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  • drug2448: Placebo
  • Placebo (459) Hydroxychloroquine (102) Standard of Care (41) Azithromycin (38) Tocilizumab (36) Remdesivir (34) Placebo oral tablet (33) Questionnaire (32) Convalescent Plasma (28) Standard of care (27) No intervention (24) Favipiravir (23) Ivermectin (23) Convalescent plasma (21) Placebos (17) Enoxaparin (16) Methylprednisolone (15) Nitazoxanide (15) Survey (15) Colchicine (14) Vitamin C (14) placebo (14) Dexamethasone (12) Hydroxychloroquine Sulfate (12) Questionnaire Administration (12) Blood sample (11) Vitamin D (11) Anakinra (10) Control (10) Ruxolitinib (10) Saline (10) Usual Care (10) blood sample (10) no intervention (10) Camostat Mesilate (9) Losartan (9) Questionnaires (9) Standard care (9) questionnaire (9) Baricitinib (8) Blood sampling (8) Lopinavir/ritonavir (8) Zinc (8) survey (8) Gam-COVID-Vac (7) Nasopharyngeal swab (7) Quality-of-Life Assessment (7) Standard treatment (7) Chloroquine (6) Clazakizumab (6) DAS181 (6) LY3819253 (6) Lung ultrasound (6) Oseltamivir (6) Prone position (6) Rivaroxaban (6) Saliva collection (6) Sarilumab (6) Vitamin D3 (6) convalescent plasma (6) Aspirin (5) Best Practice (5) COVID-19 (5) COVID-19 Convalescent Plasma (5) COVID-19 convalescent plasma (5) Camostat (5) Cholecalciferol (5) Data collection (5) Doxycycline (5) Hydroxychloroquine (HCQ) (5) Lopinavir / Ritonavir (5) Nafamostat Mesilate (5) Online Survey (5) Online questionnaire (5) Online survey (5) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (5) Standard Medical Treatment (5) Standard of Care (SOC) (5) UC-MSCs (5) blood sampling (5) hydroxychloroquine (5) questionnaire assesment (5) Acalabrutinib (4) Ad26.COV2.S (4) Ascorbic Acid (4) BCG Vaccine (4) BCG vaccine (4) BNT162b2 (4) Best Supportive Care (4) Biospecimen Collection (4) CELLECTRA® 2000 (4) Colchicine Tablets (4) HCQ (4) Heparin (4) Interferon Beta-1A (4) Interview (4) Lopinavir/Ritonavir (4) Mavrilimumab (4) Melatonin (4) Nitric Oxide (4) Normal Saline (4) Normal saline (4) Observation (4) Observational (4) Opaganib (4) Oxygen (4) Placebo Administration (4) Povidone-Iodine (4) Prednisone (4) Prone positioning (4) REGN10933+REGN10987 combination therapy (4) RLS-0071 (4) SARS-CoV-2 (4) SARS-CoV-2 convalescent plasma (4) Sargramostim (4) Standard Care (4) Survey Administration (4) Telemedicine (4) Telerehabilitation (4) anti-SARS-CoV-2 convalescent plasma (4) standard care (4) 0.9% saline (3) 3D Telemedicine (3) ACE inhibitor (3) AG0302-COVID19 (3) AZD1222 (3) AZD7442 (3) Abatacept (3) Allocetra-OTS (3) Anti-SARS-CoV2 Serology (3) Apremilast (3) BCG-Denmark (3) BNT162b1 (3) Blood draw (3) Blood samples (3) COVID-19 RT-PCR (3) COViage (3) Chloroquine or Hydroxychloroquine (3) Chloroquine phosphate (3) Clinical assessment (3) Clinical data (3) Clopidogrel (3) Control group (3) Cyclosporine (3) DWRX2003 (3) EIDD-2801 (3) Echocardiography (3) Famotidine (3) Hydrocortisone (3) INO-4800 (3) Ibrutinib (3) Inactivated SARS-CoV-2 Vaccine (Vero cell) (3) Interferon Beta-1B (3) Interferon beta-1a (3) Interferon beta-1b (3) Lenzilumab (3) Leronlimab (700mg) (3) Mesenchymal Stromal Cells (3) Mesenchymal stromal cells (3) Methotrexate (3) Naltrexone (3) Niclosamide (3) Nitric Oxide Gas (3) No Intervention (3) PLACEBO (3) Phase 2 (3) Placebo (Normal saline solution) (3) Placebo oral capsule (3) Plasma (3) Povidone-Iodine Nasal Spray and Gargle (3) Probiotic (3) Prone Positioning (3) Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health (3) RT-PCR (3) Ravulizumab (3) Remestemcel-L (3) Ribavirin (3) Saline Placebo (3) Selinexor (3) Serological test (3) SnPP Protoporphyrin plus Sunlight exposure (3) Standard of care (SOC) (3) Supportive Care (3) Suspension of heat killed (autoclaved) Mycobacterium w (3) TY027 (3) Telmisartan (3) Tofacitinib (3) Usual care (3) VPM1002 (3) Vitamin Super B-Complex (3) Yoga (3) blood donation SMS (3) exhaled breath sampling (3) hzVSF-v13 (3) mRNA-1273 (3) observational (3) self-administered questionnaire (3) serology (3) standard of care (3) standard therapy (3) 0.9% Saline (2) 100 mg/mL Virazole (2) 2D Telemedicine (2) 300 mg of omega3-FA (2) 50 mg/mL Virazole (2) AG0301-COVID19 (2) ARB (2) AVIGAN 200 MG Film Tablets (2) Abidol hydrochloride (2) Acebilustat (2) Aeonose (2) Aerobic Exercise Training (2) Alteplase 50 MG [Activase] (2) Ampion (2) Angiotensin 1-7 (2) Angiotensin converting enzyme inhibitor (2) Angiotensin-(1-7) (2) Apixaban 2.5 MG (2) Assessment of behavioral response to emotional stimulation (2) Assessment of work-related stress (2) Atorvastatin (2) Attention Placebo (2) Ayurveda (2) Azithromycin Tablets (2) Bacille Calmette-Guérin (BCG) (2) Baricitinib Oral Tablet (2) Bemiparin (2) Bevacizumab Injection (2) Bicalutamide 150 Mg Oral Tablet (2) Biological data (2) Biological sample collection (2) Blood collection on admission and longitudinally (2) Blood collection on their first consultation and 10 to 14 days later (2) Blood test (2) Blood tests (2) Breath Biopsy face masks with removable filters and fitted PVA strip (2) Brequinar (2) Bucillamine (2) COVID Convalescent Plasma (2) COVID-19 Serology (2) COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection (2) COVID-19 exposure (2) COVID-19 pandemic (2) COVID-19 patients (2) COVID-19 survey (2) CT-P59 (2) CT-Scan (2) CVnCoV Vaccine (2) CYT107 (2) Camostat Mesylate (2) Canakinumab (2) Cannabidiol (2) Cardiac and electrodermal recordings (2) Carrimycin (2) ChAdOx1 nCoV-19 (2) Chloroquine Sulfate (2) Chloroquine or hydroxychloroquine (2) Ciclesonide (2) Clinical Examination (2) Convalescent COVID 19 Plasma (2) Convalescent Plasma (CP) (2) Convalescent Plasma (anti-SARS-CoV-2 plasma) (2) Convalescent Plasma Transfusion (2) Conventional treatment (2) Corticosteroid (2) Crizanlizumab (2) Daclatasvir (2) Data Collection (2) Data record (2) Deferoxamine (2) Defibrotide (2) Dexamethasone injection (2) Diagnostic Laboratory Biomarker Analysis (2) Diagnostic test (2) Disulfiram (2) Dornase Alfa Inhalation Solution [Pulmozyme] (2) Double-Trunk Mask (2) Duvelisib (2) EC-18 (2) ECG (2) EDP1815 (2) EXO 1 inhalation (2) EXO 2 inhalation (2) Early-Dexamethasone (2) Ebselen (2) Eculizumab (2) Electronic Health Record Review (2) Electronic questionnaire (2) Enoxaparin 40 Mg/0.4 mL Injectable Solution (2) Exercise (2) Exercise & Nutrition (2) Exercise training (2) Exposure (2) Expressive writing (2) Famotidine 20 MG (2) Favipiravir Placebo (2) Fisetin (2) Flow cytometric analysis (2) Fluoxetine (2) Fluvoxamine (2) Follow up (2) Fostamatinib (2) Guduchi Ghan Vati (2) HB-adMSCs (2) HFNC (2) High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule (2) Human Amniotic Fluid (2) Human biological samples (2) Human immunoglobulin (2) Hydroxychloroquine + azithromycin (2) Hydroxychloroquine - Weekly Dosing (2) Hydroxychloroquine 200 Mg Oral Tablet (2) Hydroxychloroquine Sulfate 200 MG (2) Hydroxychloroquine Sulfate 200 MG [Plaquenil] (2) Hydroxychloroquine Sulfate Loading Dose (2) Hydroxychloroquine Sulfate Regular dose (2) Hydroxychloroquine Sulfate Tablets (2) Hydroxychloroquine and Azithromycin (2) Hyperbaric oxygen (2) ICU treatment (2) IMU-838 (2) IVIG (2) Icosapent ethyl (2) Infliximab (2) Interleukin-7 (2) Intramuscular injection (2) Iodine Complex (2) Ion Mobility Spectrometry (IMS) (2) Ivermectin Oral Product (2) Ivermectin Pill (2) Ivermectin and Doxycycline (2) KB109 + Self Supportive Care (SSC) (2) Ketogenic diet (2) L-ascorbic acid (2) LY3832479 (2) Leflunomide (2) Lopinavir-Ritonavir (2) Low Dose Radiation Therapy (2) Low Dose Radiotherapy (2) Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule (2) Low molecular weight heparin (2) M5049 (2) MSC (2) MW33 injection (2) MW33 injection placebo (2) MagPro X100 Stimulator, B70 Fluid-Cooled Coil (2) Matching Placebo (2) Meditation (1 x 20-minute guided audio training) (2) Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule (2) Meplazumab for Injection (2) Metformin (2) Methylprednisolone Sodium Succinate (2) Mindfulness (2) Mindfulness Based Intervention (2) Molnupiravir (2) N-Acetyl cysteine (2) N-acetylcysteine (2) NORS (Nitric Oxide Releasing Solution) (2) Nasal swab (2) Nasopharyngeal swabs (2) Niclosamide Oral Tablet (2) Nigella Sativa / Black Cumin (2) Nitrogen gas (2) Observational study (2) Olokizumab 64 mg (2) Online Questionnaire (2) Ophthalmologic exam (2) PLX-PAD (2) PUL-042 Inhalation Solution (2) Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances (2) Peginterferon Lambda-1A (2) Pentoxifylline (2) Peripheral blood draw (2) Phase 1 (2) Physiotherapy (2) Pirfenidone (2) Placebo (NaCl 0.9%) (Group 2D) (2) Placebo Comparator (2) Placebo inhalation (2) Placebo on a 0- and 28-day schedule (2) Poly-ICLC (Hiltonol®) (2) Practice details (2) Pulmonary Rehabilitation (2) Pulmozyme (2) RECOP unit patient (2) RLF-100 (aviptadil) (2) RTB101 (2) Radiation therapy (2) Remdesivir placebo (2) Routine care for COVID-19 patients (2) Ruxolitinib Oral Tablet (2) SAB-185 (2) SARS-CoV-2 PCR (2) SARS-CoV-2 diagnostic rapid test (2) SARS-CoV-2 rS/Matrix-M1 Adjuvant (2) SARS-Cov2 testing (2) SCTA01 (2) SOC (2) SOC + Placebo (2) Saline solution (2) Saliva sample collection (2) Sample collection (2) Self Supportive Care (SSC) Alone (2) Semi-directive interview (2) Seraph 100 (2) Serology test for COVID-19 (2) Serum testing (2) Sevoflurane (2) Silmitasertib (2) Siltuximab (2) Simple cognitive task intervention (2) Simvastatin (2) Single Dose of Hydroxychloroquine (2) Sirolimus (2) SivoMixx (200 billion) (2) Spirometry (2) Standard Therapy (2) Standard of Care (SoC) (2) Standard of Care Treatment (2) Standard of care treatment (2) Stellate Ganglion Block (2) TD-0903 (2) Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. (2) Therapeutic Plasma Exchange (2) Therapeutic anticoagulation (2) Throat swab (2) Thymalfasin (2) Tocilizumab (TCZ) (2) Tocilizumab Injection (2) Tofacitinib 10 mg (2) Tranexamic acid (2) Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (2) Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (2) Two doses of placebo at the schedule of day 0,28 (2) Unfractionated heparin (2) Volatile Organic Compounds analysis (2) basic treatment (2) blood draw (2) blood samples (2) blood test (2) conjunctival swab (2) human monoclonal antibody DZIF-10c (Group 1A-2D) (2) lung ultrasound (2) nasopharyngeal swab (2) online survey (2) other (2) oxygen therapy (2) pregnant women with laboratory-confirmed 2019-n-CoV (2) retrospective analysis (2) unfractionated Heparin (2) venous ultrasound (2) vv-ECMO + cytokine adsorption (Cytosorb adsorber) (2) vv-ECMO only (no cytokine adsorption) (2) "Calm" is a mindfulness meditation mobile app (1) "Sham"-block with Placebo (Isotone NaCl) (1) "Vernonia amygdalina" (1) (Standard of Care) SoC (1) - Synthetic anti-malarial drugs (1) 0.075% Cetylpyridinium Chloride (1) 0.12% Chlorhexidine Gluconate (1) 0.12% Chlorhexidine Gluconate Mouth Rinse (1) 0.12% Chlorhexidine oral/nasal rinse (1) 0.5% Povidone Iodine (1) 0.5% Povidone/Iodine oral/nasal rinse (1) 0.9% (w/v) saline (1) 0.9% Normal Saline (1) 0.9% Sodium-chloride (1) 0.9% sodium chloride (normal saline) (1) 0.9%NaCl (1) 0.9%sodium chloride (1) 1% Hydrogen Peroxide (1) 1% w/v Povidone-iodide (1) 1. Characterize the immune response after infection with SARS-CoV-2 (1) 1.5-2% w/v Hydrogen Peroxide (1) 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse (1) 150 ppm Nitric Oxide delivered through LungFit Delivery System (1) 18F-αvβ6-BP (1) 1: ILT101 (1) 1: Naproxen (1) 1: Prone positioning (1) 1: Usual practice (1) 1: discontinuation of RAS blocker therapy (1) 2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks (1) 20 Mg Prednisone for 14 days (1) 2019-nCoV IgG/IgM Rapid Test Cassette (1) 2019-nCoV PCR (1) 21% Ethanol plus essential oils (1) 24 hour Holter ECG (1) 25-OH cholecalciferol (1) 2: No instruction regarding positioning (1) 2: Placebo Comparator (1) 2: Standard of care (1) 2: Usual practice + SYMBICORT RAPIHALER (1) 2: continuation of RAS blocker therapy (1) 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) (1) 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) (1) 38 questions questionnaire (1) 38-questions questionnaire (1) 40-Steps-test (1) 40ml blood sample (1) 4Plants/Azythromycin (1) 5-ALA-Phosphate + SFC (5-ALA + SFC) (1) 6 minute walk test (1) 80 ppm Nitric Oxide delivered through LungFit Delivery System (1) A $10 Survey Incentive (1) A $20 Survey Incentive (1) A short video intervention (1) A vignette intervention (1) AAZ Covid-19 rapid test (1) ABBV-47D11 (1) ABPM (1) ABX464 (1) ACE Inhibitors and Calcium Channel Blockers (1) ACE inhibitor, angiotensin receptor blocker (1) ACEI (1) ACEI/ARB (1) ACEIs (1) ACP Decisions Video Program (1) ACT-20-CM (1) ACT-20-MSC (1) ADAM Sensor (1) ADM03820 (1) AI model (1) AK119 (1) ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (1) AMA Acknowledgement Drug Pricing (1) AMY-101 (1) AN69-Oxiris (1) AN69-Standard (1) ANNE One (1) APL-9 (1) APPS (1) ARBIDOL 100 MG KAPSUL (1) ARBOX (1) ARBs and/or ACE inhibitors (1) ARCT-021 Dose 1 (1) ARCT-021 Dose 2 (1) ARCT-021 Dose 3 (1) ARCT-021 Dose 4 (1) ARCT-021 Dose Regimen 1 (1) ARCT-021 Dose Regimen 2 (1) ARCT-021 single dose priming (1) ARCT-021 two higher dose priming (1) ARCT-021 two lower dose priming (1) ARDSNet (1) ARFC mask (1) ART Therapy (1) AS03-adjuvanted SCB-2019 vaccine (1) ASC09/ritonavir group (1) ASC09F+Oseltamivir (1) AT-001 (1) AT-100 (1) AT-527 (1) ATAFENOVIR 200 MG KAPSUL (1) ATI-450 (1) ATYR1923 1 mg/kg (1) ATYR1923 3 mg/kg (1) AV-COVID-19 (1) AVICOD 200 MG Film Tablet (1) AVIGAN (1) AVIGAN 200 mg FT (1) AVIGAN 200 mg Film Tablets (1) AVM0703 (1) AWARD advice (1) AWARD plus COVID-specific advice (1) AZD1656 (1) AZVUDINE (1) AZVUDINE placebo (1) Abdominal ultrasound (1) Abidol Hydrochloride combined with Interferon atomization (1) Abivertinib (1) Acacia Senegal (1) Acalabrutinib Treatment A (1) Acalabrutinib Treatment B (1) Acalabrutinib Treatment C (1) Acalabrutinib Treatment D (1) Accuchek Inform II platform (1) Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB (1) Acetyl L-Carnitine (1) Acetylsalicylic acid (1) Acknowledgement Racial Injustice AMA (1) Active COVID-19 disease (1) Active Comparator (1) Active PBMT/sMF (1) Active control:Healthy Living (1) Activity (1) Ad5-nCoV (1) AdCLD-CoV19 (1) AdCOVID (1) Additional and minimal collection of products of the human body carried out during a sample for standard of care (1) Additional biological samples (1) Adenosine (1) Adenovirus Type-5 Vectored COVID-19 Vaccine (1) AdimrSC-2f (1) Adipose tissue (1) Administration of Equine immunoglobulin anti SARS-CoV-2 (1) Admission to ICU for COVID-19 (1) Adsorbed COVID-19 (inactivated) Vaccine (1) Aerobic Exercises (1) Aerobic training (1) Aerolized Hydroxychloroquine Sulfate (1) Aerosol Box (1) Aerosol-reducing Mask (1) Aerosolized 13 cis retinoic acid (1) Aerosolized 13 cis retinoic acid plus Inhalation Inhaled testosterone (1) Aerosolized 13 cis retinoic acid plus Inhalation administration by nebulization captopril 25mg (1) Aerosolized All trans retinoic acid (1) Aerosolized All-Trans Retinoic acid plus oral Tamoxifen (1) Aerosolized Isotretinoin plus Tamoxifen (1) African American Sender Acknowledgement (1) African American Sender in Informational Videos. (1) After COVID-19 Pandemic (1) AirFLO2 (1) AirGo Respiratory Monitor (1) Airwave Oscillometry (1) Airway pressure release ventilation (1) Alexa Amazon (1) Alisporivir (1) AlloStim (1) Allogeneic NK transfer (1) Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells (1) Allogenic pooled olfactory mucosa-derived mesenchymal stem cells (1) Almitrine (1) Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C (1) Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose (1) Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment (1) Alteplase (1) Alvelestat (1) Ambrisentan (1) Amiodarone (1) Amlodipine (1) Amoxicillin-clavulanate (1) An auto-questionnaire comprising three psychometric scales (1) Anakinra +/- Ruxolitinib (stages 2b/3) (1) Anakinra 100Mg/0.67Ml Inj Syringe (1) Anakinra 149 MG/ML Prefilled Syringe [Kineret] (1) Anakinra Prefilled Syringe (1) Anakinra alone (stages 2b/3) (1) Anakinra and Ruxolitinib (Advanced stage 3) (1) Anakinra and Ruxolitinib (overcome stage 3) (1) Anakinra plus oSOC (1) Analogs, Prostaglandin E1 (1) Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. (1) Anger message (1) Angiography scanner (1) Angiotensin II (1) Angiotensin II Receptor Blockers (1) Angiotensin Receptor Blockers (1) Angiotensin receptor blocker (1) Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) (1) Anluohuaxian (1) Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients (1) Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients (1) Anti- SARS-CoV-2 Plasma (1) Anti-COVID-19 human immunoglobulin (1) Anti-SARS-CoV-2 Human Convalescent Plasma (1) Anti-SARS-CoV-2 IgT seropositivity (1) Anti-SARS-CoV-2 convalescent plasma (1) Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) (1) Anti-SARS-CoV-2 immunoglobulin (1) Anti-SARS-CoV2 serological controls and serum neutralization (1) Anti-Sars-CoV-2 Convalescent Plasma (1) Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients (1) Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients (1) Antibiotic (1) Antibiotics (1) Antibody Test (1) Antibody test (SARS-CoV2) (1) Antibody testing (1) Antibody titration (1) Antibody-Rich Plasma from COVID-19 recovered patients (1) Anticoagulant Therapy (1) Anticoagulation Agents (Edoxaban and/or high dose LMWH) (1) Antihypertensive Agents (1) Antioxidation Therapy (1) Antithrombin III (1) Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 (1) Antiviral Agents (1) Antroquinonol (1) Anxiety Reduction Training (1) Apilimod Dimesylate Capsule (1) Apixaban (1) Apixaban 5MG (1) Apo-Hydroxychloroquine (1) Appendectomy (1) Apple Watch Series 5 (1) Aprepitant injectable emulsion (1) Aprotinin (1) Arbidol (1) Arbidol Hydrochloride Granules (1) Argatroban (1) Artemesia annua (1) ArtemiC (1) Artemisia Annua Leaf (1) Artemisinin / Artesunate (1) Arterial Blood Gas test (ABG) (1) Arterial blood gas (1) Artesunate (1) Artesunate-amodiaquine (1) Ascorbic Acid and Zinc Gluconate (1) Ashmolean Website (1) Aspirin 100mg (1) Aspirin 75mg (1) Aspirin 81 mg (1) Assembled mask (1) Assessing antibody responses, neutralizing capacity and memory B-cell function (1) Assessing impact of COVID19 (1) Assessment of Dietary Changes in Adults in the Quarantine (1) Assessment of cardiovascular diseases and cardiovascular risk factors (1) Assessment of coagulopathy, Platelets activation and Platelets-Neutrophils interplay (1) Assessment of lung mechanics and heart-lung interactions (1) Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery (1) Assessment of ventilator-associated pneumonia criteria (1) Assigned Strategies: Active Choice (1) Assigned Strategies: Enhanced Active Choice (1) Assigned Strategies: Opt-in (1) Association of diltiazem and niclosamide (1) AstroStem-V (1) Asunercept (1) Asynchronies detection (1) Atazanavir (1) Atazanavir and Dexamethasone (1) Atorvastatin 20 Mg Oral Tablet (1) Atorvastatin 20mg (1) Atorvastatin 40mg (1) Atovaquone/Azithromycin (1) Attention control (1) Audio-Visual Triage System (AVT) (1) Auditory Evoked Potentials (AEP) (1) Auricular neuromodulation (1) Auricular percutaneous neurostimulation (1) Auscul-X (1) Auto-questionnaires (patients co infected HIV Sras-CoV-2) (1) Autologous Adipose MSC's (1) Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) (1) Automated oxygen administration - FreeO2 (1) Autophagy inhibitor (GNS651) (1) Auxora (1) Avdoralimab (1) Aviptadil 67μg (1) Aviptadil by intravenous infusion + standard of care (1) Awake Prone Positioning (1) Awake Proning (1) Awake prone positioning (1) Awake proning (1) Ayurvedic Kadha (1) Azinc (1) Azithromycin (Azithro) (1) Azithromycin / Ivermectin / Ribaroxaban / Paracetamol (1) Azithromycin / Ribaroxaban / Paracetamol (1) Azithromycin 250 MG (1) Azithromycin 250 MG Oral Capsule (1) Azithromycin 500 milligram (mg) oral Tablet (1) Azithromycin 500Mg Oral Tablet (1) Azithromycin Capsule (1) Azithromycin and hydroxychloroquine (1) Azithromycin with amoxicillin/clavulanate (1) Açaí palm berry extract - natural product (1) BACMUNE (MV130) (1) BAT (1) BAT + Calcifediol (1) BAT2020 (1) BBV152 (1) BBV152A - Phase I (1) BBV152A - Phase II (1) BBV152B - Phase I (1) BBV152B - Phase II (1) BBV152C - Phase I (1) BCG (1) BCG GROUP (1) BCG vaccine (Freeze-dried) (1) BCG-10 vaccine (1) BDB-001 Injection (1) BGB DXP593 (1) BGB-DXP593 (1) BI 764198 (1) BIO 300 Oral Suspension (1) BIO101 (1) BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM (1) BIOVITALS (1) BLD-2660 (1) BM-Allo.MSC (1) BM-MSCs (1) BMS-986253 (1) BNT162a1 (1) BNT162b3 (1) BNT162c2 (1) BRII-196 (1) BRII-198 (1) BTL-TML-COVID (1) BVA-100 (1) Background questionnaire (1) Bactek-R (1) Bacterial species isolated (1) Bamlanivimab (1) Bardoxolone methyl (1) Bariatric procedures (1) Baricitinib (janus kinase inhibitor) (1) Baricitinib 4 MG Oral Tablet (1) Baricitinib or Anakinra (1) Base therapy (1) Baseline and during hospitalization blood samples (1) Baseline blood sample (1) Baseline message (1) Basic Body Awareness Therapy (1) Beck Depression Inventory (BDI) (1) Bedside lung ultrasound (1) Behavioral Activation SSI (1) Behavioral: OCAT (1) Behavioral: OCAT-sham (1) Behaviour Change Technique Intervention to Improve Quality of Life (1) Bemiparin sodium (1) Bempegaldesleukin (1) Berberine (1) Bereavement Virtual Support Group (1) Best Available Therapy (1) Best Message + Augmented Message or Implementation Strategy (1) Best Message Alone (1) Best Standard of Care (1) Best Standard of Care + CARDIO (1) Best available care (1) Best available treatment (1) Best standard of care (1) Best supportive care" which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy (1) Bevacizumab (1) Bicalutamide 150 mg (1) BioMedomics COVID-19 IgM-IgG Rapid Test (1) Bioarginina® (1) Biobehavioral Tele-rehabilitation Sessions (1) Biocollection (1) Biological (1) Biological Sample Collection (1) Biological collection (patients co infected HIV Sras-CoV-2) (1) Biological collection with nasopharyngeal samples, saliva, blood, stool and urine (1) Biological sample and clinical data collection (1) Biological samples specific to research (1) Biological sampling (1) Biological test (1) Biological/Vaccine: Angiotensin peptide (1-7) derived plasma (1) Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group (1) Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group (1) Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group (1) Biological: COVID-19 convalescent plasma (1) Biological: mRNA-1273: 100 mcg (1) Biological: mRNA-1273: 50 mcg (1) Biological: oral polio vaccine (1) Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT) (1) Biomarkers expression (1) Biosensor (1) Biosensors (1) Biospecimen collection (1) Bivalirudin Injection (1) Blink and Masseter Inhibitory Reflex (1) Blood D-dimer assay (1) Blood Sample (1) Blood analysis (1) Blood and derivatives. (1) Blood collection (1) Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection (1) Blood donation from convalescent donor (1) Blood for anti-drug antibody (ADA) (1) Blood for pharmacokinetic samples (1) Blood for research purposes (1) Blood group determination (1) Blood plasma (1) Blood sample and data record (1) Blood sample collection (1) Blood sample for serological test (1) Blood sample for serology to measure past infection with SARS-CoV-2 (1) Blood sample for whole genome sequencing (1) Blood samples (collection of 5 mL of blood in a dry tube) (1) Blood samples collection (1) Blood sampling (venesection) (1) Blood test for IgG antibodies against SARS-CoV-2 (1) Blood tests sputum, nasal lavage and brushing (1) Bloodwork (1) Bolus placebo (1) Bolus vitamin D3 (1) Bone Marrow Harvest (1) Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment (1) Bone conduction headphones (1) Botulinum Neurotoxin (1) Bovine Lactoferrin (1) Bovine Lipid Extract Surfactant (1) Brain MRI (1) Brain MRI scan (1) Brainstem Responses Assessment Sedation Score (BRASS) (1) Brazilian Green Propolis Extract (EPP-AF) (1) Breath Biopsy (1) Breath Biopsy Analysis (1) Breath Test & Cheek Swab (1) Breath biopsy sampling using the ReCIVA Breath Sampler (1) Breath sample (1) Breath test (1) Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation (1) Brexanolone (1) Bridge therapy (1) Brief Behavioral Activation with Mental Imagery (1) Brief Interpersonal Telepsychotherapy (1) Brief Psychiatric Rating Scale (1) Brief Skills for Safer Living (1) Brief cognitive behavioral therapy (1) Brief educational video (1) Brief informational infographic (1) Bromhexine 8 MG (1) Bromhexine Hydrochloride (1) Bromhexine Hydrochloride Tablets (1) Bromhexine Oral Tablet and/or hydroxychloroquine tablet (1) Bromhexine and Spironolactone (1) Broncho-Vaxom® (1) Bronchoalveolar Lavage (BAL) (1) Budesonide (1) Budesonide Nasal (1) Budesonide dry powder inhaler (1) Burnout (1) Butterfly (1) Butterfly iQ (1) C-reactive protein (1) C21 (1) C2Rx (1) C3+ Holter Monitor (1) CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection (1) CAG length <22 (1) CAG length >=22 (1) CAP-1002 (1) CAP-1002 Allogeneic Cardiosphere-Derived Cells (1) CAStem (1) CBD Isolate (1) CCP (1) CD24Fc (1) CERC-002 (1) CHAMindWell (1) CHEST CT SCAN (1) CHLORPROMAZINE (CPZ) (1) CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) (1) CIG Axial (1) CIG Tilted (1) CK0802 (1) CLBS119 (1) CLIA of IgG and IgM against SARS-Cov-2 (1) CM4620-IE (Injectable Emulsion) (1) CNM-ZnAg (1) CNS magnetic resonance imaging (MRI) imaging (1) COM-COVID anonimous survey (1) COMPASS (1) CONTROL GROUP (1) CONVALESCENT PLASMA (1) COPAN swabbing and blood sample collection (1) COR-101 (1) CORVax (1) COSH Self-help smoking cessation booklet (1) COVI-AMG (1) COVI-GUARD (1) COVI-VAC (1) COVICU (1) COVID 19 Convalescent Plasma (1) COVID 19 Diagnostic Test (1) COVID 19 Self-Questionnaire (1) COVID 19 diagnostic test by PCR (1) COVID 19 impact (1) COVID 19 serology (1) COVID WHELD (1) COVID Watch (1) COVID positive via testing (1) COVID visitation restrictions (1) COVID-19 Androgen Sensitivity Test (CoVAST) (1) COVID-19 Antibody testing (1) COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support (1) COVID-19 Breastfeeding Support (1) COVID-19 Convalescent Plasma (CCP) (1) COVID-19 Convalscent Plasma (1) COVID-19 Diagnostic and Assessment Tests (1) COVID-19 FACILITY (1) COVID-19 IgG / IgM rapid test (whole blood, serum, plasma) (1) COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) (1) COVID-19 PCR (1) COVID-19 PCR Swab (1) COVID-19 PCR and Serology (1) COVID-19 PCR and serology testing (1) COVID-19 Pandemic (1) COVID-19 Pneumonia (1) COVID-19 Specific T Cell derived exosomes (CSTC-Exo) (1) COVID-19 Swab (1) COVID-19 and Intensive Care (1) COVID-19 antibodies testing (1) COVID-19 antibody point of care test kit (1) COVID-19 barrier box (1) COVID-19 convalescent hyperimmune plasma (1) COVID-19 convalescent plasma (CCP) plus standard of care (SOC) (1) COVID-19 convalescent plasma treatment (1) COVID-19 diagnostic PCR (1) COVID-19 diagnostic test (1) COVID-19 e-package: Psychological wellbeing for healthcare workers (1) COVID-19 experience surveys (1) COVID-19 infection (1) COVID-19 infection status (1) COVID-19 positive via testing (1) COVID-19 related health warning leaflet (1) COVID-19 standard care (1) COVID-19 swap test PCR (1) COVID-19 test (1) COVID-19 test, polymerase chain reaction for SARS-CoV-2 (1) COVID-19 testing (1) COVID-19 treatment (1) COVID-19 treatments (1) COVID-19+ observational (1) COVID-HIGIV (1) COVID-VIRO® test (1) COVID-surgRES questionaire (1) COVID19 (1) COVID19 convalescent plasma infusion (1) COVID19 immunization testing (1) COVID19 vaccine (1) COVIDSeq Test (1) COVSurf Drug Delivery System (1) CPAP (1) CPAP treatment (1) CPI-006 (1) CRI management (1) CSL324 (1) CSL760 (1) CT of the chest (1) CT score (1) CT-P59/Placebo (1) CT-V (1) CT-imaging (1) CT-scan (1) CT-scan with minimal invasive autopsy (1) CTUS examination (1) CUROSURF® (poractant alfa) (1) CVnCoV (1) CVnCoV 12 μg (1) CVnCoV 12μg (1) CVnCoV 6 μg (1) CYNK-001 (1) CYP-001 (1) Calcium Channel Blockers (1) Calm Meditation App (1) Cambridge Validated Viral Detection Method (1) CanSwab (1) Canakinumab 150 MG/ML [Ilaris] (1) Canakinumab Injection 300mg (1) Canakinumab Injection 600mg (1) Candesartan (1) Canine odor detection of Volatile Organic Compounds (1) Cannabidiol, pharmaceutically produced with < 5 ppm THC (1) Cannabis, Medical (1) Capillary Collection & Testing (1) Capillary and salivary sampling (1) Capnography (1) Caption AI (1) Cardiac CT (1) Cardiac MRI (1) Cardiac Magnetic resonance imaging (1) Cardiac surgery (1) Cardiopulmonary resuscitation (1) Cardiorespiratory Exercise (1) Cardiovascular Magnetic Resonance (CMR) Imaging (1) Caring Contacts (1) Carotid Artery Reactivity Testing (1) Carrageenan nasal and throat spray (1) Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients. (1) Case fatality rate (1) Cash transfer (1) Ceftaroline (1) Ceftriaxone (1) Cell therapy protocol 1 (1) Cell therapy protocol 2 (1) Cellular response (1) Cenicriviroc (1) Cenicriviroc (CVC) (1) Centricyte 1000 (1) Centrum Adult (under 50) multivitamin (1) Cerebral compliance and hemodynamics monitoring (1) Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies (1) Certified cloth face mask plus preventive information (1) ChAdOx1 nCoV-19 (Abs 260) (1) ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost (1) ChAdOx1 nCoV-19 (qPCR) (1) ChAdOx1 nCoV-19 0.5mL boost (1) ChAdOx1 nCoV-19 0.5mL prime plus boost (1) ChAdOx1 nCoV-19 full boost (1) ChAdOx1 nCoV-19 half boost (1) ChAdOx1 nCoV-19 single dose + paracetamol (1) ChAdOx1 nCoV-19 two dose + paracetamol (1) Change in knowledge, motivation, skills, resources (1) Change in preference to surgery under COVID-19 pandemic. (1) Chat-based instant messaging support (1) Chat-based support (1) Chemotherapy (1) Chest MRI (1) Chest computed tomography (CT) (1) Chest physiotherapy post-covid19 (1) Chest physiotherapy using a non-invasive oscillating device (1) Chinese Herbal Medicine (1) Chinese medicine treatment (1) Chiropractic care (1) Chiropractic care (more than one visit) (1) Chiropractic care (one visit) (1) Chloroquine Diphosphate (1) Chloroquine Phosphate Tablets (1) Chloroquine diphosphate (1) Chlorpromazine (1) Choice of Assignment: Active Choice (1) Choice of Assignment: Enhanced Active Choice (1) Choice of Assignment: Opt-in (1) Choices and judgements (1) ChulaCov19 mRNA vaccine (1) Ciclesonide Inhalation Aerosol (1) Ciclesonide Metered Dose Inhaler [Alvesco] (1) Clarithromycin (1) Clarithromycin 500mg (1) Clazakizumab 12.5 mg (1) Clazakizumab 25 mg (1) Clevudine (1) Clinical Observation (1) Clinical Trial Matching (1) Clinical diagnosis of COVID-19 by a health care professional (1) Clinical examination (1) Clinical interview (1) Clinical, functional and radiological lung involvement evolution (1) Clinical, laboratory and imaging characteristics of pneumonia (1) Cliniporator (1) CloSYS mouthwash (1) Clofazimine (1) Clopidogrel 75mg (1) Closed face shield with Surgical face mask use (1) Closed-loop control of oxygen supplementation by O2matic (1) Cloth Face Mask (1) Clungene rapid test cassette (1) Co-mestring (co-coping) (1) Cod liver oil (1) Cognitive Behavioral Brief-Telepsychotherapy (1) Cognitive Behavioural Group Therapy for Perinatal Anxiety (1) Cognitive and behavioral intervention. (1) Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum (1) Cognitive testing (1) Cognitive training (1) Cohort (1) Colchicine 0.5 MG (1) Colchicine 1 MG Oral Tablet (1) Colchicine Pill (1) Colchicine plus symptomatic treatment (paracetamol) (1) Colgate Peroxyl mouthwash (1) Colgate Total mouthwash (1) Colgate periogard mouthwash (1) Collagen-Polyvinylpyrrolidone (1) Collection of Biological Samples (1) Collection of blood samples in order to create a biocollection (1) Collection of blood, salivary and nasopharyngeal samples. (1) Collection of breath sample (1) Collection of odour samples (1) Collection of samples (1) Collection of tears and saliva. (1) Colonoscopy (1) Colorectal resections (1) Combination (1) Combination of oral polio vaccine and NA-831 (1) Combined ART/hydroxychloroquine (1) Combined use of a respiratory broad panel multiplex PCR and procalcitonin (1) Communication (1) Communication type (1) Community interest message (1) Community popular opinion leader (POL) based intervention (1) Community-based, mobile van testing (1) Community-driven messages to promote COVID-19 testing (1) Comparable Placebo (1) Comparable Placebo of Oral Polio Vaccine and Placebo of drug (1) Comparable Placebo of drug (1) Comparative Observational Cohort Study (1) Comparator (1) Compassion focused intervention (1) Complement dosage (1) Complete blood picture, bone marrow aspiration cytology (1) Complete thrombophilic profile testing by multiplex PCR (1) Completion of post telemedicine encounter survey (1) Completion of pre-pandemic survey (1) Completion of survey after peak of pandemic (1) Complex diagnostic panel (1) Comprehensive treatment (1) Computed Tomography (CT) (1) Computer task questionnaires (1) Conestat alfa (1) Confinement and Communication During the COVID-19 Pandemic (1) Conjunctival swab and nasopharyngeal swab (1) Connected devices measurements (1) Connor-Davidson Resilience Scale 10 items (CD-RISC 10) (1) Contain COVID Anxiety SSI (1) Continuation of ACEi/ARB (1) Continuation of ARB/ACEI (1) Continuous Positive Airway Pressure (1) Continuous positive airway pressure (CPAP) treatment (1) Continuous renal replacement therapy (1) Continuous vital sign monitoring - Isansys Patient Status Engine (1) Contrast-enhanced CMR (1) Control (albumin 5%) (1) Control Blend (1) Control Group (1) Control Group (pharmacotherapy and/or psychotherapy, n=10) (1) Control Period (1) Control Test (1) Control arm (1) Control message (1) Control patients (1) Control swab (1) ConvP (1) Convalescent Immune Plasma (1) Convalescent Plasma 1 Unit (1) Convalescent Plasma 2 Units (1) Convalescent Plasma Infusion (1) Convalescent Plasma as Therapy for Covid-19 patients (1) Convalescent Plasma from COVID-19 donors (1) Convalescent Plasma of patients with COVID-19 (1) Convalescent SARS COVID-19 plasma (1) Convalescent Serum (1) Convalescent anti-SARS-CoV-2 MBT Plasma (1) Convalescent anti-SARS-CoV-2 MBT plasma (1) Convalescent anti-SARS-CoV-2 plasma (1) Convalescent plasma (CP) (1) Convalescent plasma transfusion (1) Convalesscent Plasma (1) Conventional N95 respirator (1) Conventional Oxygen Therapy (1) Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) (1) Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules (1) Conventional oxygen therapy (1) Conventional physical therapy (1) Conventional therapy first (1) Coping strategies video (1) Cordio App (1) Core Warming (1) Corn oil (placebo) (1) Coromec Registry with ECL-19 (1) CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test (1) CoronaVac (1) Coronavirus Anxiety Scale , COVID-19 Phobia Scale (1) Coronavirus Disease 2019 (1) Corticosteroid injection (1) Corticosteroid with or without colchicine (1) Corticosteroids and Derivatives (1) Cospherunate/Azythromycine (1) Cospherunate/Phytomedicine/Azythromycien (1) Cost-Benefit Frame (1) CovX (1) Covax-19™ (1) Covid ICU containment measures (1) Covid-19 + patients (1) Covid-19 Antibody testing (IgG and IgM) (1) Covid-19 PCR , IGM (1) Covid-19 Rapid Test Kit (RAPG-COV-019) (1) Covid-19 Standard of Care (1) Covid-19 presto test (1) Covid-19 swab PCR test (1) Covid19 (1) Covid19 RT-PCR (1) Covidfree@home (1) Covigenix VAX-001 (1) Covigenix VAX-001 placebo (1) Crest Pro-Health Multi-Protection mouthwash (1) Crisis intervention therapy (1) Crisis management coaching (1) Cross Sectional study using scientifically validated psychometric Scales (1) Cross-sectional observational study (1) Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms (1) Cross-sectional study investigating the association of NPIs with mental health (1) Cross-sectional survey (1) Curently used therapy for COVID-19 non-critical patients (1) Current care per UCLA treating physicians (1) Customized questionnaire (1) Cyclosporin A (1) CytoSorb (1) CytoSorb 300 mL device (1) CytoSorb-Therapy (1) Cytokine Adsorption (1) Cytokines dosage (1) Cytokines measurement (1) D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester (1) D-dimer,CBC.ESR,CRP, (1) DAS181 COVID-19 (1) DAS181 OL (1) DASS-21 instrument (depression and anxiety) (1) DB-001 (1) DFV890 (1) DIG Axial (1) DIG Tilted (1) DUR-928 (1) DWJ1248 (1) Daclatasvir 60 mg (1) Daily Coping Toolkit (1) Daily Monitoring (1) Daily Vitamin D3 (1) Daily placebo (1) Dalcetrapib (1) Danoprevir+Ritonavir (1) Dapagliflozin (1) Dapagliflozin 10 MG (1) Darunavir and Cobicistat (1) Darunavir/Cobicistat (1) Data Collection: Clinical Care Assessments (1) Data collection and clinical testing of subjects (1) Data collection and rhinopharyngeal swab (1) Data collection from blood draw (1) Data collection from lumbar puncture (1) Data collection from medical files (1) Data collection up to 1 year (1) Data monitoring for 48h within the first 12 hours of admission for COVID-19 (1) Data registry (1) Data research, database analysis (1) Ddrops® products, 50,000 IU, Oral (1) Decidual Stromal Cells (DSC) (1) Decitabine (1) Deep Breathing training (1) Deep Venous Disease Diagnostic (1) Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days (1) Defibrotide Injection (1) Degarelix (1) DeltaRex-G (1) Dental pulp mesenchymal stem cells (1) Depression, Anxiety and Stress Scale (1) Descartes 30 (1) Description of groups caracteristics (1) Desferal 500 MG Injection (1) Desidustat (1) Detection of anti-COVID-19 antibody level (1) Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus. (1) Device used to record voice for screening (1) Dexamethasone (high dose) (1) Dexamethasone 2 MG/ML (1) Dexamethasone and Hydroxychloroquine (1) Dexcom G6 (1) Dexmedetomidine Injectable Product (1) DiaBetter Together (1) DiaNose (1) Diabetes type 2 (1) Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta (1) Diagnostic Test: serology test for COVID-19 (1) Diagnostic examination for venous thromboembolism (1) Diagnostic test Covid-19 (1) Diagnostic test for SARS-Cov2 for patients and health staff (1) Diagnostic test for detection of SARS-CoV-2 (1) Dialectical Behavioral Therapy (DBT) Skills (1) Dialyzable Leukocyte Extract (1) Diet tracking and survey (1) Dietary Supplement containing resistant starch (1) Dietary counselling on Food Groups according to IYC Feeding practices, WHO (1) Dietary supplementation in patients with covid disease admitted to hospital (1) Differences in triage (1) Differential Leucocyte Count (CLDC) device and algorithm (1) Difficulties lived by disabled children's parents in the period of COVID-19 pandemic (1) Diffusing capacity of carbon monoxide (1) DigiVis visual acuity app (1) Digital Health Online Platform (1) Digital cardiac Counseling (1) Digital oximeter monitoring (1) Digital problem solving tool (1) Diphenhydramine (1) Dipyridamole (1) Dipyridamole 100 Milligram(mg) (1) Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care (1) Direct Antigen Tests for COVID-19 (1) Direct laryngoscopy (1) Discontinuation of ACEi/ARB (1) Discontinuation of ARB/ACEI (1) Discussion Board for Social Support +Basic Feedback (1) Discussion Board for Social Support+Personalized Feedback (1) Disease-modifying antirheumatic drugs (DMARDs) (1) Distilled water (1) Dociparastat sodium (1) Doctella telehealth monitoring (1) Doctor Spot (1) Doctorgram Patient Kit (1) Doppler Echo (1) Dornase Alfa (1) Dornase Alfa Inhalation Solution (1) Dose Finding Phase (MTD) (1) Dose of Tinzaparin or Dalteparin (1) Dose of tinzaparin or dalteparin (1) Double-Blind NT-I7 (1) Double-Blind Placebo (1) Doxycyclin (1) Doxycycline Hcl (1) Drug COVID19-0001-USR (1) Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment (1) Drug: GS-5734 - 1.00 mg/kg (1) Drug: GS-5734 - 2.00 mg/kg (1) Drug: Isotretinoin plus Tamoxifen (1) Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) (1) Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) plus Aerosolized Itraconazole (1) Drug: NA-831 (1) Drug: NA-831 - 0.10 mg/kg (1) Drug: NA-831 - 0.20 mg/kg (1) Drug: Standard treatment Standard treatment (1) Drugs and supportive care (1) Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) (1) Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) (1) DuACT (1) Duplex ultrasound and Computed Tomography Angiography (1) During COVID-19 Pandemic (1) Dutasteride (1) Duty Frame (1) Dysphagia Handicap Index (DHI) (1) ECCO2R (1) ECG from handheld device (1) ECG-Holter (1) ECMO Implantation (1) EEG (1) EG-HPCP-03a (1) EG-HPCP-03a Placebo (1) EIT-Group (1) ELISA (1) ELISA and Rapid test to detect antibodies against COVID-19 (1) ELISPOT (1) ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY (1) ELMO PROJECT AT COVID-19: STUDY IN HUMANS (1) EMDR (1) ENT exam (1) EP (1) EPDS (Edinburgh Postnatal Depression Scale) (1) EPIC risk score display (1) EQ001 (1) EQ001 Placebo (1) ESOGER (1) EUROIMMUN assay (1) EXTRA-CVD Virtual Care (1) EarSats Pulse Oximeter Probe (1) Early rehabilitation (1) EasyCov POC (1) Eating habits (1) Echo-Doppler (1) Economic benefit message (1) Economic freedom message (1) Edinburgh Postnatal Depression Scale (EDPS) (1) Edoxaban Tablets (1) Education (1) Education sessions (1) Educational meetings and visual prompts (1) Eicosapentaenoic acid gastro-resistant capsules (1) Ejaculated semen sample (1) Elective Cancer Surgery (1) Electric pad for human external pain therapy (1) Electrical Impedance Tomography (EIT) (1) Electrical Impedance tomography (1) Electro impedance tomography (1) Electrocardiogram (ECG) (1) Electrocardiogram, telemetry, echocardiogram, laboratory values (1) Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care (1) Electroencephalogram with EKG lead (1) Electronic Survey questionnaire (1) Electronic survey (1) Elisa-test for IgM and IgG to SARS-CoV-2 (1) Eltrombopag (1) Emapalumab (1) Embarrassment message (1) Emergency Laparotomy (1) Emergency Ventilator Splitter (1) Emergency surgery (1) Emotion Regulation Training via Telehealth (1) Emotional Freedom Technique (1) Emotional Support Plan (1) Emphasis of Academic Researchers Involvement (1) Emphasis of Government Involvement (1) Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet (1) Emtricitabine/tenofovir (1) Emtricitabine/tenofovir disoproxil (1) Endoscopic intervention (1) Endoscopic management according to standard of care (1) Endoscopic procedure (1) Endothelial damage and angiogenic biomarkers (1) Endotracheal intubation (1) Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 (1) Enhanced hygiene measures (1) Enoxaparin 1 mg/kg (1) Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml (1) Enoxaparin Higher Dose (1) Enoxaparin Prefilled Syringe [Lovenox] (1) Enoxaparin Prophylactic Dose (1) Enoxaparin sodium (1) Enoxaparin/Lovenox Intermediate Dose (1) Enriched Survey Feedback (1) Ensifentrine Dose 1 (1) Entrée: Behavioral skills (1) Entrée: Cognitive skills (1) Entrée: Interpersonal skills (1) Environmental exposure and clinical features (1) Enzalutamide (1) Enzalutamide Pill (1) EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) (1) Equipment with smartwatch throughout hospital stay on the general ward (1) Eritoran (1) Escin (1) Essential Oil Blend (1) Essential oils (1) Estradiol patch (1) Estrogen Therapy (1) Ethanol with Asprin (1) Etoposide (1) Evaluate HACOR score effectivity in this patients (1) Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer (1) Evaluation of clinical, instrumental and laboratory diagnostics tests (1) Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2) (1) Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells (1) Examinations for the research: (1) Examine the impact of COVID-19 during pregnancy (1) Exebacase (1) Exercise Group (1) Exercise booklet (1) Exercise brochure (1) Exercise capacity (1) Exercise physiology (1) Exercise program (1) Exercise test ECG (1) Exercise training group (1) Experience of pandemic (1) Experiences in Close Relationship Scale questionnaire (ECR-S) (1) Experimental Group (1) Experimental drug (1) Experimental: Questionnaire without precaution information (1) Experts consensus (1) Expiratory training device (1) Exposure (not intervention) - SARS-CoV-2 infection (1) Exposure to the Dutch measures due to the Covid-19 pandemic. (1) Exposure to the SARS-CoV-2 (1) Exposure to the SARS-CoV-2 and its consequences (1) Exposure: Covid-19 infection (1) Expression of receptors and activating proteases (1) Extended sampling and procedures (1) External evacuation device (EED) (1) Extra blood sample (1) Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter (1) Extracorporeal left hemicolectomy anastomosis (1) Extracorporeal membrane oxygenation (1) Extraoral vacuum aspirator (EVA) (1) Extravascular Lung Water Index (1) Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol (1) F-652 (1) FAVICOVIR 200 mg Film Tablet (1) FAVIR 200 MG FT (1) FAVIRA 200 MG Film Tablet (1) FFP (1) FFP2 (1) FMD (1) FNC dummy tablet+Standard of Care (1) FNC+Standard of Care (1) FOY-305 (1) FSD201 (1) FT516 (1) FX06 (1) Face Mask + Soap (1) Face mask (1) Face mask awareness (1) Face mask sampling (1) Facebook Ads on the importance of staying safe during the Thanksgiving holiday (1) Facial fractures reduction or osteosynthesis (1) Facial mask (1) Family Nurture Intervention (FNI) (1) FamilyChildCare (provisional name of app) (1) Farmalarm (1) Fast dissolving film (1) Favipiravir (3200 mg + 1200 mg) (1) Favipiravir (3200 mg + 1200 mg) combined with Azithromycin (1) Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine (1) Favipiravir (3600 mg + 1600 mg) (1) Favipiravir + Currently used therapy (1) Favipiravir + Standard of Care (1) Favipiravir Combined With Tocilizumab (1) Favipiravir and Hydroxychloroquine (1) Favipiravir plus Nitazoxanide (1) Feeling Good Digital App (1) Fenofibrate (1) Fiberoptic Bronchoscopy (FOB) (1) Fibreoptic Endoscopic Evaluation of Swallowing (FEES) (1) Fibrin generation markers assays (1) File Scanning (1) File scanning (1) FilmArray PCR on respiratory samples (1) FilmArray Pneumonia (1) Filtration Test (1) Fingerstick (1) Fingolimod 0.5 mg (1) Fit test (1) Five-days oseltamivir (1) Fixed site standard of care testing (1) Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC) (1) Fixed-duration Hydrocortisone (1) Fixed-duration higher dose Hydrocortisone (1) Flow controlled ventilation (Evone-ventilator) (1) Flow cytometry (1) Flu shot (1) Flucelvax (1) Fluvirin (1) Fluzone High Dose (1) FoTv (1) Focused/Targeted Message (1) Folic Acid (1) Follow up calls (1) Follow-up at 14 days (1) Follow-up of patients with COVID-19 (1) Follow-up phone call (1) Follow-up visit (1) Fondapariniux (1) Fondaparinux (1) Freestyle Libre 14 day CGM system (1) Full Spectrum CBD Oil (1) Functional MRI (1) Fuzheng Huayu Tablet (1) Fuzheng Huayu tablet (1) GAD-7 (7-item Generalized Anxiety Disorder) (1) GAD-7 (General Anxiety Disorder) scale (1) GAD-7 General anxiety disorder scale (1) GAMUNEX-C (1) GC4419 (1) GC5131 (1) GENETIC (1) GLS-1027 (1) GLS-1200 (1) GLS-5310 (1) GNS561 (1) GO2 PEEP MOUTHPIECE (1) GPs reports of potential patient safety incidents, non-COVID-19 related (1) GRAd-COV2 (1) GX-19 (1) Galidesivir (1) Gam-COVID-Vac Lyo (1) Gamification (1) Ganovo+ritonavir+/-Interferon nebulization (1) Garadacimab, Factor XIIa Antagonist Monoclonal Antibody (1) Gargle/Mouthwash (1) Gas exchange measurement (1) Gas exchanges at different PEEP (1) Gastrointestinal endoscopy (1) General Communication Message (1) General Public cohort (1) General health education (1) Generalized Anxiety Disorder-7 (GAD 7) (1) Generalized Anxiety Disorder-7 (GAD-7) (1) Gimsilumab (1) Global Longitudinal Strain (1) Glucose tablets (1) Glycaemic levels (1) Glycine (1) Graded exercise test (1) Grocery store gift cards (1) Group 1 (1) Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed (1) Group 2: control group with enoxaparin 40mg/d (1) Group A (AG0302-COVID19) (1) Group A (Placebo) (1) Group A HCQ (1) Group A: oropharygeal spray and immunostimulant (1) Group B (AG0302-COVID19) (1) Group B (Placebo) (1) Group B Control (1) Group B: Placebo oropharyngeal spray + Active principle immunostimulant (1) Group C:Active principle oropharyngeal spray + Placebo taken PO (1) Group D:Placebo oropharyngeal spray + Placebo taken PO (1) Group1 (1) Growth Hormone (1) Growth Mindset SSI (1) Guided online support program (1) Guilt message (1) HADS (1) HADS questionnaire (1) HB-adMSC (1) HCFWO (1) HCQ & AZ (1) HCQ & AZ vs HCQ+SIR (1) HCQ+AZT (1) HFB30132A (1) HFNO (1) HIT-exercise (1) HLX70 (1) HLX71 (1) HOME-CoV rule implementation (1) HOPE intervention (1) Health Care Worker Survey (1) Health Enhancement Program (1) Health Questionnaire (1) Health supplements (1) Health warning leaflet (1) Health-related quality of life (1) Healthy Minds Program Foundations Training (1) Healthy lifestyle advise (1) Helmet CPAP (1) Helmet Continuous Positive Airway Pressure (CPAP) (1) Helmet non-invasive ventilation (1) Hemodynamics changes at different PEEP (1) Hemopurifier (1) Heparin - Prophylactic dosage (1) Heparin - Therapeutic dosage (1) Heparin Infusion (1) Heparin SC (1) Heparin sodium (1) Hepatitis A vaccine (1) Hesperidin and Diosmin mixture (1) Heterologous stimuli (1) Hidroxicloroquina (1) High Dose of KBP-COVID-19 (1) High Flow Nasal Oxygen (HFNO) (1) High Flow Nasal Therapy (1) High Intensity Interval Training group (1) High PEEP with end inspiratory pause (1) High PEEP without end inspiratory pause (1) High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule (1) High dose Interferon-beta 1a (1) High dose radiation 100 cGy (1) High flow nasal cannula (1) High flow nasal cannula HFNC (1) High intensity interval training (1) High volume evacuation (HVE) (1) High-Concentration Essential Oil (1) High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma (1) High-Titer COVID-19 Convalescent Plasma (HT-CCP) (1) High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen (1) High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen (1) High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen (1) High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen (1) High-dose placebo (18-59 years) & Three dose regimen (1) High-dose placebo (18-59 years) & Two dose regimen (1) High-dose placebo (60-85 years) & Three dose regimen (1) High-dose placebo (60-85 years) & Two dose regimen (1) High-flow nasal cannula treatment (1) High-titer Convalescent COVID-19 Plasma (CCP1) (1) Home Pulse Oximetry Monitoring (1) Home Sleep Apnea Testing or In-hospital Polysomnography (1) Home exercise (1) Home exercise program (1) Home sample collection of concerning mole with physician supervision (1) Home-based exercise (1) Home-based exercise training (1) Home-use Test and Follow-up Questionnaire (1) Honey (1) Hormones (1) Hospital admission (1) Hospital anxiety and depression scale (1) Hospital: DD-CA (1) Hospital: Usual Care (UC) (1) Hospitalized Patients for COVID-19 Infection (1) Huaier Granule (1) Human Biological samples (1) Human Coach first, then Virtual Assistant (1) Human Ezrin Peptide 1 (HEP1) (1) Human milk donors (1) Human umbilical cord derived CD362 enriched MSCs (1) Human umbilical cord mesenchymal stem cells + best supportive care (1) Humoral and cellular immunity (1) Hydrogen Oxygen Generator with Nebulizer (1) Hydrogen Peroxide (1) Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 (1) Hydroxychloroquin with Azithromycin (1) Hydroxychloroquine (placebo) (1) Hydroxychloroquine + Azithromycin (1) Hydroxychloroquine + Metabolic cofactor supplementation (1) Hydroxychloroquine + Sorbitol (1) Hydroxychloroquine + azithromycin + / - tocilizumab (1) Hydroxychloroquine + lopinavir/ritonavir (1) Hydroxychloroquine + placebo (1) Hydroxychloroquine , Sofosbuvir, daclatasvir (1) Hydroxychloroquine - Daily Dosing (1) Hydroxychloroquine - Daily dosing (1) Hydroxychloroquine Only Product in Oral Dose Form (1) Hydroxychloroquine Oral Product (1) Hydroxychloroquine Pill (1) Hydroxychloroquine Pre-Exposure Prophylaxis (1) Hydroxychloroquine SAR321068 (1) Hydroxychloroquine Sulfate (HCQ) (1) Hydroxychloroquine Sulfate + Azithromycin (1) Hydroxychloroquine Sulfate + Azythromycin (1) Hydroxychloroquine Sulfate 200 milligram (mg) Tab (1) Hydroxychloroquine Sulfate 400 mg twice a day (1) Hydroxychloroquine Sulfate 600 mg once a day (1) Hydroxychloroquine Sulfate 600 mg twice a day (1) Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets (1) Hydroxychloroquine and azithromycin treatment (1) Hydroxychloroquine and azithromycin treatment arm. (1) Hydroxychloroquine as post exposure prophylaxis (1) Hydroxychloroquine combined with Azithromycin (1) Hydroxychloroquine in combination of Azithromycin (1) Hydroxychloroquine plus Nitazoxanide (1) Hydroxychloroquine plus standard preventive measures (1) Hydroxychloroquine sulfate (1) Hydroxychloroquine sulfate &Azithromycin (1) Hydroxychloroquine, Azithromycin (1) Hydroxychloroquine, Clindamycin (1) Hydroxychloroquine, Clindamycin, Primaquine - high dose. (1) Hydroxychloroquine, Clindamycin, Primaquine - low dose. (1) Hydroxychloroquine, Doxycycline (1) Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) (1) Hydroxychloroquine/Azithromycine (1) Hydroxychloroquine/Chloroquine (1) Hydroxycloroquine and Azythromycine (1) Hyperbaric Chamber (1) Hyperbaric Oxygen (1) Hyperbaric Oxygen Therapy (1) Hyperbaric Oxygen Therapy (HBOT) (1) Hyperbaric oxygen therapy (1) Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device) (1) Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) (1) Hyperimmune plasma (1) Hyperpolarized Xe129 (1) Hyperpolarized Xenon-129 MRI of the lungs (1) Hypertension (1) Hypothermia (1) Hypothermia Via Cooling Machine- Arctic Sun 5000 (1) IC14 (1) IC14, a monoclonal antibody against CD14 (1) ICU Recovery + Physical Therapy (1) ID NOW vs. Accula (1) IER-R (posttraumatic stress) (1) IIBR-100 high-dose (prime) (1) IIBR-100 low-dose (prime-boost) (1) IIBR-100 medium dose (prime) (1) IIBR-100, low dose (prime) (1) IIEF-5 questionnaire (1) IL-12 plasmid (1) IMM-101 (1) IN01 vaccine (1) INB03 (1) INC424 / Ruxolitinib (1) INM005 (1) INOpulse (1) IP-10 in CDS protocol (1) IPSS questionnaire (1) ISIS 721744 (1) IV Deployment Of cSVF In Sterile Normal Saline IV Solution (1) IV Dexamethasone (1) IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. (1) Ibudilast (1) Ibuprofen (1) Icatibant (1) Icosapent ethyl (IPE) (1) Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus (1) Identification of genetic variants (1) IgG (1) IgG SARS CoV 2 antibodies (1) IgG SARS CoV2 (1) IgG antibodies immunoassay (1) IgG test (1) IgIV (1) IgM and IgG antibodies assay (1) IgM and IgG diagnostic kits to SARS-CoV-2 (1) Iloprost (1) Imaging (1) Imaging by thoracic scanner (1) Imaging of the lungs (1) Imatinib (1) Imatinib Mesylate (1) Imatinib tablets (1) Immediate vs. delayed provision of antibody test results (1) Immune response study (1) Immunfluorescence (1) ImmunoFormulation (1) Immunofree tablets and Reginmune capsule (1) Immunoglobulin (1) Immunoglobulin of cured patients (1) Immunoglubulins (1) Immunological profiling (1) Immunosuppressive (1) Immunosuppressive Agents (1) Impact Event Score (1) Impact of COVID-19 questionnaire (1) Impact of Event Scale-Revised (1) Impact of respiratory isolation on quality of life (1) In-person instruction (1) In-person postoperative visit (1) Inactivated SARS CoV 2 vaccine (Vero cell). Wuhan (1) Inactivated SARS-CoV-2 vaccine (Vero cell) (1) Inactivated convalescent plasma (1) Increasing Willingness and Uptake of COVID-19 Testing and Vaccination (1) Individualised Ayurveda (1) Individualized-Chinese herbal medicine (1) Indomethacin (1) Infectious Disease and Cardiology Clinical Consultations (1) Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration (1) Information (1) Informational videos and social media campaigns encouraging cancer screening. (1) Informed consent (1) Infrared Energy and Dietary Supplement (1) Infusion IV of Mesenchymal Stem cells (1) Infusion placebo (1) Inhaled Hypertonic ibuprofen (1) Inhaled ILOPROST (1) Inhaled Supplemental Oxygen (1) Inhaled budesonide (1) Inhaled nitric oxide (iNO) (1) Inhaled nitric oxide gas (1) Inhaled sedation (1) Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs (1) Innova Lateral Flow Device (1) Inspiratory training device (1) Instrumental Activities of Daily Living Shaping (1) Insulin (1) Insulin film (1) Insulin regimen (1) Interferon alfa (1) Interferon-Alpha2B (1) Interferon-Beta (1) Interferon-ß-1a (1) Interferon-β 1a (1) Interferon-β1a (1) Interleukin 6 (IL6) Antagonist (1) Interleukin 6 (IL6) Antagonist and corticosteroids (1) Interleukin assessment in semen (1) Interleukin-1 receptor antagonist (1) Interleukin-6 Gene-174C detection (1) Intermediate dose thromboprophylaxis (1) Intermittent prone positioning instructions (1) Internet Cognitive Behavioral Therapy plus CHAMindWell (1) Internet-based Cognitive Behavioral Therapy (1) Internet-based guided self-help based on CBT principles (1) Internet-based self-help (1) Internet-based self-help after 3 weeks (1) Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic (1) Interpersonal Psychotherapy (1) Intervention (1) Intervention App (1) Intervention for COVID-19 preventive protocols (1) Intervention for TECC Model (1) Intervention group CoronaCope (1) Intervention group_rehabilitation program (1) Intervention program (1) Intervention training: (1) Intervention, TBN (1) Interview by psychologists (1) Intracorporeal left hemicolectomy anastomosis (1) Intramuscular Vaccine (1) Intramuscular vaccine (1) Intranasal heparin sodium (porcine) (1) Intraosseous access (1) Intravenous Immune Globulin (1) Intravenous Immunoglobulin (1) Intravenous Infusions of Stem Cells (1) Intravenous access (1) Intravenous drug (1) Intravenous saline injection (Placebo) (1) Intravenous sedation (1) Intubation Box (1) Invasive mechanical ventilation (1) Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours (1) Investigation of smell and taste disorders (1) Investigation of the prevalence of test positivity (1) Investigational Product - ViraCide (1) Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops) (1) Iota-Carrageenan (1) Isoflurane Inhalant Product (1) Isoprinosine (1) Isoquercetin (1) Isoquercetin (IQC-950AN) (1) Isotonic saline (1) Isotonic saline 0.9% (1) Isotretinoin Only Product in Oral Dose Form (1) Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment (1) Itolizumab IV infusion (1) Ivermectin (IVM) (1) Ivermectin + Doxycycline (1) Ivermectin + Doxycycline + Placebo (1) Ivermectin + Placebo (1) Ivermectin 3mg Tab (1) Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets (1) Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU. (1) Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets (1) Ivermectin 6 MG Oral Tablet (2 tablets) (1) Ivermectin Injectable Solution (1) Ivermectin Tablets (1) Ivermectin and Doxycyline (1) Ivermectin nasal (1) Ivermectin oral (1) Ivermectin plus Nitazoxanide (1) JS016 (anti-SARS-CoV-2 monoclonal antibody) (1) Janus Kinase Inhibitor (ruxolitinib) (1) KELEA Excellerated Water (1) KIR phenotype evaluation (1) Kaletra and beta interferon (1) Kamada Anti-SARS-CoV-2 (1) Kaplan Meier analysis (1) Ketamine (1) Ketogenic diet with phytoextracts (1) Ketotifen 1 MG (1) Kevzara sc (1) Knowledge, Attitude, Practice, Awareness, Preference (1) Kukaa Salama: mHealth intervention (1) Kundalini Yoga and Anxiety Reduction Training (1) L-Citrulline (1) L-citrulline (1) LAMP (1) LAU-7b (1) LB1148 (1) LEAF-4L6715 (1) LMWH (1) LSALT peptide (1) LY3127804 (1) LYMPHOCYTE MONOCYTE RATIO (1) LYT-100 (1) Lab workup (on admission and regularly during follow up). (1) Laboratory Analyses (1) Laboratory test positive for SARS-CoV-2 virus (1) Laboratory tests (1) Lactobaciltus rhamnosus GG (1) Lactobaciltus rhamnosus GG Placebo (1) Lactoferrin (1) Lactoferrin (Apolactoferrin) (1) Lambda 180 mcg S.C (1) Lanadelumab (1) Late dexamethazone (1) Late-Dexamethasone (1) Lateral Position (left and right lateral decubitus) (1) Learning running subcuticular sutures on the Gamified Educational Network (1) Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. (1) Let It Out (LIO)-C (1) Leukapheresis (1) Levamisole (1) Levamisole Pill + Budesonide+Formoterol inhaler (1) Levamisole and Isoprinosine (1) Levamisole and isoprinosine (1) Levilimab (1) Lianhua Qingwen (1) Liberase Enzyme (Roche) (1) Licensed seasonal influenza vaccine (1) Licorice extract (1) Lidocaine 2% (1) Life2000® Ventilator (1) LifeSignals Biosensor 1AX* (1) Lifelight® Data Collect Blood Pressure Group (1) Lifelight® Data Collect Oxygen Saturation Group (1) Lifestyle change promotion program (1) Lift (1) Limbix Spark (1) Linagliptin (1) Linagliptin 5 MG (1) Linagliptin tablet (1) Liquid Alpha1-Proteinase Inhibitor (Human) (1) Listerine Mouthwash Product (1) Liu-Wei-Di-Huang formula (1) Liver function tests (1) Liver function tests ,serum ferritin and PCR for COVID-19 . (1) Liver injury (1) Liver, lung, heart and kidney biopsy (1) Local standard of care (1) Lock-down and social distancing (1) Longeveron Mesenchymal Stem Cells (LMSCs) (1) Lopinavir (1) Lopinavir / ritonavir tablets combined with Xiyanping injection (1) Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride (1) Lopinavir 200 MG / Ritonavir 50 MG [Kaletra] (1) Lopinavir 200Mg/Ritonavir 50Mg FT Reference (1) Lopinavir 200Mg/Ritonavir 50Mg FT Test (1) Lopinavir 200Mg/Ritonavir 50Mg Tab (1) Lopinavir and ritonavir (1) Lopinavir-Ritonavir Drug Combination (1) Lopinavir/ Ritonavir (1) Lopinavir/ Ritonavir Oral Tablet (1) Lopinavir/ Ritonavir Placebo (1) Lopinavir/Ritonavir + hydoxychloroquine (1) Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet (1) Lopinavir/Ritonavir 400 mg/100 mg (1) Lopinavir/ritonavir treatment (1) Losartan 50 mg and Spironolactone 25 mg pillules oral use (1) Losmapimod oral tablet (1) Lovenox 40 MG in 0.4 mL Prefilled Syringe (1) Low Dose (10 mg) Control (1) Low Dose Radiation Therapy (LD-RT) (1) Low Dose of KBP-COVID-19 (1) Low Molecular Weight Heparin (1) Low PEEP - FiO2 high (1) Low PEEP - FiO2 low (1) Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule (1) Low dose Interferon-beta 1a (1) Low dose Low molecular weight heparin or Placebo (1) Low dose Radiotherapy (1) Low dose prednisolone (1) Low dose radiation 35 cGy (1) Low dose radiation therapy (1) Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis (1) Low flow ECMO driving by CVVH machine (1) Low or upper respiratory tract sample (1) Low-Concentration Essential Oil (1) Low-Intensity Psychosocial Interventions through Telemental health (1) Low-dose Chest CT (1) Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen (1) Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen (1) Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen (1) Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen (1) Low-dose placebo (18-59 years) & Three dose regimen (1) Low-dose placebo (18-59 years) & Two dose regimen (1) Low-dose placebo (60-85 years) & Three dose regimen (1) Low-dose placebo (60-85 years) & Two dose regimen (1) Low-dose radiotherapy (1) Lower-dose prophylactic anticoagulation (1) Lucinactant (1) Lung CT (1) Lung CT scan analysis in COVID-19 patients (1) Lung Function Test (1) Lung Function tests (1) Lung Low Dose Radiation (1) Lung Ultrasound (1) Lung impedance technique (1) Lung ultrasound use in patients hospitalized with COVID (1) LungFit™ (1) MAGEC Spine Rod (1) MANAGEMENT OF COVID-19 (1) MAS825 (1) MCC IMS (1) MCN (Methylene blue, vitamin C, N-acetyl cysteine) (1) MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg (1) MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg (1) MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg (1) MFS (1) MK-5475 (1) MLS Laser (1) MMR vaccine (1) MPT0B640 (1) MR or M-M-R II ® vaccine (1) MR-Pro-ADM (1) MRG-001 (1) MRI (1) MRI (heart, brain, lungs, liver) (1) MRI scans (1) MRx-4DP0004 (1) MSC Treatment (1) MSCT (1) MSCs (1) MSCs-derived exosomes (1) MSTT1041A (1) MSTT1041A-matched Placebo (1) MVA-SARS-2-S vaccinations (days 0 & 28) (1) MVC-COV1901 (1) Machine Learning/AI Algorithm (1) Machine learning model (1) Macrolide administered for 3-5 days (1) Macrolide administered for up to 14 days (1) Magnetic Resonance Imaging (1) Magnetic Resonance Spectroscopy (MRS). (1) Maintenance or reduction of immunosuppression (1) MakAir (1) Male Sexual Health Questionnaire (MSHQ) (1) Maltodextrin (1) Mannitol (1) Manremyc (1) Maraviroc (1) Maraviroc + Currently used therapy (1) Maraviroc 300 mg (1) Maraviroc+Favipiravir+CT (1) Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) (1) Masimo, LidCO (1) Masitinib (1) Mask with Mask Adhesive/Arm 1 (1) Mask without Mask Adhesive / Arm 2 (1) Masked Saline Placebo (1) Maslach Burnout Inventory (MBI) (1) Massive parallel sequencing of host genome (1) Matched Placebo (1) Matched Placebo Hydroxychloroquine (1) Matched placebo (1) Matching placebo (1) Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores (1) Maternal stress (1) Maximal effort test (1) Measles-Mumps-Rubella Vaccine (1) Mechanical Trombectomy (1) Mechanical ventilation with the automated BVM compressor (1) Media Intervention (1) Medical Mask (1) Medical Music (1) Medical Ozone procedure (1) Medical Record Review (1) Medical Record Review - Inpatient Treatment (1) Medication Review (1) Meditation Therapy (1) Meditation and Anxiety Reduction Training (1) Meditation app usage (1) Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule (1) Medium dose prednisolone (1) Mefloquine (1) Mefloquine + azithromycin + / - tocilizumab (1) MejoraCare (1) Melatonin 2mg (1) Melatonin intravenous (1) Melphalan (1) MenACWY (1) MenACWY boost (1) MenACWY prime & saline placebo boost + paracetamol (1) MenACWY single dose + paracetamol (1) MenACWY vaccine (1) MenCare+/Bandebereho fathers'/couples' group education (1) Mental Health questionnaire (1) Mental imagery (1) Merimepodib (1) Mesenchymal Stem Cell (1) Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords (1) Mesenchymal Stromal Cells infusion (1) Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 (1) Mesenchymal cells (1) Mesenchymal stem cell (1) Mesenchymal stem cell therapy (1) Mesenchymal stem cells (1) Mesenchymal stromal cell-based therapy (1) Message directing subjects to information on COVID-19 vaccine safety and efficacy (1) Messaging (1) MetaNeb® System (1) Metformin Glycinate (1) Methotrexate-LDE phase 1 (1) Methotrexate-LDE phase 2 (1) MethylPREDNISolone 80 Mg/mL Injectable Suspension (1) Methylene Blue (1) Methylene Blue 5 MG/ML (1) Methylene-Blue Photodisinfection (1) Methylprednisolone Injectable Product (1) Methylprednisolone Injection (1) Methylprednisolone, Placebo (1) Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) (1) Microcrystalline Cellulose, NF (1) Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension (1) Microscopy of defined brain regions on autopsy specimens (1) MindRhythm Harmony (1) Mindfullness based cognitive program (1) Mindfulness + Compassion Intervention (MC) (1) Mindfulness Alone (MO) Intervention (1) Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell (1) Mindfulness Rounds (1) Mindfulness based intervention (1) Mindfulness intervention (1) Mindfulness program (1) Mindfulness session(s) (1) Mindfulness training (1) Mindfulness training (MT) Connect (1) Mindfulness-Based Cognitive Therapy (1) Minimal Attention Control Intervention (1) MinnRAP Peer Support Program (1) Mixture 3,6% H2 in N2 (96.4%) (1) Mobile Mental Health App - 1 (1) Mobile Mental Health App - 10 (1) Mobile Mental Health App - 2 (1) Mobile Mental Health App - 3 (1) Mobile Mental Health App - 4 (1) Mobile Mental Health App - 5 (1) Mobile Mental Health App - 6 (1) Mobile Mental Health App - 7 (1) Mobile Mental Health App - 8 (1) Mobile Mental Health App - 9 (1) Model Building (1) Model validation (1) Moderate Intensity Aerobic Exercises (1) Modified Bai He Gu Jin Tang (1) Modified CariesCare International management (1) Modified Rankin score (1) Molgramostim nebuliser solution (1) Monalizumab (1) Monitoring Visit - Baseline (1) Monitoring Visit - Week 4 (1) Monitoring Visit - Week 8 (1) Monitoring for aggravation (1) Monitoring physiological data with the Hexoskin smart shirt (1) Montelukast 10mg (1) Montmorrillonite (1) Motivational social support from nurse (1) Motivational social support from nurse with additional support from significant other (1) Motivational telephone intervention (1) Moxibustion plus Cupping (1) Moxifloxacin or Levofloxacin (1) Mucodentol (1) MultiStem (1) Multicapillary column coupled ion mobility spectrometry (1) Multifrequency Bioimpedance Spectroscopy (1) Multiple Doses of Anti-SARS-CoV-2 convalescent plasma (1) Muscle Relaxation Therapy (1) Muscle ultrasound (1) MuscleSound Ultrasound (1) Museum virtual guided tours (1) Music Therapy (1) N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I (1) N-803 (1) N-95 Respirator (1) N-acetyl cysteine (1) N95 respirator (1) NA (no intervention) (1) NA-831 (1) NA-831 and Atazanavir (1) NA-831and Dexamethasone (1) NAD+ (1) NBT-NM108 (1) NETosis markers (1) NG Biotech (1) NG test (1) NGM621 (1) NHANES smell and taste tests (1) NIO® (Intraosseous access) (1) NIVOLUMAB (1) NK Cells (1) NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells (1) NK-1R antagonist (1) NO intervention planned due to the observational study design - only a diagnostic testing (1) NO intervention planned due to the observational study design only a diagnostic testing (1) NO-Immunosuppressive (1) NOX66 (1) NP-120 (Ifenprodil) (1) NRICM101 (1) NT-I7 (1) NaCl (1) NaCl 0.9% (1) NaCl Solution (1) Nafamostat Mesylate (1) Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) (1) Narrative Writing (1) Nasal Brushing (1) Nasal Dexamethasone (1) Nasal Irrigation (1) Nasal Spray (1) Nasal Swab (1) Nasal lavage (1) NasoVAX (1) Nasopharyngeal (NP) swab (1) Nasopharyngeal Swab (1) Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR (1) Nasopharyngeal swab and main laboratory (1) Nasopharyngeal, oropharyngeal, or saliva swab (1) Natural Honey (1) Natural Killer Cells infusion (1) Nebulised heparin (1) Nebulised unfractionated heparin (UFH) (1) Nebulized Furosemide (1) Nebulized Platelet Lysate (1) Nebulized Saline (1) Nebulized Sterile Saline (1) Nebulized administration of RLF-100 or Placebo (1) Negative COVID Test Result - Hypothetical Scenario (1) Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection (1) Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection (1) NestaCell® (1) Neural network diagnosis algorithm (1) Neurocognitive assessment (1) Neuromuscular Blocking Agents (1) Neuromuscular Electrical Stimulation (1) Neuromuscular evaluation (1) Neutral writing control (1) Neutralizing antibodies (1) New QIAstat-Dx fully automatic multiple PCR detection platform (1) New screening strategy (1) Newsfeed function (1) Next generation Sequencing (NGS) analysis (1) Niclosamide suspension (1) Nicotinamide riboside (1) Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour (1) Nicotine patch (1) Nigella sativa (1) Nil intervention (1) Nintedanib (1) Nintedanib 150 MG (1) Nintedanib 150 MG [Ofev] (1) Nitazoxanide 500 MG (1) Nitazoxanide 500Mg Oral Tablet (1) Nitazoxanide Tablets (1) Nitazoxanide and atazanavir/ritonavir (1) Nitazoxanide with ivermectin (1) Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation (1) Nitric Oxide delivered via LungFit™ system (1) Nitric Oxide lozenges, 30 mg (1) Nitric Oxide-Continuous and Sessions (1) Nitric Oxide-Releasing Drug (1) Nitric Oxide-Sessions (1) Nivolumab (1) Nivolumab Injection (1) No Messaging (1) No Personal protective equipment (PPE) (1) No Racial Inequality Highlighting (1) No intervention (survey study for medical doctors). (1) No intervention - exposure is to COVID-19 (1) No intervention - quality of life measure (1) No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups (1) No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests (1) No intervention on patients (1) No intervention, observational (1) No intervention, this is an observational study that uses validated questionnaires and qualitative interviews.. (1) No interventions (1) No interventions planned (1) No interverntion (1) No research related technology based social interactions (1) No special intervention (1) Non Intervention (1) Non applicable (1) Non interventional study (1) Non invasive visual acuity testing (1) Non-ACEI/ARB (1) Non-Interventional (1) Non-Mindfulness intervention (1) Non-contact ECG (1) Non-contact MCE system (1) Non-convalescent Plasma (control plasma) (1) Non-convalescent fresh frozen plasma (Standard plasma) (1) Non-enhanced CT scan of the chest (1) Non-hospitalization procedures (1) Non-interventional (1) Non-interventional study (1) Non-invasive cardiac imaging (1) Non-invasive red LLLT treatment to chest of patient. (1) Non-invasive ventilatory support (1) None - NA (1) Noninvasive ventilation treatment (1) Normal Saline 0.9% (1) Normal Saline Infusion + standard of care (1) Normal Saline intranasal (1) Normal saline 0.9% (1) Normal saline solution (NSS), Placebo - Phase 1 (1) Normal saline solution (NSS), Placebo - Phase 2 (1) Normal saline solution (NSS), Placebo, Day 189 - Phase 2 (1) Normal saline solution (NSS), Placebo, Day 21 - Phase 1 (1) Normal saline solution (NSS), Placebo, Day 21 - Phase 2 (1) Not bravery message (1) Novaferon (1) Novel laser inferometry test for CORONA virus (1) NuSepin® 0.1 mg (1) NuSepin® 0.2 mg (1) Nudge (1) Nursing care to reduce anxiety, fear and loneliness (1) Nutrition (1) Nutrition Consult and Protein Supplementation (1) Nutrition support (1) Nutritional assessment (1) Nutritional support system (NSS) (1) Nuvastatic (1) NİCaS (1) OCTAPLAS (1) OLO-1 Medical Molecular Sieve Oxygen Generator (1) OP-101 (1) Obesity (1) Observation for study group (1) Observation of behavior and COVID-19 infection will be conducted. (1) Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings (1) Observation of patients with known, suspected, or at risk for COVID-19 infection (1) Observation only (1) Observational (registry) (1) Observational Study (1) Observational cohort study on the natural history of hospitalized SARS-COV-2 patients. (1) Observational measurement of biometric data. No change to health care provided. (1) Observational only (1) Observational study only (1) Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples (1) Obvio-19 app (1) Occupational health workers (1) Octagam (1) Octagam 10% (1) Odd/Even birth year intervention groups (1) Olfaction testing (1) Olfactometry (1) Olfactory retraining (1) Omega 3/Nigella Sativa Oil (1) Omega 3/Nigella Sativa Oil/Anise seed capsule (1) Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice (1) Omega 3/Nigella Sativa Oil/Indian Costus (1) Omega 3/Nigella Sativa Oil/Quinine pills (1) Omega-3 Fatty Acid Supplement (1) Omegaven® (1) Omeprazole 20mg (1) Omnibiotic AAD (1) On-Line Survey (1) One COVID-19 vaccine candidate (TMV-083) administration - High dose (1) Online Intervention Grief COVID-19 (1) Online Intervention Mental Health COVID-19 (1) Online Questionnaires (1) Online Survey about Dietary and Lifestyle Habits (1) Online bibliotherapy programme (1) Online cognitive behavioral therapy (CBT) (1) Online instruction (1) Online questionnaire and interviews (1) Online support Group (1) Only Standard Treatment (1) Ophtamesone (1) Opt-in Recruitment Email (1) Opt-out Recruitment Email (1) Optical Coherence Tomography (OCT) (1) Optical coherence tomography angiography (1) Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East (1) Optional blood completion (1) Optional questionnaire completion (1) Oral (1) Oral 25-Hydroxyvitamin D3 (1) Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions (1) Oral fluid swab (1) Oral supplement enriched in antioxidants (1) Oral-B Mouth Sore mouthwash (1) Oropharyngeal Swab (1) Orthopaedic Surgical Procedures (1) Oseltamivir 75mg (1) Other (1) Others(No intervention) (1) Otilimab (1) Outpatient MRI (1) Ovotransferrin (1) Oxaloacetate Medical Food/Dietary Supplement (1) Oxidative Stress ELISA Kit (1) Oxygen Hood (1) Oxygen Therapy (1) Oxygen gas (1) Oxygen supply (1) Oxygen-ozone therapy, probiotic supplementation and Standard of care (1) Oxytocin (1) Ozanimod (1) Ozone auto-hemotherapy (1) Ozonized oil (HOO (1) P2Et (Caesalpinia spinosa extract) (1) PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) (1) PCR (1) PCR Value (1) PCR for COVID-19 (1) PCR, lung ultrasound (1) PD-1 blocking antibody+standard treatment (1) PEEP trial (1) PEP flute (1) PET-CT of 18F-FDG (1) PF-06650833 (1) PF-07304814 (1) PH94B (1) PHQ-9 (9-item Patient Health Questionnaire) (1) PHQ-9 (Patient Health Questionnaire) Depression Scale (1) PHQ-9 Depression Scale (1) PHR160 Spray (1) PLACEBO GROUP (1) PLN-74809 (1) POOL LAMP (1) POOL RT-PCR (1) PRAYER (1) PRO-SERO-COV (1) PROTECTIVE VENTILATION (1) PSC-04 (1) PSG (1) PSQI (1) PSS (Perceived Stress Scale) (1) PT-PCR test for SARS-CoV-2 (1) PT-Pal (1) PT-X and IMT (1) PTC299 (1) PTSD (1) PWV (1) Pacebo: Calcium citrate (1) Pacritinib (1) Pamrevlumab (1) Pandemic control measures (1) Paracetamol (1) Paraclinical examination (1) Part 1 - TL-895 (1) Part 2 - Placebo (1) Part 2 - TL-895 (1) Partially HLA-matched SARS-CoVSTs (1) Participate in a massive musical event (1) Passed infection of SARS-CoV-2 (1) Passive Microwave Radiometry (1) Patch, Nicotine (1) Patch, Placebo (1) Pathogen-specific aAPC (1) Patient Characteristics (1) Patient Education (1) Patient Health Questionnaire (PHQ-9) (1) Patient Health Questionnaire-9 (PHQ-9) (1) Patient Status Engine (1) Patient management suffering of coronavirus infection (1) Patient sampling (1) Patient with SAR-CoV-2 infection (1) Patient-centred advice on Telephone Consultation in TB Patients: (1) Patients admitted in Intensive Care Units (1) Patients admitted to Intensive Care Unit with SARS-CoV2 (1) Patients received standard of care treatment during hospitalization (1) Patients with the treatment agains COVID19 (1) Pectin (1) Peer Mentor Delivery (1) Peer Resilience Champion (1) Peginterferon Lambda-1a (1) Peginterferon beta-1a (1) Peginterferon lambda alfa-1a subcutaneous injection (1) Pegylated Interferon-α2b (1) Pegylated interferon lambda (1) Pembrolizumab (MK-3475) (1) Pemziviptadil (PB1046) (1) Percutaneous Coronary Revascularization for STEMI (1) Performance of the test antigenic and test RT-PCR (1) Performing of lung ultrasound (1) Performing routine care (clinical and paraclinical tests) (1) Peripheral Blood (1) Peripheral blood sampling (1) Peripheral venous ultrasound (1) Personal Exercise Intervention (1) Personal Protective Testing Booth (1) Personal behaviours (1) Personal freedom message (1) Personal protective equipment (1) Personal protective equipment (PPE) (1) Personal protective equipment from biological hazard (1) Personalized ambulatory training (1) Personalized health education (1) Phage Therapy (1) Philips Lumify Ultrasound System (1) Phlebotomy (1) Phone call (1) Phone call interview (1) Phone interviews (1) Phone-call screening and management by a medical student/general practitioner tandem (1) Phsyiotherapy (1) Physical Exercises (1) Physical Therapy (1) Physical Therapy Exercise (1) Physical and Cognitive Activity (1) Physical examination (1) Physical exercise (1) Physical exercise training (1) Physiological saline solution (1) Physiological serum (1) Physiology (1) Piclidenoson (1) Pilot a rapid SARS-CoV-2 testing strategy (1) Pioglitazone (1) Pioglitazone 30 mg (1) Pioglitazone 45 mg (1) Piperacillin-tazobactam (1) Piperacillin/tazobactam (1) Placebo (0.9% normal saline) (1) Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) (1) Placebo (Methylcellulose) capsule (1) Placebo (PB0) (1) Placebo (PBO) (1) Placebo (Plasma-Lyte 148) (1) Placebo (carrier control) (1) Placebo (human albumin 1%) (1) Placebo (potato starch and magnesium stearate) (1) Placebo (saline) (1) Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) (1) Placebo (two doses), priming (1) Placebo - Phase I (1) Placebo - Starch Powder Soft gels (1) Placebo 0.10 mg + 1.00 mg/kg (1) Placebo 0.20 mg + 2.00 mg/kg (1) Placebo 0.9% NaCl solution (1) Placebo 250 cc 24 hours continuous infusion for 15 days (1) Placebo Atazanavir (1) Placebo Atrovastatin (1) Placebo Control (1) Placebo Daclatasvir 60 mg (1) Placebo EC-18 (1) Placebo Group (1) Placebo Hydroxychloroquine (1) Placebo Nitazoxanide (1) Placebo Oil (1) Placebo PBMT/sMF (1) Placebo Ribavirin (1) Placebo Saline (1) Placebo Sofusbuvir + Daclatasvir 60 mg (1) Placebo Starch (1) Placebo Subcutaneous Solution (1) Placebo Tablet (1) Placebo Vaccine (1) Placebo booster (1) Placebo capsules (1) Placebo comparator: DW-NI (1) Placebo comparator: DW-NS (1) Placebo control (non-behavioral infographic) (1) Placebo control + best supportive care (1) Placebo for "Deficiency of Qi and Yang" (1) Placebo for "Deficiency of Qi and Yin" (1) Placebo for ABBV-47D11 (1) Placebo for Azithromycin (1) Placebo for Hydroxychloroquine (1) Placebo intravenous (1) Placebo mouthwash (water) (1) Placebo multiple (1) Placebo nebuliser solution (1) Placebo of FX06 (1) Placebo of Hydroxychloroquine (1) Placebo of LPV/r Tablets (1) Placebo of NICOTINE Transdermal patch (1) Placebo of excipient(s) will be administered (1) Placebo on a 0- and 14-day schedule (1) Placebo oral (1) Placebo oral capsule; From August 2020 'no additional treatment' (1) Placebo pMDI (1) Placebo patch (1) Placebo plus standard preventive measures (1) Placebo single (1) Placebo solution (1) Placebo to Match RDV (1) Placebo videos (1) Placebo- 0.10 mg/kg (1) Placebo- 0.20 mg/kg (1) Placebo- 1.00 mg/kg (1) Placebo- 2.00 mg/kg (1) Placebo-LDE phase 2 (1) Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine (1) Placebo/Control (1) Placebo: Emtricitabine/tenofovir disoproxil Placebo (1) Placebo: Hydroxychloroquine (1) Placebo; 0.9% saline (1) Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells (1) Plant Polyphenol (1) Plaquenil 200Mg Tablet (1) Plasma Donation (1) Plasma IgG levels (1) Plasma exchange (1) Plasma exchange and convalescent plasma (1) Plasma expansion with Ringer's Acetate (1) Plasma from COVID-19 convalescent patient (1) Plasma from a volunteer donor (1) Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 (1) Pleth variability index (1) Plethysmography & DLCO (1) Plitidepsin 1.5 mg/day (1) Plitidepsin 2.0 mg/day (1) Plitidepsin 2.5 mg/day (1) Pneumococcal vaccine (1) Point-of-Care Ultrasonography (POCUS) (1) Point-of-care test for SARS-CoV-2 (1) Polymorphism of the HSD3B1 (1) Polyoxidonium (1) Positive COVID Test Result - Hypothetical Scenario (1) Positive feedback (1) Post COVID-19 Functional Satus Scale (1) Post Traumatic Stress Disorder questionnaire (PTSD-8) (1) Post-intensive Care unit syndrome (1) Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 (1) Postural Positioning (1) Povidine iodine nasal swabs (1) Povidone-Iodine 0.4% NI (1) Povidone-Iodine 0.5% (1) Povidone-Iodine 0.5% NI (1) Povidone-Iodine 0.5% NS (1) Povidone-Iodine 0.6% NI (1) Povidone-Iodine 0.6% NS (1) Povidone-Iodine 2% (1) Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP (1) Povidone-iodine (1) Prasugrel (1) Prasugrel Hydrochloride 10 MG Oral Tablet (1) Prazosin (1) Prediction Market (1) Predictive factors for clinical response in patients with COVID-19. (1) Predictors adverse evolution (1) Predictors of health care provide (1) Prednisolone 5 mg (1) Prednisone tablet (1) Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 (1) Premier Biotech COVID-19 IgG/IgM Rapid test Cassette (1) Presence of specific anti-SARS-CoV-2 antibodies (1) PreserVision AREDS formulation gel tabs (1) Preservative-free saline (1) Prevalence of COVID-19 (1) Preventive information (1) Previfenon® (1) Primary care (1) Primary care professionals reports of potential patient safety incidents, non-COVID-19 related (1) Primary exposure is hypoxia (no intervention) (1) PrimePro (1) Pro BNP , Vitamin D (1) Probiorinse (1) Probiotics (1) Probiotics (2 strains 10x10^9 UFC) (1) Problem-solving and relationship improvement intervention. (1) Produce prescription program (1) Progesterone 100 MG (1) Prognostic score (1) Progressive cycling exercise test to exhaustion (1) Progressive muscle relaxation (1) Project ECHO (1) Prolastin (1) Prolectin-M; a (1-6)-alpha-D-Mannopyranose class (1) Prolonged Exposure Therapy (1) Prolonged Proned Positioning (1) Prone (1) Prone Position (PP) (1) Prone Positioning (PP) (1) Prone decubitus (1) Prone position ventilation (1) Prone positioning (PP) (1) Prophylactic/Intermediate Dose Enoxaparin (1) Propofol (1) Propranolol Hydrochloride (1) Proprietary extract of Nerium oleander (1) Prosocial acts (1) Prospective Chart Review (1) Prospective oberservational registry (1) Prospective observation (1) Prospective study across two time-points examining the impact of viral mitigation protocols on mental health (1) Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout (1) Protocolised mechanical ventilation strategy (1) Prototype swab (1) Proxalutamide (1) Psychiatric counseling (1) Psycho-Social Questionnaire (1) Psycho-education (1) Psychoeducation (1) Psychoeducational intervention (1) Psychological and Behaviour Change Support (1) Psychological stress and adaptation at work score (PSAS) (1) Psychological treatment (1) Public Health England Gold Standard (1) Public space exposure (1) Pulmonary Function Tests (PFT) (1) Pulmonary Physiotherapy Techniques (1) Pulmonary Vascular Permeability Index (1) Pulmonary and Motor Rehabilitation (1) Pulmonary function testing (1) Pulmonary function tests (1) Pulmonary tele-rehabilitation (1) Pulmonary ultrasound (1) Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) (1) Pulse Oximeter (1) Pulse oximetry (1) Pyridostigmine Bromide (1) Pyronaridine-Artesunate (1) Pyronaridine-artesunate (1) Q-NRG Metobolic Cart Device (1) Q16 testing (1) QUANTIFERON (1) QazCovid-in® - COVID-19 inactivated vaccine (1) QuadraMune(TM) (1) Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19) (1) Quality of Life (1) Quality of life assessment (1) Quality of life promotion (1) Quantitative IgG Test (1) Quantitative analysis of SARS-CoV-2 antibodies (1) Quantitative analysis of anti-SARS-CoV-2-antibodies (1) Quantitative and qualitative assessments of mental health (1) Quantra System (1) Quasistatic pressure-volume curve (1) Quercetin (1) Quercetin Phytosome (1) Quercetin Prophylaxis (1) Quercetin Treatment (1) Querying the INSEE database (1) Questionaire (1) Questionnaire : Preparedness for Caregiving Scale (1) Questionnaire and interview (1) Questionnaire by phone call (1) Questionnaire collection (1) Questionnaire completion (1) Questionnaire for evaluation of confinement on deviant sexual fantasies (1) Questionnaire forms (1) Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index (1) Questionnaire with precaution information (1) Questionnaire, phone call (1) Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. (1) Questionnaire-based observational study (1) Questionnaires for specific phobia (1) Questionnaires on psychological quality of life (1) Questionnaires, spirometry (1) Questionnary (1) Quetiapine (1) Quidel Sofia SARS Antigen FIA (1) Quinquina-Stevia/Azythromycin (1) RAAS inhibitor [continued standard of care] (1) RAPA-501-Allo off-the-shelf Therapy of COVID-19 (1) RAPID-3 (1) RBA-2 (1) RBT-9 (90 mg) (1) RD-X19 (1) RDV (1) RECHARGE (1) REGN10933 + REGN10987 (1) REGN10933+REGN10987 (1) RESP301, a Nitric Oxide generating solution (1) REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) (1) RIA-device (Remote Investigation and Assessment) (1) RPH-104 80 mg (1) RT PCR SARS-CoV-2 (1) RT-PCR Covid-19 (1) RT-PCR SARS-Cov2 (1) RT-PCR and antibody testing (1) RT-qPCR test (1) RUTI® vaccine (1) Racial Inequality Highlighted (1) Racial/Ethnic Frame (1) Radiological Detection (1) Radiotherapy (1) Raman analysis of saliva, characterization of the Raman database and building of the classification model (1) Ramelteon 8mg (1) Ramipril 2.5 MG Oral Capsule (1) Random Donor Plasma (1) Randomized booster (1) Rapamycin (1) Rapid Antigen Test (1) Rapid Diagnostic Test vs PCR (1) Rapid Onsite COVID-19 Detection (1) Rapid Pathogen Detection (1) Rapid detection test (1) Rapid molecular test (1) Rarefaction (1) Rayaldee 30Mcg Extended-Release (ER) Capsule (1) Razuprotafib (1) Razuprotafib Subcutaneous Solution (1) Reading a Book (1) Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) (1) Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid (1) Recombinant Human Interferon α2b Spray (1) Recombinant Interferon Alfa-2b (1) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo (1) Recombinant human angiotensin-converting enzyme 2 (rhACE2) (1) Recombinant human interferon α1β (1) Recombinant human plasma gelsolin (Rhu-pGSN) (1) Recombinant new coronavirus vaccine (CHO cell) group (1) Recombinant new coronavirus vaccine (CHO cells) placebo group (1) Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) (1) Recombinase aided amplification (RAA) assay (1) Reference: Favipiravir 200 mg (Avigan) (1) Referral card (1) Regadenoson (1) Registery Data Collection (1) Regular Inpatient Medical Care (1) Rehabilitation (1) Rehabilitation by Concentric exercises (1) Rehabilitation by Eccentric exercises (1) Rehabilitation exercise protocol (1) Rehabilitation-focused program (1) Reinforcement learning message delivery (1) Relation between frailty and clinical outcomes in elderly patients with COVID-19. (1) Remain COVID Free SSI (1) Remdesivir (RDV) (1) Remdesivir-HU (1) Remimazolam (1) Remote Automated Monitoring System (1) Remote Cognitive Behavioral Therapy for Insomnia (1) Remote Ischemic Conditioning (1) Remote Problem Management Plus (1) Remote consultation (1) Remote controlled exercise (1) Remote pulmonary rehabilitation (1) Removal of dead space filter (1) Renin-angiotensin system inhibitors (1) Repeat SARS-CoV-2 IgG antibodies at 45-65 days (1) Reporting of anosmia, ageusia and other clinical symptoms (1) ResCure™ (1) Resilience Program (1) Respiratory Exercise Training (1) Respiratory Mechanics (1) Respiratory Training (1) Respiratory and psychological rehabilitation (1) Respiratory infections (1) Respiratory mechanics measurement (1) Respiratory monitoring (1) Respiratory muscles ultrasound (1) Respiratory physiotherapy (1) Respiratory rehabilitation (1) Respiratory rehabilitation program (RR). (1) Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening (1) Respiratory tele-rehabilitation program (TRR). (1) Resting 12 lead ECG (1) Resveratrol (1) Resveratrol Placebo (1) Retrospective case-control analysis (1) Retrospective data collection (1) Reverse transcription polymerase chain reaction (1) Reverse-transcription polymerase chain reaction (RT-PCR) (1) Review of medical patient file (1) Reward Re-Training (1) RhACE2 APN01 (1) Rhea Health Tone® (1) Ringer solution (1) Ringer's lactate (1) Rintatolimod (1) Risankizumab (1) Risk factors (1) Ritonavir (1) Ritonavir+Oseltamivir (1) Ritonavir/lopinavir (1) Rivaroxaban 10 MG (1) Rivaroxaban 2.5 MG (1) RoActemra iv (1) RoActemra sc (1) Robot Assisted Percutaneous Cardiovascular Intervention (1) Robotic therapy (1) Rosuvastatin (1) Routine care (no SARS-CoVSTs) (1) Routine standard of care (1) Rt PCR (1) Ruconest (1) Ruxolitinib 5 MG (1) Ruxolitinib administration (1) Ruxolitinib plus simvastatin (1) SAMBA II (Diagnostic for the Real World) (1) SAR443122 (1) SARILUMAB (1) SARS-CoV 2 RNA PCR Semen (1) SARS-CoV 2 RNA PCR Urine (1) SARS-CoV-2 Ab (1) SARS-CoV-2 Antibody Analysis (1) SARS-CoV-2 IgG (1) SARS-CoV-2 IgG Antibody Testing Kit (1) SARS-CoV-2 S1/S2 IgG (1) SARS-CoV-2 Specific T Cells (1) SARS-CoV-2 and/or MIS-C Exposure (1) SARS-CoV-2 antibody based IVIG therapy (1) SARS-CoV-2 antibody immunoassays (1) SARS-CoV-2 antibody test (1) SARS-CoV-2 antibody testing (1) SARS-CoV-2 convalescent plasma treatment (1) SARS-CoV-2 inactivated vaccine (1) SARS-CoV-2 non-immune Plasma (1) SARS-CoV-2 plasma (1) SARS-CoV-2 questionnaire survey (1) SARS-CoV-2 rS - Phase 1 (1) SARS-CoV-2 rS/Matrix M1-Adjuvant (1) SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 (1) SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 (1) SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 (1) SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 (1) SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 (1) SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France) (1) SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics (1) SARS-CoV-2 serological assessment (IgG) (1) SARS-CoV-2 serology (1) SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen (1) SARS-CoV-2 vaccine (inactivated) (1) SARS-CoV-2 vaccine formulation 1 with adjuvant 1 (1) SARS-CoV-2 vaccine formulation 1 with adjuvant 2 (1) SARS-CoV-2 vaccine formulation 2 with adjuvant 1 (1) SARS-CoV-2 vaccine formulation 2 with adjuvant 2 (1) SARS-CoV-2 vaccine formulation 2 without adjuvant (1) SARS-CoV-2 viral composition (1) SARS-CoV-2-test (1) SARS-CoV2 Autoantibody detection (1) SARS-CoV2 Infection (1) SARS-CoV2 nasal swab (1) SARS-CoV2 serum antibody testing (1) SARS-Cov-2 infection (1) SARSCoV2 Convalescent Plasma (1) SBI-101 (1) SCB-2019 (1) SCB-2019 with AS03 adjuvant (1) SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant (1) SCD (1) SCH Intervention (1) SECRET questionnaire (1) SELF-BREATHE (1) SF12, EQ-5D-5L and work status standardized quantitative assessments (1) SHG (1) SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) (1) SIR1-365 (1) SLEDD with a L-MOD (1) SMS message support (1) SMS-based support (1) SNDX-6352 (1) SNG001 (1) SNO (1) SOC + IFX-1 (1) SOC + Intravenous Famotidine (1) SOC plus 15mg/kg EB05 IV (1) SOC plus Placebo IV (1) SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales (1) SPIN-CHAT Program (1) SSE educational intervention (1) STC-19 score (1) STI-5656 (1) STP + COVID-19 Convalescent Plasma (CP) (1) STP + Standard Plasma (SP) (1) Saline Control (1) Saline Nasal Irrigation (1) Saline containing 1% Human serum albumin(solution without UC-MSCs) (1) Saline nasal and throat spray (1) Saline oral/nasal rinse (1) Saline with Baby Shampoo Nasal Irrigation (1) Saline-sodium citrate (SSC) buffer (1) Saliva Assay (1) Saliva and NPS test (1) Saliva based assay: crude RNA extraction (1) Saliva sample (1) Saliva specimen (1) Saliva test kit (1) Saliva-based testing (1) Sample (1) Sample Collection/Performance Evaluation (A) (1) Sample Collection/Performance Evaluation (B) (1) Sampler skills (1) Sampling (1) Sampling (EDTA blood, pharyngeal and nose swabs, bronchoalveolar lavage ,urine) (1) Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol (1) Sampling of tissue (1) Sampling salivary (1) Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] (1) Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] (1) Sarilumab Prefilled Syringe (1) Sarilumab SAR153191 (1) Sars-Cov-2 serology (1) Sars-Cov2 serology (1) Satisfaction evaluation (1) Savicell's ImmunoBiopsy™ (1) Scanning Chest X-rays and performing AI algorithms on images (1) Schirmer Test I (1) Screening test for covid ( RT PCR and CT Chest) (1) Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] (1) Self Study (1) Self measurement with pulse oximeter (1) Self-Compassion for Chronic Pain Virtual Group Treatment Program (1) Self-Help Therapy (1) Self-acupressure (1) Self-administered questionnaires (1) Self-collected, home-based testing (1) Self-focused acts (1) Self-guided exercises (1) Self-help booklet (1) Self-interest message (1) Self-management booklet (SWitCh: Stay well during COVID-19) (1) Self-prone position recommendation (1) Self-questionnary (1) Semen Qualitative Analysis (1) Semi-structured telephone questionnaire (1) Sending thorax ct video images via smartphone applications (1) Senicapoc (1) Sensbiosys (1) SensiumVitals wearable sensor (1) Sequencing (1) Seraph®-100 Microbind® Affinity Blood Filter (1) Serelogy testing, RT PCR (1) Serial seroconversion measurements in hospital employees during the COVID-19 pandemic (1) Serologic SARS-CoV-2 screening (1) Serologic assays for antibodies to SARS-CoV-2 (1) Serologic immunoassays to SARS-CoV-2 antibodies (1) Serologic testing (1) Serological Assay or IgG for SARS-CoV-2 (1) Serological analyses to be lead on a pre-existing biobank (1) Serological screening for IgG and IgM antibodies against COVID-19 (1) Serological test and phone interview (1) Serological test for COVID-19. (1) Serological testing (1) Serological tests will be applied on patients blood sampling (1) Serology (1) Serology SARS-CoV2 (1) Serology Test (1) Serology for Covid-19 (1) Serology test follow-up (1) Seroprevalence of SARS-CoV-2 infection in patients with HIV infection (1) Serum SARs COV 2 IGg screening in health care workers (1) Serum protein level analysis (1) Serum test (1) Serum tube collection (1) Serum zinc, vitamin d vitamin b12 levels . (1) Severe Acute Respiratory Syndrome CoronaVirus 2 detection (1) Sevoflurane inhalant product (1) Sham (1) Sham Device Treatment (1) Sham intervention (1) Sham irradiation (1) Shanshamani Vati Plus (1) Shared Decision Making (1) Shock-dependent hydrocortisone (1) Sildenafil (1) Sildenafil citrate tablets (1) Silymarin (1) Simha Kriya (1) Simple chest tomography (1) Simulation Intervention (1) Simulation of Repurposed Drugs for COVID-19 (1) Single fraction whole lung radiotherapy (1) Single high dose vitamin D (1) Single passive leg movement (1) Sirolimus 1 MG/ML (1) Sirukumab (1) Sitagliptin (1) Six Minute Walk Test (6MWT) (1) Six-minute walk test (6MWT) (1) Six-month ARV dispensing (1) Skin biopsy (1) Slef questionnaires fulfilment (1) Smartphone-based voice and self-reported symptom collection (1) Social Distancing Advertisements (1) Social media & news consumption (1) Socialization (1) Sodium Bicarbonate (1) Sodium Bicarbonate 150Meq/L/D5W Inj (1) Sodium Chloride 9mg/mL (1) Sodium Nitrite (1) Sodium bicarbonate (1) Sodium chloride (1) Sofosbuvir (1) Sofosbuvir 400 MG plus Daclatasvir 200mg (1) Sofosbuvir and Ledipasvir (1) Sofosbuvir ledipsavir (1) Sofosbuvir plus Ledipasvir (1) Sofosbuvir/Daclatasvir (1) Sofosbuvir/daclatasvir (1) Software Messaging (1) Sofusbuvir + Daclastavir 60 mg (1) Soluble Urokinase Plasminogen Activator Receptor (1) Solution-Focused Support Program (1) Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA (1) Sonoclot (1) Soterix taVNS model 0125-LTE Stimulator - Active-Active Group (1) Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group (1) Spartan COVID-19 System (1) Spartan COVID-19 Test (1) Spartan COVID-19 v2 System (1) Spartan Cube Point-of Care Covid-19 test (1) Specific anti-SARS-CoV-2 antibodies (1) Specimen Collection (1) Speed of Processing Training (1) Sphenopalatine Ganglion Block with Local Anesthetic (1) Sphenopalatine Ganglion Block with Placebo (Isotone NaCl) (1) Spironolactone 100mg (1) Sputum analysis (1) St. George's Respiratory Questionnaire (SGRQ) (1) Staff Wellbeing Centres (1) Stakeholder of TIP-OA Program (1) Standar medical treatmen (1) Standar of care (1) Standard (specific) therapy for COVID-19 (1) Standard 12-lead ECG, NT-proBNP, echocardiography (1) Standard COVID-19 care (1) Standard COVID-19 therapies (1) Standard Care Plus Monitoring (1) Standard Care Therapy (1) Standard Donor Plasma (1) Standard Mask (1) Standard Of Care (SOC) (1) Standard Of Care (SOC) + Placebo (1) Standard Oxygen Delivery System (1) Standard Plasma (FFP) (1) Standard Public Health measures (1) Standard Therapy Protocol (STP) (1) Standard Treatment (1) Standard Ventilation Strategy (1) Standard administration of oxygen flow (1) Standard care delivered in the isolation hospitals. (1) Standard care therapy (1) Standard charity resources (1) Standard interface (1) Standard medical care (1) Standard of Care (Intravenous access) (1) Standard of Care (SOC) + ANG-3777 (1) Standard of Care (SOC) and Colchicine+Rosuvastatin (1) Standard of Care thromboprophylaxis (1) Standard of care (Paracetamol) (1) Standard of care (SOC) plus placebo (1) Standard of care for SARS-CoV-2 infection (1) Standard of care management (1) Standard of care therapies (1) Standard of care therapy (1) Standard of care. (1) Standard oxygen therapy (1) Standard screening strategy (1) Standard supportive care (1) Standard therapeutic protocol (1) Standard therapy (1) Standard therapy for COVID-19 according to the stablished hospital protocols. (1) Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation (1) Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection (1) Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation (1) Standard therapy recommended by the Ministry of Health of the Russian Federation. (1) Standard treatment according to the Clinical protocols (1) Standard treatment for COVID-19 (1) Standard-of-care (1) Standard-of-care treatment (1) Standard-titer Convalescent COVID-19 plasma (CCP2) (1) Standardised questionnaires (1) Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) (1) Standards of Care (1) State-trait anxiety inventory scale (1) Statins (Cardiovascular Agents) (1) Stem Cell Educator-Treated Mononuclear Cells Apheresis (1) Stem Cell Product (1) Sterile Normal Saline for Intravenous Use (1) Sterile Water for Injection (1) Sterile normal saline (0.9%) (1) Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection (1) Stool collection (1) Stool collection or fecal swab (1) Stools (1) Storage of operating waste (1) Stress and emotion management (1) Study A (1) Study Arm (1) Study B (1) Study C (1) Study D (1) Study Group (1) Study of immune-mediated mechanisms in patients tested positive for SARS-CoV-2 (1) Subacute rehabilitation (1) Sublingual Methylene blue (1) Sudarshan Kriya Yoga (SKY) (1) Sulfonatoporphyrin(TPPS) plus Sunlight exposure. (1) Sulfur hexafluoride lipid-type A microspheres (1) Sulodexide (1) Supine Positioning (1) Supine position (1) Support treatment (1) Supportive Therapy (1) Supportive Therapy SSI (1) Supportive tratment (1) Surfactant (1) Surfactant assessment (1) Surge capacity (1) Surgery (1) Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail (1) Surgical Mask (1) Surgical face mask use only (1) Surgical facial mask (1) Surgical procedures performed under general anesthesia (1) Survey Group (1) Survey administration (1) Survey and Questionnaire (1) Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later (1) Surveys (1) Susceptibility to infection (1) Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors (1) Swab (1) Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST) (1) Symptom Survey (1) Symptom and Exposure Surveys (1) Symptomatic drugs (1) Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) (1) Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA) (1) Symptoms entered into the CovidX application (1) Symptoms questionnare (1) Synthetic neutralising antibodies (1) Systemic indirect endovenous ozone therapy (1) T memory cells and NK cells (1) T-Detect™ SARS-CoV-2 Assay (1) T-cell receptor (TCR) repertoire (1) T3 solution for injection (1) T89 (1) T89 capsule (1) TAK-671 (1) TAK-671 Placebo (1) TAK-919 (1) TAK-981 (1) TAPE-Software (1) TAVR or SAVR (1) TCC-COVID mHealth solution (1) TCM prescriptions (1) TD139 (1) TDR (1) TEM-tPA (1) TJ003234 (1) TLRs activation measurement (1) TM5614 (1) TNKase (1) TOF protocol (1) TRV027 (1) TXA127 (1) Tacrolimus (1) Tafenoquine Oral Tablet (1) Taking biological samples (1) Tap water (1) Taste and olfactory function evaluation (1) Tear Collection (1) Tears swab (1) Technology based social interactions (1) Tele-Pulmonary rehabilitation (1) Tele-Yoga Therapy (1) Tele-delivered psychological intervention (1) Tele-interventions related to diabetes management and mental well-being (1) Tele-medicine platform (1) Tele-yoga therapy (1) Teleconsultation either by phone or by computer consultation (1) Telehealth (1) Telehealth coaching sessions (1) Telehealth monitoring (1) Telehealth phone calls (1) Telemedicine to remote outpatient visit in bariatric patient (1) Telemedicine visit (1) Telephone follow-up (1) Telephone interview (1) Telephone survey (1) Telephonic interview during the Italian lockdown. (1) Telephonic medical visit (1) Telepsychoeducation (1) Telepsychoeducation with personalized videos (1) Telepsychoeducation without personalized videos (1) Telerehabilitation-Based (1) Telesimulation (1) Telmisartan 40Mg Oral Tablet (1) Telmisartan 40mg (1) Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care. (1) Temporarily holding the RAAS inhibitor [intervention] (1) Ten-days oseltamivir (1) Tenecteplase (1) Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE) (1) Test Group: experimental - UVC Therapy applied (1) Test PCR (1) Test for SARS-CoV-2 (1) Test: Favipiravir 200 mg (LOQULAR) (1) TestNPass (1) Tested for SARS-CoV-2 (regardless of the result) (1) Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals (1) Testing for SARS-CoV-2 (1) Testing of SARS-CoV-2 antibodies (1) Testing procedure for Binding antibodies (1) Tetrandrine (1) Text material for psychoeducation and audio for relaxation techniques (1) Thalidomide (1) The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: (1) The PREPARE program (1) The Vie Scope laryngoscope (1) The control group will not receive hydroxychloroquine (1) The demographic, clinical, laboratory, and instrumental data (1) The psychosocial effects of COVID-19 pandemic on dental professionals (1) The standard Macintosh laryngoscope (1) The standard of care (1) The standard therapy (1) The study does not required (1) The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19 (1) The usual treatment (1) Therapeutic Anticoagulation (1) Therapeutic Exercise and Education (1) Therapeutic Plasma Exchange (TPE) (1) Therapeutic Plasma exchange (1) Therapeutic plasma exchange (1) Therapeutic plasma exchange (TPE) (1) Therapist Guided E-Therapy (1) Therapy Intervention (1) There is no intervention (1) There is no intervention in this study (1) Thermography (1) Thiazide or Thiazide-like diuretics (1) This is an online survey with no intervention. (1) Thoracic CT Scan (1) Thorax CT (1) Thoraxic computed tomography (1) Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 (1) Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 (1) Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 (1) Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# (1) Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# (1) Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) (1) Threshold IMT device (1) Throat swab sample for measuring current infection with SARS-CoV-2 (1) Thrombin Generation Assay (TGA) (1) Thrombin generation test assay (1) Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) (1) Thromboprophylaxis (1) Thymosin+standard treatment (1) Thyroidectomy (1) Ticagrelor (1) Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine (1) Tigerase® and best available care (1) Tinzaparin or unfractionated heparin (1) Tirofiban Injection (1) Tissue plasminogen activator (1) Titanium blood test (1) To assess for development of IgG antibodies against SARS-CoV2 (1) Tociliuzumab (1) Tocilizumab +/- ruxolitinib (stages 2b/3) (1) Tocilizumab 180 MG/ML (1) Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA] (1) Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (1) Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) (1) Tocilizumab Injection [Actemra] (1) Tocilizumab Prefilled Syringe (1) Tocilizumab and Ruxolitinib (Advanced stage 3) (1) Tomeka® (1) Toraymyxin PMX-20R (PMX Cartridge) (1) Toremifene (1) Tracheal intubation and cardiopulmonary resuscitation (1) Tracheostomy (1) Tracheostomy with aerosol box in COVID-19 positive patients (1) Tracheotomy (1) Tradipitant (1) Traditional Chinese Medicine Prescription (1) Traditional Proning Arm (1) Traditional antirheumatic drugs (1) Training clinicians in basic critical care and the management of severe COVID-19 cases (1) Training for Awareness, Resilience, and Action (TARA) (1) Training load (1) Training of youth, community health assistants and community health workers. (1) Training session adressing information and health literacy (1) Training video on anxiety, fear and loneliness in the COVID-19 environment. (1) Tramadol (1) Tranexamic acid tablets (1) Trans Sodium Crocetinate (1) Transcendental Meditation (1) Transcutaneous Auricular Vagus Nerve Stimulation (1) Transfer Package from CI Therapy (1) Transfusion of COVID-19 convalescent plasma (1) Transfusion of SARS-CoV-2 Convalescent Plasma. (1) Transfusion of standard Plasma. (1) Transitional Online Peer Support Group (n=20) (1) Transparent mask (1) Transplant patient (1) Transpulmonary pressure measurements (1) Transpulmonary thermodilution (1) Transthoracic echocardiogram (TTE) (1) Trauma Informed Psychotherapy (1) Trauma Informed Yoga (1) Trauma-informed yoga video recording (1) Travelan OTC (1) Treamid (1) Treatment and prophylaxis (1) Treatment as usual (1) Treatment as usual vitamin D (1) Treatment for COVID-19 (1) Treatment group (1) Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : (1) Treatment with Dexmedetomidine (1) TriCor® 145mg tablets (1) Triazavirin (Riamilovir) (1) Trier Social Stress Test (1) Trimodulin (1) Trust in science message (1) Tuberculin test (1) Two COVID-19 vaccine candidate (TMV-083) administrations - High dose (1) Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose (1) Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL (1) Two dose ChAdOx1 nCoV-19/Covishield 0.5mL (1) Two dose MenACWY vaccine (1) Two dose MenACWY vaccine min. 4 weeks apart (1) Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 (1) Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule (1) Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule (1) Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (1) Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 (1) Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 (1) Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule (1) Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule (1) Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 (1) Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 (1) Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 (1) Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly (1) Two doses of placebo at the emergency vaccination schedule (1) Two doses of placebo at the routine vaccination schedule (1) Two doses of placebo at the schedule of day 0, 14 #High-dose group# (1) Two doses of placebo at the schedule of day 0, 14 #middle-dose group# (1) Two doses of placebo at the schedule of day 0, 28(high-dose group) (1) Two doses of placebo at the schedule of day 0, 28(middle-dose group) (1) Tympanic Temperature (1) Typical surgical covered mask (1) UB-612 (1) UCMSCs (1) ULTRAPROTECTIVE VENTILATION (1) UNI911 INHALATION (1) UNIKINON (Chloroquine phosphate) 200mg tablets (1) UTTR1147A (1) UTTR1147A-matched Placebo (1) UV Light Treatment (1) Ulinastatin (1) Ultra Brief Online Mindfulness-based Intervention (1) Ultra-Low-dose radiotherapy (1) Ultrasonography (1) Ultrasound lung imaging as part of FAST+ evaluation (1) Ultrasound of the lower limbs (1) Umbilical Cord Lining Stem Cells (ULSC) (1) Umbilical Cord Mesenchymal Stem Cells (1) Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. (1) Umbilical cord Wharton's jelly-derived human (1) Umbilical cord derived mesenchymal stem cells (1) Umifenovir (1) Unavailable COVID Test Result - Hypothetical Scenario (1) Unfractionated Heparin IV (1) Unfractionated heparin SC (1) Unfractionated heparin nebulized (1) Unified Protocol for COVID-19 Parenting Stress (UP-COVID) (1) Uniform random message delivery (1) Unsupervised physical activities (1) Use of Facetime with child and parents during induction (1) Use of mobile application (1) Use of social media during COVID-19 (1) Use of the pinpointIQ solution (physIQ, Inc.) (1) Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures (1) Usual Care Only (1) Usual antibiotic treatment (1) Usual care positioning with no instructions (1) V-SARS (1) V/Q SPECT-CT (1) V/Q Vest (1) V590 (1) V591 (1) VC (1) VCPM (1) VESTA respirator (1) VIB7734 (1) VIR-7831 (1) VITROS Anti-SARS-CoV-2 IgG test (1) VLA2001 (1) VR for psychoeducation and relaxation (1) VXA-CoV2-1 (1) Vacciantion status in health care workers (1) Vaccinated with polio vaccine (IPV) (1) Vaccine Therapy (1) Vaccine coverage assessment (1) Vaginal fluid Covid-19 PCR test (1) Validation of the LAMP assays (1) Validation of the NGS method (1) Validation of the POCT Antigen tests (1) Valproate (1) Valsartan (Diovan) (1) Vascular surgery (1) Vehicle + Heparin along with best supportive care (1) Vehicle Control (1) Venepuncture (1) Venous Draw & Testing (1) Venous blood was collected for biochemistry testing (1) Venous blood was collected for biochemistry testing. (1) VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) (1) Verapamil (1) Veru-111 (1) VibroLUNG (1) Video Chat + Basic Feedback (1) Video Chat +Personalized Feedback (1) Video Dance classes (1) Video about safety and effectiveness of adult seasonal flu vaccination (1) Video based aerobic exercise (1) Video based exercise (1) Video-Based (1) Video-Based intervention (1) Videofluoroscopic Swallowing Study (VFSS) (1) Videofluoroscopy (1) Vie Scope laryngoscopy (1) Vielight RX Plus (1) Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic (1) Viral Specific T-cells (VSTs) (1) Virtual Assistant first, then Human Coach (1) Virtual Care and Remote Automated Monitoring (1) Virtual Care at Home (1) Virtual Family-Based Treatment (1) Virtual Group Exercise (1) Virtual Group Intervention (1) Virtual Peer Support Platform (1) Virtual Reality (1) Virtual reality therapy first (1) Virtual-Care Cognitive Behavioural Therapy (1) Viruxal Oral and Nasal Spray (1) Vit D (1) VitalConnect Vital Sign Patch (1) VitalTalk communication skills training (1) Vitamin B12 (1) Vitamin C tablets (1) Vitamin D 1000 IU (1) Vitamin D supplementation (1) Vitamin D3 (cholecalciferol) (1) Vitamin D3 or Placebo (1) Vitamin E (1) Vitamins (1) Vitamins and Minerals (1) Viusid and Asbrip (1) VivaDiag™ COVID-19 lgM/IgG Rapid Test (1) Voice Symptom Scale (VoiSS) (1) Volunteer of TIP-OA Program (1) WEB embolization (1) WFI 5% glucose (1) WFI water nebulization (1) WHO recommendations (waiting condition) (1) WHOQOL-BREF (1) WHOQOL-BREF survey (1) WJ-MSCs (1) Walk Test (1) Water Without an Elevated Level of KELEA (1) Wearable Medical Device (Empatica E4) (1) Wearing surgical face mask sprayed with hypertonic saline (1) Web Based Questionnaire (1) Web Based Survey (1) Web application users (1) Web-based REDCap survey (1) Web-based psychosocial peer-to-peer support (1) WebEx Physical Activity Program (1) Weck-cel Swab Collection (1) Weekly Assessment (1) Weight Counseling (1) Wharton's jelly derived Mesenchymal stem cells. (1) White Sender in Acknowledgement (1) White Sender in Informational Videos (1) Whole Exome Sequencing (1) Whole Genome Analysis (1) Whole exome sequencing (1) Withings ScanWatch (1) Woebot Substance Use Disorder (1) WofB (1) Written Information (1) Written Summary of Rounds (1) XAV-19 (1) XC221 (1) XC7 100 mg single (1) XC7 200 mg multiple (1) XC7 200 mg single (1) XCEL-UMC-BETA (1) Xiang-Sha-Liu-Jun formula (1) Xiyanping injection (1) Yin Hu Qing Wen Granula(low does) (1) YinHu QingWen Decoction (1) YinHu QingWen Decoction(low dose) (1) Yinhu Qingwen Granula (1) Yoga group (1) Yu-Ping-Feng formula (1) Zanubrutinib (1) Zaritt Burden Interview (1) Zavegepant (BHV-3500) (1) Zilucoplan® (1) Zinc (Placebo) (1) Zinc (zinc gluconate) (1) Zinc (zinc gluconate) & Vitamin D (cholecalciferol) (1) Zinc Citrate (1) Zinc Gluconate (1) Zinc Picolinate (1) Zinc Picolinate Placebo (1) Zinc Sulfate (1) Zinc Sulfate 220 MG (1) Zinc gluconate (1) Zithromax Oral Product (1) Zofin (1) ZofinTM (OrganicellTM Flow) (1) Zotatifin (1) [18F]FP-R01-MG-F2 (1) [68Ga]Ga-DOTA-(RGD)2 PET/CT (1) [TIMP-2]*[IGFBP-7] (1) a specifically designed self-administered questionnaire (1) a survey (1) acetylsalicylic acid (1) actigraphy (1) acute kidney injury (1) additional blood tubes (1) aerosol box (1) aerosolized DNase (1) after-each-case room disinfection (1) agenT-797 (1) airway management during sedation or general anesthesia (1) all treatment about COVID-2019 (1) allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) (1) allogeneic mesenchymal stem cell (1) alpha one antitrypsin inhalation (1) alpha1-proteinase inhibitor (1) alveolar recruitment (1) amoxicillin/clavulanate (1) anti-SARS-CoV-2 IgY (1) anti-SARS-CoV-2 human convalescent plasma (1) anti-SARS-CoV-2 plasma (1) antidiabetic treatment (1) appendectomy (1) assessment of the sequelae after hospitalization for Sars-COV-2 (1) attendance by ambulance crew (1) autologous adipose-derived stem cells (1) autopsy (1) avdoralimab (1) azithromycin (1) azoximer bromide (1) bacTRL-Spike (1) bamlanivimab (1) bidirectional oxygenation mouthpiece (1) biochemical analysis (1) biological assays in particular on the lipid metabolism (1) biological sample (1) biological samples collection (1) biological samples day of delivery (1) biological samples, questionnaires and interviews (1) biopsies of subcutaneous adipose tissue (1) blood collection via fingerprick (1) blood sample for seroepidemiological investigation (1) blood sampling for biobank (1) blood test for SARS-COV2 serology (1) blood tests (1) bovhyaluronidase azoxymer (1) brief mindfulness based intervention (1) bromelain (1) canakinumab (1) captopril 25mg (1) cardiac magnetic resonance (1) cardiovascular and respiratory systems monitoring (1) care as usual (1) care modalities (1) carotid-femoral pulse-wave velocity (1) cellulose-containing placebo capsules (1) cenicriviroc (1) chest radiography (1) chest x-ray (1) chlorine dioxide (1) chlorine dioxide 3000 ppm (1) chloroquine (1) cholecalciferol 200,000 IU (1) cholecalciferol 50,000 IU (1) clinical features and laboratory values (1) collection of biological samples (1) collection of mucosal lining fluid (1) collection of swabs (1) community health worker support (1) comparison of sample collection methods (1) complication (1) congenital malformation (1) conjunctival RT PCR (1) consultation (1) control (1) control group (1) convalescent plasma application to SARS-CoV-2 infected patients (1) convalescent plasma from recovered COVID 19 donor (1) conventional management of patients (1) conventional oxygen (1) corticosteroid nasal irrigation (1) covid-19 positive pregnant women (1) cries 13 questionnaire (1) current IPAC-UHN PPE (1) daily room disinfection (1) daily syndromic surveillance (1) dapansutrile capsules (1) data record (1) decisions of limitations and stop processing (1) demographic and clinical data obtained from hospital's electronic medical record. (1) diagnostic (1) diagnostic tests for COVID-19 infection (1) dialysis (1) double gloves (1) draw blood (1) duplex sonography (1) e-Psychotherapy (1) e-ink screen (1) eHealth (1) eHealth +counselling contacts (1) echocardiogram 2D (1) eculizumab (1) electrolytes (1) ensoETM device (1) evaluation of skin microvascular flow and reactivity (1) exchange blood transfusion from normal donor (1) exercise brochure (1) exercise capacity (1) exercise group (1) exercise training (1) exposure (1) faecal sample collector (1) favipiravir (1) favorable outcome (1) feces samples (COVI-BIOME ancillary study) (1) fingertip tests for POC assays (1) fostamatinib (1) fsfi survey (1) further processing of health data (1) gammaCore® (Vagus nerve stimulation) (1) gammaCore® Sapphire (non-invasive vagus nerve stimulator) (1) geko T3 (1) glenzocimab (1) global survey (1) glucose control and sensor usage (1) hAd5-S-Fusion+N-ETSD vaccine (1) heat therapy (1) high flow nasal cannula (HFNC) (1) high flow nasal cannula device (1) high-titer anti-Sars-CoV-2 plasma (1) home care monitoring (1) home spirometry (1) hormones (1) hospital bedroom booking (1) hospitalisation, necessity of ICU, mortality rate, lung involvement (1) hospitalization for premature birth (1) hospitalized children with Covid19 (1) host genotype (1) host immune factors (1) human cord tissue mesenchymal stromal cells (1) hydrocortisone (1) hydroxychloroquine + azithromycin (1) hydroxychloroquine in combination with camostat mesylate (1) hydroxychloroquine placebo (1) hydroxychloroquine sulfate 200 MG (1) hyper immunoglobulins containing anti-Corona VS2 immunoglobulin (1) hyperbaric oxygen therapy (HBOT) (1) hyperimmune plasma (1) hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint (1) iAMP test (1) iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System (1) identify SARS-CoV-2 infection by serology (1) imPulse™ Una e-stethoscope (1) imaging, blood tests (1) immune plasma (1) impliminting Online Distance Learning (1) in-hospital mortality rate (1) indirect calorimetry (1) inhalable hydroxychloroquine (HCQ) (1) inhaled hydroxychloroquine (1) inhaled type I interferon (1) inspiratory muscle traiing (1) insurance navigation (1) integrated clinical evaluation (1) intensive care unit admission ratio (1) interleuken 6 level measurment (1) intermediate dose Enoxaparin/ unfractionated heparin (1) intradermal injection of BCG Vaccine (1) intramuscular accine (1) intravenous immunoglobulin therapy (1) it is a survey (1) iv Tocillizumab (TCZ) (1) laboratory biomarkers (1) labs (1) lactoferrin, green tea extract (1) lanadelumab (1) laparoscopic or open appendicectomy (1) lay telephone coaching (1) less-frequency hemodialysis (1) life questionnaires (1) liposomal lactoferrin (1) lopinavir/ritonavir (1) lopinavir/ritonavir group (1) lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate (1) low-molecular-weight heparin (1) lung mechanics at different PEEP (1) lung ultrasound (LUS) (1) mHealth Assessments (1) mMRC (Modified Medical Research Council) Dyspnea Scale (1) mRNA in urine test (1) management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia (1) maslach burnout inventory questionnair (1) mavrilimumab (1) measurement of circulating sFlt1 concentration (1) mechanical ventilation (1) mechanical ventilator settings and position (1) melatonin (1) mesenchymal stem cells (1) metenkefalin + tridecactide (1) metformin glycinate (1) methylprednisolone therapy (1) microcirculation recording (1) miniprobe Alveoflex (1) mobile internet survey on self-test (1) modification of the planned therapeutic management (1) modified IPAC-UHN PPE (1) molecular testing for virus RNA using RT-PCR (1) mometasone furoate nasal spray (1) monthly serologic IgM/G test (1) morning Yoga-based breathing support (1) mortality (1) mouthrinse with bêta-cyclodextrin and citrox (1) mouthrinse without bêta-cyclodextrin and citrox (1) multipeptide cocktail (1) muscle ultrasound (1) n/a - samples collected along routine care samples only (1) nCapp, a cell phone-based auto-diagnosis system (1) nangibotide (1) nasal pharyngeal (NP) swab samples (1) nasopharyngeal Covid 19 RT-PCR (1) nasopharyngeal and throat swab (1) nebulised recombinant tissue-Plasminogen Activator (rt-PA) (1) newborns from covid 19 positive mothers (1) no intervention-mechanistic study (1) no intervention. observational cohort study (1) no interventional study (1) non (1) non applicable (1) non interventional study (1) non-RAS blocking antihypertensives (1) non-contact magnetically-controlled capsule endoscopy (1) non-interventional (1) none - observational (1) none, this study is observational (1) noninvasive ventilation (1) normal saline (1) nosocomial infection/hospital acquired infection (1) not applicable (observational study) (1) not required (1) nutritional intervention (1) oSOC (1) observation (1) observation of covid 19 pneumonia (1) olfactory and gustatory tests (1) olfactory device (1) online KKH Sports Singapore Program with Usual Care (1) online mindfulness group (1) online questionnaires (1) oral co-trimoxazole (1) oral polio vaccine + information (1) oropharyngeal and intestinal microbiota (1) oropharyngeal swabs (1) oxygen treatment (1) oxyhydrogen (1) pathogen reduced SARS-CoV-2 convalescent plasma (1) patients COVID 19 (1) patients receiving nasal high flow (1) performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection (1) peripheral blood draw (1) personal protective Measures (1) phone call (1) photobiomodulation and photodynamic therapy (1) physical activity program (1) physiological effects of awake prone position in COVID 19 patients (1) placebo (hartmann plus albumine) (1) placebo capsules (1) placebo for clazakizumab (1) placebo rinse (1) plasma from convalescent patients with COVID-19 (1) plasma hyperimmune (1) plasma therapy using convalescent plasma with antibody against SARS-CoV-2 (1) poractant alfa (1) power breathe (1) prayer (1) pre-operative screening (1) pre_dinner Yoga-based breathing support (1) pre_lunch Yoga-based breathing support (1) predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? (1) prone position (1) proper diet (1) prophylactic heparin (1) prophylactic lactoferrin daily (1) psycho-education video (1) psychological and sociological interviews (1) psychological assessment (1) pulmonary anomalies 4 months after documented COVID-19 pneumonia (1) pulmonary rehabilitation (1) pulmonary ultrasound (1) pulse oximeter (1) qRT-PCR and serology (1) quality of life questionnaires (1) quality of live assessment (1) quesionnair (1) questionaire to husband and wife (1) questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality (1) questionnaire and optional interview (1) questionnaire filling (1) quetionnary (1) rNAPc2 (1) rapid salivary test (1) rapid serological test (1) realtime PCR (1) recombinant human interferon Alpha-1b (1) recovered covid 19 patients plasma (1) rectal swab (1) regular care (1) research specific blood sample (1) respiratory function rehabilitation training (1) retrospective metagenomics on clinical samples collected during hospitalization (1) revised HOME-CoV score (1) rhDNase I (1) rhTPO (1) risk factors (1) saint george respiratory questionnaire (1) saliva collection (1) saliva sample (1) samling of oropharynx and nasopharynx (1) sample of blood and saliva (1) self-administered structured questionnaire (1) self-care tools (1) semaglutide (1) semen analysis (1) serological test (1) serology test (1) serum NGAL and cystatin c (1) serum chemistry analysis (1) serum inflammatory biomarkers (1) service of questionnaire (1) severe covid-19 pneumonia with ET (1) severity of lung involvement with COVID-19. (1) smell household Items (1) sodium chloride 0.9% (1) sofosbuvir (1) specific exercise rehabilitation treatment (1) spirometry (1) spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire (1) standard concomitant therapy (1) standard medical treatment (1) standard operating procedures (1) standard procedure (1) standard prophylactic dose Enoxaparin/ unfractionated heparin (1) standard protocol (1) standard treatment (1) standard western medicine treatment (1) standardized Lung Ultrasound (LUS) examination (1) stem cells (1) stress and anxiety questionnaire (1) supportive and symptomatic treatment (1) survey work (1) surveys and questionnaires (1) suspected of COVID-19 infection (1) sweat samples (COVIDOG ancillary study) (1) teleconsultation (1) telehealth applications (1) telemedicine (1) telephone consult (1) test (1) thalidomide (1) therapeutic plasmaexchnage (1) theraputic heparin (1) this study is non- interventional (1) thoracic CT-scan (1) thoracic computed tomography scan (1) thoracic lung ultrasound (1) thromboprofylaxis protocol (1) thromboprophylaxis with low-molecular-weight heparin or fondaparinux (1) thymosin alpha 1 (1) topical steroids and cyclosporin-A (1) traditional communication tools (1) transparent sheet (1) treated with hyperimmune plasma (1) turkish physicians (1) unfractionated heparin (1) urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic (1) users (1) vaccine (1) vaccine BCG (1) vadadustat (1) venipuncture in peripheral vein (1) ventilatory support with oxygen therapy (1) viral sequence (1) virgin coconut oil (VCO) (1) visual analogue scale (1) vitamin D (1) vitamin d (1) vv-ECMO (1) washed microbiota transplantation (1) web based survey (1) zinc (1) zinc acetate (1) zinc gluconate and ascorbic acid (1) ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF. (1) γ-Globulin (1) Оxygen therapy (1)

    Placebo

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (768)


    Name (Synonyms) Correlation
    drug2153 Nitazoxanide Wiki 0.13
    drug1750 LY3819253 Wiki 0.11
    drug1472 Hydroxychloroquine Wiki 0.11
    Name (Synonyms) Correlation
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    drug2786 Remestemcel-L Wiki 0.05
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    drug2333 PF-06650833 Wiki 0.05
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    drug234 Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Wiki 0.05
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    drug1804 Lopinavir Wiki 0.05
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    drug2752 Rayaldee 30Mcg Extended-Release (ER) Capsule Wiki 0.05
    drug1556 INM005 Wiki 0.05
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    drug2620 Prone position ventilation Wiki 0.05
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    drug3637 Zavegepant (BHV-3500) Wiki 0.05
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    drug592 COVID-19 IgG / IgM rapid test (whole blood, serum, plasma) Wiki 0.05
    drug31 1: Usual practice Wiki 0.05
    drug526 Budesonide Wiki 0.05
    drug4006 semen analysis Wiki 0.05
    drug533 C21 Wiki 0.05
    drug409 Bempegaldesleukin Wiki 0.05
    drug3204 Support treatment Wiki 0.05
    drug1894 MSC Treatment Wiki 0.05
    drug155 AdCOVID Wiki 0.05
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    drug3014 Serological analyses to be lead on a pre-existing biobank Wiki 0.05
    drug3912 not applicable (observational study) Wiki 0.05
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    drug2476 Placebo Group Wiki 0.05
    drug1710 Ivermectin 3mg Tab Wiki 0.05
    drug116 AV-COVID-19 Wiki 0.05
    drug1357 Group 2: control group with enoxaparin 40mg/d Wiki 0.05
    drug3511 V591 Wiki 0.05
    drug1879 MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg Wiki 0.05
    drug1429 High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma Wiki 0.05
    drug3270 Taste and olfactory function evaluation Wiki 0.05
    drug2633 Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout Wiki 0.05
    drug3809 hydrocortisone Wiki 0.05
    drug3477 Ulinastatin Wiki 0.05
    drug171 Aerosol-reducing Mask Wiki 0.05
    drug2164 Nitric Oxide-Continuous and Sessions Wiki 0.05
    drug1554 INB03 Wiki 0.05
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    drug1647 Interleukin 6 (IL6) Antagonist Wiki 0.05
    drug2802 Respiratory Mechanics Wiki 0.05
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    drug1977 Mesenchymal cells Wiki 0.05
    drug3678 anti-SARS-CoV-2 plasma Wiki 0.05
    drug3564 Virtual Reality Wiki 0.05
    drug2125 Nebulized administration of RLF-100 or Placebo Wiki 0.05
    drug1387 HLX70 Wiki 0.05
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    drug564 COR-101 Wiki 0.05
    drug1764 Late dexamethazone Wiki 0.05
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    drug3263 TXA127 Wiki 0.05
    drug2565 Povidone-Iodine 0.4% NI Wiki 0.05
    drug3230 Symptom Survey Wiki 0.05
    drug1778 Levilimab Wiki 0.05
    drug156 Additional and minimal collection of products of the human body carried out during a sample for standard of care Wiki 0.05
    drug2364 Paracetamol Wiki 0.05
    drug3057 Single high dose vitamin D Wiki 0.05
    drug3122 Standard Of Care (SOC) Wiki 0.05
    drug2954 Saliva specimen Wiki 0.05
    drug2149 Nil intervention Wiki 0.05
    drug3653 Zotatifin Wiki 0.05
    drug346 BACMUNE (MV130) Wiki 0.05
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    drug1267 Favipiravir + Currently used therapy Wiki 0.05
    drug3714 captopril 25mg Wiki 0.05
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    drug1558 INOpulse Wiki 0.05
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    drug1095 EIT-Group Wiki 0.05
    drug2593 Previfenon® Wiki 0.05
    drug356 BCG Wiki 0.05
    drug1269 Favipiravir Combined With Tocilizumab Wiki 0.05
    drug660 CVnCoV Wiki 0.05
    drug3737 conjunctival RT PCR Wiki 0.05
    drug3869 melatonin Wiki 0.05
    drug3190 Study Arm Wiki 0.05
    drug3198 Sudarshan Kriya Yoga (SKY) Wiki 0.05
    drug4010 serum NGAL and cystatin c Wiki 0.05
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    drug1382 HCQ+AZT Wiki 0.05
    drug1769 Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. Wiki 0.05
    drug373 BM-MSCs Wiki 0.05
    drug97 ARCT-021 Dose 4 Wiki 0.05
    drug3782 feces samples (COVI-BIOME ancillary study) Wiki 0.05
    drug3201 Sulodexide Wiki 0.05
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    drug647 CSL324 Wiki 0.05
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    drug1881 MFS Wiki 0.05
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    drug1492 Hydroxychloroquine Sulfate Wiki 0.01
    drug1166 Enoxaparin Wiki 0.01

    Correlated MeSH Terms (165)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.38
    D045169 Severe Acute Respiratory Syndrome NIH 0.31
    D007239 Infection NIH 0.21
    Name (Synonyms) Correlation
    D012128 Respiratory Distress Syndrome, Adult NIH 0.18
    D055371 Acute Lung Injury NIH 0.18
    D003141 Communicable Diseases NIH 0.17
    D011014 Pneumonia NIH 0.17
    D012127 Respiratory Distress Syndrome, Newborn NIH 0.17
    D013577 Syndrome NIH 0.14
    D055370 Lung Injury NIH 0.10
    D000077062 Burnout, Psychological NIH 0.09
    D012141 Respiratory Tract Infections NIH 0.08
    D011658 Pulmonary Fibrosis NIH 0.07
    D009164 Mycobacterium Infections NIH 0.07
    D000755 Anemia, Sickle Cell NIH 0.07
    D000690 Amyotrophic Lateral Sclerosis NIH 0.07
    D016472 Motor Neuron Disease NIH 0.07
    D058345 Asymptomatic Infections NIH 0.07
    D000370 Ageusia NIH 0.07
    D011024 Pneumonia, Viral NIH 0.06
    D007249 Inflammation NIH 0.06
    D014947 Wounds and Injuries NIH 0.06
    D018450 Disease Progression NIH 0.06
    D012140 Respiratory Tract Diseases NIH 0.06
    D014777 Virus Diseases NIH 0.05
    D001987 Bronchiectasis NIH 0.05
    D001321 Autistic Disorder NIH 0.05
    D008231 Lymphopenia NIH 0.05
    D008171 Lung Diseases, NIH 0.05
    D019973 Alcohol-Related Disorders NIH 0.05
    D000544 Alzheimer Disease NIH 0.05
    D000532 Altitude Sickness NIH 0.05
    D008569 Memory Disorders NIH 0.05
    D000067877 Autism Spectrum Disorder NIH 0.05
    D009877 Endophthalmitis NIH 0.05
    D000071074 Neonatal Sepsis NIH 0.05
    D000070627 Chronic Traumatic Encephalopathy NIH 0.05
    D002481 Cellulitis NIH 0.05
    D006948 Hyperkinesis NIH 0.05
    D058070 Asymptomatic Diseases NIH 0.05
    D011470 Prostatic Hyperplasia NIH 0.05
    D002532 Intracranial Aneurysm NIH 0.05
    D015817 Eye Infections NIH 0.05
    D054517 Orbital Cellulitis NIH 0.05
    D000783 Aneurysm, NIH 0.05
    D050197 Atherosclerosis NIH 0.05
    D000741 Anemia, Aplastic NIH 0.05
    D015004 Yellow Fever NIH 0.05
    D006965 Hyperplasia NIH 0.05
    D010265 Paraproteinemias NIH 0.05
    D011552 Pseudomonas Infections NIH 0.05
    D018184 Paramyxoviridae Infections NIH 0.05
    D001469 Barotrauma NIH 0.05
    D011645 Puerperal Infection NIH 0.05
    D056660 Hereditary Autoinflammatory Diseases NIH 0.05
    D008998 Monoclonal Gammopathy of Undetermined Significance NIH 0.05
    D066087 Perinatal Death NIH 0.05
    D005879 Tourette Syndrome NIH 0.05
    D004646 Emphysema NIH 0.05
    D000275 Adjustment Disorders NIH 0.05
    D017093 Liver Failure NIH 0.05
    D008218 Lymphocytosis NIH 0.05
    D010505 Familial Mediterranean Fever NIH 0.05
    D002006 Brucellosis NIH 0.05
    D003424 Crohn Disease NIH 0.05
    D016739 Behavior, Addictive NIH 0.05
    D008258 Waldenstrom Macroglobulinemia NIH 0.05
    D007010 Hyponatremia NIH 0.05
    D019896 Alpha 1-Antitrypsin Deficiency NIH 0.05
    D063130 Maternal Death NIH 0.05
    D000071257 Emergence Delirium NIH 0.05
    D012120 Respiration Disorders NIH 0.04
    D000073397 Occupational Stress NIH 0.04
    D007676 Kidney Failure, Chronic NIH 0.04
    D003333 Coronaviridae Infections NIH 0.04
    D014115 Toxemia NIH 0.04
    D016638 Critical Illness NIH 0.04
    D005355 Fibrosis NIH 0.04
    D002318 Cardiovascular Diseases NIH 0.04
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.04
    D001008 Anxiety Disorders NIH 0.04
    D017563 Lung Diseases, Interstitial NIH 0.04
    D013927 Thrombosis NIH 0.04
    D000860 Hypoxia NIH 0.04
    D008173 Lung Diseases, Obstructive NIH 0.04
    D030341 Nidovirales Infections NIH 0.03
    D005356 Fibromyalgia NIH 0.03
    D005334 Fever NIH 0.03
    D007945 Leukemia, Lymphoid NIH 0.03
    D012598 Scoliosi NIH 0.03
    D000505 Alopecia NIH 0.03
    D000070642 Brain Injuries, Traumatic NIH 0.03
    D018805 Sepsis NIH 0.03
    D012640 Seizures NIH 0.03
    D009190 Myelodysplastic Syndromes NIH 0.03
    D002659 Child Development Disorders, Pervasive NIH 0.03
    D020522 Lymphoma, Mantle-Cell NIH 0.03
    D016470 Bacteremia NIH 0.03
    D003231 Conjunctivitis NIH 0.03
    D001528 Behcet Syndrome NIH 0.03
    D000068376 Compassion Fatigue NIH 0.03
    D000067073 Psychological Trauma NIH 0.03
    D012327 RNA Virus Infections NIH 0.03
    D006526 Hepatitis C NIH 0.03
    D000428 Alcohol Drinking NIH 0.03
    D044882 Glucose Metabolism Disorders NIH 0.03
    D001714 Bipolar Disorder NIH 0.03
    D000857 Olfaction Disorders NIH 0.03
    D059350 Chronic Pain NIH 0.03
    D058186 Acute Kidney Injury NIH 0.03
    D004417 Dyspnea NIH 0.03
    D014808 Vitamin D Deficiency NIH 0.03
    D011251 Pregnancy Complications, Infectious NIH 0.03
    D007319 Sleep Initiation and Maintenance Disorders NIH 0.03
    D008659 Metabolic Diseases NIH 0.03
    D001249 Asthma NIH 0.03
    D001289 Attention Deficit Disorder with Hyperactivity NIH 0.03
    D045888 Ganglion Cysts NIH 0.03
    D000257 Adenoviridae Infections NIH 0.03
    D015451 Leukemia, Lymphocytic, Chronic, B-Cell NIH 0.03
    D003550 Cystic Fibrosis NIH 0.03
    D053120 Respiratory Aspiration NIH 0.03
    D013315 Stress, Psychological NIH 0.03
    D019966 Substance-Related Disorders NIH 0.02
    D007938 Leukemia, NIH 0.02
    D003643 Death, NIH 0.02
    D003327 Coronary Disease NIH 0.02
    D003324 Coronary Artery Disease NIH 0.02
    D016769 Embolism and Thrombosis NIH 0.02
    D003863 Depression, NIH 0.02
    D007154 Immune System Diseases NIH 0.02
    D001930 Brain Injuries, NIH 0.02
    D001927 Brain Diseases NIH 0.02
    D003693 Delirium NIH 0.02
    D009102 Multiple Organ Failure NIH 0.02
    D001327 Autoimmune Diseases NIH 0.02
    D007674 Kidney Diseases NIH 0.02
    D007153 Immunologic Deficiency Syndromes NIH 0.02
    D010300 Parkinsonian NIH 0.02
    D008223 Lymphoma, NIH 0.02
    D004194 Disease NIH 0.02
    D040921 Stress Disorders, Traumatic NIH 0.02
    D003920 Diabetes Mellitus, NIH 0.02
    D009103 Multiple Sclerosis NIH 0.02
    D011665 Pulmonary Valve Insufficiency NIH 0.02
    D006331 Heart Diseases NIH 0.02
    D003289 Convalescence NIH 0.02
    D015212 Inflammatory Bowel Diseases NIH 0.02
    D013313 Stress Disorders, Post-Traumatic NIH 0.02
    D009369 Neoplasms, NIH 0.02
    D006333 Heart Failure NIH 0.02
    D054556 Venous Thromboembolism NIH 0.02
    D060825 Cognitive Dysfunction NIH 0.02
    D007251 Influenza, Human NIH 0.01
    D020246 Venous Thrombosis NIH 0.01
    D001172 Arthritis, Rheumatoid NIH 0.01
    D003924 Diabetes Mellitus, Type 2 NIH 0.01
    D020521 Stroke NIH 0.01
    D001168 Arthritis NIH 0.01
    D011655 Pulmonary Embolism NIH 0.01
    D004617 Embolism NIH 0.01
    D006973 Hypertension NIH 0.01
    D013923 Thromboembolism NIH 0.01
    D003866 Depressive Disorder NIH 0.01
    D004630 Emergencies NIH 0.01

    Correlated HPO Terms (72)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.17
    HP:0011947 Respiratory tract infection HPO 0.08
    HP:0002206 Pulmonary fibrosis HPO 0.07
    Name (Synonyms) Correlation
    HP:0006802 Abnormal anterior horn cell morphology HPO 0.07
    HP:0000224 Hypogeusia HPO 0.07
    HP:0007354 Amyotrophic lateral sclerosis HPO 0.07
    HP:0002110 Bronchiectasis HPO 0.05
    HP:0001888 Lymphopenia HPO 0.05
    HP:0002088 Abnormal lung morphology HPO 0.05
    HP:0003811 Neonatal death HPO 0.05
    HP:0002487 Hyperkinetic movements HPO 0.05
    HP:0002354 Memory impairment HPO 0.05
    HP:0002617 Vascular dilatation HPO 0.05
    HP:0008711 Benign prostatic hyperplasia HPO 0.05
    HP:0100827 Lymphocytosis HPO 0.05
    HP:0012133 Erythroid hypoplasia HPO 0.05
    HP:0002863 Myelodysplasia HPO 0.05
    HP:0002902 Hyponatremia HPO 0.05
    HP:0004944 Dilatation of the cerebral artery HPO 0.05
    HP:0002511 Alzheimer disease HPO 0.05
    HP:0040187 Neonatal sepsis HPO 0.05
    HP:0100658 Cellulitis HPO 0.05
    HP:0100280 Crohn's disease HPO 0.05
    HP:0002621 Atherosclerosis HPO 0.05
    HP:0001399 Hepatic failure HPO 0.05
    HP:0030858 Addictive behavior HPO 0.05
    HP:0005508 Monoclonal immunoglobulin M proteinemia HPO 0.05
    HP:0001626 Abnormality of the cardiovascular system HPO 0.04
    HP:0006510 Chronic pulmonary obstruction HPO 0.04
    HP:0006515 Interstitial pneumonitis HPO 0.04
    HP:0006536 Pulmonary obstruction HPO 0.04
    HP:0012418 Hypoxemia HPO 0.04
    HP:0100806 Sepsis HPO 0.03
    HP:0000717 Autism HPO 0.03
    HP:0001945 Fever HPO 0.03
    HP:0005526 Lymphoid leukemia HPO 0.03
    HP:0005550 Chronic lymphatic leukemia HPO 0.03
    HP:0100754 Mania HPO 0.03
    HP:0002293 Alopecia of scalp HPO 0.03
    HP:0000509 Conjunctivitis HPO 0.03
    HP:0000458 Anosmia HPO 0.03
    HP:0012532 Chronic pain HPO 0.03
    HP:0001919 Acute kidney injury HPO 0.03
    HP:0100512 Low levels of vitamin D HPO 0.03
    HP:0002098 Respiratory distress HPO 0.03
    HP:0001250 Seizure HPO 0.03
    HP:0002099 Asthma HPO 0.03
    HP:0007018 Attention deficit hyperactivity disorder HPO 0.03
    HP:0000729 Autistic behavior HPO 0.03
    HP:0100785 Insomnia HPO 0.03
    HP:0001677 Coronary artery atherosclerosis HPO 0.02
    HP:0000077 Abnormality of the kidney HPO 0.02
    HP:0002960 Autoimmunity HPO 0.02
    HP:0002665 Lymphoma HPO 0.02
    HP:0001298 Encephalopathy HPO 0.02
    HP:0002721 Immunodeficiency HPO 0.02
    HP:0000819 Diabetes mellitus HPO 0.02
    HP:0002037 Inflammation of the large intestine HPO 0.02
    HP:0010444 Pulmonary insufficiency HPO 0.02
    HP:0002664 Neoplasm HPO 0.02
    HP:0001635 Congestive heart failure HPO 0.02
    HP:0001268 Mental deterioration HPO 0.02
    HP:0001370 Rheumatoid arthritis HPO 0.01
    HP:0001909 Leukemia HPO 0.01
    HP:0002625 Deep venous thrombosis HPO 0.01
    HP:0005978 Type II diabetes mellitus HPO 0.01
    HP:0001297 Stroke HPO 0.01
    HP:0001369 Arthritis HPO 0.01
    HP:0002204 Pulmonary embolism HPO 0.01
    HP:0000822 Hypertension HPO 0.01
    HP:0001907 Thromboembolism HPO 0.01
    HP:0000716 Depressivity HPO 0.01

    Clinical Trials

    Navigate: Correlations   HPO

    There are 459 clinical trials


    1 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

    This 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.

    NCT03808922
    Conditions
    1. Lower Respiratory Tract Infection
    2. Parainfluenza
    3. Immunocompromised
    4. COVID-19
    Interventions
    1. Drug: DAS181
    2. Drug: Placebo
    3. Drug: DAS181 COVID-19
    4. Drug: DAS181 OL
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Paramyxoviridae Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Removal of all oxygen support (with stable SpO2)

    Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

    Time: by Day 28

    Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

    Time: Day 14

    Secondary Outcomes

    Measure: All-cause mortality rate (main study)

    Time: at Day 28

    Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

    Time: by Day 21

    Measure: Time (in days) to RTRA (main study)

    Time: Days 10, 14, 21, 28

    Measure: Percent of subjects who achieve clinical stability (main study)

    Time: by Day 28

    Measure: Percent of subjects discharged (without mortality and hospice) (main study)

    Time: by Days 14, 21, 28 and 35

    Measure: Time (in days) to first hospital discharge (without hospice) (main study)

    Time: through Day 35

    Measure: Total number of inpatient days (main study)

    Time: up to Day 35

    Measure: Baseline SAD-RV infection-related mortality rate (main study)

    Time: at Day 28

    Measure: Baseline SAD-RV infection-related mortality rate (main study)

    Time: at Day 35

    Measure: All-cause mortality rate (main study)

    Time: at Day 35

    Measure: Change in pulmonary function (FEV1% predicted) (main study)

    Time: Day 1, Day 7, Day 14, Day 28

    Measure: Time to improved COVID19 clinical status (Sub-study)

    Time: Day 5, Day 10, Day 21, Day 28

    Measure: Time to RTRA

    Time: Day 10, Day 14, Day 21, Day 28

    Measure: Time to Clinical stability

    Time: Day 14, Day 21, Day 28

    Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

    Time: Day 5, Day 10, Day 14, Day 21, Day 28

    Measure: Time to Clinical deterioration

    Time: Day 5, Day 10, Day 14, Day 21, Day 28

    Measure: Time to Discharge from hospital (without readmission before Day 28).

    Time: Day 14, Day 21, Day 28

    Measure: Time to Death (all causes)

    Time: Day 14, Day 21, Day 28
    2 Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

    Maternal 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.

    NCT03871491
    Conditions
    1. Maternal Death
    2. Maternal Infections Affecting Fetus or Newborn
    3. Neonatal SEPSIS
    4. Maternal Sepsis During Labor
    5. Neonatal Death
    6. Postpartum Sepsis
    Interventions
    1. Drug: Azithromycin
    2. Drug: Placebo
    MeSH:Infection Sepsis Toxemia Neonatal Sepsis Pregnancy Complications, Infectious Puerperal Infection Perinatal Death Maternal Death Death
    HPO:Neonatal death Neonatal sepsis Sepsis

    Primary Outcomes

    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-delivery

    Secondary Outcomes

    Description: 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 delivery

    Description: 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-delivery

    Description: 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-delivery

    Description: 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-delivery

    Description: 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-delivery

    Description: Maternal readmissions within 42 days of delivery

    Measure: Incidence of maternal readmissions

    Time: within 42 days post-delivery

    Description: Maternal admission to special care units

    Measure: Incidence of maternal admission to special care units

    Time: within 42 days post-delivery

    Description: Maternal unscheduled visit for care

    Measure: Incidence of maternal unscheduled visit for care

    Time: within 42 days post-delivery

    Description: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.

    Measure: Incidence of maternal GI symptoms

    Time: within 42 days post-delivery

    Description: 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-delivery

    Description: Incidence of other neonatal infections.

    Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection)

    Time: within 42 days post-delivery

    Description: 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 delivery

    Description: Neonatal readmissions within 42 days of delivery

    Measure: Incidence of neonatal readmissions

    Time: within 42 days of delivery

    Description: Neonatal admission to special care units

    Measure: Incidence of neonatal admission to special care units

    Time: within 28 days of delivery

    Description: Neonatal unscheduled visit for care

    Measure: Incidence of neonatal unscheduled visit for care

    Time: within 42 days post-delivery

    Description: 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 delivery

    Description: 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 delivery
    3 A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19

    This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19.

    NCT03891420
    Conditions
    1. COVID-19
    2. Yellow Fever
    Interventions
    1. Drug: Galidesivir
    2. Drug: Placebo
    MeSH:Yellow Fever Fever
    HPO:Fever

    Primary Outcomes

    Measure: number of subjects with treatment emergent adverse events and serious adverse events

    Time: absolute number through the end of the study, approximately 56 days

    Measure: number of subjects with change in laboratory parameters

    Time: absolute number and change from baseline through the end of the study, approximately 56 days

    Measure: exposure of galidesivir as measured by plasma concentrations

    Time: 24 hours post dose on Day 1 through 12 hours post dose on Day 7

    Secondary Outcomes

    Measure: yellow fever virus (YFV) titer (Group A)

    Time: change in YFV titer from baseline through Day 21

    Measure: antiviral effect on SARS-CoV-2 in the respiratory tract - COVID-19 (Group B)

    Time: change in SARS-CoV-2 from baseline through Day 21

    Measure: changes in clinical status using 8-point ordinal scale in COVID-19 (Group B)

    Time: through Day 21

    Measure: changes from baseline and time to improvement using NEWS in COVID-19 (Group B)

    Time: through Day21

    Measure: mortality

    Time: mortality at Day 56
    4 Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19

    The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.

    NCT04273646
    Conditions
    1. 2019 Novel Coronavirus Pneumonia
    2. COVID-19
    Interventions
    1. Biological: UC-MSCs
    2. Drug: Placebo
    MeSH:Coronavirus Infections Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Evaluation of Pneumonia Improvement

    Measure: Pneumonia severity index

    Time: From Baseline (0W) to 12 week after treatment

    Description: Evaluation of Pneumonia Improvement

    Measure: Oxygenation index (PaO2/FiO2)

    Time: From Baseline (0W) to 12 week after treatment

    Secondary Outcomes

    Description: Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.

    Measure: Side effects in the UC-MSCs treatment group

    Time: From Baseline (0W) to 96 week after treatment

    Description: Marker for efficacy of treatment

    Measure: 28-days survival

    Time: Day 28

    Description: Markers of organ function(Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.)

    Measure: Sequential organ failure assessment

    Time: Day 28

    Description: Markers of Infection

    Measure: C-reactive protein

    Time: From Baseline (0W) to 12 week after treatment

    Description: Markers of Infection

    Measure: Procalcitonin

    Time: From Baseline (0W) to 12 week after treatment

    Description: Marker of Immunological function

    Measure: Lymphocyte count

    Time: From Baseline (0W) to 12 week after treatment

    Description: Marker of Immunological function

    Measure: CD3+, CD4+ and CD8+ T celll count

    Time: From Baseline (0W) to 12 week after treatment

    Description: Marker of Immunological function

    Measure: CD4+/CD8+ratio

    Time: From Baseline (0W) to 12 week after treatment
    5 The Efficacy of Treating Pulmonary Fibrosis and Pulmonary Function Injury in COVID-19 With the Fuzheng Huayu Tablets: a Multicenter Randomized Controlled Trial

    According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.

    NCT04279197
    Conditions
    1. Pulmonary Fibrosis Due to COVID-19
    Interventions
    1. Drug: Fuzheng Huayu Tablet
    2. Drug: Vitamin C tablets
    3. Other: Placebo
    4. Other: respiratory function rehabilitation training
    MeSH:Pulmonary Fibrosis Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.

    Measure: The improvement proportion of pulmonary fibrosis

    Time: Week 24

    Secondary Outcomes

    Description: Evaluation of Lung Function Improvement

    Measure: Blood oxygen saturation

    Time: Week 24

    Description: Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19

    Measure: Clinical symptom score

    Time: Week 24

    Description: This scale can reflect the quality of life of patients to some extent.

    Measure: Quality of Life-BREF (QOL-BREF)

    Time: Week 24

    Description: This scale can reflect the quality of life of patients to some extent.

    Measure: Patient Health Questionnaire-9(PHQ-9)

    Time: Week 24

    Description: This scale can reflect the quality of life of patients to some extent.

    Measure: Generalized anxiety disorder-7(GAD-7)

    Time: Week 24

    Description: Evaluation of Lung Function Improvement

    Measure: The 6-minute walk distance

    Time: Week 24
    6 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

    This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

    NCT04280705
    Conditions
    1. COVID-19
    Interventions
    1. Other: Placebo
    2. Drug: Remdesivir

    Primary Outcomes

    Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.

    Measure: Time to Recovery

    Time: Day 1 through Day 29

    Secondary Outcomes

    Description: Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Alanine Transaminase (ALT)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Aspartate Transaminase (AST)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Creatinine

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Glucose

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Hemoglobin

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Platelets

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Prothrombin Time (PT)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Total Bilirubin

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in White Blood Cell Count (WBC)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Neutrophils

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Lymphocytes

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Monocytes

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Basophils

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Eosinophils

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.

    Measure: Change in National Early Warning Score (NEWS) From Baseline

    Time: Days 1, 3, 5, 8, 11, 15, 22, and 29

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1

    Time: Day 1

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3

    Time: Day 3

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5

    Time: Day 5

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8

    Time: Day 8

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11

    Time: Day 11

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15

    Time: Day 15

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22

    Time: Day 22

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29

    Time: Day 29

    Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

    Measure: Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)

    Time: Day 1 through Day 29

    Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

    Measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)

    Time: Day 1 through Day 29

    Description: Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.

    Measure: Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics

    Time: Day 1 through Day 10

    Description: Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

    Measure: Duration of Hospitalization

    Time: Day 1 through Day 29

    Description: Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

    Measure: Duration of New Non-invasive Ventilation or High Flow Oxygen Use

    Time: Day 1 through Day 29

    Description: Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die .

    Measure: Duration of New Oxygen Use

    Time: Day 1 through Day 29

    Description: Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

    Measure: Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

    Time: Day 1 through Day 29

    Description: New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.

    Measure: Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use

    Time: Day 1 through Day 29

    Description: The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline

    Measure: Percentage of Participants Requiring New Oxygen Use

    Time: Day 1 through Day 29

    Description: The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline

    Measure: Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

    Time: Day 1 through Day 29

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.

    Measure: Mean Change in the Ordinal Scale

    Time: Day 1, 3, 5, 8, 11, 15, 22, and 29

    Description: The mortality rate was determined as the proportion of participants who died by study Day 15.

    Measure: 14-day Participant Mortality

    Time: Day 1 through Day 15

    Description: The mortality rate was determined as the proportion of participants who died by study Day 29.

    Measure: 29-day Participant Mortality

    Time: Day 1 through Day 29

    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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant

    Measure: Time to an Improvement by at Least One Category Using an Ordinal Scale

    Time: Day 1 through Day 29

    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. Time to improvement by at least two categories was determined for each participant

    Measure: Time to an Improvement of at Least Two Categories Using an Ordinal Scale

    Time: Day 1 through Day 29

    Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.

    Measure: Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First

    Time: Day 1 through Day 29
    7 Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus

    The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.

    NCT04293692
    Conditions
    1. COVID-19
    Interventions
    1. Biological: UC-MSCs
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Evaluation of Pneumonia change

    Measure: Size of lesion area by chest imaging

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Evaluation of Pneumonia change

    Measure: Blood oxygen saturation

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Secondary Outcomes

    Description: Marker for efficacy of treatment

    Measure: Rate of mortality within 28-days

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: 0-4 score, the higher the score is, the poor of the prognosis will be.

    Measure: Sequential organ failure assessment

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Number of participants with treatment-related adverse events

    Measure: Side effects in the UC-MSCs treatment group

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Markers of the heart function

    Measure: Electrocardiogram, the changes of ST-T interval mostly

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Markers of infection

    Measure: Concentration of C-reactive protein C-reactive protein, immunoglobulin

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Marker of Immunology and inflammation

    Measure: CD4+ and CD8+ T cells count

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Marker of Immunology and inflammation

    Measure: Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α)

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Markers of the heart function

    Measure: Concentration of the myocardial enzymes

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
    8 A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

    This 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.

    NCT04298060
    Conditions
    1. Influenza Infection
    2. SAD-RV Infection and COVID-19
    Interventions
    1. Drug: DAS181
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Influenza, Human

    Primary Outcomes

    Description: Percent of subjects who have returned to room air

    Measure: Percent of subjects who have returned to room air

    Time: 7 days

    Description: 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 days
    9 Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)

    The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other staff working in a facility where there are cases of either proven, or suspected, COVID-19, who can be followed reliably for 5 months. 40,000 participants will be recruited and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.

    NCT04303507
    Conditions
    1. COVID19
    2. Coronavirus
    3. Acute Respiratory Illnesses
    Interventions
    1. Drug: Chloroquine or Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups

    Measure: Number of symptomatic COVID-19 infections

    Time: Approximately 90 days

    Secondary Outcomes

    Description: Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.

    Measure: Symptoms severity of COVID-19

    Time: Approximately 90 days

    Description: Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.

    Measure: Number of asymptomatic cases of COVID-19

    Time: Approximately 90 days

    Description: Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

    Measure: Number of symptomatic acute respiratory illnesses

    Time: Approximately 90 days

    Description: Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

    Measure: Severity of symptomatic acute respiratory illnesses

    Time: Approximately 90 days

    Other Outcomes

    Description: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.

    Measure: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.

    Time: Approximately 90 days

    Description: Number of days lost to work in relation to the treatment arm

    Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic.

    Time: Approximately 90 days

    Description: The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.

    Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs

    Time: Approximately 90 days

    Description: The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.

    Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L)

    Time: Approximately 90 days
    10 Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

    Study 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.

    NCT04308668
    Conditions
    1. Corona Virus Infection
    2. Acute Respiratory Distress Syndrome
    3. SARS-CoV Infection
    4. Coronavirus
    5. Coronavirus Infections
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    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 days

    Description: 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 days

    Secondary Outcomes

    Description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

    Measure: Incidence of Hospitalization

    Time: 14 days

    Description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

    Measure: Incidence of Death

    Time: 90 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    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 among those who are symptomatic at trial entry

    Time: 14 days
    11 Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

    This 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).

    NCT04311177
    Conditions
    1. Corona Virus Infection
    2. Acute Respiratory Distress Syndrome
    3. SARS-CoV Infection
    Interventions
    1. Drug: Losartan
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. There is no validated, unified single score and each item is evaluated individually.

    Measure: Change in PROMIS Dyspnea scale

    Time: 10 days

    Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

    Measure: Change in SF-12 Physical Composite Score

    Time: 10 days

    Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

    Measure: Change in SF-12 Mental Composite Score

    Time: 10 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: Outcome reported as the mean number of days participants in each arm did not require ventilator use.

    Measure: Ventilator-Free Days

    Time: 28 days

    Description: 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 days

    Description: 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 days

    Description: 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 days
    12 Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

    This 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.

    NCT04312009
    Conditions
    1. Corona Virus Infection
    2. Acute Respiratory Distress Syndr
    3. Acute Respiratory Distress Syndrome
    4. SARS-CoV Infection
    Interventions
    1. Drug: Losartan
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: 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 days

    Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

    Measure: Hypotension Requiring Vasopressors

    Time: 10 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: Outcome reported as the number of participants who have expired at 28 days post enrollment.

    Measure: 28-Day Mortality

    Time: 28 days

    Description: Outcome reported as the number of participants who have expired at 90 days post enrollment.

    Measure: 90-Day Mortality

    Time: 90 days

    Description: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

    Measure: ICU Admission

    Time: 10 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. There is no validated, unified single score and each item is evaluated individually.

    Measure: Change in PROMIS Dyspnea scale

    Time: 10 days

    Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

    Measure: Change in SF-12 Physical Composite Score

    Time: 10 days

    Description: The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

    Measure: Change in SF-12 Mental Composite Score

    Time: 10 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days
    13 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

    Adults 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

    NCT04312997
    Conditions
    1. COVID-19
    Interventions
    1. Drug: PUL-042 Inhalation Solution
    2. Drug: Placebo
    MeSH:Infection Respiratory Aspiration

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy

    Measure: SARS-CoV-2 infection

    Time: 28 days

    Description: 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 days

    Description: 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 days

    Description: The requirement for ICU admission within 28 days from the start of the experimental therapy.

    Measure: ICU admission

    Time: 28 days

    Description: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.

    Measure: Mechanical Ventilation

    Time: 28 days

    Description: All cause mortality at 28 days from the start of experimental therapy

    Measure: Mortality

    Time: 28 days
    14 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

    Subjects 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.

    NCT04313023
    Conditions
    1. COVID-19
    Interventions
    1. Drug: PUL-042 Inhalation Solution
    2. Drug: Placebo
    MeSH:Infection Disease Progression

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: The requirement for ICU admission within 28 days from the start of experimental therapy.

    Measure: ICU admission

    Time: 28 days

    Description: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.

    Measure: Mechanical ventilation

    Time: 28 days

    Description: All cause mortality at 28 days from the start of experimental therapy.

    Measure: Mortality

    Time: 28 days
    15 An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19

    Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline. Phase 3 Cohort 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.

    NCT04315298
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Sarilumab
    2. Drug: Placebo

    Primary Outcomes

    Description: Phase 2

    Measure: Percent change in C-reactive protein (CRP) levels in patients with serum IL-6 level greater than the upper limit of normal

    Time: Day 4

    Description: Phase 3 Cohort 1 7-point Ordinal Scale: 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: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with critical COVID-19 receiving mechanical ventilation at baseline

    Time: Up to day 22

    Description: Phase 3 Cohort 2

    Measure: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with COVID-19 receiving mechanical ventilation at baseline

    Time: Up to day 22

    Secondary Outcomes

    Description: Phase 2

    Measure: Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical patients with serum IL-6 levels greater than the upper limit of normal

    Time: Up to day 29

    Description: Phase 2

    Measure: Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale reporting in severe or critical patients with all IL-6 levels

    Time: Up to day 29

    Description: Phase 2 Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary) Documented fever defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary)

    Measure: Time to resolution of fever for at least 48 hours without antipyretics in patients with documented fever

    Time: Up to day 29

    Description: Phase 2 Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)

    Measure: Time to resolution of fever for at least 48 hours without antipyretics by clinical severity

    Time: Up to day 29

    Description: Phase 2 Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)

    Measure: Time to resolution of fever for at least 48 hours without antipyretics by baseline IL-6 levels

    Time: Up to day 29

    Description: Phase 2 Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to improvement in oxygenation for at least 48 hours

    Time: Up to day 29

    Description: Phase 2 Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to improvement in oxygenation for at least 48 hours by clinical severity

    Time: Up to day 29

    Description: Phase 2 Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to improvement in oxygenation for at least 48 hours by baseline IL-6 levels

    Time: Up to day 29

    Description: Phase 2 Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary) Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to resolution of fever and improvement in oxygenation for at least 48 hours

    Time: Up to day 29

    Description: Phase 2

    Measure: Mean change in the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 2

    Measure: Percentage of patients in each clinical status category using the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 2 NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)

    Measure: Time to discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours

    Time: Up to day 29

    Description: Phase 2

    Measure: Change from baseline in NEWS2 scoring system

    Time: Up to day 29

    Description: Phase 2 Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)

    Measure: Number of days with fever

    Time: Up to day 29

    Description: Phase 2

    Measure: Proportion of patients alive, off oxygen

    Time: At day 29

    Description: Phase 2

    Measure: Number of days of resting respiratory rate >24 breaths/min

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of days with hypoxemia

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of days of supplemental oxygen use

    Time: Up to day 29

    Description: Phase 2

    Measure: Time to saturation ≥94% on room air

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of ventilator free days in the first 28 days

    Time: Baseline to day 29

    Description: Phase 2

    Measure: Number of patients requiring initiation of mechanical ventilation

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of patients requiring non-invasive ventilation

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of patients requiring the use of high flow nasal cannula

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of patients admitted into an intensive care unit (ICU)

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of days of hospitalization among survivors

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of deaths due to any cause

    Time: Up to day 60

    Description: Phase 3

    Measure: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale

    Time: Up to day 22

    Description: Phase 3 Defined as discharged, or alive without supplemental oxygen use or at pre-COVID oxygen use

    Measure: Proportion of patients who recover

    Time: Up to day 22

    Description: Phase 3

    Measure: Proportion of deaths

    Time: Through day 29

    Description: Phase 3

    Measure: Proportion of patients alive not receiving mechanical ventilation

    Time: At day 22

    Description: Phase 3

    Measure: Proportion of patients alive not requiring extracorporeal membrane oxygenation (ECMO)

    Time: At day 22

    Description: Phase 3

    Measure: Proportion of patients with a 2-point improvement in clinical status on the 7-point ordinal scale

    Time: Up to day 22

    Description: Phase 3

    Measure: Time to at least 1-point improvement in clinical status assessment on the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 3

    Measure: Time to at least 2-point improvement in clinical status assessment on the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 3

    Measure: Proportion of patients receiving mechanical ventilation

    Time: Up to day 22

    Description: Phase 3

    Measure: Proportion of patients receiving ECMO

    Time: Up to day 22

    Description: Phase 3

    Measure: Proportion of patients discharged and alive

    Time: At day 22

    Description: Phase 3 Defined as discharged or alive without supplemental oxygen use or at pre-COVID oxygen use

    Measure: Time to recovery

    Time: Up to day 29

    Description: Phase 3

    Measure: Proportion of deaths

    Time: Through day 60

    Description: Phase 3

    Measure: Time to death due to any cause

    Time: Through day 60

    Description: Phase 3

    Measure: Number of ventilator free days

    Time: Up to day 29

    Description: Phase 3

    Measure: Number of days of hospitalization among survivors

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with serious adverse events

    Time: Up to Day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with Grade 4 neutropenia (ANC <500/mm3)

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with Grade 4 neutropenia (ANC <500/mm3)

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with hypersensitivity reactions

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with infusion reactions

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with gastrointestinal perforation

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: White blood cell count

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Hemoglobin levels

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Platelet count

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Creatinine levels

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Total bilirubin level

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Alanine aminotransferase (ALT) level

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Aspartate aminotransferase (AST) level

    Time: Up to day 29 if still hospitalized
    16 Exploratory Clinical Study to Assess the Efficacy of NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia

    This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.

    NCT04315987
    Conditions
    1. COVID-19 Pneumonia
    Interventions
    1. Biological: NestaCell®
    2. Biological: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Ordinal scale (WHO ordinal scale that measures illness severity over time)

    Measure: Change in Clinical Condition

    Time: 10 days

    Secondary Outcomes

    Description: Evaluation of Pneumonia change

    Measure: Rate of mortality within 10-days

    Time: 10 days

    Description: Evaluation of Pneumonia change

    Measure: Change of Clinical symptoms - respiratory rate

    Time: 10 days

    Description: oxygen saturation

    Measure: Hypoxia

    Time: 10 days

    Description: oxygen saturation

    Measure: PaO2 / FiO2 ratio

    Time: 10 days

    Description: Marker of Immunological function

    Measure: CD4+ and CD8+ T cell count

    Time: Days 1, 2, 4, 6 and 8.

    Description: PaO2 / FiO2 ratio

    Measure: Changes of blood oxygen

    Time: 10 days

    Description: Number of participants with treatment-related adverse events

    Measure: Side effects in the treatment group

    Time: 10 days

    Description: Complete blood count, ALT, AST, GGT, CK, CKmB and creatinine

    Measure: Complete blood count, cardiac, hepatic and renal profiles;

    Time: Days 1, 2, 4, 6 and 8.
    17 A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment

    The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe and critical COVID 19. Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 270 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

    NCT04317040
    Conditions
    1. Covid19
    Interventions
    1. Drug: CD24Fc
    2. Drug: Placebo

    Primary Outcomes

    Description: Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 2, 3, or 4" to "scale 5 or higher" based on NIAID ordinal scales.

    Measure: Improvement of COVID-19 disease status

    Time: 29 days

    Secondary Outcomes

    Description: Proportion of patients who died or had respiratory failure, defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high flow oxygen devices, at Day 29

    Measure: Proportion of patients who died or had respiratory failure.

    Time: 29 days

    Description: Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation, or ESMO, or death, or from NIAID scale 2 to death.

    Measure: Disease progression of COVID-19

    Time: 29 days

    Description: All cause of death

    Measure: All cause of death

    Time: 15 days and 29 days

    Description: Proportion of clinical relapse, as defined by rate of return to oxygen support for more than 1 day within 29 days from randomization after initial recovery

    Measure: Proportion of clinical relapse

    Time: 29 days

    Description: Conversion rate of clinical status on days 8 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

    Measure: Conversion rate of clinical status at Day 8

    Time: 8 days

    Description: Conversion rate of clinical status on days 15 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

    Measure: Conversion rate of clinical status at Day 15

    Time: 15 days

    Description: The discharge time, calculated after the randomization.

    Measure: Hospital discharge time

    Time: 29 days

    Description: Duration of mechanical ventilation (IMV, NIV) (days)

    Measure: Duration of mechanical ventilation

    Time: 29 days

    Description: Duration of pressors (days)

    Measure: Duration of pressors

    Time: 29 days

    Description: Duration of extracorporeal membrane oxygenation (days)

    Measure: Duration of ECMO

    Time: 29 days

    Description: Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days)

    Measure: Duration of high flow oxygen therapy

    Time: 29 days

    Description: Changes of absolute lymphocyte count in peripheral blood

    Measure: Absolute lymphocyte count

    Time: 29 days

    Description: The changes of plasma concentration of D-dimers

    Measure: Change of D-dimers

    Time: 15 and 29 days
    18 A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

    This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

    NCT04320615
    Conditions
    1. COVID-19 Pneumonia
    Interventions
    1. Drug: Tocilizumab (TCZ)
    2. Drug: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Measure: Clinical Status Assessed Using a 7-Category Ordinal Scale

    Time: Day 28

    Secondary Outcomes

    Measure: Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of Time: Up to 60 days

    Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status

    Time: Up to 60 days

    Measure: Incidence of Mechanical Ventilation

    Time: Up to 60 days

    Measure: Ventilator-Free Days to Day 28

    Time: Up to Day 28

    Measure: Incidence of Intensive Care Unit (ICU) Stay

    Time: Up to 60 days

    Measure: Duration of ICU Stay

    Time: Up to 60 days

    Measure: Time to Clinical Failure

    Time: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days). If already in ICU on ventilation, failure = a one-category worsening on the ordinal scale, withdrawal, or death

    Measure: Mortality Rate

    Time: Days 7, 14, 21, 28, and 60

    Measure: Time to Hospital Discharge

    Time: Up to 60 days

    Measure: Time to Recovery

    Time: Up to 60 days

    Measure: Duration of Time on Supplemental Oxygen

    Time: Up to 60 days

    Measure: Percentage of Participants with Adverse Events

    Time: Up to 60 days

    Measure: COVID-19 (SARS-CoV-2) Viral Load Over Time

    Time: Up to 60 days

    Measure: Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity

    Time: Up to 60 days

    Measure: Proportion of Participants with Post-Treatment Infection

    Time: Up to 60 days

    Measure: Serum Concentration of IL-6

    Time: Up to 60 days

    Measure: Serum Concentration of sIL-6R

    Time: Up to 60 days

    Measure: Serum Concentration of Ferritin

    Time: Up to 60 days

    Measure: Serum Concentration of C-Reactive Protein (CRP)

    Time: Up to 60 days

    Measure: Serum Concentration of TCZ

    Time: Up to 60 days
    19 Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

    A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated. Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening. The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

    NCT04325893
    Conditions
    1. Coronavirus
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.

    Time: Day 14

    Secondary Outcomes

    Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.

    Time: Day 28

    Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

    Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 14

    Time: Day 14

    Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

    Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.

    Time: Day 28

    Measure: Number of all-cause mortality at day 14

    Time: Day 14

    Measure: Number of all-cause mortality at day 28

    Time: Day 28

    Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 5

    Time: Day 5

    Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10

    Time: Day 10

    Measure: The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.

    Time: Day 28

    Measure: Number of all-cause mortality at day 28 in patients aged 75 and older

    Time: day 28

    Measure: Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older

    Time: day 28

    Measure: Rate of severe adverse events at day 28

    Time: day 28

    Measure: Number of all-cause mortality at day 14 in patients aged 75 and older

    Time: day 14
    20 ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

    This 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.

    NCT04326426
    Conditions
    1. Coronavirus Infection
    Interventions
    1. Drug: Tradipitant
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

    Time: 14 days or discharge

    Secondary Outcomes

    Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

    Time: 14 days or discharge

    Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

    Time: 14 days or discharge

    Measure: In-hospital mortality

    Time: 14 days or discharge

    Measure: Mean change in NEWS2 score from baseline

    Time: 14 days or discharge

    Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

    Time: 14 days or discharge

    Measure: Reduction from baseline of NRS for cough

    Time: 14 days or discharge

    Measure: Reduction from baseline of NRS for nausea

    Time: 14 days or discharge

    Measure: Time to normalization of fever for at least 48 hours

    Time: 14 days or discharge

    Measure: Time to improvement in oxygenation for at least 48 hours

    Time: 14 days or discharge
    21 An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

    Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19 Secondary Objectives: - Evaluate the 28-day survival rate - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity - Evaluate changes in the National Early Warning Score 2 (NEWS2) - Evaluate the duration of predefined symptoms and signs (if applicable) - Evaluate the duration of supplemental oxygen dependency (if applicable) - Evaluate the incidence of new mechanical ventilation use during the study - Evaluate the duration of new mechanical ventilation use during the Study - Evaluate the proportion of patients requiring rescue medication during the 28-day period - Evaluate need for admission into intensive care unit (ICU) - Evaluate duration of hospitalization (days) - The secondary safety objectives of the study are to evaluate the safety of sarilumab through hospitalization (up to day 29 if patient is still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events (SAEs) - Major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia - Grade ≥2 infusion related reactions - Grade ≥2 hypersensitivity reactions - Increase in alanine transaminase (ALT) ≥3X upper limit of normal (ULN) (for patients with normal baseline) or >3X ULN AND at least 2-fold increase from baseline value (for patients with abnormal baseline) - Major or opportunistic bacterial or fungal infections

    NCT04327388
    Conditions
    1. Corona Virus Infection
    Interventions
    1. Drug: Sarilumab SAR153191
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

    Measure: Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale

    Time: Baseline to Day 29

    Secondary Outcomes

    Measure: Percent of patients alive at Day 29

    Time: Day 29

    Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

    Measure: Proportion of patients with one point improvement from baseline in clinical status assessment at days 4, 7, 15, 21, 29 using the 7-point ordinal scale

    Time: Baseline to Days 4, 7, 15, 21, 29

    Description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

    Measure: Mean change in the 7-point ordinal scale from baseline to Days 4, 7, 15, 21, and 29 (or until discharge)

    Time: Baseline to Days 4, 7, 15, 21, 29 (or until discharge)

    Description: Defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner.

    Measure: Time to resolution of fever

    Time: Baseline to Day 29

    Description: Resolution of both fever and improvement in oxygenation. Resolution of fever is defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner. Improvement in oxygenation is defined as SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours, or until discharge, whichever is sooner.

    Measure: Time to resolution of fever and improvement in oxygenation

    Time: Baseline to Day 29

    Description: Fever is defined as >37.4°C (axilla), or >38.0 °C (oral), or >38.4°C (rectal or tympanic) based on maximum value observed during a 24-hour period.

    Measure: Days with fever

    Time: Baseline to Day 29

    Description: The National Early Warning Score (NEWS2) is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

    Measure: Time to change in NEWS2 from baseline

    Time: Baseline to Day 29

    Description: The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

    Measure: Time to NEWS2 of <2 and maintained for 24 hours

    Time: Baseline to Day 29

    Description: The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

    Measure: Mean change from baseline to days 4, 7, 15, 21, and 29 in NEWS2

    Time: Baseline to days 4, 7, 15, 21, and 29

    Description: SpO2/FiO2 of 50 or greater compared to the nadir for at least 48 hours, or until discharge, whichever is sooner. SpO2 is oxygen saturation and FiO2 is the fraction of inspired oxygen.

    Measure: Time-to-improvement in oxygenation

    Time: Baseline to Day 29

    Description: Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

    Measure: Alive off supplemental oxygen at day 29

    Time: Day 29

    Description: Hypoxemia is defined as SpO2 <93% on room air, or requiring supplemental oxygen, or mechanical ventilatory support.

    Measure: Days of hypoxemia

    Time: Baseline to Day 29

    Description: Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

    Measure: Days of supplemental oxygen use

    Time: Baseline to Day 29

    Measure: Days of resting respiratory rate >24 breaths/min

    Time: Baseline to Day 29

    Measure: Time to saturation ≥94% on room air

    Time: Baseline to Day 29

    Measure: Ventilator free days in the first 28 days (to day 29)

    Time: Baseline to Day 29

    Description: For those not requiring these interventions at baseline.

    Measure: The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula

    Time: Baseline to Day 60

    Measure: Proportion of patients requiring rescue medication during the 28-day period

    Time: Baseline to Day 28

    Description: For patients are not in ICU at baseline

    Measure: The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available)

    Time: Baseline to Day 60

    Measure: Days of hospitalization among survivors

    Time: Baseline to Day 60

    Measure: Incidence of serious adverse events

    Time: Baseline to Day 60

    Measure: The incidence of major or opportunistic bacterial or fungal infections

    Time: Baseline to Day 60

    Measure: The incidence of major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia

    Time: Baseline to Day 60

    Measure: The incidence of hypersensitivity reactions, infusion reactions, gastrointestinal perforation

    Time: Baseline to Day 60

    Measure: The number of patients with clinically significant laboratory abnormalities

    Time: Baseline to Day 60
    22 Reducing Health Care Workers Absenteeism in COVID-19 Pandemic by Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial.

    Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands would seriously challenge the available hospital capacity, and this would be augmented by absenteeism of healthcare workers (HCW). Strategies to prevent absenteeism of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported significant reductions in morbidity and mortality. The hypothesis is that BCG vaccination can reduce HCW absenteeism during the epidemic phase of Covid-19. Objective: Primary objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of Covid-19. Secondary objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of Covid-19. Study design: A placebo-controlled adaptive multi-centre randomized controlled trial. Study population: HCW with direct patient contacts among which nurses and physicians working at emergency rooms and wards where Covid-19-infected patients are treated. Intervention: Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio. Main study parameters/endpoints: Primary endpoint: number of days of (unplanned) absenteeism for any reason. Secondary endpoints include the number of days of (unplanned) absenteeism because of documented Covid-19 infection, and the cumulative incidence of hospital admission, Intensive Care Admission, and death. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of Covid-19 infection. The primary endpoint and the adaptive design with frequent interim analyses facilitate maximum efficiency of the trial, so that results can inform policy making during the ongoing epidemic.

    NCT04328441
    Conditions
    1. COVID-19
    Interventions
    1. Drug: BCG Vaccine
    2. Drug: Placebo

    Primary Outcomes

    Description: Number of days of unplanned absenteeism for any reason

    Measure: Health Care Workers absenteeism

    Time: Maximum of 365 days

    Secondary Outcomes

    Measure: the cumulative incidence of documented COVID-19

    Time: Maximum of 365 days

    Measure: the cumulative incidence of Hospital Admission due to documented COVID-19

    Time: Maximum of 365 days

    Measure: the number of days of unplanned absenteeism, because of documented COVID-19

    Time: Maximum of 365 days

    Measure: the cumulative incidence of self-reported acute respiratory symptoms or fever

    Time: Maximum of 365 days

    Measure: the cumulative incidence of death due to documented COVID-19

    Time: Maximum of 365 days

    Measure: the cumulative incidence of Intensive Care Admission due to documented COVID-19

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the number of days of absenteeism, because of imposed quarantine as a result of exposure to COVID-19

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented COVID-19

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the number of days of unplanned absenteeism because of self-reported acute respiratory symptoms

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the number of days of self-reported fever (≥38 gr C)

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence of self-reported fever (≥38 gr C)

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the number of days of self-reported acute respiratory symptoms

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence of self-reported acute respiratory symptoms

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence of death for any reason

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence of Intensive Care Admission for any reason

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence of Hospital Admission for any reason

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period

    Time: Maximum of 365 days

    Description: Exploratory

    Measure: the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period

    Time: 3-6 months after inclusion
    23 Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

    Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

    NCT04328467
    Conditions
    1. COVID-19
    2. Corona Virus Infection
    3. ARDS
    4. Acute Respiratory Distress Syndrome
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    Description: Outcome reported as the percent of participants in each arm who are COVID-19-free at the end of study treatment.

    Measure: COVID-19-free survival

    Time: up to 12 weeks

    Secondary Outcomes

    Description: Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.

    Measure: Incidence of confirmed SARS-CoV-2 detection

    Time: up to 12 weeks

    Description: Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment.

    Measure: Incidence of possible COVID-19 symptoms

    Time: up to 12 weeks

    Description: Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.

    Measure: Incidence of all-cause study medicine discontinuation

    Time: up to 12 weeks

    Description: Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), or Hospitalization with ICU stay or death (score=4). Possible scores range from 1-4 with higher scores indicating greater disease severity.

    Measure: Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end

    Time: up to 12 weeks

    Description: Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.

    Measure: Incidence of Hospitalization for COVID-19 or death

    Time: up to 12 weeks

    Description: Outcome reported as the percent of participants in each arm who experience medication-related side effects during study treatment.

    Measure: Incidence of study medication-related side effects

    Time: up to 12 weeks
    24 A Phase 2 Randomized, Single-Blind Study of a Single Dose of Peginterferon Lambda-1a (Lambda) Compared With Placebo in Outpatients With Mild COVID-19

    To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.

    NCT04331899
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Peginterferon Lambda-1a
    2. Other: Placebo

    Primary Outcomes

    Description: Time to first of two consecutive negative respiratory secretions obtained by oropharyngeal and/or anterior nare swabs for SARS-CoV-2 by qRT-PCR.

    Measure: Duration of Viral shedding of SARS-CoV-2 by qRT-PCR

    Time: 28 days

    Secondary Outcomes

    Description: Sars-CoV-2 RNA level in oropharyngeal and/or anterior nare swabs collected daily.

    Measure: Sars-CoV-2 viral load

    Time: 28 days

    Description: Area under the curve of SARSCoV-2 viral load in oropharyngeal and/or anterior nare swabs collected daily.

    Measure: Area under the curve of SARS-COV-2 viral load

    Time: 28 days

    Description: Time to alleviation of all symptoms (fever, chills, cough, nasal congestion, muscle pains), defined as the time from initiation of treatment until all symptoms are rated as absent or mild in symptomatic patients.

    Measure: Time to alleviation of all symptoms Time to alleviation of all symptoms

    Time: 28 days

    Measure: Number of participants requiring emergency department visits or hospitalizations within 28 days of initiation of treatment

    Time: 28 days
    25 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

    ORCHID 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.

    NCT04332991
    Conditions
    1. Coronavirus
    2. Acute Respiratory Infection
    3. SARS-CoV Infection
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
    HPO:Respiratory tract infection

    Primary Outcomes

    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 15

    Secondary Outcomes

    Description: 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 15

    Description: 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 29

    Description: 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 3

    Description: 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 8

    Description: 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 29

    Description: 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 28

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: The number of days spent out of the ICU to day 28.

    Measure: ICU-free days to Day 28

    Time: 28 days after randomization

    Description: 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 randomization

    Other Outcomes

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization

    Description: 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 randomization
    26 Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Trial

    Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.

    NCT04333472
    Conditions
    1. COVID-19
    2. Coronavirus Infection
    Interventions
    1. Drug: Piclidenoson
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29

    Measure: Proportion of subjects alive and free of respiratory failure

    Time: 29 days

    Description: Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29

    Measure: Proportion of subjects discharged home alive

    Time: 29 days

    Description: Proportion of patients experiencing AEs

    Measure: Treatment-emergent adverse events (AEs)

    Time: 29 days

    Secondary Outcomes

    Description: • Clinical status at Day 29 on NIAID 8-point ordinal scale (NIH 2020): Not hospitalized, no limitations Not hospitalized, with limitations Hospitalized, no active medical problems Hospitalized, not on oxygen Hospitalized, on oxygen Hospitalized, on high-flow oxygen or noninvasive mechanical ventilation Hospitalized, on mechanical ventilation or ECMO Death

    Measure: Clinical status

    Time: 29 days

    Description: Time (days) to improvement of 2 points on 7-point ordinal clinical scale

    Measure: Time to improvement

    Time: 29 days

    Description: Proportion of patients who require mechanical ventilation

    Measure: Incidence of mechanical ventilation

    Time: 29 days

    Description: Ventilator-free days to Day 29

    Measure: Ventilator-free days

    Time: 29 days

    Description: Proportion of patients who require ICU admission

    Measure: Incidence of Intensive Care Unit (ICU) admission

    Time: 29 days

    Description: Duration (days) of ICU stay

    Measure: Duration of ICU stay

    Time: 29 days

    Description: Time (days) to hospital discharge

    Measure: Time to hospital discharge

    Time: 29 days

    Description: Duration (days) of need for supplemental oxygen

    Measure: Duration of need for supplemental oxygen

    Time: 29 days

    Description: Time (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling

    Measure: Time to virus negativity

    Time: 29 days

    Description: SARS-CoV-2 viral load (number of copies) by quantitative RT-PCR

    Measure: SARS-CoV-2 viral load

    Time: 29 days

    Description: Proportion of patients experiencing AEs leading to early discontinuation of trial treatment

    Measure: AEs leading to withdrawal

    Time: 29 days

    Description: Proportion of patients experiencing SAEs

    Measure: Treatment-emergent serious AEs (SAEs)

    Time: 29 days

    Description: Proportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs

    Measure: Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs)

    Time: 29 days

    Description: Proportion of patients who meet study safety-related stopping rules

    Measure: Incidence of meeting safety-related stopping rules

    Time: 29 days

    Description: Plasma concentrations over time of piclidenoson

    Measure: Pharmacokinetics of piclidenoson in this patient population

    Time: 5 days

    Description: Change from baseline in serum concentrations of cytokines

    Measure: Serum cytokine levels

    Time: 29 days
    27 A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

    Primary Objective: To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19 Secondary Objectives: - To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19 - To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

    NCT04333654
    Conditions
    1. Coronavirus Infection
    Interventions
    1. Drug: Hydroxychloroquine SAR321068
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Viral load assessed by PCR from a nasopharyngeal swab

    Measure: Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)

    Time: Baseline to Day 3

    Description: Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab

    Measure: Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)

    Time: Baseline to Day 3

    Secondary Outcomes

    Description: Viral load assessed by PCR from a nasopharyngeal swab

    Measure: Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load

    Time: Baseline to Day 5

    Description: Viral load assessed by PCR from a nasopharyngeal swab

    Measure: Number of participants by PCR result status (positive or negative)

    Time: Baseline to end of study (Day14)

    Description: COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe)

    Measure: Number of participants with COVID-19 symptoms by severity

    Time: Baseline to end of study (Day14)

    Description: COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe). Resolution of a symptom is defined as when a symptom previously scored ≥ 1 on the scale is scored as 0

    Measure: Time to resolution of COVID-19 Symptoms

    Time: Baseline to end of study (Day14)

    Description: Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

    Measure: Time to resolution of fever

    Time: Baseline to end of study (Day14)

    Description: Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

    Measure: Percentage of participants with resolution of fever

    Time: Baseline to end of study (Day14)

    Measure: Percentage of participants hospitalized

    Time: Baseline to end of study (Day14)

    Measure: Number of participants with Adverse Events

    Time: Baseline to end of study (Day14)
    28 An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Healthcare Workers

    The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using combinations of approved and safe repurposed interventions, with complementary mechanisms of action.

    NCT04333732
    Conditions
    1. COVID 19
    Interventions
    1. Drug: MR or M-M-R II ® vaccine
    2. Drug: Placebo

    Primary Outcomes

    Description: To determine the incidence of the trial intervention(s) in preventing laboratory test-confirmed, symptomatic COVID19 (i.e. any of the following: cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea), in healthcare workers with repeated exposures to SARS-CoV-2 by day 60 after enrollment.

    Measure: Symptomatic COVID-19

    Time: 60 days

    Secondary Outcomes

    Description: Severity of COVID-19 will be graded on a simplified version of the ordinal World Health Organization COVID-19 severity scale (WHO COVID-19 severity scale).

    Measure: Severity of COVID-19 over the study period

    Time: 60 days

    Description: SARS-CoV-2 infection (by serology) over up to 5 months of follow-up

    Measure: Effectiveness of preventing/reducing SARS-CoV-2 infection

    Time: 5 months
    29 A Randomised, Double-blind, Placebo Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalised Subjects With Confirmed SARS-CoV-2

    This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.

    NCT04335032
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Drug: Eicosapentaenoic acid gastro-resistant capsules
    2. Drug: Placebo

    Primary Outcomes

    Description: Time to treatment failure during the 28-day treatment period. Treatment failure is defined as additional or alternative treatment required, or intubation and invasive ventilation, or transfer to intensive care unit, or death.

    Measure: Evaluation of EPA-FFA efficacy compared to placebo

    Time: 28 days

    Secondary Outcomes

    Description: To determine whether EPA-FFA gastro-resistant capsules decreases the time to and amount of clinical improvement as determined by the WHO 9-point ordinal scale during the study.

    Measure: Time to and amount of clinical improvement

    Time: 28 days

    Description: To determine whether EPA-FFA gastro-resistant capsules increases the number of subjects alive and discharged home without supplemental oxygen therapy.

    Measure: Change in recovery and survival rate

    Time: 28 days

    Description: To determine whether EPA-FFA gastro-resistant capsules decreases CRP and IL-6 during the study.

    Measure: Reduction of CRP and IL-6

    Time: 28 days

    Description: To determine whether EPA-FFA gastro-resistant capsules increases IFN-γ during the study

    Measure: Increase in IFN-γ

    Time: 28 days

    Description: To determine whether EPA-FFA gastro-resistant capsules decreases other proinflammatory chemokines and cytokines.

    Measure: Reduction in proinflammatory chemokines and cytokines.

    Time: 28 days

    Other Outcomes

    Description: To evaluate the safety of EPA-FFA gastro-resistant capsules in the treatment of COVID-19 (SARS-CoV-2) by assessing subjects clinical lab parameters and vital signs, and the number and proportion of subjects with AEs.

    Measure: Safety - Vitals, AEs and Clinical lab parameters

    Time: throughout the study, about 3 months
    30 CORON-ACT - a Multicenter, Double-blind, Randomized Controlled Phase II Trial on the Efficacy and Safety of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)

    The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the immune system to the virus, causing a cytokine storm with features of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and low platelets. There is increasing data that cytokine-targeted biological therapies can improve outcomes in CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been approved for the treatment of CRS and is used in patients with MAS. Based on these data, it is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS and ARDS. The overall purpose of this study is to evaluate whether treatment with TCZ reduces the severity and mortality in patients with COVID-19.

    NCT04335071
    Conditions
    1. SARS-CoV-2 Infection
    Interventions
    1. Drug: Tocilizumab (TCZ)
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Measure: Number of patients with ICU admission

    Time: 7 days after randomisation

    Measure: Number of patients with intubation

    Time: 14 days after randomisation

    Measure: Number of patients with death

    Time: 28 days after randomisation

    Secondary Outcomes

    Description: Assessed by the 8-point WHO scale

    Measure: Illness severity

    Time: At days 2, 7, 14, 28 after randomisation

    Description: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale

    Measure: Number of patients with clinical improvement

    Time: At days 2, 7, 14, 28 after randomisation

    Description: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale

    Measure: Time to clinical improvement (days)

    Time: Up to day 28 after randomisation

    Measure: Duration of hospitalization (days)

    Time: Up to day 28 after randomisation

    Measure: Time to ICU admission (days)

    Time: Up to day 28 after randomisation

    Measure: Duration of ICU stay

    Time: Up to day 28 after randomisation

    Measure: Time to intubation

    Time: Up to day 28 after randomisation

    Measure: Duration of mechanical ventilation (days)

    Time: Up to day 28 after randomisation

    Other Outcomes

    Measure: Number of deaths

    Time: Within 28 days after randomisation

    Measure: Number of patients with ICU admission

    Time: Within 28 days after randomisation

    Measure: Number of patients with intubation

    Time: Within 28 days after randomisation

    Description: Events of special interest are defined as secondary infections, acute kidney failure, hepatic, and cardiac failure

    Measure: Number of patients with events of special interest

    Time: Within 28 days after randomisation

    Measure: Number of patients with SAEs considered by the investigator to be at least probably related to the IMP

    Time: Within 28 days after randomisation
    31 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Patients With COVID-19-Moderate Type

    This study evaluates treatment with Favipiravir combined with supportive care for adult patients with COVID-19-moderate type.

    NCT04336904
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Favipiravir
    2. Other: Placebo

    Primary Outcomes

    Description: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72 hours.

    Measure: Time from randomization to clinical recovery

    Time: 90 days

    Secondary Outcomes

    Description: 1. Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization;

    Measure: Time from randomization to negativity in RT-PCR nucleic acid test

    Time: 28 days

    Description: Incidence of deterioration/aggravation of pneumonia (defined as SPO2≤93% or PaO2/FiO2 ≤300 mmHg or distressed RR≥30/min without oxygen inhalation and requiring oxygen therapy or more advanced breath support) within 28 days of randomization;

    Measure: Incidence of deterioration/aggravation of pneumonia

    Time: 28 days

    Description: Time from randomization to resolution of pyrexia (defined the same as for the primary efficacy variable; applicable to subjects with pyrexia at enrolment) within 28 days of randomization;

    Measure: Time from randomization to resolution of pyrexia

    Time: 28 days

    Description: Time from randomization to relief of cough (defined the same as for the primary efficacy variable; applicable to subjects with cough at enrolment) within 28 days of randomization; It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0: Mild: Requires non-prescription treatment; Moderate: Requires medication treatment; limits instrumental activities of daily living; Severe: Limits self-care activities of daily living

    Measure: Time from randomization to relief of cough

    Time: 28 days

    Description: Time from randomization to relief of dyspnoea (defined as subject-perceived improvement or resolution of dyspnoea; applicable to subjects with dyspnoea at enrolment) within 28 days of randomization;

    Measure: Time from randomization to relief of dyspnoea

    Time: 28 days

    Description: 6. Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization

    Measure: Rate of auxiliary oxygen therapy

    Time: 28 days

    Description: ICU admission rate within 28 days of randomization

    Measure: ICU admission rate

    Time: 28 days

    Description: All-cause mortality within 28 days of randomization

    Measure: Mortality

    Time: 28 days
    32 Efficacy and Safety of Nintedanib Ethanesulfonate Soft Capsule in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID-9(COVID 19) : a Single-center, Randomized, Placebo-controlled Study

    This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.

    NCT04338802
    Conditions
    1. COVID-19
    2. Nintedanib
    3. Safety
    4. Effect of Drugs
    Interventions
    1. Drug: Nintedanib 150 MG
    2. Other: Placebo
    MeSH:Pulmonary Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Changes in forced vital capacity (FVC) after treatment compared to baseline.

    Measure: Changes in forced vital capacity (FVC)

    Time: 8 weeks

    Secondary Outcomes

    Description: Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.

    Measure: Changes in carbon monoxide dispersion (DLco%)

    Time: 8 weeks

    Description: Changes in the six-minute walk test (6MWT) after treatment compared to baseline.

    Measure: Changes in the six-minute walk test (6MWT)

    Time: 8 weeks

    Description: Changes in High resolution CT score after treatment compared to baseline.The minimum and maximum values are 0 and 25 , and higher scores mean a worse outcome. As for the score, it is the expected value and will be determined according to the actual result

    Measure: Changes in High resolution CT score

    Time: 8 weeks
    33 Evaluation of the Efficacy and Safety of Camostat Mesilate + Hydroxychloroquine Combination Therapy in Hospitalized Patients With Moderate COVID-19 Infection

    Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.

    NCT04338906
    Conditions
    1. COVID
    Interventions
    1. Drug: Camostat Mesilate
    2. Drug: Placebo
    3. Drug: Hydroxychloroquine

    Primary Outcomes

    Measure: Not hospitalized

    Time: day 14 from baseline

    Secondary Outcomes

    Measure: Time to improvement of 2 categories from admission on a 7-point ordinal scale

    Time: day 14

    Measure: Proportion of participants in each group with normalization of fever

    Time: day 7 and day 14

    Measure: Proportion of participants in each group with oxygen saturation > 94% on room air for >24h

    Time: day 7 and day 14

    Measure: Time to fever normalization (if febrile at baseline)

    Time: within 14 days

    Measure: Time to first negative SARS-CoV-2 PCR in NP swap (if pos. at baseline)

    Time: within 14 days

    Measure: Time to first negative SARS-CoV-2 PCR in lower respiratory tract specimens (sputum, bronchoalveolar lavage, tracheal aspirate) (if positive at baseline)

    Time: within 14 days

    Measure: Duration of oxygen therapy

    Time: within 28 days

    Measure: Proportion of participants in each group with need for mechanical ventilation

    Time: within 28 days

    Measure: Duration of hospitalization

    Time: within 28 days

    Measure: All cause mortality

    Time: day 28
    34 Clinical Research of Human Mesenchymal Stem Cells in the Treatment of COVID-19 Pneumonia

    The COVID-19 pneumonia has grown to be a global public health emergency since patients were first detected in Wuhan, China, in December 2019, which spread quickly to worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 pneumonia. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 pneumonia patients, especially the critically ill cases. The significant clinical outcome and well tolerance was observed by the adoptive transfer of allogenic MSCs. We proposed that the adoptive transfer therapy of MSCs might be an ideal choice to be used. We expect to provide new options for the treatment of critically ill COVID-19 pneumonia patients and contribute to improving the quality of life of critically ill patients.

    NCT04339660
    Conditions
    1. COVID-19
    Interventions
    1. Biological: UC-MSCs
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Improvement and recovery time of inflammatory and immune factors

    Measure: The immune function (TNF-α 、IL-1β、IL-6、TGF-β、IL-8、PCT、CRP)

    Time: Observe the immune function of the participants within 4 weeks

    Description: Evaluation of Pneumonia change

    Measure: Blood oxygen saturation

    Time: Monitor blood oxygen saturation of the participants within 4 weeks

    Secondary Outcomes

    Description: Marker for efficacy of treatment

    Measure: Rate of mortality within 28-days

    Time: At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

    Description: Evaluation of Pneumonia change

    Measure: Size of lesion area by chest imaging

    Time: At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

    Description: Marker of Immunology and inflammation

    Measure: CD4+ and CD8+ T cells count

    Time: At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

    Description: Degree of infection

    Measure: Peripheral blood count recovery time

    Time: At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

    Description: Indirect response to lung function

    Measure: Duration of respiratory symptoms (fever, dry cough, difficulty breathing, etc.)

    Time: At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

    Description: Clearance time of COVID-19 in participant

    Measure: COVID-19 nucleic acid negative time

    Time: At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4
    35 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial

    Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

    NCT04339816
    Conditions
    1. COVID-19
    2. Respiratory Failure
    Interventions
    1. Drug: Azithromycin
    2. Drug: Hydroxychloroquine
    3. Drug: Placebo
    MeSH:Respiratory Insufficiency

    Primary Outcomes

    Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.

    Measure: Proportion of alive patients free off mechanical ventilation

    Time: 14 days after enrolment

    Secondary Outcomes

    Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline.

    Measure: Proportion of patients who avoided the need of mechanical ventilation

    Time: 14 days

    Description: Length of stay in intensive care unit

    Measure: ICU LOS

    Time: 28 days

    Description: Proportion of patients who died by day 28

    Measure: Mortality28

    Time: 28 days

    Description: Proportion of patients who died by day 90

    Measure: Mortality90

    Time: 90 days
    36 Hydroxychloroquine for the Treatment of Mild COVID-19 Disease

    The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 [1] replication and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine. The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.

    NCT04340544
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo

    Primary Outcomes

    Measure: Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment

    Time: 28±2 days

    Secondary Outcomes

    Measure: Difference between hydroxychloroquine- and placebotreated patients on an ordinal outcome scale until Day 28 (death, admission to intensive care, hospitalization, continuing disease, recovered)

    Time: 28±2 days

    Measure: All-cause mortality within 28 days

    Time: 28±2 days

    Other Outcomes

    Measure: Proportion of patients with negative COVID-19 PCR test at day 14 in per protocol population as per throat swab

    Time: 28±2 days

    Measure: Change in COVID-19 virus load from baseline to day 14

    Time: 28±2 days
    37 A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

    This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.

    NCT04341116
    Conditions
    1. Coronavirus Disease 2019 COVID-19
    Interventions
    1. Drug: TJ003234
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Measure: Proportion (%) of subjects recovered

    Time: Day 1 through Day 14

    Secondary Outcomes

    Measure: Proportion (%) of subjects recovered on Day 30

    Time: Day 1 through Day 30

    Measure: All-cause mortality rate by Day 30

    Time: Day 1 through Day 30

    Measure: Time to recovery among subjects alive by Day 30

    Time: Day 1 through Day 30

    Measure: Length of hospitalization

    Time: Day 1 through Day 30

    Measure: Incidence of treatment-emergent Adverse events by Day 30

    Time: Day 1 through Day 30
    38 A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

    This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.

    NCT04341389
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
    2. Other: Placebo
    MeSH:Adenoviridae Infections

    Primary Outcomes

    Measure: Occurrence of adverse reactions

    Time: 0-14 days post vaccination

    Measure: Anti SARS-CoV-2 S IgG antibody response(ELISA)

    Time: 28 days post vaccination

    Measure: Neutralizing antibody response to SARS-CoV-2

    Time: 28 days post vaccination

    Secondary Outcomes

    Measure: Occurrence of adverse events

    Time: 0-28 days post vaccination

    Measure: Occurrence of serious adverse reaction

    Time: 0-6 months post vaccination

    Measure: Anti SARS-CoV-2 S IgG antibody response(ELISA)

    Time: 0, 14 days and 6 months post vaccination

    Measure: Neutralizing antibody response to SARS-CoV-2

    Time: 0 and 6 months post vaccination

    Measure: Neutralizing antibody response to Ad5-vector

    Time: 0, 28 days and 6 months post vaccination

    Measure: IFN-γ ELISpot responses to SARS-CoV-2 spike protein

    Time: 0 and 28 days post vaccination
    39 Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)

    The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 30 subjects will be randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.

    NCT04341675
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Sirolimus
    2. Drug: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group. * CPAP use for known obstructive sleep apnea will not be considered as disease progression.

    Measure: Proportion of patients who are alive and free from advanced respiratory support measures at day 28.

    Time: 28 days

    Secondary Outcomes

    Description: Progression to a higher level of care, e.g. ICU

    Measure: Proportion of patients who require escalation in care

    Time: 14 days

    Description: Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)

    Measure: Change over time in study-specific biomarkers (LDH, Ferritin, D-dimer, lymphocyte count)

    Time: 14 days

    Description: Survival to hospital discharge

    Measure: Proportion of patients surviving to hospital discharge

    Time: days

    Description: Incidence and type of adverse events

    Measure: Drug safety profile

    Time: 14 days

    Description: Number of days spent on advanced respiratory support measures

    Measure: Duration of advanced respiratory support

    Time: days

    Description: Length of hospitalization (in patients who survive to discharge)

    Measure: Duration of hospital stay

    Time: days

    Description: Number of days between study initiation and death (in the subset of patients who die during the hospitalization)

    Measure: Time from treatment initiation to death

    Time: days

    Description: Time (in days) to resolution of fever

    Measure: Time to resolution of fever

    Time: 14 days

    Description: Patients needing off-label treatments such as Anti-IL-6 inhibitors at the discretion of primary clinicians

    Measure: Proportion of patients who require initiation of off-label therapies

    Time: 14 days
    40 Randomized Controlled Trial of Hydroxychloroquine Versus Placebo for the Treatment of Adult Patients With Acute Coronavirus Disease 2019 - COVID-19

    The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine. We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.

    NCT04342221
    Conditions
    1. COVID-19, Hydroxychloroquine Sulfate
    Interventions
    1. Drug: Hydroxychloroquine Sulfate
    2. Drug: Placebo

    Primary Outcomes

    Description: Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number ≤100, measured by real time reverse-transcription polymerase chain reaction RT-PCR in throat swabs.

    Measure: Effect of HCQ on in vivo viral clearance

    Time: 6 months

    Other Outcomes

    Measure: In-hospital mortality

    Time: 60 days

    Measure: All-cause mortality

    Time: 60 days

    Measure: Proportion requiring non-invasive or invasive ventilation

    Time: 6 months

    Measure: Proportion admitted to ICU

    Time: 6 months

    Measure: Duration of hospitalization

    Time: 6 months

    Measure: Reduction in viral RNA load in upper respiratory tract specimen as assessed by area under viral load curve

    Time: 6 months

    Measure: Reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels or to below detection level

    Time: 6 months
    41 A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

    The 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.

    NCT04342663
    Conditions
    1. COVID 19
    2. Coronavirus
    Interventions
    1. Drug: Fluvoxamine
    2. Drug: Placebo
    MeSH:Infecti Infection Coronavirus Infections

    Primary Outcomes

    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)

    Secondary Outcomes

    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)
    42 A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19

    A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19. The study may last up to 9 weeks and include daily visits up to day 28, and follow-up visits by phone.

    NCT04342897
    Conditions
    1. COVID-19
    2. Pneumonia
    Interventions
    1. Drug: LY3127804
    2. Drug: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Number of days on which a participant breathes without assistance

    Measure: Number of Ventilator Free Days

    Time: Day 1 to Day 28

    Secondary Outcomes

    Description: The scale is an assessment of clinical status. 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: Number of Participants Reporting Each Severity Rating on the National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Assessment

    Time: Day 1 to Day 28

    Description: Survival without Respiratory Failure

    Measure: Percentage of Participants who are Alive and Respiratory Failure Free

    Time: Day 1 to Day 28

    Description: Mortality

    Measure: Mortality

    Time: Day 1 to Day 28

    Description: Days of Hospitalization

    Measure: Length of Hospitalization

    Time: Day 1 to Day 28

    Description: Number of Participants with any Serious Adverse Event (SAE)

    Measure: Number of Participants with any Serious Adverse Event (SAE)

    Time: Day 1 to Day 28

    Description: Number of Participants with any Treatment Emergent Adverse Event (TEAE)

    Measure: Number of Participants with any Treatment Emergent Adverse Event (TEAE)

    Time: Day 1 to Day 28
    43 A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

    Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

    NCT04343248
    Conditions
    1. COVID-19
    2. Viral Respiratory Illnesses
    Interventions
    1. Drug: Nitazoxanide
    2. Drug: Placebo
    3. Dietary Supplement: Vitamin Super B-Complex

    Primary Outcomes

    Description: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period.

    Measure: Symptomatic laboratory-confirmed COVID-19

    Time: up to 6 weeks

    Description: The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period.

    Measure: Symptomatic laboratory-confirmed VRI

    Time: up to 6 weeks
    44 Pyridostigmine in Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 Infection

    We 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.

    NCT04343963
    Conditions
    1. COVID-19
    2. SARS-CoV-2
    Interventions
    1. Drug: Pyridostigmine Bromide
    2. Drug: Placebo
    MeSH:Infection

    Primary Outcomes

    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 days

    Description: Kinetics of circulating IL-6

    Measure: IL-6

    Time: 14 days in-hospital, hospital discharge, or death
    45 A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

    In 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.

    NCT04343989
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Clazakizumab 25 mg
    2. Drug: Clazakizumab 12.5 mg
    3. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    Measure: Cumulative incidence of serious adverse events associated with clazakizumab or placebo

    Time: 60 days

    Secondary Outcomes

    Measure: Cumulative incidence of intubation

    Time: 14 days

    Measure: Time to extubation

    Time: 14 days

    Measure: Length of ICU stay

    Time: 14 days

    Measure: Number of patients who present a decrease in C-reactive protein

    Time: 14 days

    Description: Number of patients who remain alive at time point.

    Measure: Patient Survival

    Time: 28 days

    Description: Number of patients who remain alive at end of study.

    Measure: Patient Survival

    Time: 60 days
    46 SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)

    This study will the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19.

    NCT04344184
    Conditions
    1. COVID-19
    2. Lung Injury, Acute
    3. Kidney Injury
    Interventions
    1. Drug: L-ascorbic acid
    2. Other: Placebo
    MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

    Primary Outcomes

    Description: COVID disease status will be measured by the 9-point (from 0 to 8) World Health Organization (WHO) ordinal scale for disease improvement at 28 days.

    Measure: Change in COVID disease status

    Time: Baseline to 28, 60 and 90 days

    Secondary Outcomes

    Description: Change in serum oxalate levels

    Measure: Renal safety biomarkers - serum oxalate

    Time: On days 5,7 and 14

    Description: Microscopic analysis of urine for presence of oxalate stones

    Measure: Renal safety biomarkers - urine oxalate stones

    Time: On days 5,7 and 14

    Description: 24-hour urine oxalate levels

    Measure: Renal safety biomarkers - 24-hour urine oxalate levels

    Time: On days 5,7 and 14

    Description: Renal-failure free days, with AKI defined by the KDIGO criteria

    Measure: Acute Kidney Injury-free days

    Time: On day 28, 90

    Description: Mortality by all causes

    Measure: Number of deaths

    Time: On day 28, 60 and 90 days

    Description: Difference in plasma ferritin levels in ng/mL, compared to baseline levels

    Measure: Change in plasma ferritin levels

    Time: Days 1-7 compared with baseline

    Description: Difference in D-dimer levels in mcg/mL, compared to baseline levels

    Measure: Change in plasma D-dimer levels

    Time: Days 1-7 compared with baseline

    Description: Difference in lactate dehydrogenase (LDH) levels in units/L, compared to baseline levels

    Measure: Change in serum lactate dehydrogenase (LDH) levels

    Time: Days 1-7 compared with baseline

    Description: Difference in plasma IL-6 levels in pg/mL, compared to baseline levels

    Measure: Change in plasma IL-6 levels

    Time: Days 1-7 compared with baseline

    Description: Respiratory failure defined as resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation

    Measure: Proportion of patients alive and free of respiratory failure

    Time: At 28-days

    Description: Percentage of patients alive and not requiring invasive mechanical ventilation

    Measure: Proportion of patients alive and free of invasive mechanical ventilation

    Time: At 28-days
    47 A Randomized Double Blind, Placebo-Controlled Study of Auxora for the Treatment of Severe COVID-19 Pneumonia (CARDEA)

    Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 will consist of a randomized, double blind, placebo-controlled (RCT) study that will evaluate efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19 pneumonia. Four hundred patients will be randomized 1:1 to receive Auxora or matching placebo. Patients with an estimated PaO2/FiO2 of 75-200 will be stratified to ensure balanced randomization between the Auxora and placebo arms. The number of patients with an imputed PaO2/FiO2 >200 randomized into the study will be capped at 80. Subgroup analyses will be performed to explore how time to recovery is influenced by baseline variables and to evaluate the treatment effect at different levels of each of these variables. The dose of Auxora will be 2.0 mg/kg (1.25 mL/kg) administered at 0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the SFISD. The dose of placebo will be 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24 hours and 1 mL/kg at 48 hours from the SFISD. Remdesivir, corticosteroids and convalescent plasma will be allowed. The infusion of Auxora will start within 12 hours from the time the patient or LAR provides informed consent.

    NCT04345614
    Conditions
    1. Pneumonia
    Interventions
    1. Drug: Auxora
    2. Drug: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Defined as the number of days hospitalized but not requiring supplemental oxygen or ongoing medical care, or; discharged and requiring supplemental oxygen, or; discharged, not requiring supplemental oxygen.

    Measure: Number of days from the Start of the First Infusion of Study Drug (SFISD) to recovery

    Time: From start of first infusion of study drug to day 30

    Secondary Outcomes

    Measure: Proportion of patients requiring invasive mechanical ventilation or dying

    Time: from start of start of first infusion of study drug and up to day 30

    Measure: Proportion of patients requiring invasive mechanical ventilation

    Time: from start of start of first infusion of study drug and up to day 30

    Description: The ordinal scale is an assessment of the clinical status in a given day. The scale is as follows: 1. Death 2. Hospitalized, requiring invasive mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow supplemental oxygen 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care 6. Hospitalized, not requiring supplemental oxygen or ongoing medical care 7. discharged, requiring supplemental oxygen 8. Discharged, not requiring supplemental oxygen

    Measure: Differences in outcomes as measured by an 8-point ordinal scale

    Time: from randomization through Days 12 and 30

    Measure: Proportion of patients who have died at day 30 (mortality)

    Time: Day 30

    Measure: Number of days in the hospital

    Time: from admission into the hospital until discharge from the hospital

    Measure: Number of days in the Intensive Care Unit (ICU)

    Time: from admission into ICU until discharge from ICU

    Measure: Incidence of treatment emergent adverse events (TEAE) and serious adverse events (SAE)

    Time: from randomization and through day 30

    Description: Concentration measured using a validated assay

    Measure: CM4620-IE serum concentration

    Time: enrollment through 72 hours
    48 Safety and Efficacy of Intravenous Infusion of Bone Marrow-Derived Mesenchymal Stem Cells in Severe Patients With Coronavirus Disease 2019 (COVID-19): A Phase 1/2 Randomized Controlled Trial

    Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm.Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.

    NCT04346368
    Conditions
    1. Coronavirus Disease 2019 (COVID-19)
    Interventions
    1. Biological: BM-MSCs
    2. Biological: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Evaluation of pneumonia improvement

    Measure: Changes of oxygenation index (PaO2/FiO2)

    Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

    Description: Proportion of participants with treatment-related adverse events

    Measure: Side effects in the BM-MSCs treatment group

    Time: Baseline through 6 months

    Secondary Outcomes

    Description: Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.

    Measure: Clinical outcome

    Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

    Description: days of the patients in hospital

    Measure: Hospital stay

    Time: Baseline through 6 months

    Description: Evaluation of pneumonia improvement

    Measure: CT Scan

    Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

    Description: (deep sputum / pharyngeal swab / nasal swab / anal swab / tear fluid / stomach fluid / feces / blood or alveolar lavage fluid)

    Measure: Changes in viral load

    Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

    Description: Immunological status

    Measure: Changes of CD4+, CD8+ cells count and concentration of cytokines

    Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.

    Description: Marker for efficacy

    Measure: Rate of mortality within 28-days

    Time: From baseline to day 28

    Description: Markers of Infection

    Measure: Changes of C-reactive protein

    Time: At baseline, 6 hour, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6.
    49 BHV3500-203: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of Zavegepant* (BHV-3500) Intranasal (IN) for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen

    The purpose of this study is to determine if a CGRP receptor antagonist may potentially blunt the severe inflammatory response at the alveolar level, delaying or reversing the path towards oxygen desaturation, ARDS, requirement for supplemental oxygenation, artificial ventilation or death in patients with COVID-19 on supplemental oxygen. * BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.

    NCT04346615
    Conditions
    1. COVID-19 Infection
    Interventions
    1. Drug: Zavegepant (BHV-3500)
    2. Drug: Placebo

    Primary Outcomes

    Description: a. Efficacy will be measured by the difference between groups in the meah 6-point severity rating at Day 15. The severity ratings are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

    Measure: To compare the efficacy of zavegepant (BHV-3500) to placebo in subjects hospitalized with COVID-19 infection requiring supplemental oxygen, using a six-point rating scale at Day 15. .

    Time: Baseline to Day 15

    Secondary Outcomes

    Measure: Proportion of subjects who have a 6-point severity rating of 5 or 6, are alive, and do not use supplemental oxygen as a procedure at Day 29.

    Time: Baseline to Day 29

    Measure: Proportion of subjects who have a 6-point severity rating of 2 or 3, or use any ventilation or high-flow nasal cannula as procedures, on any day through Day 29.

    Time: Baseline to Day 29

    Measure: Proportion of subjects admitted into an ICU on any day through Day 29 from AE eCRFs.

    Time: Baseline to Day 29

    Measure: Proportion of subjects who have a 6-point severity rating of 3, 4, 5, or 6, are alive, and do not use invasive mechanical ventilation as a procedure at Day 15. The analogous definition is applied to Day 29.

    Time: Baseline at Day 15 and at Day 29

    Measure: Proportion of subjects who have a 6-point severity rating of 4, 5 or 6, or use a low- or high-flow nasal, are alive, and do not use any ventilation at Day 15. The analogous definition is applied to Day 29.

    Time: Baseline at Day 15 and at Day 29

    Measure: Difference between treatment groups in the mean 6-point severity rating at Day 29

    Time: Baseline to Day 29

    Measure: Number of days from baseline to the first day through Day 29 with any 6-point severity rating greater than baseline.

    Time: Baseline to Day 29

    Measure: Number of days from baseline to the first of any 2 consecutive days through Day 29 with all SpO2/FiO2 ratios > 400 on both days.

    Time: Baseline to Day 29

    Measure: Number of days from baseline to the first day through Day 29 with ≥ 1-point decrease in any NEWS2 score from baseline.

    Time: Baseline to Day 29

    Measure: Number of days from baseline to the first day through Day 29 with all NEWS2 scores < 2 on that day.

    Time: Baseline to Day 29

    Measure: Mean change from baseline in NEWS2 score at Days 15 and 29 for subjects who are alive at these time points

    Time: Baseline at Day 15 and at Day 29.

    Measure: Proportion of subjects who have a 6-point severity rating of 5 or 6, are alive, and do not use supplemental oxygen as a procedure at Day 15.

    Time: Baseline to Day 15

    Measure: Proportion of subjects who are discharged from the hospital, have a 6-point severity rating of 6 on any day after discharge, and use supplemental oxygen on any day after discharge.

    Time: Baseline to Day 60

    Measure: Mean number of days with respiratory rate > 24 breaths/minute through Day 29 for subjects who are alive at Day 29 and do not use invasive mechanical ventilation.

    Time: Baseline to Day 29

    Measure: Mean number of days with supplemental oxygen use through Day 29 for subjects who are alive at Day 29. A day in which any 6-point severity rating is 2, 3, or 4, or supplemental oxygen is used as a procedure counts.

    Time: Baseline to Day 29

    Measure: Number of days from baseline to the first day through Day 29 on which any SpO2 ≥ 90%, any 6-point severity rating is 5 or 6, and no supplemental oxygen is used as a procedure.

    Time: Baseline to Day 29

    Measure: Mean number of ventilator-free days through Day 29 for subjects who are alive at Day 29.

    Time: Baseline to Day 29

    Measure: Mean SOFA total scores at ICU admission and Day 29 (if still in ICU), from SOFA and AE eCRFs.

    Time: Baseline to Day 29

    Measure: Mean number of days of hospitalization through Day 29 for subjects who are alive on Day 29. All days on study on or before hospitalization discharge are days of hospitalization, from 6-point severity rating scale eCRFs

    Time: Baseline to Day 29

    Measure: Number of days from baseline to the first of any 2 consecutive days through Day 29 in which all temperatures show lack of fever on both days and no antipyretics are used on either day.

    Time: Baseline to Day 29

    Measure: Number of subjects with deaths, SAEs, severe AEs, and Grade 3 or 4 laboratory test abnormalities at any time on study.

    Time: Screening to Day 60

    Measure: Number and percentage of subjects with severe or life-threatening bacterial, invasive fungal, or opportunistic infections at any time through Day 29 from AE/SAE eCRFs.

    Time: Baseline to Day 29

    Measure: Number and percentage of subjects with intranasal administration reactions at any time through Day 29 from AE/SAE eCRFs.

    Time: Baseline to Day 29

    Measure: Proportion of subjects with ≥ 50% reduction in eGFR from baseline at any time on study from laboratory test eCRFs.

    Time: Baseline to Day 60
    50 A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19

    The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.

    NCT04346628
    Conditions
    1. Sars-CoV2
    2. COVID-19
    Interventions
    1. Drug: Favipiravir
    2. Drug: Placebo
    3. Other: Standard of care treatment

    Primary Outcomes

    Description: Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.

    Measure: Time until cessation of oral shedding of SARS-CoV-2 virus

    Time: Up to 28 days

    Secondary Outcomes

    Description: Viral load (nucleic acid) will be assessed by RT-PCR over time.

    Measure: Sars-CoV-2 viral load

    Time: Up to 28 days

    Description: Clinical worsening will be determined by clinician assessment.

    Measure: Count of participants with clinical worsening of COVID-19 disease

    Time: Up to 28 days

    Measure: Count of participants with development of SARS-CoV-2 antibodies

    Time: Up to 28 days

    Measure: Time until cessation of symptoms

    Time: Up to 28 days

    Description: This outcome will be assessed in patient who are asymptomatic of COVID-19 infection at the time of enrollment

    Measure: Count of participant with absence of development of any symptoms

    Time: Up to 28 days

    Description: Cmax is a pharmacokinetic parameter that measures the maximum concentration of drug in plasma.

    Measure: Cmax of favipiravir

    Time: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)

    Description: Cmin is a pharmacokinetic parameter that measures the minimum concentration of drug in plasma.

    Measure: Cmin of favipiravir

    Time: Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration)
    51 Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate

    To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.

    NCT04346667
    Conditions
    1. SARS-CoV-2
    2. Coronavirus Infection
    3. Asymptomatic Condition
    4. COVID-19
    Interventions
    1. Drug: Hydroxychloroquine Sulfate Regular dose
    2. Drug: Hydroxychloroquine Sulfate Loading Dose
    3. Drug: Chloroquine
    4. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Asymptomatic Diseases

    Primary Outcomes

    Description: Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

    Measure: RT-PCR negative status

    Time: 6-7 days

    Secondary Outcomes

    Description: Time to progression to next stage of SARS-CoV-2 disease severity index

    Measure: Progression of symptoms

    Time: 7 days

    Description: Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).

    Measure: Development of Symptoms

    Time: 7 days

    Description: Drug related adverse events as determined by data safety and monitoring board (DSMB)

    Measure: Adverse events

    Time: 7 days
    52 A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection

    The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.

    NCT04347174
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Suspension of heat killed (autoclaved) Mycobacterium w
    2. Drug: Placebo
    MeSH:Mycobacterium Infections Critical Illness

    Primary Outcomes

    Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale

    Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death)

    Time: Change in Ordinal scale from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.

    Description: 28 day mortality

    Measure: 28 day mortality

    Time: Till day 28, post-randomization or death or discharge, whichever is earlier.

    Secondary Outcomes

    Description: Any AE / SAE or event of clinical significance observed during the study.

    Measure: Incidence of AE / SAE or event of clinical significance

    Time: Till day 28

    Description: Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.

    Measure: SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample

    Time: At days 3, 7, 14, 21, and 28

    Description: ICU length of stay

    Measure: ICU length of stay

    Time: Till day 28

    Description: Duration of mechanical ventilation

    Measure: Duration of mechanical ventilation

    Time: Till day 28

    Description: Duration of hospitalization

    Measure: Duration of hospitalization

    Time: Till day 28

    Description: Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.

    Measure: Clinical improvement

    Time: From baseline to day 14 & Day 28

    Description: Time (in days) from treatment initiation to death.

    Measure: Time (in days) from treatment initiation to death

    Time: Till day 28

    Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction

    Measure: Sequential Organ Failure Assessment (SOFA) scores

    Time: Change in SOFA score from baseline to day 3, day 7, day 14, day 21 and day 28 and day of transfer from ICU, if discharged earlier than 28 days post-randomization.
    53 A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19

    The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate COVID-19.

    NCT04347915
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Clevudine
    2. Drug: Placebo

    Primary Outcomes

    Description: The primary efficacy endpoint for this clinical trial is the rate of patients with negative SARS-Coronavirus-2 (SARS-CoV-2) in a two-day continuous Real-Time-RT-PCR test from baseline to before the 15th day.

    Measure: The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)

    Time: within 15days

    Secondary Outcomes

    Measure: The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests

    Time: Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline

    Measure: The rate of subjects indicated by the improvement of lung invasive

    Time: within Day 29 (or EOT)

    Measure: The change of viral load

    Time: Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline
    54 Proof of Concept, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Safety and Efficacy of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Moderate Condition.

    This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

    NCT04348409
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Nitazoxanide Tablets
    2. Drug: Placebo

    Primary Outcomes

    Description: PCR will be done to evaluate the change in viral load

    Measure: Viral load

    Time: day 1, 4, 7, 14 and 21

    Secondary Outcomes

    Description: Time to wean off oxygen supplementation

    Measure: Evolution of acute respiratory syndrome

    Time: 21 days

    Description: WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; 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 non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)

    Measure: Change in Clinical Condition

    Time: 21 days

    Description: Time to be discharged from hospital

    Measure: Hospital discharge

    Time: 21 days

    Description: Evaluation of change in acute respiratory syndrome

    Measure: Rate of mortality within 21-days

    Time: 21 days

    Description: Evaluation of change in acute respiratory syndrome

    Measure: Need of mechanical ventilation

    Time: 21 days
    55 Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)

    This 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.

    NCT04348513
    Conditions
    1. Pulmonary Infection
    2. Covid-19
    Interventions
    1. Drug: T3 solution for injection
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases

    Primary Outcomes

    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 days

    Secondary Outcomes

    Description: Hemodynamic status will be assessed by continuous blood pressure measurements (systolic BP in mmHg)

    Measure: Assessment of hemodynamic status

    Time: 30 days

    Description: Hemodynamic status will be assessed by continuous blood pressure measurements (diastolic BP in mmHg)

    Measure: Assessment of hemodynamic status

    Time: 30 days

    Description: Hemodynamic status will be assessed by continuous blood pressure measurements (mean BP in mmHg)

    Measure: Assessment of hemodynamic status

    Time: 30 days

    Description: Hemodynamic status will be assessed by the number of participants with use of inotropic and vasoactive drugs

    Measure: Assessment of hemodynamic status

    Time: 30 days

    Description: 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 days

    Description: 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 days

    Description: Pulmonary function will be assessed by arterial measurement of lactate levels (in mmol/L)

    Measure: Assessment of pulmonary function

    Time: 30 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: Urine volume during 24 hours (in ml) will be recorded.

    Measure: Assessment of renal function

    Time: 30 days

    Description: Changes in urea (in mg/dL) will be recorded.

    Measure: Assessment of renal function

    Time: 30 days

    Description: Changes in uric acid (in mg/dL) will be recorded.

    Measure: Assessment of renal function

    Time: 30 days

    Description: Changes in creatinine (in mg/dL) will be recorded.

    Measure: Assessment of renal function

    Time: 30 days

    Description: Echocardiographic assessment of cardiac left ventricular ejection fraction (LVEF, %)

    Measure: Assessment of cardiac function

    Time: 30 days

    Description: Measurements of cardiac troponin I (in μg/L) will be used to assess myocardial injury

    Measure: Assessment of cardiac injury

    Time: 30 days

    Description: 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 days

    Description: 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 days

    Description: 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 days

    Description: COVID-19 infection will be assessed by temperature monitoring (in degrees Celsius)

    Measure: Assessment of the course of COVID-19 infection

    Time: 30 days

    Description: 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 days

    Description: 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 days

    Description: 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 days
    56 A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

    The 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.

    NCT04349098
    Conditions
    1. Coronavirus Infection
    Interventions
    1. Drug: Selinexor
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale

    Time: Baseline to Day 14

    Secondary Outcomes

    Measure: Time to Clinical Improvement (TTCI)

    Time: Up to Day 28

    Measure: Overall Death Rate

    Time: Day 14, Day 28

    Measure: Rate of Mechanical Ventilation

    Time: Up to Day 28

    Measure: Time to Mechanical Ventilation

    Time: Up to Day 28

    Measure: Overall Survival

    Time: Up to Day 28

    Measure: Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale

    Time: Baseline, Day 28

    Measure: Time to Intensive Care Unit (ICU) Admission

    Time: Up to Day 28

    Measure: Rate of Intensive Care Unit (ICU) Admission

    Time: Up to Day 28

    Measure: Length of Stay in Hospital

    Time: Up to Day 28

    Measure: Percentage of Participants Discharged from Hospital

    Time: Up to Day 28

    Measure: Length of Stay in Intensive Care Unit (ICU)

    Time: Up to Day 28

    Measure: Duration of Oxygen Supplementation

    Time: Up to Day 28

    Measure: Duration of Mechanical Ventilation

    Time: Up to Day 28

    Measure: Time to Clinical Improvement in Participants ≤ 70 Years Old

    Time: Up to Day 28

    Measure: Time to Clinical Improvement in Participants > 70 Years Old

    Time: Up to Day 28

    Measure: Time to Clinical Improvement in Participants with Pre-existing Diseases

    Time: Up to Day 28

    Measure: Change in Oxygenation Index

    Time: Up to Day 28

    Measure: Time to Improvement of One Point Using WHO Ordinal Scale Improvement

    Time: Up to Day 28

    Measure: Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point

    Time: Up to Day 28

    Measure: Change from Baseline in C-reactive protein (CRP) Levels

    Time: Up to Day 28

    Measure: Change from Baseline in Ferritin Levels

    Time: Up to Day 28

    Measure: Change from Baseline in Lactate Dehydrogenase (LDH) Levels

    Time: Up to Day 28

    Measure: Changes from Baseline in Blood Plasma Cytokines Levels

    Time: Up to Day 28

    Measure: Number of Participants with Adverse Events (AE)

    Time: From start of study drug administration up to Day 28
    57 Value of Early Treatment With Polyvalent Immunoglobulin in the Management of Acute Respiratory Distress Syndrome Associated With SARS-CoV-2 Infections

    As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with acute renal failure. No specific pharmacological treatment is available yet. The lung lesions are related to both the viral infection and to an intense inflammatory reaction. Because of it's action, as an immunomodulatory agent that can attenuate the inflammatory reaction and also strengthen the antiviral response, it is proposed to evaluate the effectiveness and safety of intravenous immunoglobulin administration (IGIV) in patients developing ARDS post-SARS-CoV2. IGIV modulates immunity, and this effect results in a decrease of pro-inflammatory activity, key factor in the ARDS related to the COVID-19. It should be noted that IGIV is part of the treatments in various diseases such as autoimmune and inflammatory diffuse interstitial lung diseases. In addition, they have been beneficial in the post-influenza ARDS but also have been in 3 cases of post-SARS-CoV2 ARDS. IGIV is a treatment option because it is well tolerated, especially concerning the kidney. These elements encourage a placebo-controlled trial testing the benefit of IGIV in ARDS post-SARS-CoV2.

    NCT04350580
    Conditions
    1. Acute Respiratory Distress Syndrome
    2. COVID-19
    Interventions
    1. Drug: Human immunoglobulin
    2. Drug: Placebo
    MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

    Primary Outcomes

    Description: Sum of the days the patient did not receive VM, but if death occurs before D28, the score is zero

    Measure: Ventilator-free days

    Time: 28 days

    Secondary Outcomes

    Description: Vital status at 28 and 90 days

    Measure: Mortality

    Time: 28 and 90 days

    Description: Used to determine the extent of a person's organ function or rate of failure, from 0 to 24, with severity increasing the higher the score

    Measure: Sequential Organ Failure Assessment Score

    Time: Days 1, 3, 7, 14, 21 and 28

    Description: Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage)

    Measure: P/F ratio

    Time: Days 1, 3, 7, 14, 21 and 28

    Description: Measure of lung compliance

    Measure: Lung compliance

    Time: Days 1, 3, 7, 14, 21 and 28

    Description: Severity scoring of lung oedema on the chest radiograph

    Measure: Radiological score

    Time: Days 1, 3, 7, 14, 21 and 28

    Description: Concentration in mg/L

    Measure: Biological efficacy endpoints - C-reactive protein

    Time: Days 1, 3, 7, 14, 21 and 28

    Description: Concentration in microgram/L

    Measure: Biological efficacy endpoints - Procalcitonin

    Time: Days 1, 3, 7, 14, 21 and 28

    Description: Number of CD4 HLA-DR+ and CD38+, CD8 lymphocytes

    Measure: Immunological profile

    Time: Up to 28 days

    Description: Use of corticosteroids, antiretroviral, chloroquine

    Measure: Number of patients using other treatments for COVID-19 related ARDS

    Time: Up to 28 days

    Description: Diagnosis of deep vein thrombosis or pulmonary embolism through imaging exam (eg ultrasound and CT scan)

    Measure: Occurrence of deep vein thrombosis or pulmonary embolism

    Time: 28 days

    Description: Total time of mechanical ventilation, weaning and use of neuromuscular blockade

    Measure: Total duration of mechanical ventilation, ventilatory weaning and curarisation

    Time: 28 days

    Description: Divided in 3 stages, with higher severity of kidney injury in higher stages

    Measure: Kidney Disease: Improving Global Outcomes (KDIGO) score and need for dialysis

    Time: 28 days

    Description: Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)

    Measure: Occurrence of adverse event related to immunoglobulins

    Time: 28 days

    Description: Medical research council sum score on awakening

    Measure: Occurrence of critical illness neuromyopathy

    Time: Up to 28 days

    Description: Radiological and clinical context associated with a bacteriological sampling in culture of tracheal secretions, bronchiolar-alveolar lavage or a protected distal sampling

    Measure: Occurrence of ventilator-acquired pneumonia

    Time: Up to 28 days
    58 An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients With COVID-19

    This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US and other countries with high prevalence of COVID-19. The study is evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily for 30 days in addition to background local standard of care therapy, in reducing disease progression, complications, and all-cause mortality.

    NCT04350593
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Dapagliflozin 10 MG
    2. Drug: Placebo
    MeSH:Respiratory Insufficiency

    Primary Outcomes

    Description: Respiratory decompensation (e.g., invasive or non-invasive mechanical ventilation) New or worsening congestive HF Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest Initiation of renal replacement therapy

    Measure: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up, defined as at least one of the following:

    Time: Randomization through Day 30

    Secondary Outcomes

    Description: Time to death from any cause Time to new/worsened organ dysfunction (as defined in the primary outcome measure) Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction (using points 3 to 5 of a 7-point ordinal scale) Time to hospital discharge

    Measure: Hierarchical composite outcome measures including time to death from any cause, time to new/worsened organ dysfunction, clinical status at day 30 and time to hospital discharge

    Time: Randomization through Day 30

    Description: Time to hospital discharge

    Measure: Time to hospital discharge

    Time: Randomization through Day 30

    Description: Total number of days alive, out of hospital, and/or free from mechanical ventilation

    Measure: Total number of days alive, out of hospital, and/or free from mechanical ventilation

    Time: Randomization through Day 30

    Description: Total number of days alive, not in the ICU, and free from mechanical ventilation (as defined in the primary outcome measure)

    Measure: Total number of days alive, not in the ICU, and free from mechanical ventilation (as defined in the primary outcome measure)

    Time: Randomization through Day 30

    Description: Time to death from any cause

    Measure: Time to death from any cause

    Time: Randomization through Day 30

    Description: Time to new/worsened organ dysfunction

    Measure: Time to new/worsened organ dysfunction

    Time: Randomization through Day 30

    Description: Time to acute kidney injury (defined as doubling of s-Creatinine compared to baseline)

    Measure: Time to acute kidney injury (defined as doubling of s-Creatinine compared to baseline)

    Time: Randomization through Day 30
    59 A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

    This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.

    NCT04350736
    Conditions
    1. Acute Lung Injury (ALI) Associated With COVID-19
    2. Inflammatory Lung Conditions Associated With COVID-19
    Interventions
    1. Drug: TD-0903
    2. Drug: Placebo
    MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult

    Primary Outcomes

    Description: Number and severity of treatment emergent adverse events

    Measure: Safety and Tolerability of SAD of TD-0903: Adverse Events

    Time: Day 1 to Day 8

    Description: Number and severity of treatment emergent adverse events

    Measure: Safety and Tolerability of MAD of TD-0903: Adverse Events

    Time: Day 1 to Day 14

    Secondary Outcomes

    Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

    Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC

    Time: Day 1 through Day 4

    Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Maximum observed concentration (Cmax)

    Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax

    Time: Day 1 through Day 4

    Description: Multiple PK variables of TD-0903 will be assessed during SAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

    Measure: Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax

    Time: Day 1 through Day 4

    Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)

    Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC

    Time: Day 1 through Day 9

    Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Maximum observed concentration (Cmax)

    Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax

    Time: Day 1 through Day 9

    Description: Multiple PK variables of TD-0903 will be assessed during MAD and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)

    Measure: Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax

    Time: Day 1 through Day 9
    60 Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic RT-PCR Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate

    To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.

    NCT04351191
    Conditions
    1. Sars-CoV2
    2. Symptomatic Condition
    3. Covid-19
    Interventions
    1. Drug: Hydroxychloroquine Sulfate Regular dose
    2. Drug: Hydroxychloroquine Sulfate Loading Dose
    3. Drug: Chloroquine
    4. Drug: Placebo

    Primary Outcomes

    Description: Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

    Measure: RT-PCR result

    Time: 6th and 7th day

    Secondary Outcomes

    Description: Time to progression to next stage of SARS-CoV-2 disease severity index

    Measure: Progression of symptoms

    Time: 7 days

    Description: Death

    Measure: Mortality

    Time: 30 days
    61 A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)

    Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.

    NCT04351243
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Gimsilumab
    2. Drug: Placebo
    MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury

    Primary Outcomes

    Measure: Incidence of mortality

    Time: Day 43

    Secondary Outcomes

    Measure: Incidence of subjects who are alive and not on mechanical ventilation

    Time: Day 29

    Description: Subjects who die will be assigned "0" ventilator-free days

    Measure: Number of ventilator-free days

    Time: Baseline to Day 29

    Measure: Time to hospital discharge

    Time: Baseline to Day 43
    62 Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients

    Patients over equal or older than 65 yearswill be treated with a hydroxychloroquine versus placebo reduced loading dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days resulting in a total duration of therapy of 7 days. Measurement of Hydroxychloroquine-levels will be performed on day 7, . A follow-up by video or telephone conference will be performed to observe drug intake and collect adverse events during treatment phase on a daily base on working days and once during the weekend (i.e. 6 out of 7 days). After treatment phase follow-up by telephone calls will be done on day 10, 30, 60 (+/- 2 days).

    NCT04351516
    Conditions
    1. SARS-CoV 2
    2. COVID-19
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo

    Primary Outcomes

    Measure: ● Rate of hospitalization or death at day 7 after study inclusion

    Time: 7 days
    63 RAndomized Clinical Trial in COvid19 Patients to Assess the Efficacy of the Transmembrane Protease Serine 2 (TMPRSS2) Inhibitor NAfamostat (RACONA Study)

    RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung function deterioration and need for intensive care admission in COVID-19 patients. Design: Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate (administered intravenously) on top of best standard of care. Primary outcome measures: the 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 or live discharge from the hospital, whichever comes first.

    NCT04352400
    Conditions
    1. COVID19
    Interventions
    1. Drug: Nafamostat Mesilate
    2. Drug: Placebo

    Primary Outcomes

    Description: Time-to-clinical improvement (time from randomization to an improvement of two points (from the status at randomization) on a 7 category ordinal scale or live discharge from the hospital, whichever came first.

    Measure: Time-to-clinical improvement

    Time: day 1 until day 28

    Secondary Outcomes

    Description: Rate of patients showing improvement of 2 points in 7 category ordinal scale (with 7 points the worst)(PubMed ID: 32187464)

    Measure: Responders

    Time: day 1 until day 28

    Description: Proportion of patients who will progress to critical illness/death

    Measure: Critical or dead patients

    Time: day 1 until day 28

    Description: Change in pO2/FiO2 ratio over time

    Measure: pO2/FiO2 ratio

    Time: day 1 until day 28

    Description: Change Sequential organ failure assessment score (SOFA score) over time. The Score ranges from 0 to 24 (with 24 the worst)(PubMed ID: 11594901)

    Measure: SOFA score over time

    Time: day 1 until day 28

    Description: Duration of hospitalization in survivors (days)

    Measure: Hospitalization

    Time: day 1 until day 28

    Description: Number of patients who require ventilation

    Measure: Mechanical ventilation

    Time: day 1 until day 28

    Description: Duration of ventilation (days)

    Measure: Mechanical ventilation duration

    Time: day 1 until day 28

    Description: Proportion of patients who develop arrhythmia, or myocardial infarction, or other cardiovascular disease not present at the baseline

    Measure: Cardiovascular disease

    Time: day 1 until day 28
    64 A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics

    To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.

    NCT04353271
    Conditions
    1. Covid 19
    2. Corona Virus Infection
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs

    Measure: Percentage of virus free subjects

    Time: 7 days after initiation of trial

    Description: Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .

    Measure: Disease severity

    Time: 6 days

    Secondary Outcomes

    Description: Number of subjects in each arm who are hospitalized for Covid 19 infection

    Measure: Incidence of hospitalization

    Time: 14 days

    Description: Number of subjects in each arm who die secondary to Covid-19 infection

    Measure: Incidence of Death

    Time: 70 Days (10 weeks)

    Description: Number of subjects in each arm who have confirmed Covid-19 infection

    Measure: Incidence of confirmed SARS-CoV-2 Detection

    Time: 14 days

    Description: Number of subjects in each arm who discontinue or withdraw medication use for any reason

    Measure: Incidence of all-cause study medication discontinuation or withdrawal

    Time: 14 days

    Description: Blood tests to determine level of immunity in each subject

    Measure: Immunity to Covid-19

    Time: 70 days (10 weeks)
    65 The Effect of Camostat Mesylate on COVID-19 Infection in Ambulatory Patients: An Investigator-Initiated Randomized, Placebo-Controlled, Phase IIa Trial

    The rationale of the present clinical trial is that an orally available drug given to outpatients that could reduce the viral burden in the upper respiratory tract could forestall complications of SARS-CoV-2 infection and reduce transmission from one infected individual to another.

    NCT04353284
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Camostat Mesilate
    2. Other: Placebo

    Primary Outcomes

    Description: To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

    Measure: Change in SARS-COV-2 viral load

    Time: 5 days

    Secondary Outcomes

    Description: To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 2 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

    Measure: Change in SARS-COV-2 viral load

    Time: 3 days

    Description: To determine whether camostat mesylate reduces SARS-COV-2 viral load in early COVID-19 disease, change from day 0 to day 6 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

    Measure: Change in SARS-COV-2 viral load

    Time: 7 days

    Description: Change in risk for a positive COVID-19 test at day 6 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

    Measure: Change in positive COVID-19 status

    Time: 7 days

    Description: Change in risk for a positive COVID-19 test at day 13 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

    Measure: Change in positive COVID-19 status

    Time: 14 days

    Description: Change in risk for a positive COVID-19 test at day 27 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

    Measure: Change in positive COVID-19 status

    Time: 28 days

    Description: Change of COVID-19 symptom severity from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

    Measure: Change in COVID-19 symptom severity

    Time: 7 days

    Description: Change of COVID-19 symptom severity from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

    Measure: Change in COVID-19 symptom severity

    Time: 14 days

    Description: Change of COVID-19 symptom score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

    Measure: Change in COVID-19 symptom frequency

    Time: 7 days

    Description: Change of COVID-19 symptom score from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

    Measure: Change in COVID-19 symptom frequency

    Time: 14 days

    Description: Change of COVID-19 symptom score from baseline to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

    Measure: Change in body temperature

    Time: 7 days

    Description: Change of COVID-19 symptom score from baseline to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score for the frequency of symptoms (20) indicates the greatest burden of symptom frequency. The last question (39) asks patients for their highest temperature in Fahrenheit.

    Measure: Change in body temperature

    Time: 14 days
    66 A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.

    This clinical trial is a randomized, blinded, two arms, placebo controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice to prevent COVID 19 in subjects at risk of getting infected with COVID 19.

    NCT04353518
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Suspension of heat killed (autoclaved) Mycobacterium w
    2. Other: Placebo
    MeSH:Mycobacterium Infections

    Primary Outcomes

    Description: To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose

    Measure: Number of subject acquiring COVID-19 infection

    Time: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..

    Secondary Outcomes

    Description: Any AE / SAE observed during the study.

    Measure: Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)

    Time: Till 8 weeks

    Description: Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.

    Measure: Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms

    Time: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.

    Description: Whether administration of Mw prevents development of severe COVID-19 infection.

    Measure: Number of subject developing severe COVID-19 infection based on ordinal scale

    Time: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
    67 DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

    It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.

    NCT04354389
    Conditions
    1. COVID-19
    Interventions
    1. Drug: DAS181
    2. Drug: Placebo
    3. Drug: DAS181

    Primary Outcomes

    Measure: Percent of subjects return to room air (RTRA)

    Time: Day 14

    Secondary Outcomes

    Description: Percent of subjects who reach level 1 of COVID-19 Clinical Classification (discharged or return to normal activity)

    Measure: Percent of subjects who have recovered

    Time: Day 5, 10, 14, 21, 28

    Description: time to Improved COVID-19 Clinical Classification 1 to 6 (where higher score means worse outcome)

    Measure: Improved COVID-19 Clinical Classification

    Time: Day 28

    Description: Percent of subjects RTRA

    Measure: Return To Room Air (RTRA)

    Time: Day 10, 21, 28

    Measure: Percent of subjects who achieve clinical stability

    Time: Day 28

    Description: Time to

    Measure: SARS-CoV-2 RNA undetectable

    Time: Day 28

    Description: Time to

    Measure: Clinical Deterioration

    Time: Day 28

    Description: Percent of subjects discharge

    Measure: Percent of subjects discharged

    Time: Day 14, 21, 28

    Description: Time to

    Measure: Death (all cause)

    Time: Day 28
    68 Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia: a Randomized Controlled Double-blind Study From the Skip-icu Consortium

    The COVID-19 outbreak is associated with a surge in ICU bed requirement and substantial mortality (estimated between 0.5% and 3.6%). Admission in the intensive care unit (ICU) and need for mechanical ventilation is reportedly associated with an estimated hospital mortality of more than 30%. Furthermore, the surge in ICU bed requirement is a worldwide-shared issue, leading to sub-optimal ICU management. In acute respiratory failure due to COVID-19-related pneumonia, vasoplegia with vascular enlargement inside the lung lesions and dilation of small vessels seen on chest CT scan largely account for severe hypoxemia whose physiological response is hyperventilation leading to hypocapnia. Almitrine, initially described to reduce intrapulmonary shunt by enhancement of hypoxic pulmonary vasoconstriction in combination with inhaled nitric oxide (iNO), redistributes pulmonary blood flow from shunt areas to lung units with normal ventilation/perfusion (VA/Q) ratio. Low dose of intravenous almitrine (2 µg.kg-1.min-1) alone also improves oxygenation (without combination with iNO) by selective pulmonary vasoconstriction of precapillary pulmonary arteries perfusing lung areas exposed to a hypoxic challenge with a slight increase in mean arterial pulmonary. Therefore, our hypothesis is that 5 days of low dose of almitrine therapy may improve the ventilation-perfusion (VA/Q) ratio at a relatively early stage of this specific lung disease and limit respiratory worsening and subsequent need for mechanical ventilation.

    NCT04357457
    Conditions
    1. Covid 19
    2. Hypoxemic Respiratory Failure
    Interventions
    1. Drug: Almitrine
    2. Drug: Placebo
    MeSH:Pneumonia Respiratory Insufficiency
    HPO:Pneumonia

    Primary Outcomes

    Description: Endotracheal intubation within 7 days after randomization Death will be considered as a failure (endotracheal intubation).

    Measure: Rate of endotracheal intubation

    Time: 7 days

    Secondary Outcomes

    Measure: 28-day mortality

    Time: 28 days

    Measure: In-hospital mortality

    Time: 28-day

    Measure: Number of ventilator-free days

    Time: 28 days

    Measure: Number of days in the ICU

    Time: 28 days

    Measure: Number of days in the hospital

    Time: 28 days

    Description: safety assessment: discontinuation rate of the treatment for arterial lactate more than 4 mmol/L, ALT/AST levels greater than 3 times the upper limit, and diagnosis of pulmonary arterial hypertension or acute cor pulmonale documented by echocardiography.

    Measure: Discontinuation rate of the treatment

    Time: 28 days
    69 Use of a Medical Device, Viruxal Oral and Nasal Spray, for Treating the Symptoms of COVID-19 Via Application to the Naso- and Oropharyngeal Mucosa

    Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf (the "Device"). A double blind clinical trial will be conducted to evaluate the Device against placebo in COVID-19 positive, symptomatic patients in Iceland. Immediate access to COVID-19 patients is available through a well-organized COVID-19 outpatient follow-up clinic. Up to 128 patients with mild to moderate symptoms of COVID-19 will be recruited (so called "higher end of the low risk group"). These patients will be positive for COVID-19, be symptomatic with upper respiratory symptoms, but without involvement of the entire respiratory system. The patients will be randomized to receive treatment with the Study Device or to receive placebo. 64 patients will be randomized into the Study Device group and 64 patients into the Control group. Patients will administer Study Device or Control for 14 days and will have their symptoms recorded until no further symptoms are reported, up to a maximum of 28 days follow-up.

    NCT04357990
    Conditions
    1. COVID-19
    Interventions
    1. Device: Viruxal Oral and Nasal Spray
    2. Other: Placebo

    Primary Outcomes

    Description: The number of days until participants report no symptoms, which they attribute to COVID-19, will be compared between groups. Symptoms include: Fever (38.0°C or higher), chills, dry cough, cough with rise, shortness of breath (rest), shortness of breath (Exercise), dyspnoea, sore throat, runny nose, headache, myalgia/bone pain, anorexia, nausea, vomiting, loss of smell, osteoporosis, abdominal pain, diarrhea, weakness.

    Measure: Number of days until complete resolution of symptoms per group

    Time: 28 days

    Description: The number of participants admitted to hospital due to deterioration of their condition due to COVID-19 will be compared between groups.

    Measure: Number of hospital admissions per group

    Time: 28 days

    Secondary Outcomes

    Description: The number of days until participants report a reduction in symptoms, which they attribute to COVID-19, will be compared between groups. Symptoms include: Fever (38.0°C or higher), chills, dry cough, cough with rise, shortness of breath (rest), shortness of breath (Exercise), dyspnoea, sore throat, runny nose, headache, myalgia/bone pain, anorexia, nausea, vomiting, loss of smell, osteoporosis, abdominal pain, diarrhea, weakness.

    Measure: Number of days until a reduction in symptoms per group

    Time: 28 days

    Description: The number of adverse events reported will be compared between groups.

    Measure: Number of adverse events per group

    Time: 28 days
    70 A Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease

    Two recent studies have suggested that in patients with Covid19, treatment with hydroxychloroquine may shorten the duration of symptoms and improve viral clearance, an effect that appears most pronounce when combined with azithromycin. Hydroxychloroquine treatment may inhibit viral nucleic acid-mediated activation of various innate immune pathways, as well as blockade of lysosomal functions in cell types relevant for viral entry and antigen presentation. The purpose of the study is to determine if oral hydroxychloroquine monotherapy, or in combination with azithromycin results in clinical benefit in patients hospitalized with COVID19 pneumonia.

    NCT04358081
    Conditions
    1. Covid-19
    Interventions
    1. Drug: HCQ
    2. Drug: HCQ+AZT
    3. Drug: Placebo

    Primary Outcomes

    Description: To demonstrate in patients receiving standard of care that the percentage who achieve clinical response with hydroxychloroquine or hydroxychloroquine and azithromycin is superior to placebo at Day 15

    Measure: Percentage of participants who achieve clinical response

    Time: 15 days

    Secondary Outcomes

    Description: To demonstrate in patients receiving standard of care that the percentage with viral clearance at Day 15 with hydroxychloroquine or hydroxychloroquine and azithromycin is superior to placebo

    Measure: Percentage of Participants with Viral Clearance

    Time: 15 Days

    Description: To assess in patients receiving standard of care the safety of hydroxychloroquine or hydroxychloroquine and azithromycin compared to placebo

    Measure: Number of participants receiving hydroxychloroquine or hydroxychloroquine and azithromycin with adverse events of hydroxychloroquin or hydroxychloroquine and azithromycin compared to placebo

    Time: 40 days
    71 A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study To Evaluate Efficacy And Safety Of Recombinant Human Plasma Gelsolin (Rhu-pGSN) Added To Standard Of Care In Subjects With Severe Covid-19 Pneumonia

    Study Objectives: Primary - To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or 6 on the World Health Organization (WHO) 9-point severity scale - To evaluate the safety and tolerability of three IV doses of rhu-pGSN administered to hospitalized subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5, or 6 on the WHO 9-point severity scale Secondary - To further assess the efficacy of IV administered rhu-pGSN - To assess changes in WHO 9-point severity score for SOC with or without rhu-pGSN - To evaluate the effect of administered rhu-pGSN on survival rates - To assess the relationship of pGSN levels (and other biomarkers) at baseline with clinical outcomes - [OPTIONAL] To follow the pharmacokinetics (PK) of administered rhu-pGSN Immunogenicity • To investigate the development of antibodies against rhu-pGSN post-treatment

    NCT04358406
    Conditions
    1. Sars-CoV2
    Interventions
    1. Drug: Recombinant human plasma gelsolin (Rhu-pGSN)
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Proportion of subjects alive not on vasopressors, mechanical ventilator, and dialysis

    Measure: Efficacy: Proportion of subjects alive not on vasopressors, mechanical ventilator, and dialysis

    Time: Day 14

    Description: Proportion of subjects with SAEs as judged by the investigator

    Measure: Safety and Tolerability: Proportion of subjects with serious adverse events (SAEs)

    Time: Continuous through Day 28

    Secondary Outcomes

    Description: Daily change in the 9-point Severity Score (ordinal scale) proposed by a special WHO committee for COVID-19 pneumonia where a score of 8 indicates death and 0 is no clinical or virological evidence of COVID-19 infection

    Measure: Efficacy: Daily change in the WHO 9-point severity score

    Time: Daily through at least Day 14

    Description: All cause mortality rate using Kaplan-Meier survival analysis

    Measure: Efficacy: All cause mortality rate at Days 28 and 90

    Time: At Days 28 and 90

    Description: Proportion of subjects alive without the ongoing use of vasopressors, ongoing intubation/mechanical ventilation, ongoing residence in an intensive care unit, new ongoing need for dialysis/renal replacement therapy

    Measure: Efficacy: Proportion of subjects alive without the ongoing use of vasopressors, ongoing intubation/mechanical ventilation, ongoing residence in an intensive care unit (ICU), new ongoing need for dialysis/renal replacement therapy

    Time: Days 7, 28, 60, and 90

    Description: Proportion of subjects discharged to home or immediate prior residence

    Measure: Efficacy: Proportion of subjects discharged to home or immediate prior residence

    Time: Continuous through Day 28

    Description: LOS of surviving subjects in the hospital and in ICU

    Measure: Efficacy: Length of stay (LOS) of surviving subjects in the hospital and in ICU

    Time: Continuous through day 28

    Description: Proportion of subjects readmitted to the hospital

    Measure: Efficacy: Proportion of subjects readmitted to the hospital

    Time: Up to 90 days

    Description: Proportion of subjects with adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measure: Safety and Tolerability: Proportion of subjects with adverse events (AEs)

    Time: Continuous through Day 28

    Description: Proportion of subjects with new or worsening clinically significant laboratory abnormalities

    Measure: Safety and Tolerability: Proportion of subjects with new or worsening clinically significant laboratory abnormalities

    Time: Continuous through Day 28

    Description: Proportion of subjects with rhu-pGSN antibodies

    Measure: Immunogenicity: Proportion of subjects with rhu-pGSN antibodies

    Time: Days 1, 28, and 90

    Description: Blood samples for dose #1 will be collected within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), and 12 (±30 min) hours after end of administration (but prior to Dose #2); for Dose #3 within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), 12 (±30 min) and 24 (±30 min) hours after the end of administration (participants refusing these blood samplings can enter and remain in the trial).

    Measure: Pharmacokinetics: Maximum concentration (C max) of added rhu-pGSN

    Time: Continuous through day 3

    Description: Blood samples for dose #1 will be collected within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), and 12 (±30 min) hours after end of administration (but prior to Dose #2); for Dose #3 within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), 12 (±30 min) and 24 (±30 min) hours after the end of administration (participants refusing these blood samplings can enter and remain in the trial).

    Measure: Pharmacokinetics: Time to maximum concentration (T max) of added rhu-pGSN

    Time: Continuous through day 3

    Description: Blood samples for dose #1 will be collected within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), and 12 (±30 min) hours after end of administration (but prior to Dose #2); for Dose #3 within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), 12 (±30 min) and 24 (±30 min) hours after the end of administration (participants refusing these blood samplings can enter and remain in the trial)

    Measure: Pharmacokinetics: Half-life (T 1/2) of added rhu-pGSN

    Time: Continuous through day 3

    Description: Blood samples for dose #1 will be collected within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), and 12 (±30 min) hours after end of administration (but prior to Dose #2); for Dose #3 within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), 12 (±30 min) and 24 (±30 min) hours after the end of administration (participants refusing these blood samplings can enter and remain in the trial)

    Measure: Pharmacokinetics: Area under the curve from time 0 to 8 hours (AUC 0-8) of added rhu-pGSN

    Time: Continuous through day 3

    Description: Blood samples for dose #1 will be collected within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), and 12 (±30 min) hours after end of administration (but prior to Dose #2); for Dose #3 within 15 minutes predose, and at 1 (±15 min), 2 (±15 min), 6 (±30 min), 12 (±30 min) and 24 (±30 min) hours after the end of administration (participants refusing these blood samplings can enter and remain in the trial)

    Measure: Pharmacokinetics: Area under the curve from time 0 to infinity (AUC 0-inf) of added rhu-pGSN

    Time: Continuous through day 3
    72 A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.

    This is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.

    NCT04358809
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Suspension of heat killed (autoclaved) Mycobacterium w
    2. Other: Placebo
    MeSH:Mycobacterium Infections Critical Illness

    Primary Outcomes

    Description: To compare the difference in proportion of patients with increased disease severity

    Measure: Number of patients with increased disease severity

    Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

    Secondary Outcomes

    Description: To evaluate safety of Mw in COVID-19 patients admitted to hospital

    Measure: Incidence of adverse events and serious adverse events (Safety)

    Time: Till day 28

    Description: To compare the proportion of patients discharged from hospital

    Measure: Number of COVID-19 patients discharged from hospital

    Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

    Description: To compare the proportion of patients transfer to ICU

    Measure: Number of COVID-19 patients transfer to ICU

    Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

    Description: To compare the proportion of patients with reduction in disease severity by 1 ordinal scale

    Measure: Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale

    Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.

    Description: To compare the proportion of symptom free patients

    Measure: Number of of symptom free patients

    Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
    73 Comparative Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 in Healthcare Personnel

    Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.

    NCT04359537
    Conditions
    1. COVID 19
    Interventions
    1. Drug: Hydroxychloroquine Sulfate 200 MG
    2. Other: Placebo

    Primary Outcomes

    Description: Outcome reported as the percentage of participants in each arm who are COVID-19-free at the end of study treatment

    Measure: COVID-19-free survival in experimental arms compared to placebo

    Time: 12 weeks

    Secondary Outcomes

    Description: Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.

    Measure: Incidence of confirmed SARS-COV-2 detection

    Time: 12 weeks

    Description: Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment

    Measure: Incidence of possible COVID-19 symptoms

    Time: 12 weeks

    Description: Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.

    Measure: Incidence of all-cause study medicine discontinuation

    Time: 12 weeks

    Description: Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), Hospitalization with ICU stay (score 4),Death from COVID 19(score=5) Possible scores range from 1-5 with higher scores indicating greater disease severity.

    Measure: Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end

    Time: 12 weeks

    Description: Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.

    Measure: Incidence of Hospitalization for COVID-19 or death

    Time: 12 weeks

    Description: Outcome reported as the percent of participants experiencing any possible adverse events from Hydroxychloroquine

    Measure: Incidence of study medication-related adverse events

    Time: 12 weeks
    74 A Randomized, Double-Blind, Placebo Controlled Trial 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

    Trial 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

    NCT04359680
    Conditions
    1. COVID-19
    2. Viral Respiratory Illnesses
    Interventions
    1. Drug: Nitazoxanide
    2. Drug: Placebo
    3. Dietary Supplement: Vitamin Super B-Complex
    MeSH:Infection

    Primary Outcomes

    Measure: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period.

    Time: Up to 6 weeks

    Measure: The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period.

    Time: Up to 6 weeks
    75 Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19

    Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.

    NCT04360096
    Conditions
    1. SARS-CoV 2
    2. COVID
    3. ARDS
    4. ALI
    5. Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
    6. Dyspnea
    Interventions
    1. Drug: RLF-100 (aviptadil)
    2. Drug: Placebo
    3. Device: Nebulized administration of RLF-100 or Placebo
    MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Sy Respiratory Distress Syndrome, Adult Acute Lung Injury Dyspnea Lung Injury
    HPO:Dyspnea Respiratory distress

    Primary Outcomes

    Description: Progression to ARDS is defined as the need for mechanical ventilation

    Measure: Progression to ARDS

    Time: 28 days

    Secondary Outcomes

    Description: Blood PO2 as measured by pulse oximetry

    Measure: Blood oxygenation

    Time: 28 days

    Description: 0 = no shortness of breath at all 0.5 = very, very slight shortness of breath = very mild shortness of breath = mild shortness of breath = moderate shortness of breath or breathing difficulty = somewhat severe shortness of breath = strong or hard breathing 7 = severe shortness of breath or very hard breathing 8 9 = extremely severe shortness of breath 10 = shortness of breath so severe you need to stop the exercise or activity

    Measure: RDP Dsypnea Scale

    Time: 28 days

    Description: Distance walked in six minutes

    Measure: Distance walked in six minutes

    Time: 28 days
    76 Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

    This study will enroll 40 symptomatic outpatients tested positive for Coronavirus 2019 (COVID-19). Patients to be randomized 1:1 to Telmisartan (40 mg) vs placebo to be administered orally once daily x 21 days. Daily, the study patients will be asked to keep a record of the severity of their fever, dyspnea and fatigue and take their blood pressure (BP) and temperature. Study visits to occur on day 1 (entry), day 4, day 10 and day 21. Oro-pharyngeal swabs, and approximately 25 cc of blood will be collected at each study visit for safety labs and for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of inflammation, coagulation and fibrosis.

    NCT04360551
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Telmisartan 40mg
    2. Drug: Placebo

    Primary Outcomes

    Description: Based on a modified World Health Organization (WHO) COVID-19 7-point ordinal scale

    Measure: Maximum clinical severity of disease

    Time: Over the 21 day period of study

    Secondary Outcomes

    Description: Number of adverse events grade 2 and above utilizing the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014

    Measure: Incidence of treatment emergent adverse events

    Time: Through study completion at day 21 of study

    Description: Angiotensin I (AngI), AngII, Ang1-9 and Ang1-7

    Measure: Renin angiotensin system peptides

    Time: At each study time point (day 4, day 10, day 21)

    Description: plasma biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion by Luminex multiplexing assays such as TNF-alpha, IL-6, CK-MB, Troponin I, Fractalkine, MCP-1, PD-1, TIMP-1

    Measure: Plasma biomarkers

    Time: At each study time point (day 4, day 10, day 21)
    77 Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease

    Double-blind randomized controlled clinical trial (RCT) of low-dose lenalidomide in the treatment of elderly patients (> 60 years of age) with mild to moderate clinical signs of COVID-19 disease from the Hospital Universitario of Getafe. The study will include patients of both sexes (> 60 years of age) with mild to moderate clinical presentation of COVID-19 (ROX index > 10). Subjects will be randomly assigned to the experimental arm with lenalidomide (5 mg/24h, day 1, 3 and 5) or to the controlled arm. Other concomitant medication for the treatment of COVID-19 will be also considered.

    NCT04361643
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
    2. Drug: Placebo

    Primary Outcomes

    Description: Days to clinical recovery or days until discharge

    Measure: Clinical improvement

    Time: 30 days

    Description: o Improvement of the neutrophil-to-lymphocyte ratio (NLR)

    Measure: Immune-inflammatory improvement

    Time: 30 days

    Secondary Outcomes

    Description: All-cause mortality at 30 days after enrollment

    Measure: Mortality

    Time: 30 days
    78 Double Blind, Placebo-controlled, Phase II Trial to Evaluate Safety and Efficacy of Allogenic Mesenchymal Stromal Cells MSV_allo for Treatment of Acute Respiratory Failure in Patients With COVID-19 Pneumonia (COVID_MSV)

    Novel coronavirus COVID-19 has become a health emergency around the world. Since first patients were detected in Wuhan China, in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the phase I/II, placebo- controlled, randomized MSCs for treatment of severe COVID-19 pneumonia.

    NCT04361942
    Conditions
    1. COVID-19 Pneumonia
    Interventions
    1. Biological: Mesenchymal Stromal Cells
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Index of therapy success to preserve Intensive Care Hospitalization space

    Measure: Proportion of patients who have achieved withdrawal of invasive mechanical ventilation

    Time: 0-7 days

    Description: To measure global success

    Measure: Rate of mortality

    Time: 28 days

    Secondary Outcomes

    Description: Index based in the 4 most relevant symptoms and signs: fever, shortness of bread, %Hemoglobin Saturation and PaO2 / FiO2

    Measure: Proportion of patients who have achieved clinical response

    Time: 0-7days

    Description: Evaluation of pneumonia changes

    Measure: Proportion of patients who have achieved radiological responses

    Time: 0-28 days

    Other Outcomes

    Description: Haemogram and cell subpopulations

    Measure: Blood white cell counts and their subpopulations.

    Time: 0-180 days

    Description: Lymphocyte profiles, CD3, CD19, CD16+CD56, CD4/CD8, Tregs

    Measure: Cellular markers of inflammation

    Time: 0-180 days

    Description: IL-10, IL-6, IP-10, TNF-alpha

    Measure: Cytokines and chemokines in peripheral blood

    Time: 0-180 days
    79 Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020

    Until 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.

    NCT04362124
    Conditions
    1. COVID-19
    Interventions
    1. Biological: vaccine BCG
    2. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    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 study

    Secondary Outcomes

    Description: Incidence of severe or critical infection in COVID-19 cases

    Measure: Secondary outcome

    Time: From date to diagnosis to 1 month after

    Description: Lethality of the infection in both groups

    Measure: Secondary outcome

    Time: From date to diagnosis to 1 month after

    Description: 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 study

    Description: Prevalence of SARS-Cov-2 infection

    Measure: Secondary outcome

    Time: At baseline evaluation
    80 Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

    This is a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 pneumonia.

    NCT04362137
    Conditions
    1. Cytokine Storm (Covid-19)
    Interventions
    1. Drug: Ruxolitinib
    2. Drug: Placebo

    Primary Outcomes

    Description: Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care for the treatment of COVID-19.

    Measure: Proportion of patients who die, develop respiratory failure [require mechanical ventilation] or require intensive care unit (ICU) care

    Time: 29 days

    Secondary Outcomes

    Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.

    Measure: Clinical status

    Time: Day 15, Day 29

    Description: Percentage of patients with at least two points improvement in clinical status on the 9-point ordinal scale.

    Measure: Percentage of patients with at least two-point improvement from baseline in clinical status

    Time: Baseline, Day 15, Day 29

    Description: Percentage of patients with at least one point improvement in clinical status on the 9-point ordinal scale.

    Measure: Percentage of patients with at least one-point improvement from baseline in clinical status

    Time: Baseline, Day 15, Day 29

    Description: Percentage of patients with at least one point deterioration in clinical status on the 9-point ordinal scale.

    Measure: Percentage of patients with at least one-point deterioration from baseline in clinical status

    Time: Baseline, Day 15, Day 29

    Description: Time to improvement from baseline category to one less severe category of the 9-point ordinal scale.

    Measure: Time to improvement in clinical status

    Time: 29 days

    Description: Mean change from baseline in the 9-point ordinal scale.

    Measure: Mean change from baseline in the clinical status

    Time: Baseline, Day 15, Day 29

    Description: Mortality rate at Day 15 and at Day 29

    Measure: Mortality rate

    Time: Day 15, Day 29

    Description: Proportion of patients requiring mechanical ventilation

    Measure: Proportion of patients requiring mechanical ventilation

    Time: 29 days

    Description: Duration of hospitalization

    Measure: Duration of hospitalization

    Time: 29 days

    Description: The time to discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours whichever comes first. The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst).

    Measure: Time to discharge or to a NEWS2 score of ≤2

    Time: 29 days

    Description: The National Early Warning Score 2 (NEWS2) is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst).

    Measure: Change from baseline in NEWS2 score

    Time: Baseline, Days 3, 5, 8, 11, 15, and 29

    Description: Change from baseline in peripheral oxygen saturation / fraction of inspired oxygen ratio (SpO2/FiO2 ratio)

    Measure: Change from baseline in SpO2/FiO2 ratio.

    Time: Baseline, Day 15, Day 29

    Description: No oxygen therapy is required if oxygen saturation is ≥ 94% on room air.

    Measure: Proportion of patients with no oxygen therapy

    Time: Day 15, Day 29
    81 Passive Immunity Trial for Our Nation (PassItOn)

    The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

    NCT04362176
    Conditions
    1. COVID-19
    2. Coronavirus
    3. SARS-CoV-2
    Interventions
    1. Biological: pathogen reduced SARS-CoV-2 convalescent plasma
    2. Biological: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death

    Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale

    Time: Study Day 15

    Secondary Outcomes

    Description: All-location, all-cause 14-day mortality

    Measure: All-location, all-cause 14-day mortality

    Time: Baseline to Study Day 14 (assessed on Study Day 15)

    Description: All-location, all-cause 28-day mortality

    Measure: All-location, all-cause 28-day mortality

    Time: Baseline to Study Day 28 (assessed on Study Day 29)

    Description: Number of participants that survived to Day 28

    Measure: Survival through 28 days

    Time: Baseline to Day 28 (assessed on Study Day 29)

    Description: Number days from admission to discharge thru Day 28

    Measure: Time to hospital discharge through 28 days

    Time: Admission to discharge (assessed on Study Day 29)

    Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death

    Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3

    Time: Baseline to Study Day 3

    Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death

    Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8

    Time: Study Day 8

    Description: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death

    Measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29

    Time: Study Day 29

    Description: Number of days without use of oxygen

    Measure: Oxygen-free days through Day 28

    Time: Baseline to Day 28

    Description: Number of days without use of a ventilator

    Measure: Ventilator-free days through Day 28

    Time: Baseline to Day 28

    Description: Number of days without use of vasopressors

    Measure: Vasopressor-free days through Day 28

    Time: Baseline to Day 28

    Description: Number of days outside of ICU

    Measure: ICU-free days through Day 28

    Time: Baseline to Day 28

    Description: Number of days outside of the hospital

    Measure: Hospital-free days through Day 28

    Time: Baseline to Day 28

    Other Outcomes

    Description: Number of participants with Acute kidney injury

    Measure: Acute kidney injury

    Time: Baseline to Day 28

    Description: Number of participants requiring renal replacement therapy

    Measure: Renal replacement therapy

    Time: Baseline to Day 28

    Description: Number of participants with documented venous thromboembolic disease (DVT or PE)

    Measure: Documented venous thromboembolic disease (DVT or PE)

    Time: Baseline to Day 28

    Description: Number of Participants with myocardial infarction or ischemic stroke

    Measure: Documented cardiovascular event (myocardial infarction or ischemic stroke)

    Time: Baseline to Day 28

    Description: Number of participants with transfusion reaction (fever/rash)

    Measure: Transfusion reaction

    Time: Baseline to Day 28

    Description: Number of participants with transfusion related acute lung injury (TRALI)

    Measure: Transfusion related acute lung injury (TRALI)

    Time: Baseline to Day 28

    Description: Number of participants with transfusion associated circulatory overload (TACO)

    Measure: Transfusion associated circulatory overload (TACO)

    Time: Baseline to Day 28

    Description: Number of participants with transfusion related infection

    Measure: Transfusion related infection

    Time: Baseline to Day 28
    82 A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

    Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.

    NCT04362189
    Conditions
    1. COVID-19
    Interventions
    1. Drug: HB-adMSC
    2. Drug: Placebo

    Primary Outcomes

    Description: change from baseline in interleukin-6

    Measure: Interleukin-6

    Time: screening, day 0, 7, 10

    Description: Change from baseline in C Reactive protein

    Measure: C Reactive protein

    Time: screening, day 0, 7, 10

    Description: change from baseline oxygenation (%)

    Measure: Oxygenation

    Time: screening, day 0, 7, 10

    Description: change from baseline in TNF alpha

    Measure: TNF alpha

    Time: screening, day 0, 7, 10

    Description: change from baseline level of IL-10 in the blood (pg/mL)

    Measure: IL-10

    Time: screening, day 0, 7. 10

    Description: Time to return to room air

    Measure: Return to room air (RTRA)

    Time: Day 0, 3, 7, 10, 28

    Secondary Outcomes

    Description: Monitoring for changes in qt interval

    Measure: EKG qt interval

    Time: screening, day 0, 3, 7, 10

    Description: change from baseline in leukocyte differential

    Measure: Leukocyte differential

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of glucose in the blood (mg/dL)

    Measure: Glucose

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of calcium in the blood (mg/dL)

    Measure: Calcium

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of albumin in the blood (g/dL)

    Measure: Albumin

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of total protein in the blood (g/dL)

    Measure: Total protein

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of sodium in the blood (mol/L)

    Measure: Sodium

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of total carbon dioxide in the blood (mmol/L)

    Measure: Total carbon dioxide

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of potassium in the blood (mmol/L)

    Measure: Potassium

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of chloride in the blood (mmol/L)

    Measure: Chloride

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of BUN in the blood (mg/dL)

    Measure: BUN

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of creatinine in the blood (mg/dL)

    Measure: Creatinine

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)

    Measure: Alkaline phosphatase

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)

    Measure: Alanine aminotransferase

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of total bilirubin in the blood (mg/dL)

    Measure: Total bilirubin

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of white blood cells in the blood (x10^3/uL)

    Measure: White blood cells

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of red blood cells in the blood (x10^6/uL)

    Measure: Red blood cells

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of hemoglobin in the blood (g/dL)

    Measure: Hemoglobin

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of hematocrit in the blood (%)

    Measure: Hematocrit

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of mean corpuscular volume in the blood (fL)

    Measure: Mean corpuscular volume

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of mean corpuscular hemoglobin in the blood (pg)

    Measure: Mean corpuscular hemoglobin

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of mean corpuscular hemoglobin concentration in the blood (g/dL)

    Measure: Mean corpuscular hemoglobin concentration

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of red cell distribution width in the blood (%)

    Measure: Red cell distribution width

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of neutrophils in the blood (%)

    Measure: Neutrophils

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of lymphocytes in the blood (%)

    Measure: Lymphs

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of monocytes in the blood (%)

    Measure: Monocytes

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of eosinophils in the blood (%)

    Measure: Eosinophils

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of basophils in the blood (%)

    Measure: Basophils

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of absolute neutrophils in the blood (x10^3/uL)

    Measure: Absolute neutrophils

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of absolute lymphocytes in the blood (x10^3/uL)

    Measure: Absolute lymphs

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of absolute monocytes in the blood (x10^3/uL)

    Measure: Absolute monocytes

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of absolute eosinophils in the blood (x10^3/uL)

    Measure: Absolute eosinophils

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of absolute basophils in the blood (x10^3/uL)

    Measure: Absolute basophils

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of immature granulocytes in the blood (x10^3/uL)

    Measure: Immature granulocytes

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of platelets in the blood (x10^3/uL)

    Measure: Platelets

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of time for blood to coagulate (seconds)

    Measure: Prothrombin time

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of international normalized ratio of blood coagulation (no unit)

    Measure: INR

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of percentage of cells CD3- and CD54+ (%)

    Measure: NK cell surface antigen (CD3-CD54+)

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of ratio of CD4+ cells to CD8+ cells (no unit)

    Measure: CD4+/CD8+ ratio

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of myoglobin in the blood (ng/mL)

    Measure: Myoglobin

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of myoglobin in the blood (ng/mL)

    Measure: Troponin

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of creatinine kinase in the blood (U/L)

    Measure: Creatinine kinase MB

    Time: screening, day 0, 7, 10

    Description: clinical lab evaluation of level of serum ferritin in the blood (ng/mL)

    Measure: Serum ferritin

    Time: screening, day 0, 7, 10

    Description: incidence of adverse events

    Measure: Adverse events

    Time: screening through day 28

    Description: change from baseline in ordinal scale score; scale of 1-7; a score of 1 indicates death and 7 indicates subject is not hospitalized and has no limitations on activities.

    Measure: 7-point ordinal scale

    Time: screening, day 0, 3, 7, 10, 28

    Description: change from baseline in D-dimer

    Measure: D-dimer

    Time: screening, day 0, 7, 10

    Description: change from baseline chest x-ray result

    Measure: Chest X-ray

    Time: Day 0, Day 28

    Description: change from baseline CT scan result

    Measure: CT scan

    Time: Day 0, Day 28

    Description: time to achieve negative PCR test results

    Measure: PCR test for SARS-CoV-2

    Time: day 0, 3, 7, 10
    83 Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Canakinumab on Cytokine Release Syndrome in Patients With COVID-19-induced Pneumonia (CAN-COVID)

    This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).

    NCT04362813
    Conditions
    1. Pneumonia and Cytokine Release Syndrome (Covid-19)
    Interventions
    1. Drug: Canakinumab
    2. Drug: Placebo
    MeSH:Pneumonia Syndrome
    HPO:Pneumonia

    Primary Outcomes

    Description: Clinical response is defined as survival without ever requiring invasive mechanical ventilation from Day 3 to Day 29 (both inclusive). A patient will be defined as a non-responder if the worst clinical status at any time from Day 3 to Day 29 is score 6, 7 or 8 on a 9-point ordinal scale ranging from 0 up to 8. Scores 6, 7 and 8 in the 9-point ordinal scale are defined as follows: Hospitalized patients with severe disease have score 6 if they need intubation and mechanical ventilation and score 7 if they need ventilation + additional organ support (pressors, renal replacement therapy, extracorporeal membrane oxygenation). Patients who die have score 8.

    Measure: Number of patients with clinical response

    Time: Day 3 to Day 29

    Secondary Outcomes

    Description: COVID-19-related death during the 4-week period after study treatment.

    Measure: COVID-19-related death rate during the 4-week period after study treatment

    Time: 4 weeks

    Description: Clinical chemistry measurement in a blood sample.

    Measure: Ratio to baseline in the C-reactive protein (CRP)

    Time: Baseline, Day 29

    Description: Clinical chemistry measurement in a blood sample.

    Measure: Ratio to baseline in the serum ferritin

    Time: Baseline, Day 29

    Description: Clinical chemistry measurement in a blood sample.

    Measure: Ratio to baseline in the D-dimer

    Time: Baseline, Day 29

    Description: Safety will be monitored from the canakinumab or placebo dose (Day 1) up to 126 days post-dose (Day 127).

    Measure: Number of participants with Adverse Event (AE), serious adverse events (SAE), clinically significant changes in laboratory measures, and vital signs

    Time: 127 days
    84 A Pilot, Multiple Dose Study to Evaluate the Efficacy and Safety of MRx-4DP0004 in Hospitalised Patients With Symptoms of COVID-19 (SARS-CoV-2 Infection)

    This is a randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of MRx-4DP0004 in patients with COVID-19. 90 hospitalised patients will be enrolled and randomised (2:1) to receive MRx-4DP0004 or placebo for up to 14 days. MRx-4DP0004 is an immunomodulating Live Biotherapeutic Product (LBP) which is expected to prevent or reduce the hyperinflammatory response to SARS-CoV-2 infection without impairing viral clearance.

    NCT04363372
    Conditions
    1. COVID-19
    Interventions
    1. Drug: MRx-4DP0004
    2. Drug: Placebo

    Primary Outcomes

    Description: Clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement where patients are scored on a scale of 0-8 with 0 being uninfected and 8 being dead

    Measure: Change in mean clinical status score in each treatment arm

    Time: Baseline to Day 42

    Secondary Outcomes

    Description: Safety and tolerability will be determined according to clinically relevant reported adverse events

    Measure: Number of adverse events in each treatment arm

    Time: Baseline to Day 42

    Description: Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

    Measure: Number of patients with an improvement in clinical status score in each treatment arm

    Time: Day 1 to Day 42

    Description: Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

    Measure: Number of patients with a deterioration in clinical status score in each treatment arm

    Time: Day 1 to Day 42

    Description: Oxygen saturation will be measured as per local standard procedures

    Measure: Number of patients with at least 95% oxygen saturation on room air in each treatment arm

    Time: Day 1 to Day 14

    Description: Oxygen saturation will be recorded daily during hospitalisation to determine the mean time for each arm to reach at least 95% saturation

    Measure: Time to patients with at least 95% oxygen saturation on room air in each treatment arm

    Time: Day 1 to Day 14

    Description: The NEWS 2 is based on aggregate scoring of physiological measurements including respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature

    Measure: Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm

    Time: Day 1 to Day 14

    Description: The NEWS 2 is based on aggregate scoring of physiological measurements including respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature

    Measure: Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm

    Time: Day 1 to Day 14

    Description: Details of required respiratory support will be recorded throughout hospitalisation

    Measure: Number of patients requiring Continuous Positive Airway Pressure in each treatment arm

    Time: Day 1 to Day 14

    Description: Details of required respiratory support will be recorded throughout the treatment period

    Measure: Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm

    Time: Day 1 to Day 14

    Description: Details of required respiratory support will be recorded throughout the treatment period

    Measure: Time to patients requiring Continuous Positive Airway Pressure in each treatment arm

    Time: Day 1 to Day 14

    Description: Details of required respiratory support will be recorded throughout the treatment period

    Measure: Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm

    Time: Day 1 to Day 14

    Description: Length of hospital stay will be compared

    Measure: Time to discharge in each treatment arm

    Time: Day 1 to Day 42

    Description: All cause mortality will be compared

    Measure: Number of deaths in each treatment arm

    Time: Day 1 to Day 42
    85 Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

    This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

    NCT04363450
    Conditions
    1. COVID-19
    2. Corona Virus Infection
    3. Wuhan Coronavirus
    4. Prophylaxis
    5. Healthcare Worker
    6. Sars-CoV2
    7. Hydroxychloroquine
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay

    Measure: Incidence of symptomatic COVID-19 infection in healthcare workers

    Time: 12 weeks

    Secondary Outcomes

    Description: Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection

    Measure: Absenteeism from work due to COVID-19

    Time: 12 weeks

    Description: Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging >50% lung involvement, respiratory failure, end organ damage or shock)

    Measure: Severity of COVID-19 infection

    Time: 12 weeks
    86 A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

    In 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.

    NCT04363502
    Conditions
    1. Covid19
    Interventions
    1. Drug: Clazakizumab
    2. Drug: Placebo
    MeSH:Infection

    Primary Outcomes

    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 days
    87 A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)

    This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.

    NCT04363866
    Conditions
    1. COVID-19
    2. SARS-CoV-2
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo

    Primary Outcomes

    Description: A 6-point ordinal scale ranging from "Death" to "Not hospitalized with full resumption of normal activities" is used to evaluate differences in the clinical status between participants that receive placebo vs hydroxychloroquine

    Measure: Clinical Status at Day 5 Assessed by a 6-Point Ordinal Scale

    Time: Day 5

    Secondary Outcomes

    Description: Assess differences in SARS-CoV-2 viral shedding between participants that receive placebo vs hydroxychloroquine

    Measure: Number of Participants with Detectable SARS-CoV-2 Virus from Day 0 to Day 28 and at Day 5

    Time: Day 0 to Day 28 and at Day 5

    Description: Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)

    Measure: Toxicity of Study Drug Assessed by Incidence of Adverse Events

    Time: Day 0 to Day 28

    Other Outcomes

    Description: Assess length of hospitalization

    Measure: Duration of Initial Hospitalization

    Time: Day 0 to Day 28

    Description: Assess number of deaths during study follow-up

    Measure: Mortality During Follow-Up

    Time: Day 0 to Day 28

    Description: Assess number of deaths in the hospital during initial hospitalization

    Measure: Mortality During Initial Hospitalization

    Time: Day 0 to Day 28

    Description: Assessing utilization of hospital resources

    Measure: Incidence of New Hospital Resource Utilization

    Time: Day 0 to Day 28

    Description: Assessing duration of hospital resource utilization

    Measure: Duration of Hospital Resource Utilization

    Time: Day 0 to Day 28

    Description: Provide preliminary characterization of differences in inflammatory response between participants that receive placebo vs hydroxychloroquine

    Measure: Changes in Cytokine Profile

    Time: Day 0 to Day 28
    88 Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

    Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.

    NCT04365985
    Conditions
    1. COVID-19
    2. Acute Respiratory Distress Syndrome
    3. Severe Acute Respiratory Syndrome (SARS)
    4. Coronavirus Infections
    Interventions
    1. Drug: Naltrexone
    2. Drug: Ketamine
    3. Other: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

    Primary Outcomes

    Description: Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation)

    Measure: Progression of oxygenation needs

    Time: up to 1 month

    Secondary Outcomes

    Description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.

    Measure: Renal failure

    Time: up to 1 month

    Description: Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits

    Measure: Liver failure

    Time: up to 1 month

    Description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)

    Measure: Cytokine Storm

    Time: up to 1 month

    Description: Count of participants who die from COVID-19

    Measure: Mortality

    Time: up to 1 month post hospital discharge

    Description: Length of hospital stay in days

    Measure: Length of hospital stay

    Time: up to 1 month

    Description: Count of patients admitted to the ICU at any time during index hospitalization

    Measure: Intensive Care Unit (ICU) admission

    Time: up to 1 month

    Description: Length of ICU stay in days

    Measure: Intensive Care Unit (ICU) duration

    Time: up to 1 month

    Description: Count of participants requiring intubation

    Measure: Intubation

    Time: up to 1 month

    Description: Length of intubation, measured in days

    Measure: Intubation duration

    Time: up to 1 month

    Description: Time measured in days from hospital admission to determination patient is stable for discharge

    Measure: Time until recovery

    Time: up to 1 month
    89 A Randomized, Double-Blind, Placebo-Controlled, Phase 1/2 Study Evaluating AVM0703 in Patients With COVID-19

    This is a randomized, double-blind, placebo-controlled, single-ascending dose study of AVM0703 administered as a single intravenous (IV) infusion to patients with COVID-19. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single-ascending dosing of AVM0703 in patients with COVID-19.

    NCT04366115
    Conditions
    1. Covid19
    2. Acute Respiratory Distress Syndrome
    Interventions
    1. Drug: AVM0703
    2. Drug: Placebo
    3. Drug: hydrocortisone
    MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    Description: The primary endpoint of the Phase 1 portion of the study is to evaluate the safety of AVM0703 in subjects with severe or life-threatening COVID-19 infection, and to identify the RP2D.

    Measure: Dose-Limiting Toxicities

    Time: 0-12 months

    Description: The primary endpoint of the Phase 1/2 portion of the study is to evaluate the efficacy of AVM0703 in subjects with severe or life-threatening COVID-19 infection.

    Measure: 28 day all-cause mortality will be a primary end point for Phase 1 and 2

    Time: 0-12 months
    90 A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19)

    Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to COVID-19.

    NCT04367077
    Conditions
    1. ARDS
    Interventions
    1. Biological: MultiStem
    2. Biological: Placebo

    Primary Outcomes

    Measure: Ventilator-Free Days

    Time: Day 0 through Day 28.

    Measure: Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.

    Time: Day 28

    Secondary Outcomes

    Measure: All-cause mortality

    Time: Day 60

    Measure: Ranked hierarchical composite outcome of alive and ventilator-free

    Time: Day 28

    Measure: Ventilator-free days

    Time: Day 0 through Day 60
    91 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

    This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).

    NCT04368728
    Conditions
    1. SARS-CoV-2 Infection
    2. COVID-19
    Interventions
    1. Biological: BNT162b1
    2. Biological: BNT162b2
    3. Other: Placebo

    Primary Outcomes

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: Percentage of participants in Phase 1 reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: Percentage of participants in Phase 1 reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 1 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 1 reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 2

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between baseline and 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between baseline and 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

    Time: Between before dose 2 and 7 days after dose 2

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 2/3 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants in Phase 2/3 reporting serious adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: As elicited by investigational site staff

    Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events

    Time: From dose 1 through 1 month after the last dose

    Description: As elicited by investigational site staff

    Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events

    Time: From dose 1 through 6 months after the last dose

    Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.

    Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions

    Time: For 7 days after dose 1 and dose 2

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

    Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events

    Time: For 7 days after dose 1 and dose 2

    Secondary Outcomes

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point

    Time: Through 2 years after the final dose

    Description: As measured at the central laboratory

    Measure: In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels

    Time: Through 2 years after the final dose

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: Per 1000 person-years of follow-up

    Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination

    Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 years

    Description: As measured at the central laboratory

    Measure: GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age)

    Time: 1 month after the second dose
    92 A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic

    Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.

    NCT04369365
    Conditions
    1. COVID
    Interventions
    1. Drug: Azithromycin 500 milligram (mg) oral Tablet
    2. Drug: Placebo
    MeSH:Virus Diseases Coronavirus Infections

    Primary Outcomes

    Description: assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)

    Measure: Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections

    Time: 12 weeks after initiation of therapy

    Secondary Outcomes

    Description: defined as combined endpoint of hospitalization rate or death

    Measure: Number of severe COVID-19 cases

    Time: 12 weeks after initiation of therapy

    Description: grading as outlined by the world health organization (WHO)

    Measure: Severity of COVID-19 cases

    Time: 12 weeks after initiation of therapy

    Description: significant clinical and laboratory abnormalities according to CTCAE criteria

    Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time: 12 weeks after initiation of therapy

    Description: other than COVID-19

    Measure: Number of viral and bacterial infections

    Time: 12 weeks after initiation of therapy

    Description: Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test

    Measure: Number of participants with azithromycin-resistant bacterial strains in nasal swabs test

    Time: 12 weeks after initiation of therapy
    93 COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement

    To date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).

    NCT04369794
    Conditions
    1. COVID-19
    2. Therapeutic Vaccine
    3. BCG
    4. SARS-CoV 2
    5. Transmission
    Interventions
    1. Biological: BCG
    2. Biological: Placebo

    Primary Outcomes

    Description: Classified as mild, moderate and severe

    Measure: Clinical evolution of COVID-19

    Time: 45 days of symptoms onset or diagnosis

    Description: Virus detection by PCR

    Measure: SARS-CoV-2 elimination

    Time: 7 days of symptoms onset or diagnosis

    Description: Titration of anti SARS-CoV-2 IgA, IgM and IgG

    Measure: Seroconversion rate and titration

    Time: 7 days of symptoms onset or diagnosis

    Secondary Outcomes

    Description: Classified according to type and severity

    Measure: Local and systemic adverse events to BCG vaccination

    Time: 3 months

    Other Outcomes

    Description: Virus detection by PCR

    Measure: SARS-CoV-2 elimination

    Time: 21 days of symptoms onset or diagnosis

    Description: Titration of anti SARS-CoV-2 IgA, IgM and IgG

    Measure: Seroconversion rate

    Time: 21 days of symptoms onset or diagnosis

    Description: Virus detection by PCR

    Measure: SARS-CoV-2 elimination

    Time: 45 days of symptoms onset or diagnosis

    Description: Titration of anti SARS-CoV-2 IgA, IgM and IgG

    Measure: Seroconversion rate and titration

    Time: 45 days of symptoms onset or diagnosis
    94 A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)

    The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

    NCT04370236
    Conditions
    1. COVID-19
    Interventions
    1. Drug: INB03
    2. Drug: Placebo

    Primary Outcomes

    Description: Disease progression is defined by the development of need for mechanical ventilation or death. Mechanical ventilation includes CPAP, BIPAP or mechanical ventilation requiring intubation.

    Measure: Proportion of participants with disease progression from randomization to 28 days post-randomization

    Time: 28 days

    Secondary Outcomes

    Measure: Proportion of participants with all-cause mortality

    Time: 28 days

    Measure: Proportion of participants who transfer to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is < 4);

    Time: 28 days

    Measure: Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;

    Time: 28 days

    Measure: Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;

    Time: 28 days

    Measure: Proportion of participants with a new onset embolus or thrombus by Day 28;

    Time: 28 days

    Measure: Proportion of participants who develop a need for renal replacement therapy (defined as need for any type of dialysis including intermittent or continuous peritoneal or hemodialysis) by Day 28;

    Time: 28 days

    Measure: Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study;

    Time: 28 days

    Measure: Length of hospital stay defined as the number of days in hospital from time of randomization to time of discharge or death, whichever occurs first;

    Time: 28 days

    Measure: Change from baseline in inflammation markers over time.

    Time: 28 days

    Other Outcomes

    Measure: Incidence of adverse events and serious adverse events not due to underlying disease

    Time: 28 days

    Measure: Incidence of abnormal findings in clinical safety laboratory parameters, vital signs, and ECGs.

    Time: 28 days
    95 A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia

    The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).

    NCT04371367
    Conditions
    1. COVID
    Interventions
    1. Biological: avdoralimab
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: improvement of WHO ordinal scale

    Measure: Clinical improvement using WHO ordinal scale

    Time: day 28

    Description: Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU

    Measure: Number of ventilator-free days at Day 28 (VFD28)

    Time: day 28

    Secondary Outcomes

    Measure: Number of participants with treatment-related adverse events

    Time: day 28
    96 Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome

    The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

    NCT04371393
    Conditions
    1. Mesenchymal Stromal Cells
    2. Remestemcel-L
    3. Acute Respiratory Distress Syndrome
    4. COVID
    Interventions
    1. Biological: Remestemcel-L
    2. Drug: Placebo
    MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

    Primary Outcomes

    Description: Number of all-cause mortality within 30 days of randomization.

    Measure: Number of all-cause mortality

    Time: 30 days

    Secondary Outcomes

    Description: Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.

    Measure: Number of days alive off mechanical ventilatory support

    Time: 60 days

    Description: Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.

    Measure: Number of adverse events

    Time: 30 days

    Measure: Number of participants alive at day 7

    Time: 7 days

    Measure: Number of participants alive at day 14

    Time: 14 days

    Measure: Number of participants alive at day 60

    Time: 60 days

    Measure: Number of participants alive at day 90

    Time: 90 days

    Measure: Number of participants alive at 12 Months

    Time: 12 Months

    Description: The number and percent of patients with resolution and/or improvement of ARDS at day 7

    Measure: Number of participants with resolution and/or improvement of ARDS

    Time: 7 days

    Description: The number and percent of patients with resolution and/or improvement of ARDS at day 14

    Measure: Number of participants with resolution and/or improvement of ARDS

    Time: 14 days

    Description: The number and percent of patients with resolution and/or improvement of ARDS at day 21

    Measure: Number of participants with resolution and/or improvement of ARDS

    Time: 21 days

    Description: The number and percent of patients with resolution and/or improvement of ARDS at day 30

    Measure: Number of participants with resolution and/or improvement of ARDS

    Time: 30 days

    Description: severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

    Measure: Severity of ARDS

    Time: baseline and 7 days

    Description: severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

    Measure: Severity of ARDS

    Time: baseline and 14 days

    Description: severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

    Measure: Severity of ARDS

    Time: baseline and 21 days

    Description: severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

    Measure: Severity of ARDS

    Time: baseline and 30 days

    Description: Hospital length of stay

    Measure: Length of stay

    Time: 12 months

    Description: number of readmission

    Measure: Readmissions

    Time: 12 months

    Measure: Length of Stay in Intensive Care Unit

    Time: 12 months

    Description: Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.

    Measure: Clinical Improvement Scale

    Time: 7 days

    Description: Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.

    Measure: Clinical Improvement Scale

    Time: 14 days

    Description: Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.

    Measure: Clinical Improvement Scale

    Time: 21 days

    Description: Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.

    Measure: Clinical Improvement Scale

    Time: 30 days

    Description: Changes from baseline in plasma hs-CRP concentration at days 7

    Measure: Change in plasma hs-CRP concentration

    Time: baseline and 7 days

    Description: Changes from baseline in plasma hs-CRP concentration at days 14

    Measure: Change in plasma hs-CRP concentration

    Time: baseline and 14 days

    Description: Changes from baseline in plasma hs-CRP concentration at days 21

    Measure: Change in plasma hs-CRP concentration

    Time: baseline and 21 days

    Description: Changes from baseline in serum hs-CRP concentration at days 30

    Measure: Change in serum hs-CRP concentration

    Time: baseline and 30 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 7 days

    Measure: Change in IL-6 inflammatory marker level

    Time: baseline and 7 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 14 days

    Measure: Change in IL-6 inflammatory marker level

    Time: baseline and 14 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 21 days

    Measure: Change in IL-6 inflammatory marker level

    Time: baseline and 21 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 30 days

    Measure: Change in IL-6 inflammatory marker level

    Time: baseline and 30 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 7 days

    Measure: Change in IL-8 inflammatory marker level

    Time: baseline and 7 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 21 days

    Measure: Change in IL-8 inflammatory marker level

    Time: baseline and 21 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 14 days

    Measure: Change in IL-8 inflammatory marker level

    Time: baseline and 14 days

    Description: Changes from baseline in IL-6 inflammatory marker level at 30 days

    Measure: Change in IL-8 inflammatory marker level

    Time: baseline and 30 days

    Description: Changes from baseline in TNF-alpha inflammatory marker level at 7 days

    Measure: Change in TNF-alpha inflammatory marker level

    Time: baseline and 7 days

    Description: Changes from baseline in TNF-alpha inflammatory marker level at 14 days

    Measure: Change in TNF-alpha inflammatory marker level

    Time: baseline and 14 days

    Description: Changes from baseline in TNF-alpha inflammatory marker level at 21 days

    Measure: Change in TNF-alpha inflammatory marker level

    Time: baseline and 21 days

    Description: Changes from baseline in TNF-alpha inflammatory marker level at 30 days

    Measure: Change in TNF-alpha inflammatory marker level

    Time: baseline and 30 days

    Description: including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization

    Measure: Pulmonary symptoms

    Time: 6 months

    Description: including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization

    Measure: Pulmonary symptoms

    Time: 12 months
    97 A Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Virological Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sirolimus Adjuvant Therapy in Patients With Coronavirus Disease (COVID-19)

    This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.

    NCT04371640
    Conditions
    1. SARS-CoV-2
    2. Covid-19
    Interventions
    1. Drug: Sirolimus 1 MG/ML
    2. Drug: Placebo

    Primary Outcomes

    Description: SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR

    Measure: Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment

    Time: Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients

    Secondary Outcomes

    Description: SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR

    Measure: Change in SARS-CoV-2 viral burden at days 1-6

    Time: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients

    Description: Safety and tolerability of sirolimus in patients with COVID-19

    Measure: Rate of treatment emergent adverse events

    Time: Days 1, 2, 3, 4, 5, and 6 post-dose for all patients
    98 Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study

    The aim of the study is to compare a treatment with doxycycline vs a placebo as soon as the patient is confirmed COVID-19 + and before the onset of oxygen dependence with the aim of reducing or even abolishing the cytokine explosion and thus the evolution towards a serious form of the disease which can lead to death. Three criteria support the rational use of tetrcycline in COVI-19 (1) The coronaviruses is known to bind to metalloproteases (MMPs) of the host, in particular to ensure viral survival. Tetracyclines are known to chelate zinc from MMPs. Their chelating activity may help inhibit COVID19 infection by limiting its ability to replicate in the host. (2) Tetracyclines may also be able to inhibit the replication of positive-polarity single-stranded RNA viruses, such as COVID19 (demonstrated on the dengue virus). (3) In addition, tetracyclines are modulators of innate immunity (anti-inflammatory activity), a property used in the treatment of inflammatory skin diseases for many years. These modulating effects are noted on several targets of innate immunity: They can decrease the expression of NFKB, the release of inflammatory cytokines such as TNF-α, IL-1β and IL-6, inhibit granulomas inflammatory and free radical release. Tetracyclines could therefore participate in limiting the cytokine release induced by COVID19. Their lipophilic nature and their strong pulmonary penetration could allow them to inhibit viral replication.

    NCT04371952
    Conditions
    1. COVID19
    Interventions
    1. Drug: Doxycycline
    2. Drug: Placebo

    Primary Outcomes

    Description: Percentage of patients with clinical worsening (SaO2 ≤ 93%) after at least 48 hours of treatment

    Measure: Percentage of Patients with Clinical Respiratory Aggravation

    Time: after at least 48 hours of treatment

    Description: Percentage of patients hospitalized after at least 48 hours of experimental treatment

    Measure: Percentage of patients hospitalized

    Time: after at least 48 hours of experimental treatment

    Description: Percentage of patients requiring ventilatory assistance

    Measure: Percentage of patients requiring ventilatory assistance

    Time: Day 0 to Day 28

    Secondary Outcomes

    Description: Number of positive SARS-CoV-2 PCR tests on D-1 / D0 and D7 (+/- 2 days)

    Measure: Positive SARS-CoV-2 PCR Test

    Time: Day -1 or day 0 AND Day 7

    Description: Duration of symptoms (fever, painful symptoms: headache, sore throat, dyspnea)

    Measure: Duration of symptoms

    Time: Day 0 to Day 28

    Description: Total duration of hospitalization

    Measure: Duration of hospitalization

    Time: From day 0 until to the end of hospitalization or date of death for any cause, whichever came first, assessed up to 3 months after Day0

    Description: Duration of hospitalization in intensive care or reanimation

    Measure: Hospitalization intensive care or reanimation

    Time: From day 0 until to the end of hospitalization or date of death for any cause, whichever came first, assessed up to 3 months after Day0

    Description: Duration of mechanical ventilatory assistance

    Measure: Duration of mechanical ventilatory assistance

    Time: to the end of mechanical ventilatory assistance if any, assessed up to 3 months after Day0

    Description: Percentage of deaths related to SARS-CoV-2 infection

    Measure: Percentage of deaths related to SARS-CoV-2

    Time: Day 28, or end of hospitalization if any (assessed up to 3 months after Day0)

    Description: Number of AE / SAE in both arms

    Measure: AE / SAE in both arms

    Time: Day 28, or end of hospitalization if any (assessed up to 3 months after Day0)
    99 A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia

    This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia, and b) include an optional substudy to explore the long-term sequelae of resolved COVID-19 pneumonia.

    NCT04372186
    Conditions
    1. COVID-19 Pneumonia
    Interventions
    1. Drug: Placebo
    2. Drug: Tocilizumab
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Measure: Cumulative Proportion of Participants Requiring Mechanical Ventilation by Day 28

    Time: Up to Day 28

    Secondary Outcomes

    Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status

    Time: Up to Day 28

    Measure: Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first)

    Time: Up to Day 28

    Measure: Mortality Rate by Day 28

    Time: Up to Day 28

    Measure: Time to Hospital Discharge or "Ready for Discharge" (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or >/= 2 liters (L) supplemental oxygen)

    Time: Up to Day 28

    Measure: Percentage of Participants with Adverse Events

    Time: Up to Day 60

    Measure: Percentage of Participants with any Post-Treatment Bacterial and/or Fungal Infection

    Time: Up to Day 60

    Measure: Incidence of Post-Treatment Acute Kidney injury (defined by 50% increase of creatinine from baseline)

    Time: Up to Day 60
    100 A Pilot Study of Duvelisib to Combat COVID-19

    The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes.

    NCT04372602
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Duvelisib
    2. Procedure: Peripheral blood draw
    3. Drug: Placebo

    Primary Outcomes

    Measure: Overall survival

    Time: Through 28 days

    Secondary Outcomes

    Measure: Length of hospital stay

    Time: Through completion of follow-up (estimated to be 7 months)

    Measure: Length of ICU stay

    Time: Through completion of follow-up (estimated to be 7 months)

    Description: -For those on a ventilator at the time of randomization

    Measure: Duration of ventilator use

    Time: Through completion of follow-up (estimated to be 7 months)

    Measure: Duration of vasopressors use

    Time: Through completion of follow-up (estimated to be 7 months)

    Measure: Duration on renal replacement therapy

    Time: Through completion of follow-up (estimated to be 7 months)

    Description: -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing

    Measure: Viral kinetics as measured by virologic failure

    Time: Through completion of follow-up (estimated to be 7 months)

    Measure: Number of adverse events as measured by CTCAE v. 5.0

    Time: Through completion of follow-up (estimated to be 7 months)
    101 Trial of Early Therapies During Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19

    Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19

    NCT04372628
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Lopinavir/Ritonavir 400 mg/100 mg
    2. Other: Placebo

    Primary Outcomes

    Description: Death Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO) Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with symptoms and limitation in activity Not hospitalized with symptoms but with no limitation in activity Not hospitalized without symptoms nor limitation in activity symptoms at the milder end of the scale for this outpatient trial

    Measure: Modified COVID Ordinal Outcomes Scale: Study Day 15

    Time: Day 15

    Secondary Outcomes

    Description: Death Hospitalized on mechanical ventilation or ECMO Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with symptoms and limitation in activity Not hospitalized with symptoms but with no limitation in activity Not hospitalized without symptoms nor limitation in activity

    Measure: Modified COVID Ordinal Outcome Scale: Study Day 8

    Time: Day 8

    Description: Death Hospitalized on mechanical ventilation or ECMO Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with symptoms and limitation in activity Not hospitalized with symptoms but with no limitation in activity Not hospitalized without symptoms nor limitation in activity Ordinal Scale

    Measure: Modified COVID Ordinal Outcome Scale: Study Day 29

    Time: Day 29

    Description: Proportion hospitalized

    Measure: Proportion of patients hospitalized: Day 1 to 29

    Time: Day 1 to Day 29

    Description: Number of days from enrollment to hospitalization

    Measure: Time to hospitalization Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Number of days from enrollment to resolution of COVID-19 symptoms

    Measure: Time to symptom resolution: Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Survival status

    Measure: All-cause, all-location mortality: Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Number of Days without oxygen

    Measure: Oxygen-free days: Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Number of days without fever

    Measure: Fever-free days: Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Number of days without ventilator use

    Measure: Ventilator-free days: Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Number of days outside the ICU

    Measure: ICU-free days: Day 1 to Day 29

    Time: Day 1 to Day 29

    Description: Number of days outside the hospital

    Measure: Hospital-free days: Day 1 to Day 29

    Time: Day 1 to Day 29
    102 RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics

    The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While there are no known therapies to treat those who have become sick, there have been some reports that a medication currently used to treat rheumatoid arthritis, lupus, and malaria (Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or severity of illness, especially if combined with a medicine that treats other kinds of infections (Azithromycin, also known as Zithromax or Zmax or Zpak). There are some people who test positive for the virus but who are otherwise not ill. Current standard of care is to advise these people to self-monitor but no treatment is offered. It is not known how many of these individuals will remain symptom free, and how many will become sick or how severe those symptoms will be. This study will randomize those people who do not have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2) no active medication (placebo). All participants will be followed for 2 months. The study will determine if there is any benefit to those who are asymptomatic to taking taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit from taking these medications.

    NCT04374552
    Conditions
    1. SARS-CoV-2 Infection
    Interventions
    1. Drug: Hydroxychloroquine sulfate &Azithromycin
    2. Drug: Placebo

    Primary Outcomes

    Description: Change in SARS-CoV-2 viral from baseline to day 6

    Measure: The primary outcome is the rate of decline in viral load over the 10 days after randomization

    Time: 10 days
    103 IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)

    Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection. Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States. Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

    NCT04375397
    Conditions
    1. CoronaVirus Induced Disease-2019 (COVID-19)
    Interventions
    1. Drug: Ibrutinib
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Lung Injury

    Primary Outcomes

    Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.

    Measure: Percentage of Participants Alive and Without Respiratory Failure

    Time: Day 28

    Secondary Outcomes

    Description: WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).

    Measure: Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline

    Time: Day 14

    Description: Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.

    Measure: Median Reduction in Days Spent on Supplemental Oxygen

    Time: Up to Day 28

    Description: Percentage of participants with mortality from any cause.

    Measure: All-Cause Mortality

    Time: Up to Day 28

    Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.

    Measure: Percentage of Participants Experiencing Respiratory Failure or Death

    Time: Up to Day 28

    Description: Percentage of participants alive and not requiring mechanical ventilation.

    Measure: Mechanical Ventilation-Free Survival

    Time: Up to Day 56

    Description: Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.

    Measure: Days on Mechanical Ventilation

    Time: Up to Day 56

    Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.

    Measure: Duration of hospitalization

    Time: Up to Day 56

    Description: Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.

    Measure: Time to Discharge

    Time: Up to Day 56

    Description: PaO2:FiO2 ratio is an index of respiratory distress.

    Measure: Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio

    Time: Up to Day 56

    Description: Oxygenation Index is a parameter of pulmonary function of participants.

    Measure: Oxygenation Index

    Time: Up to Day 56

    Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measure: Number of Participants With Adverse Events

    Time: Up to Day 56

    Description: Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measure: Number of Participants With Abnormal Laboratory Findings

    Time: Up to Day 56
    104 A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

    OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of participants with severe COVID-19 related pulmonary disease. The study population will consist of hospitalized participants with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.

    NCT04376684
    Conditions
    1. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: Otilimab
    2. Biological: Placebo
    3. Drug: Standard of care
    MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

    Primary Outcomes

    Description: Participants are alive and free of respiratory failure if they are in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

    Measure: Proportion of participants alive and free of respiratory failure at Day 28

    Time: Day 28

    Secondary Outcomes

    Description: Number of deaths due to all causes will be assessed.

    Measure: Number of deaths due to all causes at Day 60

    Time: Day 60

    Description: Time to death due to all causes will be assessed.

    Measure: Time to number of deaths due to all causes up to Day 60

    Time: Up to Day 60

    Description: Participants alive and free of respiratory failure if they are in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

    Measure: Proportion of participants alive and free of respiratory failure at Days 7, 14, 42 and 60

    Time: Days 7, 14, 42, and 60

    Description: Time will be recorded from dosing to recovery from respiratory failure. Participants are in respiratory failure if they are in category 5 or above from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

    Measure: Time to recovery from respiratory failure

    Time: Up to Day 28

    Description: Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

    Measure: Proportion of participants alive and independent of supplementary oxygen at Days 7, 14, 28, 42, and 60

    Time: Days 7, 14, 28, 42, and 60

    Description: Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

    Measure: Time to last dependence on supplementary oxygen

    Time: Up to Day 28

    Description: For participants not in ICU at time of dosing, the proportion of participants admitted to the ICU prior to Day 28.

    Measure: Proportion of participants admitted to Intensive Care Unit (ICU)

    Time: Up to Day 28

    Description: Defined as the time from dosing to when the participant is discharged from the ICU.

    Measure: Time to final ICU discharge

    Time: Up to Day 28

    Description: Time from dosing to when a participant is discharged from the hospital.

    Measure: Time to final hospital discharge

    Time: Up to Day 28

    Description: AEs and SAEs will be collected.

    Measure: Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)

    Time: Up to Day 60
    105 A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

    The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.

    NCT04377620
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Placebo
    2. Drug: Ruxolitinib

    Primary Outcomes

    Description: To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.

    Measure: Proportion of participants who have died due to any cause

    Time: Up to Day 29

    Secondary Outcomes

    Description: Number of days participant did not require mechanical ventilation

    Measure: Number of Ventilator free days

    Time: Day 29

    Description: Number of days participant is out of the ICU

    Measure: Number of ICU free days

    Time: Day 29

    Description: Number of days participant did not receive supplemental oxygen

    Measure: Oxygen free days

    Time: Day 29

    Description: Number of days without use of vasopressor therapy

    Measure: Vasopressor free days

    Time: Day 29

    Description: Number of days Partcipant is out of the hospital

    Measure: Hospital free days

    Time: Day 29

    Description: Clinical status of participant at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead

    Measure: Improvement in the COVID-19 ordinal scale

    Time: Day 15 and 29

    Description: SOFA score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems.

    Measure: Change in SOFA Score

    Time: from baseline to Days 3, 5, 8, 11, 15, and 29

    Description: Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Measure: Number of treatment-related adverse events

    Time: Day 29
    106 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ciclesonide Metered-Dose Inhaler in Non-hospitalized Patients 12 Years of Age and Older With Symptomatic COVID-19 Infection

    The purpose of this study is to assess the safety and efficacy of Alvesco (ciclesonide) Inhalation Aerosol in non hospitalized patients with symptomatic COVID-19 infection in a multicenter, randomized, double-blind, placebo controlled study

    NCT04377711
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Ciclesonide
    2. Drug: Placebo

    Primary Outcomes

    Measure: Percentage of patients hospital admission or death by day 30

    Time: Day 30

    Secondary Outcomes

    Measure: All-cause mortality by day 30

    Time: Day 30

    Measure: COVID-19-related mortality by day 30

    Time: Day 30

    Measure: Percentage of patients with subsequent emergency department visit or hospital admission for reasons attributable to COVID 19 by day 30

    Time: Day 30

    Measure: Time to hospital admission or death

    Time: Day 30

    Measure: Time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, and feeling feverish, defined as symptom-free for a continuous period of more than 24 hours (ie, > 3 AM/PM assessments)

    Time: Day 30

    Measure: Change from baseline in oxygen saturation levels

    Time: Day 30

    Measure: Change from baseline in COVID-19 viral load in nasopharyngel sample nasal secretions at day 30

    Time: Day 30

    Measure: Safety will be assessed based on adverse events.

    Time: Day 60
    107 A Prospective, Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19

    At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor's choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood. Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies.

    NCT04379271
    Conditions
    1. COVID-19
    Interventions
    1. Drug: IMU-838
    2. Other: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Clinical

    Measure: Proportion of patients without any need* for INV until end-of-study (EoS)

    Time: Throughout the Study (Day 0 to Day 28)

    Secondary Outcomes

    Description: Key Secondary

    Measure: Duration of ICU treatment until EoS

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Key Secondary

    Measure: 28-day all-cause mortality

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy: defined as the time from first dose of investigational medicinal product (IMP) to an improvement of at least 2 points on the WHO 9 category ordinal scale , or live discharge from hospital without oxygen supplementation, whichever comes first

    Measure: Time to clinical improvement

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy: Duration of hospitalization (for US sites only: or treatment in special outpatient setting in lieu of hospitalization due to resource restraints)

    Measure: Duration of hospitalization

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients both for all patients and surviving patients free of renal-replacement therapy (RRT)* until EoS

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients both for all patients and surviving patients free from extracorporeal membrane oxygenation (ECMO)* until EoS

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients free of INV until Days 6 and 14*

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients free of RRT until Days 6 and 14*

    Time: Day 0 to Days 6 and 14

    Description: Efficacy

    Measure: Proportion of patients free ECMO until Days 6 and 14*

    Time: Day 0 to Days 6 and 14

    Description: Efficacy

    Measure: Proportion of patients with improvement of at least 2 points (from randomization) on the 9-category WHO ordinal scale1 on Days 6, 14, and 28

    Time: on Days 6, 14, and 28

    Description: Efficacy

    Measure: Proportion of patients with auxiliary oxygen therapy (including all types of oxygen therapy) on Days 6, 14, and 28

    Time: on Days 6, 14, and 28

    Description: Efficacy

    Measure: Proportion of patients with clinical recovery: Axillary temperature ≤36.6 ℃, or oral temperature ≤37.2 ℃, or rectal or tympanic temperature ≤37.8 ℃;

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients with clinical recovery: Respiratory frequency ≤24 times/min without oxygen inhalation; and

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients with clinical recovery: Oxygen saturation ≥98% without oxygen inhalation

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Proportion of patients with clinical improvement, defined as the time from first dose of IMP to an improvement of at least 2 points on the WHO 9 category ordinal scale, or live discharge from hospital without oxygen supplementation, whichever comes first

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Clinical patient status on the 9-category WHO ordinal scale1 on Days 6, 14, and 28

    Time: on Days 6, 14, and 28

    Description: Efficacy

    Measure: Duration of INV

    Time: Throughout the Study (Day 0 to Day 28 )

    Description: Efficacy

    Measure: Duration of ECMO

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Duration of RRT

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Duration of auxiliary oxygen therapy (including all types of oxygen therapy)

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Duration of hospitalization for survivors

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: The rate of ICU* admission on Days 6, 14, and 28

    Time: on Days 6, 14, and 28

    Description: Efficacy

    Measure: Hospital-free days

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Time from IMP treatment initiation to death

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Time to first prescription of INV

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Time to first prescription of RRT

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Time to first prescription of ECMO

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Time to first prescription of INV, RRT, and ECMO

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Time to ICU admission

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Efficacy

    Measure: Cumulative dose of vasoactive therapies and days with vasoactive therapies (daily until Day 14)

    Time: Day 0 to day 14

    Description: Efficacy

    Measure: Time to clinical recovery

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Pharmacokinetics

    Measure: Morning trough plasma levels of IMU-838 on Days 0, 1, 2, 3, 6, 14, and 28

    Time: on Days 0, 1, 2, 3, 6, 14, and 28

    Description: Pharmacokinetics

    Measure: Correlation of trough levels (quartiles) to selected clinical outcomes (Clinical improvement accoding to WHO criteria)

    Time: on Days 0, 1, 2, 3, 6, 14, and 28

    Description: Safety

    Measure: Adverse events (AEs) and serious AEs

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety Height in centimeters will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

    Measure: Vital signs: height

    Time: only at Screening

    Description: Safety Weight in kilograms will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

    Measure: Vital signs: weight

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety Body temperature can be measured axillary, oral, rectal or tympanic, but should be always measured by the same method for a patient. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

    Measure: Vital signs: body temperature (ºC)

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety Pulse must be measured with the patient in a seated position (if possible), after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

    Measure: Vital signs: pulse rates,

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety Blood pressure (systolic and diastolic) must be measured with the patient in a seated position (if possible), after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

    Measure: Vital signs: systolic and diastolic blood pressures

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety

    Measure: Clinical laboratory parameters: blood chemistry

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety

    Measure: Clinical laboratory parameters: hematology

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety

    Measure: Clinical laboratory parameters: urinalysis

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Safety

    Measure: 12-lead electrocardiogram: heart rate

    Time: Day 0 to Day 6 and Day 28

    Description: Safety

    Measure: 12-lead electrocardiogram: PQ-interval

    Time: Day 0 to Day 6 and Day 28

    Description: Safety

    Measure: 12-lead electrocardiogram: QRS-interval

    Time: Day 0 to Day 6 and Day 28

    Description: Safety

    Measure: 12-lead electrocardiogram: QT interval

    Time: Day 0 to Day 6 and Day 28

    Description: Safety

    Measure: 12-lead electrocardiogram: the heart rate-corrected QTc interval (according to Bazett's formula)

    Time: Day 0 to Day 6 and Day 28

    Description: Safety

    Measure: Temperature

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Disease markers

    Measure: D-dimer

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Disease markers

    Measure: Lactate dehydrogenase (LDH)

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Disease markers

    Measure: C-reactive protein

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Disease markers

    Measure: Troponin I

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Disease markers

    Measure: Procalcitonin

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Disease markers

    Measure: Correlation of disease markers to selected clinical outcomes (Clinical improvement accoding to WHO criteria)

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Virologic markers

    Measure: Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Decrease of SARS-CoV-2 viral load

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Virologic markers

    Measure: Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Time course of SARS-CoV-2 viral load

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Virologic markers

    Measure: Qualitative virologic clearance in spontaneous sputum and nasopharyngeal swab samples (= 2 consecutive negative SARS-CoV-2 reverse transcriptase polymerase chain reaction tests at least 24 hours apart)

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Virologic markers

    Measure: Rate of conversion to a negative SARS-CoV-2 (qualitative) test on Days 6, 14 and 28

    Time: on Days 6, 14 and 28

    Description: Virologic markers

    Measure: Time to conversion to a negative SARS-CoV-2 (qualitative) test

    Time: Throughout the Study (Day 0 to Day 28)

    Description: Biomarkers

    Measure: Interleukin (IL)-17

    Time: Day 0, 6, 14 and Day 28

    Description: Biomarkers

    Measure: Interleukin (IL)-1ß

    Time: Day 0, 6, 14 and Day 28

    Description: Biomarkers

    Measure: Interleukin (IL)-6

    Time: Day 0, 6, 14 and 28

    Description: Biomarkers

    Measure: interferon gamma (IFNγ)

    Time: Day 0, 6, 14 and 28

    Description: Biomarkers

    Measure: tumor necrosis factor alpha

    Time: Day 0, 6, 14 and 28

    Description: Serologic markers

    Measure: Immunoglobulin (Ig)A and IgG antibodies against SARS-CoV-2: • Time to appearance of IgA and/or IgG antibodies

    Time: Day 0, 6, 14 and 28

    Description: Serologic markers

    Measure: Immunoglobulin (Ig)A and IgG antibodies against SARS-CoV-2: • Proportion of patients with IgA and/or IgG antibodies on Days 6, 14, and 28

    Time: Day 0, 6, 14 and 28
    108 Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

    This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.

    NCT04379492
    Conditions
    1. COVID-19
    2. COVID19
    3. Sars-CoV2
    4. SARS-Cov-2
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo

    Primary Outcomes

    Description: Clinical improvement is defined as a composite endpoint of a two-point clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19

    Measure: Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI)

    Time: 14 days

    Description: Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization.

    Measure: Number of participants requiring mechanical ventilation for respiratory failure

    Time: 14 days
    109 An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)

    The primary objective of the study is to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study

    NCT04380519
    Conditions
    1. COVID-19
    Interventions
    1. Biological: RPH-104 80 mg
    2. Drug: Olokizumab 64 mg
    3. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Proportion of patients, responded to the study therapy, in each of the treatment groups. The patient can be considered as the therapy responder, in case tocilizumab or sarilumab were not administered and there is an improvement of a clinical status at least by 1 point on a 6-points COVID-19 scale, where 1 point means most favorable outcome, 6 points means most undesirable outcome.

    Measure: Proportion of patients, responded to the study therapy, in each of the treatment groups

    Time: Day 15

    Secondary Outcomes

    Description: Changes of patients' clinical status on a 6 points ordinal scale over time

    Measure: Changes of patients' clinical status on a 6 points ordinal scale over time

    Time: from Day 2 until Day 15, Day 29

    Description: Mortality rate over the follow-up period

    Measure: Mortality rate over the follow-up period

    Time: from Day 1 until Day 29

    Description: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.

    Measure: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.

    Time: on screening and then from Day 1 until Day 29

    Description: Proportion of patients received tocilizumab or sarilumab due to COVID-19

    Measure: Proportion of patients received tocilizumab or sarilumab due to COVID-19

    Time: from Day 1 until the Day 29

    Other Outcomes

    Description: Proportion of patients having National Early Warning Score 2 (NEWS2) of ≤ 4 maintained for 2 consecutive days

    Measure: Proportion of patients having National Early Warning Score 2 of ≤ 4 maintained for 2 consecutive days

    Time: from day 3 until day 15

    Description: Time to a NEWS2 of ≤ 2 maintained for two consecutive days

    Measure: Time to a NEWS2 of ≤ 2 maintained for two consecutive days

    Time: from day 1 until day 15

    Description: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, CRP, ferritin (if applicable), D-dimer (if applicable)

    Measure: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, C-Reactive protein (CRP), ferritin (if applicable), D-dimer (if applicable)

    Time: Day 2, Day 3, Day5, Day 7, Day 15

    Description: Mortality during an ICU stay, on days 7, 15, 29 of the study

    Measure: Mortality during an ICU stay, on days 7, 15, 29 of the study

    Time: On Day 7, Day 15, Day 29

    Description: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days

    Measure: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days

    Time: from Day 2 until Day 15

    Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period

    Measure: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period

    Time: On Day 1 and from Day 2 until Day 15

    Description: Duration of ICU stay measured in days

    Measure: Duration of ICU stay measured in days

    Time: from Day 2 until Day 15

    Description: Changes from baseline (if applicable) in severity of ARDS according to WHO criteria

    Measure: Changes from baseline (if applicable) in severity of Acute Respiratory Distress Syndrome (ARDS) according to World Health Organization (WHO) criteria

    Time: from Day 1 until Day 15

    Description: Duration of mechanical ventilation and EMO (if applicable) measured in days

    Measure: Duration of mechanical ventilation and Extracorporeal Membrane Oxygenation (EMO) (if applicable) measured in days

    Time: from Day 2 until Day 15

    Description: Duration of oxygen support (if applicable) measured in days

    Measure: Duration of oxygen support (if applicable) measured in days

    Time: from Day 1 until Day 15

    Description: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days

    Measure: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days

    Time: from day 3 until day 15

    Description: Time to a NEWS2 of ≤ 4 maintained for two consecutive days

    Measure: Time to a NEWS2 of ≤ 4 maintained for two consecutive days

    Time: from day 1 until day 15

    Description: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)

    Measure: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)

    Time: On Day 1 and from Day 2 until Day 15

    Description: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)

    Measure: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)

    Time: from day 1 until day 15

    Description: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale

    Measure: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale

    Time: from day 1 until day 29

    Description: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale

    Measure: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale

    Time: from day 1 until day 29

    Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study

    Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study

    Time: from Day 1 until Day 29

    Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable

    Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable

    Time: from Day 1 until Day 29

    Description: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)

    Measure: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)

    Time: from Day 1 until Day 29
    110 Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease

    The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.

    NCT04380961
    Conditions
    1. Severe or Critical Confirmed Coronavirus Disease (COVID)-19
    Interventions
    1. Drug: Sirukumab
    2. Drug: Placebo
    3. Other: Standard of Care (SOC)
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Time to improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale. The 6-point ordinal clinical recovery scale provides 6 mutually exclusive conditions ordered from best to worst, and the score reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are : not hospitalized (category 1); Hospitalization; not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO (category 5); death (category 6).

    Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale

    Time: Up to Day 28

    Secondary Outcomes

    Description: Percentage of participants with an improvement of at Least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.

    Measure: Percentage of Participants with an Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28

    Time: Day 28

    Description: Percentage of participants with all-cause mortality will be reported.

    Measure: Percentage of Participants with All-cause Mortality

    Time: Up to Day 28

    Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.

    Measure: Percentage of Participants with Serious Adverse Events (SAEs)

    Time: Up to Day 28

    Description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measure: Percentage of Participants with Related Adverse Events

    Time: Up to Day 28

    Description: Percentage of participants with severe or life-threatening, bacterial, invasive fungal, viral or opportunistic infections (other than severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) will be reported.

    Measure: Percentage of Participants with Severe or Life Threatening Bacterial, Invasive Fungal, Viral or Opportunistic Infections

    Time: Up to Day 28

    Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) neutropenia will be reported.

    Measure: Percentage of Participants with Grade 3 and 4 Neutropenia

    Time: Up to Day 28

    Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) lymphocytopenia will be reported.

    Measure: Percentage of Participants with Grade 3 and 4 Lymphocytopenia

    Time: Up to Day 28

    Description: Percentage of participants with increased ALT >=3 times ULN combined with increased bilirubin >2 times ULN (up to Day 28) will be reported.

    Measure: Percentage of Participants with Increased Alanine Aminotransferase (ALT) Greater than or equal to 3 Times Upper Limit of Normal (ULN) Combined with Increased Bilirubin > 2 Times ULN

    Time: Up to Day 28

    Description: Time to improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale will be reported.

    Measure: Time to Improvement of at least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale

    Time: Up to Day 28

    Description: Percentage of participants with an improvement of at Least 1 category relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.

    Measure: Percentage of Participants with an Improvement of at Least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28

    Time: Day 28

    Description: Time from study intervention to end of oxygen supplementation is defined as achieving category 1 or 2 on the 6-point ordinal clinical recovery scale.

    Measure: Time from Study Intervention to end of Oxygen Supplementation

    Time: Up to Day 28

    Description: Time from study intervention to hospital discharge among the surviving participants will be reported.

    Measure: Time from Study Intervention to Hospital Discharge Among the Surviving Participants

    Time: Up to Day 28

    Description: Total length of hospitalization (days from admission to hospital discharge) among the surviving participants will be reported.

    Measure: Total Length of Hospitalization

    Time: Up to Day 28

    Description: Number of Ventilation free Days will be reported.

    Measure: Number of Ventilation Free Days

    Time: Up to Day 28

    Description: Participant's clinical status at Day 7, 14, 21, 28 will be assessed by 6-point ordinal clinical recovery scale.

    Measure: Participant's Clinical Status at Day 7, 14, 21, 28 as Assessed by 6-Point Ordinal Clinical Recovery Scale

    Time: Day 7, 14, 21, 28

    Description: Total time on invasive mechanical ventilation will be reported.

    Measure: Total Time on Invasive Mechanical Ventilation

    Time: Up to Day 28

    Description: Percentage of participants with a worsening of at least 1 category on the 6-point ordinal clinical recovery scale over time (between Day 5 and Day 28) will be reported.

    Measure: Percentage of Participants with a Worse Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale over Time

    Time: From Day 5 up to Day 28

    Description: Percentage participants on ECMO over time will be reported.

    Measure: Percentage of Participants on Extracorporeal Membrane Oxygenation (ECMO) Over Time

    Time: Up to Day 28

    Description: Total time on ECMO will be reported.

    Measure: Total Time on ECMO

    Time: Up to Day 28

    Description: Percentage of alive participants at Day 28, Week 8 and Week 16 will be reported.

    Measure: Percentage of Alive Participants at Day 28, Week 8 and Week 16

    Time: Day 28, Week 8 and Week 16

    Description: Percentage of alive participants that required readmission (if previously discharged) at Week 8 and Week 16 will be reported.

    Measure: Percentage of Alive Participants that Required Readmission at Week 8 and Week 16

    Time: Week 8 and Week 16

    Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.

    Measure: Percentage of Participants with Serious Adverse Events (SAEs)

    Time: Up to Week 16
    111 A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

    In 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.

    NCT04381052
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Clazakizumab
    2. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    Measure: Cumulative incidence of serious adverse events associated with clazakizumab or placebo

    Time: 60 days

    Secondary Outcomes

    Measure: Cumulative Incidence of Intubation

    Time: 14 days

    Measure: Time to Extubation

    Time: 14 days

    Measure: Length of Intensive Care Unit (ICU) stay

    Time: 14 days

    Measure: Number of Patients who Present a Decrease in C-reactive protein (CRP)

    Time: 14 days

    Measure: Number of Patients with Acute Kidney Injury (AKI)

    Time: 14 days

    Measure: Number of Patients with a Need for Renal Replacement Therapy (RRT)

    Time: 14 days

    Measure: Duration of Renal Replacement Therapy (RRT)

    Time: 60 days

    Description: Number of participants alive at day 28.

    Measure: Patient Survival

    Time: 28 days

    Description: Number of participants alive at day 60, end of study.

    Measure: Patient Survival

    Time: 60 days

    Measure: Number of Patients with Hemodialysis

    Time: 60 days

    Measure: Number of Patients with Continuous Renal Replacement Therapies (CRRT)

    Time: 60 days

    Measure: Number of Patients with Peritoneal Dialysis

    Time: 60 days
    112 A Multi-centre, Adaptive, Randomized, Double-blind, Placebo-controlled Comparative Clinical Study of the Safety and Efficacy of Polyoxidonium®, Lyophilizate for Solution for Injections and Topical Application, 6 mg (NPO Petrovax Pharm LLC, Russia) in Patients With Coronavirus Disease (COVID-19).

    The purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.

    NCT04381377
    Conditions
    1. Infections, Coronavirus
    Interventions
    1. Drug: azoximer bromide
    2. Other: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: The primary efficacy outcome will be defined based on the blinded analysis of data of the first 100 patients in the 1st part of the study. There is uncertainty about the clinical course and potential different trajectories according to baseline disease severity, so the day of the primary endpoint may be modified based on a blinded evaluation of the primary efficacy outcome in various days.

    Measure: Clinical status of the patient (according to 7-point ordinal scale)

    Time: Day 15

    Secondary Outcomes

    Description: Time to improvement by one category from admission on the ordinal scale. Clinical status of the patient. Average change in the ordinal scale from baseline.

    Measure: Clinical status of the patient (according to 7-point ordinal scale)

    Time: Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29.

    Description: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Change in NEWS from baseline.

    Measure: NEWS

    Time: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.

    Description: Oxygenation free days. Incidence and duration of new oxygen use.

    Measure: Oxygenation

    Time: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.

    Description: Ventilator free days. Incidence and duration of new mechanical ventilation use.

    Measure: Mechanical Ventilation

    Time: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.

    Measure: Mortality

    Time: 28-day mortality
    113 A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)

    The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.

    NCT04381988
    Conditions
    1. COVID-19
    2. Cancer
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo
    3. Radiation: Radiation therapy

    Primary Outcomes

    Description: Any patients who are enrolled and subsequently test positive for SARS-CoV-2 by RT-PCR (outside RT-PCR test results allowed) at any point during the 9 weeks following enrollment will be an event that is considered in the 9-week SARS-CoV-2 infection rate primary endpoint.

    Measure: cumulative incidence of SARS-CoV-2 infection

    Time: within 9 weeks from randomization

    Secondary Outcomes

    Description: Patients who are positive for SARS-CoV-2 (as defined above) who develop a new oxygen requirement attributable to COVID-19, tachypnea (RR > 20), or those who require hospitalization due to COVID-19 will be considered to have severe COVID-19.

    Measure: cumulative incidence of severe COVID-19 or death

    Time: within 12 weeks of randomization
    114 A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19

    Agent 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.

    NCT04382040
    Conditions
    1. COVID-19
    2. Corona Virus Infection
    3. SARS-CoV 2
    4. Coronavirus
    5. Coronavirus Infection
    Interventions
    1. Drug: ArtemiC
    2. Drug: Placebo
    MeSH:Infection Com Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: patient will be assessed using a scoring table for changes in clinical signs

    Measure: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of Time: 24 hours

    Description: Adverse events caused by the study drug will be assessed

    Measure: Percentage of participants with definite or probable drug related adverse events

    Time: 14 days

    Secondary Outcomes

    Measure: Time to negative COVID-19 PCR

    Time: 14 days

    Measure: Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

    Time: 14 days

    Measure: COVID-19 related survival

    Time: 14 days

    Measure: Incidence and duration of mechanical ventilation

    Time: 14 days

    Measure: Incidence of Intensive Care Init (ICU) stay

    Time: 14 days

    Measure: Duration of ICU stay

    Time: 14 days

    Measure: Duration of time on supplemental oxygen

    Time: 14 days
    115 A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress

    The 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.

    NCT04382586
    Conditions
    1. COVID-19 Pulmonary Complications
    2. COVID-19
    Interventions
    1. Drug: Zanubrutinib
    2. Drug: Supportive Care
    3. Drug: Placebo
    MeSH:Infection

    Primary Outcomes

    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 Days

    Secondary Outcomes

    Measure: Median reduction in days spent on supplemental oxygen

    Time: Up to 28 Days

    Measure: All-cause mortality

    Time: Up to 28 Days

    Measure: Proportion of participants experiencing respiratory failure or death

    Time: Up to 28 Days

    Measure: Mechanical ventilation-free survival

    Time: Up to 28 Days

    Measure: Days on mechanical ventilation

    Time: Up to 28 Days

    Measure: Duration of hospitalization

    Time: Up to 28 Days

    Measure: Time to discharge

    Time: Up to 28 Days

    Measure: PaO2:FiO2 and/or oxygenation index

    Time: Up to 28 Days

    Description: 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 Days
    116 A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Complement C5 Inhibition With Zilucoplan® in Improving Oxygenation and short-and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure

    The study is a randomized controlled, open-label trial comparing subcutaneous Zilucoplan® with standard of care to standard of care alone. In the active group, Zilucoplan® will be administered subcutaneously once daily for 14 days or till discharge from the hospital, whichever comes first. The hypothesis of the proposed intervention is that Zilucoplan® (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. This hypothesis is based on experiments performed in mice showing that C5a blockade can prevent mortality and prevent ARDS in mice with post-viral acute lung injury. Eligible patients include patients with confirmed COVID-19 infection suffering from hypoxic respiratory failure defined as O2 saturation below 93% on minimal 2l/min O2 therapy and/or ratio PaO2/FiO2 below 350.

    NCT04382755
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Zilucoplan®
    2. Drug: Placebo
    MeSH:Respiratory Insufficiency

    Primary Outcomes

    Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio

    Measure: Mean change in oxygenation

    Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)

    Description: defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio

    Measure: Median change in oxygenation

    Time: at predose, day 6 and day 15 (or at discharge, whichever comes first)

    Secondary Outcomes

    Measure: number of AE's (Adverse Events)

    Time: during hospital admission (up to 28 days)

    Measure: number of SAE's (Serious Adverse Events)

    Time: during hospital admission (up to 28 days)]

    Description: 6-point ordinal scale defined as Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

    Measure: mean change in 6-point ordinal scale change

    Time: between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call).

    Description: defined as independence from supplemental oxygen

    Measure: Time since randomization until improvement in oxygenation

    Time: during hospital admission (up to 28 days)

    Description: defined as SpO2 < 93% breathing room air or the dependence on supplemental oxygen

    Measure: Number of days with hypoxia

    Time: during hospital admission (up to 28 days)

    Measure: Number of days of supplemental oxygen use

    Time: during hospital admission (up to 28 days)

    Measure: Time to absence of fever (defined as 37.1°C or more) for more than 48h without antipyretic

    Time: during hospital admission (up to 28 days)

    Description: defined as 37.1°C or more

    Measure: Number of days with fever

    Time: during hospital admission (up to 28 days)

    Measure: Mean change in CRP levels between day 1 and day 6

    Time: day 1, day 6

    Measure: Mean change in CRP levels between day 1 and day 15 (or discharge whichever comes first)

    Time: day 1, day 15

    Measure: Mean change in ferritin levels between day 1 and day 6

    Time: day 1, day 6

    Measure: Mean change in ferritin levels between day 1 and day 15 (or discharge, whichever comes first)

    Time: day 1, day 15

    Measure: Incidence of AE's

    Time: during hospital admission (up to 28 days)

    Measure: Incidence of SAE's

    Time: at 10-20 weeks follow-up

    Measure: Incidence of SUSAR's (Suspected Unexpected Serious Adverse Reaction)

    Time: during hospital admission (up to 28 days)

    Measure: Incidence of SAR's (Serious Adverse Reaction)

    Time: during hospital admission (up to 28 days)

    Measure: Duration of hospital stay

    Time: during hospital admission (up to 28 days)

    Measure: Duration of hospital stay in survivors

    Time: during hospital admission (up to 28 days)

    Description: SOFA score: 0 (best) - 24 (worse)

    Measure: Mean change of SOFA score between day 1 and day 6 (or on discharge, whichever is first)

    Time: day 1, day 6 or on discharge, whichever is first

    Description: SOFA score: 0 (best) - 24 (worse)

    Measure: Mean change of SOFA score between day 1 and day 15 or on discharge, whichever is first)

    Time: day 1, day 15 or on discharge, whichever is first

    Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

    Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale at randomization, day 6 and 15 (or discharge, whichever comes first) and day 28 (phone call)

    Time: day 1, day 6, day 15 (or discharge, whichever comes first)

    Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

    Measure: 6-point Ordinal Scale at 6 and 15 days (or discharge whichever comes first) and day 28 (phone call), in relation to serum D-dimers and complement C5a levels at randomization

    Time: day 1, day 6, day 15 (or discharge, whichever comes first)

    Measure: Incidence of nosocomial bacterial or invasive fungal infection for 28 days (phone call) after enrolment in trial

    Time: day 28

    Measure: Time since randomization until first use of high-flow oxygen devices in non-ventilated patients

    Time: during hospital admission (up to 28 days)

    Measure: Time since randomization until first use of non-invasive mechanical ventilation in non-ventilated patients

    Time: during hospital admission (up to 28 days)

    Measure: Time since randomization until first use of invasive mechanical ventilation in non-ventilated patients

    Time: during hospital admission (up to 28 days)

    Measure: Number of ventilator-free days

    Time: day 1, day 28 or discharge whichever comes first

    Measure: Duration of invasive and non-invasive mechanical ventilation in ventilated patients

    Time: during hospital admission (up to 28 days)

    Measure: Duration of ICU stay in patients that enrolled in trial on invasive or non-invasive mechanical ventilation for less than 24h prior to or after randomization

    Time: during hospital admission (up to 28 days)

    Description: criteria-defined ARDS criteria-defined ARDS according to the adapted Berlin criteria as follow: within 1 week of a known Clinical insult or new or worsening respiratory symptoms bilateral infiltrates not supposed to be of cardiac origin or fluid overload PaO2/FiO2 < 300 mmHg

    Measure: Time since randomization to progression to ARDS (Acute Respiratory Distress Syndrome)

    Time: during hospital admission (up to 28 days)

    Measure: Time to progression to ARDS in ventilated patients according to D-dimers at randomization

    Time: during hospital admission (up to 28 days)

    Measure: Time to progression to ARDS in ventilated patients according to complement C5a at randomization

    Time: during hospital admission (up to 28 days)

    Measure: All-cause mortality rate (excluding group that entered during ventilation)

    Time: at day 28

    Measure: All-cause mortality rate (including group that entered during ventilation)

    Time: at day 28

    Measure: Percentage of patients in clinical status on 6-point Ordinal Scale

    Time: at 12-22 weeks follow-up

    Measure: Incidence of lung function abnormalities at follow up

    Time: at 12-22 weeks follow-up

    Measure: Incidence of lung fibrosis on chest CT scan at follow up

    Time: at 12-22 weeks follow-up

    Measure: All cause mortality for the entire study population

    Time: at follow up 12-22 weeks
    117 Randomized, Double-blind, Placebo-controlled Clinical Trial of Convalescent Plasma for the Treatment of COVID-19 Pneumonia With Severity Criteria

    A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation.

    NCT04383535
    Conditions
    1. SARS Virus
    2. SARS-CoV-2
    3. COVID-19
    Interventions
    1. Other: Convalescent SARS COVID-19 plasma
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.

    Measure: Clinical status during follow-up at 30th day

    Time: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Secondary Outcomes

    Description: Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.

    Measure: Clinical status during follow-up at 7th day

    Time: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.

    Measure: Clinical status during follow-up at 14th day

    Time: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: Hospital discharge or intrahospital death

    Measure: Time until hospital discharge (days).

    Time: Whenever the patient is discharge from the hospital or die without discharge, through study completion, an average of 14 days from admission

    Description: ICU discharge or ICU death

    Measure: Time until discharge from ICU (days)

    Time: Whenever the patient is discharge from ICU or die in ICU, through study completion, an average of 10 days from admission

    Description: Death and time to death

    Measure: Time to death

    Time: In a 30 days follow up period

    Description: Time until complete functional recovery (according to basal status).

    Measure: Time until complete functional recovery

    Time: Whenever the patient returns to basal functional status until 1 month from discharge

    Description: Percentage of participants with adverse events / serious adverse events

    Measure: Percentage of participants with adverse events / serious adverse events

    Time: In a 30 days follow up period

    Description: Percentage of patients with negative SARS-CoV-3 PCR

    Measure: Percentage of patients with negative SARS-CoV-3 PCR at Day 14th

    Time: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: D Dimer plasma concentration

    Measure: D Dimer plasma concentration at Day 14th

    Time: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: Ferritin plasma concentration

    Measure: Ferritin plasma concentration at Day 13th

    Time: 13th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: Plasma concentration of neutralizing antibodies

    Measure: Plasma concentration of neutralizing antibodies at Day 2nd

    Time: 2nd Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: Plasma concentration of neutralizing antibodies

    Measure: Plasma concentration of neutralizing antibodies at Day 7th

    Time: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)

    Description: Post-transfusion adverse reactions between study groups

    Measure: Post-transfusion adverse reactions

    Time: In a 30 days follow up period
    118 A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Moderate to SARS Related to COVID-19 Infection vs Placebo

    The 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.

    NCT04384445
    Conditions
    1. Corona Virus Infection
    2. COVID-19
    3. SARS
    4. Acute Respiratory Distress Syndrome
    Interventions
    1. Biological: Zofin
    2. Other: Placebo
    MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    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 Days

    Description: Safety will be defined by the incidence of severe adverse events as assessed by treating physician

    Measure: Incidence of Severe Adverse Events

    Time: 60 Days

    Secondary Outcomes

    Description: Measured at day 60 or at hospital discharge, whichever comes first.

    Measure: All Cause Mortality

    Time: 60 Days

    Description: Number of participants that are alive at 60 days post first infusion follow up

    Measure: Survival Rate

    Time: 60 Days

    Description: Measure IL-6, TNF-alpha from serum of blood samples

    Measure: Cytokine Levels

    Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

    Description: 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 28

    Description: CRP from serum of blood samples

    Measure: C-reactive protein Levels

    Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

    Description: 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 8

    Description: 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 30

    Description: 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 30
    119 A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-β1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection

    SNG001 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.

    NCT04385095
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Drug: SNG001
    2. Drug: Placebo
    MeSH:Infection

    Primary Outcomes

    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 28

    Secondary Outcomes

    Description: 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 28

    Description: 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 28

    Description: 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 hours

    Description: 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 28

    Description: 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 28

    Description: Looking at blood pressure measured in mmHg

    Measure: Safety and tolerability - blood pressure II. Viral load

    Time: Day 1 to Day 28

    Description: Looking at heart rate measured in beats per minute

    Measure: Safety and tolerability - heart rate II. Viral load

    Time: Day 1 to Day 28

    Description: Looking at temperature measured in degrees Celsius

    Measure: Safety and tolerability - temperature II. Viral load

    Time: Day 1 to Day 28

    Description: Looking at respiratory rate measure in breaths per minute

    Measure: Safety and tolerability - respiratory rate II. Viral load

    Time: Day 1 to Day 28

    Description: Looking at oxygen levels measured in a %

    Measure: Safety and tolerability - oxygen saturation II. Viral load

    Time: Day 1 to Day 28

    Description: Looking at adverse events (numbers and terms)

    Measure: Safety and tolerability - adverse events II. Viral load

    Time: Day 1 to Day 28

    Description: Looking at concomitant medications given during treatment

    Measure: Safety and tolerability - concomitant medications II. Viral load

    Time: Day 1 to Day 28

    Description: 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 28

    Description: 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 28

    Description: Time to self-reported recover

    Measure: Time to self-reported recovery (home setting only)

    Time: Day 2 to Day 16

    Description: 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 28

    Description: 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 28

    Description: Time to virus clearance and viral load

    Measure: Virus clearance/load (if samples are available)

    Time: Day 1 to Day 28

    Description: Blood and sputum biomarkers

    Measure: Blood and sputum biomarkers (if samples are available).

    Time: Day 1 to Day 28

    Description: Contact with health services

    Measure: Contact with health services (home setting only

    Time: Day 1 to Day 28

    Description: Consumption of antibiotics

    Measure: Consumption of antibiotics (home setting only

    Time: Day 1 to Day 28
    120 A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals' Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System

    The aim of this study is to investigate whether vaccination of healthcare professionals with VPM1002 could reduce the number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection). 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". A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients will receive a single dose of either VPM1002 or Placebo. All subjects will be requested to enter data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions into an online questionnaire.

    NCT04387409
    Conditions
    1. Infection, Respiratory Tract
    Interventions
    1. Biological: VPM1002
    2. Biological: Placebo
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)

    Time: From day 0 to day 240

    Secondary Outcomes

    Measure: Cumulative incidence of documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (≥ 38 °C)

    Time: From day 0 to day 240

    Measure: Number of days of self-reported fever (≥ 38 °C)

    Time: From day 0 to day 240

    Measure: Number of days of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240
    121 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19

    This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.

    NCT04389450
    Conditions
    1. COVID
    2. ARDS
    Interventions
    1. Biological: PLX-PAD
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of ventilator free days

    Time: 28 days

    Secondary Outcomes

    Measure: All-cause mortality

    Time: 28 days

    Measure: Duration of mechanical ventilation

    Time: 8 weeks
    122 A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

    A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

    NCT04389840
    Conditions
    1. COVID-19
    2. Acute Lung Injury
    3. SARS-CoV-2
    Interventions
    1. Drug: Dociparastat sodium
    2. Drug: Placebo
    MeSH:Respiratory Insufficiency Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult

    Primary Outcomes

    Description: Alive and free of invasive mechanical ventilation

    Measure: Proportion of participants who are alive and free of invasive mechanical ventilation

    Time: Through Day 28

    Secondary Outcomes

    Description: Time to all-cause mortality

    Measure: All-cause mortality

    Time: Through Day 28
    123 Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

    SAINT 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.

    NCT04390022
    Conditions
    1. Covid-19
    2. Coronavirus Infection
    3. SARS-CoV-2 Infection
    Interventions
    1. Drug: Ivermectin
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. PCRs were performed using two target genes (E and N).

    Measure: Proportion of Patients With a Positive SARS-CoV-2 PCR

    Time: 7 days post-treatment

    Secondary Outcomes

    Description: Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).

    Measure: Median Viral Load

    Time: Baseline and on days 4, 7, 14 and 21

    Description: Proportion of patients with fever and cough

    Measure: Fever and Cough Progression

    Time: Days 4, 7, 14 and 21

    Description: Proportion of participants with positive IgG at day 21

    Measure: Seroconversion at Day 21

    Time: Up to and including day 21

    Description: Proportion of drug-related adverse events

    Measure: Proportion of Drug-related Adverse Events

    Time: 7 days post treatment

    Description: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay. [Results not yet available]

    Measure: Levels of IgG, IgM and IgA

    Time: Up to and including day 28

    Description: Frequency (% over total PBMC) of innate immune cells (myeloid a