the effectiveness of cod liver oil compared to placebo in the prevention of Covid-19 and airway infections in healthy adults. In this study, the investigators will investigate whether daily cod liver oil can prevent Covid-19 infections and reduce the severity of such infections. The investigators will also examine whether cod liver oil prevents other airway infections in healthy adults.
Description: The number of participants with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories in the period from one week after the start of cod liver oil/placebo taking to the end of this period together with any of the following: A) Self-reported dyspnea and fever concurrent (within four weeks) with the positive test OR B) hospitalization caused by Covid-19 concurrent (within four weeks) with the positive test OR C) death where the Covid-19 infection was wholly or partly responsible as judged by the death certificate (see endpoint in the protocol)
Measure: Number of participants diagnosed with serious Covid-19 Time: 6 monthsDescription: The number of participants diagnosed with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories from one week after the start of cod liver oil/placebo taking.
Measure: Number of participants diagnosed with New Covid-19 Time: 6 monthsDescription: Number of participants with an airway sample positive for a respiratory pathogen* (either PCR or culture). *Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.
Measure: Number of participants with laboratory confirmed respiratory tract infection Time: 6 monthsDescription: The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat
Measure: Number of participants with self-reported airway infection Time: 6 monthsDescription: Number of participants hospitalized wholly or partly caused by Covid-19.
Measure: Number of participants hospitalized due to Covid-19 Time: 6 monthsDescription: Number of participants with ICU care wholly or partly caused by Covid-19.
Measure: Number of participants in Intensiv Care Unit (ICU) caused by Covid-19 Time: 6 monthsDescription: Number of participants with any admissions to hospital based on the Norwegian Patient Registry data.
Measure: Number of participants with any admissions to hospital Time: 6 monthsDescription: An airway sample positive for a respiratory pathogen* (either PCR or culture) in the period from one week after the start of cod liver oil/placebo taking to the end of this period. *Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.
Measure: Infection with each of the mentioned pathogens Time: 6 monthsDescription: Based on The Norwegian Reimbursement Database
Measure: Number of visits at GP for infections Time: 6 monthsDescription: Based on The Norwegian Reimbursement Database
Measure: Number of visits at GP Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of Cardiovascular disease Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of Cardiovascular disease Time: 30 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of cardiovascular mortality Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of cardiovascular mortality Time: 30 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of cancer Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of cancer Time: 30 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of cancer mortality Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of cancer mortality Time: 30 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: All-cause mortality Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: All-cause mortality Time: 30 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of fracture of the hip or forearm Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incidence of fracture of the hip or forearm Time: 30 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incident dementia Time: 6 monthsDescription: Based on self-reporting and Norwegian Registries
Measure: Incident dementia Time: 30 monthsDescription: The number of participants with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories in the period from one week after the start of cod liver oil/placebo taking to the end of this period together with any of the following: A) Self-reported dyspnea and fever concurrent (within four weeks) with the positive test OR B) hospitalization caused by Covid-19 concurrent (within four weeks) with the positive test OR C) death where the Covid-19 infection was wholly or partly responsible as judged by the death certificate (see endpoint in the protocol)
Measure: Number of participants diagnosed with serious Covid-19 Time: 12 monthsDescription: The number of participants diagnosed with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories from one week after the start of cod liver oil/placebo taking.
Measure: Number of participants diagnosed with new Covid-19 Time: 12 monthsDescription: An airway sample positive for a respiratory pathogen* (either PCR or culture). *Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.
Measure: Laboratory confirmed respiratory tract infection Time: 12 monthsDescription: The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat
Measure: Self-reported airway infection Time: 12 monthsDescription: Number of participants with self-reported adverse events
Measure: Number of participants with self-reported cod liver oil related adverse events Time: 12 monthsDescription: Number of participants hospitalized for major diseases or death in the cod liver oil versus placebo group in Norwegian registries
Measure: Number of participants with cod liver oil related adverse events Time: 12 monthsThe current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (COVID-VIRO®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting
Description: COVID-VIRO® specificity is calculated using the RT-qPCR results as reference test, according to the following formulas: Specificity (%) = 100 x [Negative / (Negative + Positive)]
Measure: Evaluation of COVID VIRO® diagnostic specificity Time: Month 1Description: COVID-VIRO® sensitivity is calculated using the RT-qPCR results as reference test, according to the following formulas: Sensitivity (%) = 100 x [Positive/ (Positive + Negative)]
Measure: Evaluation of COVID VIRO® diagnostic sensitivity Time: Month 1Description: COVID-VIRO® sensitivity is calculated using the RT-qPCR results, restricting for Cycle threshold value
Measure: Evaluation of COVID VIRO® diagnostic sensitivity for RT-qPCR Cycle threshold value < or > 28 Time: Month 1This study plans to compare a direct antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) obtained by mid-turbinate nasal swab with a reverse transcription polymerase chain reaction (rt-PCR) test obtained by nasopharyngeal swab (the current reference standard) in a population of patients with symptoms suggestive of COVID-19 for fewer than 5 days. Subjects whose physicians have already ordered an rt-PCR test at a Carilion testing center will be screened and recruited by phone during a required scheduling call. The study coordinator will describe the study by phone, and the subject will be consented when they arrive at the testing center. After consenting, a mid-turbinate swab direct antigen test will be obtained just prior to the ordered nasopharyngeal swab and any other ordered tests. The subjects will receive their rt-PCR test results through the usual channels of clinical notification. The subjects will not receive their nasal antigen results. The antigen test results will be analyzed in a batch process and the results entered into RedCap by the study staff. The rt-PCR results will be extracted from the Epic electronic health record using patient identifiers and paired with the corresponding antigen result for statistical analysis.
Description: Sensitivity of antigen test compared with reference standard PCR test.
Measure: Sensitivity Time: At completion of study - approximately 3 monthsDescription: Specficity of antigen test compared with reference standard PCR test.
Measure: Specificity Time: At completion of study - approximately 3 monthsDescription: AUROC for antigen test compared with reference standard PCR test
Measure: Area under the ROC curve Time: At completion of study - approximately 3 monthsThis study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protects individual privacy but promotes rapid dissemination and implementation of knowledge.
Description: determine the risk of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in those with symptoms of SARSCOV2 infection with vs. without a positive confirmatory test.
Measure: Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Time: 18 months post enrollmentDescription: Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR
Measure: Ambulatory care and/or ED visits post enrollment Time: 18 months post enrollmentDescription: Count of hospitalizations post enrollment as obtained from the EMR
Measure: Hospitalizations post enrollment Time: 18 months post enrollmentDescription: death during hospital admission as determined by data from the EMR
Measure: Death during hospital admission Time: 18 months post enrollmentDescription: Hospital-free survival as determined by data from the EMR
Measure: Hospital-free survival Time: 18 months post enrollmentDescription: ICU-free survival as determined by data from the EMR
Measure: ICU-free survival Time: 18 months post enrollmentThe benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.
Description: Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3
Measure: Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative Time: until 3 daysDescription: Duration of hospitalization is defined as the number of days in the hospital until Day 19, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.
Measure: Duration of hospitalization Time: until 19 daysThe aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.
Description: The CD3 + T lymphocyte cell populations (CD4 + ILT2 + and CD8 + ILT2 +) will be compared between the groups of patients
Measure: Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients. Time: 1 monthDescription: Blood levels of soluble HLA-G and plasma microvesicles with expression of HLA-G will be compared between the groups of patients.
Measure: Comparison of the expression of circulating soluble HLA-G, between the groups of patients. Time: 1 dayDescription: Vital status collected 1 month post inclusion for all the patients
Measure: 1 month survival Time: 1 monthDescription: Comparison of the isoforms (alleles) of HLA-G regarding the severity of the disease for the infected patients.
Measure: Assessment of the severity of the disease according to the isoform of HLA-G Time: 1 monthDescription: The expression of the BSG cell receptor induced by HLA-G will be compared between COVID19 patients and uninfected patients.
Measure: Comparison of the expression of one of the cell receptors of the SARS-CoV-2 virus, called BSG (Basigin), whose expression is modified by the interaction between HLA-G. Time: 1 dayIn the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients. The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases. Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study). Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.
Description: Comparison of variation of Volatile Organic Compound (VOC) profiles in exhaled air of patients between patients with symptoms suggestive of COVID and infection confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and those whose infection is ruled out based on the negativity of RT-PCR and clinical data
Measure: Validate the interest of VOCs analyzed by electronic noses and / or mass spectrometry for the diagnosis of a COVID-19 infection Time: 1 dayDescription: The equivalences and differences in nature of VOCs associated with infection with SARS-CoV-2 between exhaled air and sweat.
Measure: Identify the nature of VOCs associated with infection by SARS-CoV-2 by mass spectrometry in exhaled air and in sweat Time: 1 dayDescription: Proportion of success in detecting samples from patients with symptoms suggestive of COVID and infection confirmed by PCR.
Measure: Assessment of the specificity and sensitivity of canine olfactory detection of COVs associated with infection by SARS-CoV-2 (COVID-19) Time: 1 dayThe purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.
Description: Assess hospital length of stay after mechanical ventilation
Measure: Hospital length of stay Time: Up to 60 daysDescription: Analyze the blood to assess the human metabolome and proteome in patients with COVID-19 receiving IVIG including production of inflammatory and anti-inflammatory cytokines, markers of endothelial injury, and coagulation using Mass Spectrometry
Measure: Human metabolome and proteome Time: Up to 60 daysThis study aims to provide some insight into the variation of SD-D protein levels in patients with Covid-19 (-) pneumonia, Covid-19 (+) pneumonia, and CT negative Covid-19 infection in comparison to the normal population through a larger number of cases. Objective of the study is to determine the serum surfactant protein D (SP-D) levels in Covid-19 pneumonia infection.
Description: First primary outcome is determining the serum surfactant protein D level changes in patient who have Covid-19 infection or pneumonia aganist healty controls.
Measure: Meassuring the serum surfactant protein D levels in patient who have Covid-19 infection or pneumonia. Time: 2 monthsDescription: Determining the correlation between between serum surfactant protein D levels and demographic datas (age,gender), medical history, vital findings (fever, blood pressure, sPO2), laboratory findings (complete blood count; C-reactive protein (CRP), D-dimer, Ferritin and hsTnT parameters) and radiological findings, time to onset of symptoms, Comorbid diseases, hospitalization location of the patients (service or ICU), clinical scores (PSI and CURB65 scores), CT severity scores .
Measure: Analyzing the correlations between serum surfactant protein D levels and demographic,laboratory, clinical and radiological datas. Time: 2 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports