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Coronavirus Infections (819) Severe Acute Respiratory Syndrome (567) Infection (472) Pneumonia (366) Communicable Diseases (199) Respiratory Distress Syndrome, Adult (179) Acute Lung Injury (143) Respiratory Distress Syndrome, Newborn (143) Respiratory Insufficiency (132) Syndrome (105) Virus Diseases (90) Pneumonia, Viral (82) Depression (67) Critical Illness (62) Anxiety Disorders (41) Cardiovascular Diseases (36) Emergencies (36) Respiratory Tract Infections (36) Stress, Psychological (31) Hypoxia (30) Inflammation (30) Lung Injury (30) Neoplasms (30) Wounds and Injuries (30) Stress Disorders, Post-Traumatic (29) Thrombosis (28) Diabetes Mellitus (26) Disease (26) Respiratory Tract Diseases (26) Depressive Disorder (25) Stress Disorders, Traumatic (25) Lung Diseases (23) Acute Kidney Injury (22) Disease Progression (22) Mental Disorders (21) Olfaction Disorders (20) Respiration Disorders (20) Burnout, Psychological (19) Thromboembolism (19) Hypertension (18) Embolism (16) Arthritis (15) Blood Coagulation Disorders (15) Hemostatic Disorders (15) Pulmonary Embolism (15) Pulmonary Fibrosis (15) Lung Diseases, Interstitial (14) Stroke (14) Respiratory Aspiration (13) Diabetes Mellitus, Type 2 (12) Dyspnea (12) Fibrosis (12) Influenza, Human (12) Arthritis, Rheumatoid (11) Rheumatic Diseases (11) Venous Thrombosis (11) Burnout, Professional (9) Chronic Pain (9) Cognitive Dysfunction (9) Collagen Diseases (9) Diabetes Mellitus, Type 1 (9) Heart Failure (9) Myocardial Infarction (9) Pneumonia, Ventilator-Associated (9) Pregnancy Complications (9) Problem Behavior (9) Venous Thromboembolism (9) Vitamin D Deficiency (9) Infarction (8) Liver Diseases (8) Lung Diseases, Obstructive (8) Multiple Sclerosis (8) Myocarditis (8) Parasomnias (8) RNA Virus Infections (8) Sclerosis (8) Sepsis (8) Autoimmune Diseases (7) Convalescence (7) Depression, Postpartum (7) Dyssomnias (7) Heart Diseases (7) Hematologic Neoplasms (7) Infertility (7) Inflammatory Bowel Diseases (7) Lymphopenia (7) Pulmonary Disease, Chronic Obstructive (7) Pulmonary Valve Insufficiency (7) Shock (7) Frailty (6) Immunologic Deficiency Syndromes (6) Lung Neoplasms (6) Lupus Erythematosus, Systemic (6) Lymphoma (6) Neurologic Manifestations (6) Obesity (6) Adenoviridae Infections (5) Brain Diseases (5) Brain Injuries (5) Breast Neoplasms (5) Chronic Disease (5) Coronaviridae Infections (5) Cross Infection (5) Delirium (5) Disease Susceptibility (5) Disseminated Intravascular Coagulation (5) Fatigue (5) Feeding and Eating Disorders (5) HIV Infections (5) Immune System Diseases (5) Kidney Diseases (5) Kidney Failure, Chronic (5) Multiple Organ Failure (5) Nervous System Diseases (5) Occupational Stress (5) Parkinson Disease (5) Thrombophilia (5) Toxemia (5) Acquired Immunodeficiency Syndrome (4) Acute Coronary Syndrome (4) Anemia, Sickle Cell (4) Appendicitis (4) Arrhythmias, Cardiac (4) Arthritis, Psoriatic (4) Asymptomatic Diseases (4) Autism Spectrum Disorder (4) Carcinoma (4) Coinfection (4) 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Premature (2) Oral Manifestations (2) Osteoporosis (2) Overweight (2) Pediatric Obesity (2) Pneumonia, Pneumocystis (2) Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) Premature Birth (2) Psychological Trauma (2) Psychotic Disorders (2) Rectal Neoplasms (2) Renal Insufficiency (2) ST Elevation Myocardial Infarction (2) Sarcopenia (2) Scleroderma, Diffuse (2) Scleroderma, Systemic (2) Seizures (2) Shock, Septic (2) Skin Diseases (2) Sleep Apnea Syndromes (2) Sleep Apnea, Obstructive (2) Stillbirth (2) Suicide (2) Thyroid Diseases (2) Uterine Cervical Neoplasms (2) Vision Disorders (2) Vision, Low (2) Abruptio Placentae (1) Acalculous Cholecystitis (1) Adenocarcinoma (1) Adjustment Disorders (1) Adrenal Insufficiency (1) Agoraphobia (1) Alcohol-Related Disorders (1) Alcoholic Intoxication (1) Alpha 1-Antitrypsin Deficiency (1) Altitude Sickness (1) Alzheimer Disease (1) Amblyopia (1) Anemia, Aplastic (1) Aneurysm (1) Angina Pectoris (1) Ankle Fractures (1) Aortic Valve Stenosis (1) Apnea (1) Arthritis, Juvenile (1) Atherosclerosis (1) Atrioventricular Block (1) Autonomic Nervous System Diseases (1) Bacterial Infections (1) Barotrauma (1) Behavior, Addictive (1) Binge-Eating Disorder (1) Blister (1) Body Weight (1) Body Weight Changes (1) Bradycardia (1) Bronchopulmonary Dysplasia (1) Brucellosis (1) Bulimia (1) Bulimia Nervosa (1) Carcinoma in Situ (1) Carcinoma, Ductal (1) Carcinoma, Ductal, Breast (1) Carcinoma, Hepatocellular (1) Carcinoma, Intraductal, Noninfiltrating (1) Cardiovascular Abnormalities (1) Cataract (1) Cellulitis (1) Central Nervous System Neoplasms (1) Cerebral Hemorrhage (1) Cholangitis, Sclerosing (1) Cholecystitis (1) Cholecystitis, Acute (1) Chronic Traumatic Encephalopathy (1) Ciliary Motility Disorders (1) Cognition Disorders (1) Colitis (1) Colitis, Ulcerative (1) Colonic Diseases (1) Com (1) Communicable Diseases, Emerging (1) Communication Disorders (1) Consciousness Disorders (1) Conversion Disorder (1) Coron (1) Coronavirus Infect (1) Cr (1) Crohn Disease (1) Deafness (1) Death, Sudden, Cardiac (1) Dental Caries (1) Depressive Disorder, Treatment-Resistant (1) Dermatitis (1) DiGeorge Syndrome (1) Diabetes Complications (1) Digestive System Neoplasms (1) Diphtheria (1) Down Syndrome (1) Dyskinesias (1) Dyspareunia (1) Dysphonia (1) Emergen (1) Emergence Delirium (1) Emphysema (1) Endocarditis (1) Endometrial Neoplasms (1) Endometriosis (1) Endophthalmitis (1) Endotoxemia (1) Epilepsy (1) Esophageal and Gastric Varices (1) Eye Infections (1) Facial Pain (1) Facies (1) Familial Mediterranean Fever (1) Fatigue Syndrome, Chronic (1) Femoral Fractures (1) Femoral Neck Fractures (1) Fetal Growth Retardation (1) Fetal Membranes, Premature Rupture (1) Fractures, Closed (1) Gambling (1) Gastroenteritis (1) Gastroesophageal Reflux (1) Gastrointestinal Neoplasms (1) Gestational Weight Gain (1) Glioblastoma (1) Headache Disorders, Secondary (1) Healthcare-Associated Pneumonia (1) Hearing Loss (1) Hearing Loss, Conductive (1) Heart Block (1) Heart Failure, Systolic (1) Hemoglobinopathies (1) Hemophilia A (1) Hepatitis (1) Hereditary Autoinflammatory Diseases (1) Herpes Labialis (1) Herpes Zoster (1) Hoarseness (1) Humeral Fractures (1) Hyp (1) Hyperaldosteronism (1) Hyperglycemia (1) Hyperkinesis (1) Hyperphosphatemia (1) Hyperplasia (1) Hypertension, Pregnancy-Induced (1) Hypertrophy (1) Hypokalemia (1) Hyponatremia (1) Hypotension (1) Hypoventilation (1) Inf (1) Infant, Newborn, Diseases (1) Infe (1) Infec (1) Infecti (1) Infertility, Female (1) Intellectual Disability (1) Intestinal Atresia (1) Intestinal Neoplasms (1) Intracranial Aneurysm (1) Intracranial Hypertension (1) Intracranial Thrombosis (1) Jaundice, Obstructive (1) Joint Diseases (1) Keratoconjunctivitis (1) Kidney Neoplasms (1) Laryngeal Neoplasms (1) Latent Tuberculosis (1) Leukemia, Myeloid, Acute (1) Liver Cirrhosis, Biliary (1) Liver Failure (1) Liver Neoplasms (1) Lymphedema (1) Lymphocytosis (1) Lymphoma, B-Cell (1) Lymphoma, Non-Hodgkin (1) Macrophage Activation Syndrome (1) Macular Degeneration (1) Malnutrition (1) Maternal Death (1) Maxillofacial Injuries (1) Memory Disorders (1) Meningitis (1) Meningitis, Meningococcal (1) Menorrhagia (1) Menstruation Disturbances (1) Metabolic Syndrome (1) Metabolism, Inborn Errors (1) Microvascular Rarefaction (1) Mitochondrial Diseases (1) Mobility Limitation (1) Monoclonal Gammopathy of Undetermined Significance (1) Mood Disorders (1) Mouth, Edentulous (1) Movement Disorders (1) Mucocutaneous Lymph Node Syndrome (1) Multiple Chronic Conditions (1) Muscular Dystrophies (1) Musculoskeletal Diseases (1) Myalgia (1) Mycoses (1) Myocardial Reperfusion Injury (1) Necrosis (1) Needlestick Injuries (1) Neonatal Sepsis (1) Neoplastic Cells, Circulating (1) Nephritis (1) Nervous System Malformations (1) Nervous System Neoplasms (1) Neurocognitive Disorders (1) Neurodegenerative Diseases (1) Neuromuscular Diseases (1) Neuromyelitis Optica (1) Nutrition Disorders (1) Obsessive Behavior (1) Oligospermia (1) Orbital Cellulitis (1) Osteoarthritis (1) Osteoarthritis, Hip (1) Osteoarthritis, Knee (1) Osteochondritis (1) Otitis Media with Effusion (1) Ovarian Neoplasms (1) Pain, Intractable (1) Pancreatitis (1) Paramyxoviridae Infections (1) Paraproteinemias (1) Paresis (1) Parkin (1) Perinatal Death (1) Periodontal Diseases (1) Periodontitis (1) Pharyngeal Diseases (1) Pn (1) Pneumon (1) Pneumonia, Bacterial (1) Pre-Eclampsia (1) Prediabetic State (1) Pregnancy in Diabetics (1) Primary Dysautonomias (1) Prostatic Hyperplasia (1) Protein Deficiency (1) Pseudomonas Infections (1) Psychophysiologic Disorders (1) Puerperal Infection (1) Pulmonary Alveolar Proteinosis (1) Pulmonary Atelectasis (1) Pulmonary Eosinophilia (1) Pulmonary Heart Disease (1) Purpura, Thrombocytopenic, Idiopathic (1) Recurrence (1) Renal Insufficie (1) Reperfusion Injury (1) Resp (1) Respi (1) Respiratory Distress Sy (1) Respiratory Syncytial Virus Infections (1) Retinal Vein Occlusion (1) Rupture (1) Sarcoidosis (1) Scleroderma, Localized (1) Se (1) Shock, Cardiogenic (1) Shoulder Fractures (1) Skin Manifestations (1) Skin Neoplasms (1) Skull Fractures (1) Somatoform Disorders (1) Spondylitis (1) Spondylitis, Ankylosing (1) Sprains and Strains (1) Status Epilepticus (1) Stomach Neoplasms (1) Stress Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Suicidal Ideation (1) Superinfection (1) Synovial Cyst (1) Tachycardia (1) Tachycardia, Ventricular (1) Tachypnea (1) Testicular Neoplasms (1) Thalassemia (1) Thoracic Diseases (1) Thrombocytopenia (1) Thrombophlebitis (1) Thrombotic Microangiopathies (1) Tobacco Use Disorder (1) Tonsillitis (1) Torsades de Pointes (1) Tourette Syndrome (1) Tracheal Stenosis (1) Trauma, Nervous System (1) Tuberculosis, Pulmonary (1) Urinary Tract Infections (1) Urogenital Neoplasms (1) Urologic Diseases (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Vascular Diseases (1) Ventricular Dysfunction, Right (1) Virus (1) Vitamin D Deficie (1) Voice Disorders (1) Vulvar Neoplasms (1) Waldenstrom Macroglobulinemia (1) Weight Gain (1) Weight Loss (1) Yellow Fever (1) beta-Thalassemia (1)

D018352: Coronavirus Infect

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 (1774)


Name (Synonyms) Correlation
drug2490 Placebo Wiki 0.39
drug1507 Hydroxychloroquine Wiki 0.21
drug2557 Placebo oral tablet Wiki 0.16
Name (Synonyms) Correlation
drug1740 Ivermectin Wiki 0.14
drug3191 Standard of Care Wiki 0.13
drug2827 Remdesivir Wiki 0.13
drug2215 No intervention Wiki 0.11
drug2192 Nitazoxanide Wiki 0.11
drug2730 Questionnaire Wiki 0.10
drug1861 Losartan Wiki 0.09
drug884 Convalescent Plasma Wiki 0.09
drug3628 Vitamin C Wiki 0.09
drug3199 Standard of care Wiki 0.09
drug2879 Rivaroxaban Wiki 0.09
drug341 Azithromycin Wiki 0.08
drug1292 Favipiravir Wiki 0.08
drug1366 Gam-COVID-Vac Wiki 0.08
drug2805 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.08
drug2892 Ruxolitinib Wiki 0.08
drug2985 Saline Wiki 0.08
drug2575 Placebos Wiki 0.08
drug4004 placebo Wiki 0.07
drug899 Convalescent plasma Wiki 0.07
drug3697 Zinc Wiki 0.07
drug1527 Hydroxychloroquine Sulfate Wiki 0.07
drug1672 Interferon Beta-1A Wiki 0.07
drug2903 SARS-CoV-2 Wiki 0.07
drug2916 SARS-CoV-2 convalescent plasma Wiki 0.07
drug2152 Nasopharyngeal swab Wiki 0.07
drug3430 Tocilizumab Wiki 0.06
drug1842 Lopinavir / Ritonavir Wiki 0.06
drug623 COVID-19 convalescent plasma Wiki 0.06
drug2135 Nafamostat Mesilate Wiki 0.06
drug1508 Hydroxychloroquine (HCQ) Wiki 0.06
drug3173 Standard Medical Treatment Wiki 0.06
drug1859 Lopinavir/ritonavir Wiki 0.06
drug1673 Interferon Beta-1B Wiki 0.06
drug2579 Plasma Wiki 0.06
drug761 Chloroquine or Hydroxychloroquine Wiki 0.06
drug2210 No Intervention Wiki 0.06
drug1675 Interferon beta-1a Wiki 0.06
drug1592 INO-4800 Wiki 0.06
drug2180 Niclosamide Wiki 0.06
drug1808 Leronlimab (700mg) Wiki 0.06
drug2958 SCTA01 Wiki 0.06
drug2870 Ribavirin Wiki 0.06
drug3185 Standard care Wiki 0.06
drug2998 Saliva collection Wiki 0.06
drug1786 LY3819253 Wiki 0.06
drug1906 Lung ultrasound Wiki 0.05
drug3630 Vitamin D Wiki 0.05
drug2665 Prone positioning Wiki 0.05
drug2763 REGN10933+REGN10987 combination therapy Wiki 0.05
drug3168 Standard Care Wiki 0.05
drug1995 Melatonin Wiki 0.05
drug557 CELLECTRA® 2000 Wiki 0.05
drug2607 Povidone-Iodine Wiki 0.05
drug2253 Normal saline Wiki 0.05
drug2198 Nitric Oxide Wiki 0.05
drug2249 Normal Saline Wiki 0.05
drug4084 standard care Wiki 0.05
drug1023 Dexamethasone Wiki 0.05
drug731 ChAdOx1 nCoV-19 Wiki 0.05
drug3869 human monoclonal antibody DZIF-10c (Group 1A-2D) Wiki 0.05
drug1939 MW33 injection Wiki 0.05
drug1455 High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.05
drug170 Aeonose Wiki 0.05
drug1409 HB-adMSCs Wiki 0.05
drug1587 IMU-838 Wiki 0.05
drug2700 Pulmozyme Wiki 0.05
drug3029 Self Supportive Care (SSC) Alone Wiki 0.05
drug2186 Nigella Sativa / Black Cumin Wiki 0.05
drug4053 retrospective analysis Wiki 0.05
drug3461 Tranexamic acid Wiki 0.05
drug1848 Lopinavir-Ritonavir Wiki 0.05
drug2426 Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki 0.05
drug3007 Sample collection Wiki 0.05
drug2930 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.05
drug1315 Fisetin Wiki 0.05
drug2384 PLX-PAD Wiki 0.05
drug1539 Hydroxychloroquine Sulfate Tablets Wiki 0.05
drug1710 Intramuscular injection Wiki 0.05
drug4142 vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki 0.05
drug1728 Ion Mobility Spectrometry (IMS) Wiki 0.05
drug2829 Remdesivir placebo Wiki 0.05
drug4143 vv-ECMO only (no cytokine adsorption) Wiki 0.05
drug3095 Silmitasertib Wiki 0.05
drug2449 Peripheral blood draw Wiki 0.05
drug678 CVnCoV Vaccine Wiki 0.05
drug714 Carrimycin Wiki 0.05
drug2435 Peginterferon Lambda-1A Wiki 0.05
drug519 Brequinar Wiki 0.05
drug1323 Flow cytometric analysis Wiki 0.05
drug2780 Radiation therapy Wiki 0.05
drug1866 Low Dose Radiation Therapy Wiki 0.05
drug2897 SAB-185 Wiki 0.05
drug2103 N-Acetyl cysteine Wiki 0.05
drug1228 Exercise Wiki 0.05
drug1762 KB109 + Self Supportive Care (SSC) Wiki 0.05
drug3180 Standard Therapy Wiki 0.05
drug3154 Spirometry Wiki 0.05
drug1520 Hydroxychloroquine - Weekly Dosing Wiki 0.05
drug2076 Molnupiravir Wiki 0.05
drug2618 Practice details Wiki 0.05
drug2301 Olokizumab 64 mg Wiki 0.05
drug1769 Ketogenic diet Wiki 0.05
drug1008 Deferoxamine Wiki 0.05
drug2553 Placebo on a 0- and 28-day schedule Wiki 0.05
drug1940 MW33 injection placebo Wiki 0.05
drug1068 Disulfiram Wiki 0.05
drug2494 Placebo (NaCl 0.9%) (Group 2D) Wiki 0.05
drug2023 Metformin Wiki 0.05
drug3207 Standard of care treatment Wiki 0.05
drug2918 SARS-CoV-2 diagnostic rapid test Wiki 0.05
drug2908 SARS-CoV-2 PCR Wiki 0.05
drug1343 Fostamatinib Wiki 0.05
drug2894 Ruxolitinib Oral Tablet Wiki 0.05
drug2972 SOC Wiki 0.05
drug1141 Ebselen Wiki 0.05
drug1990 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.05
drug1330 Fluvoxamine Wiki 0.05
drug1755 Ivermectin and Doxycycline Wiki 0.05
drug1037 Diagnostic test Wiki 0.05
drug2181 Niclosamide Oral Tablet Wiki 0.05
drug890 Convalescent Plasma Transfusion Wiki 0.05
drug1104 Duvelisib Wiki 0.05
drug885 Convalescent Plasma (CP) Wiki 0.05
drug1969 Matching Placebo Wiki 0.05
drug1874 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.05
drug2776 RTB101 Wiki 0.05
drug1513 Hydroxychloroquine + azithromycin Wiki 0.05
drug1496 Human biological samples Wiki 0.05
drug1751 Ivermectin Oral Product Wiki 0.05
drug1256 Expressive writing Wiki 0.05
drug3104 Single Dose of Hydroxychloroquine Wiki 0.05
drug3871 hydroxychloroquine Wiki 0.05
drug1084 Doxycycline Wiki 0.05
drug2322 Online questionnaire Wiki 0.05
drug289 Aspirin Wiki 0.05
drug2317 Online Survey Wiki 0.05
drug808 Colchicine Wiki 0.05
drug686 Camostat Mesilate Wiki 0.04
drug1193 Enoxaparin Wiki 0.04
drug3015 Sarilumab Wiki 0.04
drug756 Chloroquine Wiki 0.04
drug2663 Prone position Wiki 0.04
drug210 Anakinra Wiki 0.04
drug3065 Serological test Wiki 0.04
drug976 DWRX2003 Wiki 0.04
drug1642 Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki 0.04
drug119 AV-COVID-19 Wiki 0.04
drug1787 LY3832479 Wiki 0.04
drug3923 mRNA-1273 Wiki 0.04
drug1676 Interferon beta-1b Wiki 0.04
drug3880 hzVSF-v13 Wiki 0.04
drug3637 Vitamin Super B-Complex Wiki 0.04
drug2495 Placebo (Normal saline solution) Wiki 0.04
drug4070 serology Wiki 0.04
drug2676 Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki 0.04
drug2137 Naltrexone Wiki 0.04
drug3043 Selinexor Wiki 0.04
drug656 COViage Wiki 0.04
drug3319 TY027 Wiki 0.04
drug3196 Standard of Care (SoC) Wiki 0.04
drug1807 Lenzilumab Wiki 0.04
drug2200 Nitric Oxide Gas Wiki 0.04
drug2555 Placebo oral capsule Wiki 0.04
drug2771 RT-PCR Wiki 0.04
drug1288 Famotidine Wiki 0.04
drug16 0.9% saline Wiki 0.04
drug1116 EIDD-2801 Wiki 0.04
drug2272 Nuvastatic Wiki 0.03
drug1412 HCQ & AZ Wiki 0.03
drug2459 Personalized ambulatory training Wiki 0.03
drug2939 SARS-CoV-2 vaccine formulation 2 with adjuvant 1 Wiki 0.03
drug2766 RIA-device (Remote Investigation and Assessment) Wiki 0.03
drug2907 SARS-CoV-2 IgG Antibody Testing Kit Wiki 0.03
drug1404 Guided online support program Wiki 0.03
drug121 AVIGAN Wiki 0.03
drug887 Convalescent Plasma 1 Unit Wiki 0.03
drug3298 T89 Wiki 0.03
drug1470 High-dose placebo (18-59 years) & Two dose regimen Wiki 0.03
drug1678 Interferon-Beta Wiki 0.03
drug1598 IV Dexamethasone Wiki 0.03
drug2113 NETosis markers Wiki 0.03
drug332 Aviptadil 67μg Wiki 0.03
drug2125 NO-Immunosuppressive Wiki 0.03
drug1682 Interleukin 6 (IL6) Antagonist Wiki 0.03
drug3052 SensiumVitals wearable sensor Wiki 0.03
drug741 Change in knowledge, motivation, skills, resources Wiki 0.03
drug936 Covid-19 swab PCR test Wiki 0.03
drug3106 Single high dose vitamin D Wiki 0.03
drug4128 urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic Wiki 0.03
drug188 Airwave Oscillometry Wiki 0.03
drug2257 Normal saline solution (NSS), Placebo, Day 189 - Phase 2 Wiki 0.03
drug279 ArtemiC Wiki 0.03
drug2039 Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension Wiki 0.03
drug2207 Nitroglycerin Wiki 0.03
drug2334 Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East Wiki 0.03
drug2943 SARS-CoV-2-test Wiki 0.03
drug1813 Levamisole and Isoprinosine Wiki 0.03
drug2989 Saline containing 1% Human serum albumin(solution without UC-MSCs) Wiki 0.03
drug3639 Vitamins and Minerals Wiki 0.03
drug3850 glenzocimab Wiki 0.03
drug3206 Standard of care therapy Wiki 0.03
drug2008 Merimepodib Wiki 0.03
drug1097 Drugs and supportive care Wiki 0.03
drug2108 NA-831 Wiki 0.03
drug2762 REGN10933+REGN10987 Wiki 0.03
drug2364 P2Et (Caesalpinia spinosa extract) Wiki 0.03
drug1895 Low-dose placebo (60-85 years) & Two dose regimen Wiki 0.03
drug1401 Growth Hormone Wiki 0.03
drug2830 Remdesivir-HU Wiki 0.03
drug2940 SARS-CoV-2 vaccine formulation 2 with adjuvant 2 Wiki 0.03
drug4028 pulmonary rehabilitation Wiki 0.03
drug2714 Quality of Life Wiki 0.03
drug1606 Icosapent ethyl (IPE) Wiki 0.03
drug1938 MVC-COV1901 Wiki 0.03
drug774 Clarithromycin Wiki 0.03
drug1593 INOpulse Wiki 0.03
drug1266 F-652 Wiki 0.03
drug676 CVnCoV 12μg Wiki 0.03
drug2341 Oral supplement enriched in antioxidants Wiki 0.03
drug642 COVID-19 testing Wiki 0.03
drug2758 RDV Wiki 0.03
drug1396 Group B Control Wiki 0.03
drug1099 Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki 0.03
drug1117 EIT-Group Wiki 0.03
drug1780 LAU-7b Wiki 0.03
drug1386 Grocery store gift cards Wiki 0.03
drug1443 Hepatitis A vaccine Wiki 0.03
drug2482 Piclidenoson Wiki 0.03
drug1631 Immunoglubulins Wiki 0.03
drug3428 To assess for development of IgG antibodies against SARS-CoV2 Wiki 0.03
drug1473 High-flow nasal cannula treatment Wiki 0.03
drug2857 Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki 0.03
drug1468 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki 0.03
drug1746 Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets Wiki 0.03
drug1578 ID NOW vs. Accula Wiki 0.03
drug2078 Monitoring Visit - Baseline Wiki 0.03
drug2372 PEP flute Wiki 0.03
drug3246 Study D Wiki 0.03
drug2282 Observation of patients with known, suspected, or at risk for COVID-19 infection Wiki 0.03
drug1314 Fingolimod 0.5 mg Wiki 0.03
drug2318 Online Survey about Dietary and Lifestyle Habits Wiki 0.03
drug1512 Hydroxychloroquine + Sorbitol Wiki 0.03
drug2869 Rhea Health Tone® Wiki 0.03
drug1828 Linagliptin Wiki 0.03
drug3589 Vehicle + Heparin along with best supportive care Wiki 0.03
drug3202 Standard of care (SOC) plus placebo Wiki 0.03
drug2402 Pacritinib Wiki 0.03
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drug3273 Survey Wiki 0.02
drug428 Best Supportive Care Wiki 0.02
drug139 Acalabrutinib Wiki 0.02
drug1437 Heparin Wiki 0.02
drug3274 Survey Administration Wiki 0.02
drug812 Colchicine Tablets Wiki 0.02
drug3736 anti-SARS-CoV-2 convalescent plasma Wiki 0.02
drug2278 Observation Wiki 0.02
drug2511 Placebo Administration Wiki 0.02
drug425 Best Practice Wiki 0.02
drug769 Cholecalciferol Wiki 0.02
drug594 COVID-19 Wiki 0.02
drug991 Data collection Wiki 0.02
drug965 DAS181 Wiki 0.01
drug3802 convalescent plasma Wiki 0.01
drug776 Clazakizumab Wiki 0.01
drug2345 Oseltamivir Wiki 0.01
drug2717 Quality-of-Life Assessment Wiki 0.01
drug401 Baricitinib Wiki 0.01
drug4099 survey Wiki 0.01
drug2744 Questionnaires Wiki 0.01
drug3762 blood sample Wiki 0.01

Correlated MeSH Terms (176)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.83
D003141 Communicable Diseases NIH 0.30
D007239 Infection NIH 0.29
Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.16
D013577 Syndrome NIH 0.15
D014777 Virus Diseases NIH 0.15
D012127 Respiratory Distress Syndrome, Newborn NIH 0.11
D012128 Respiratory Distress Syndrome, Adult NIH 0.11
D011024 Pneumonia, Viral NIH 0.11
D055371 Acute Lung Injury NIH 0.10
D003333 Coronaviridae Infections NIH 0.08
D012141 Respiratory Tract Infections NIH 0.08
D012327 RNA Virus Infections NIH 0.07
D012140 Respiratory Tract Diseases NIH 0.07
D016638 Critical Illness NIH 0.06
D030341 Nidovirales Infections NIH 0.05
D009220 Myositis NIH 0.05
D003139 Common Cold NIH 0.05
D044882 Glucose Metabolism Disorders NIH 0.05
D012120 Respiration Disorders NIH 0.05
D003428 Cross Infection NIH 0.05
D008659 Metabolic Diseases NIH 0.04
D004408 Dysgeusia NIH 0.04
D003924 Diabetes Mellitus, Type 2 NIH 0.04
D003289 Convalescence NIH 0.04
D007249 Inflammation NIH 0.04
D000860 Hypoxia NIH 0.04
D008173 Lung Diseases, Obstructive NIH 0.04
D008171 Lung Diseases, NIH 0.04
D006685 Hoarseness NIH 0.03
D019965 Neurocognitive Disorders NIH 0.03
D012507 Sarcoidosis NIH 0.03
D000070627 Chronic Traumatic Encephalopathy NIH 0.03
D059246 Tachypnea NIH 0.03
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.03
D051346 Mobility Limitation NIH 0.03
D001997 Bronchopulmonary Dysplasia NIH 0.03
D008595 Menorrhagia NIH 0.03
D007319 Sleep Initiation and Maintenance Disorders NIH 0.03
D013166 Spondylitis NIH 0.03
D013167 Spondylitis, Ankylosing NIH 0.03
D006929 Hyperaldosteronism NIH 0.03
D014552 Urinary Tract Infections NIH 0.03
D058070 Asymptomatic Diseases NIH 0.03
D011470 Prostatic Hyperplasia NIH 0.03
D054559 Hyperphosphatemia NIH 0.03
D019446 Endotoxemia NIH 0.03
D055154 Dysphonia NIH 0.03
D006965 Hyperplasia NIH 0.03
D004314 Down Syndrome NIH 0.03
D000073436 Microvascular Rarefaction NIH 0.03
D024821 Metabolic Syndrome NIH 0.03
D015163 Superinfection NIH 0.03
D001424 Bacterial Infections NIH 0.03
D011649 Pulmonary Alveolar Proteinosis NIH 0.03
D018376 Cardiovascular Abnormalities NIH 0.03
D063806 Myalgia NIH 0.03
D005879 Tourette Syndrome NIH 0.03
D014832 Voice Disorders NIH 0.03
D020767 Intracranial Thrombosis NIH 0.03
D018410 Pneumonia, Bacterial NIH 0.03
D003424 Crohn Disease NIH 0.03
D000309 Adrenal Insufficiency NIH 0.03
D007008 Hypokalemia NIH 0.03
D007010 Hyponatremia NIH 0.03
D010608 Pharyngeal Diseases NIH 0.03
D006562 Herpes Zoster NIH 0.03
D016769 Embolism and Thrombosis NIH 0.03
D055501 Macrophage Activation Syndrome NIH 0.03
D003920 Diabetes Mellitus, NIH 0.03
D014808 Vitamin D Deficiency NIH 0.03
D055370 Lung Injury NIH 0.03
D000073397 Occupational Stress NIH 0.03
D000857 Olfaction Disorders NIH 0.03
D019851 Thrombophilia NIH 0.03
D004194 Disease NIH 0.03
D013927 Thrombosis NIH 0.03
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.03
D011665 Pulmonary Valve Insufficiency NIH 0.03
D015212 Inflammatory Bowel Diseases NIH 0.03
D013313 Stress Disorders, Post-Traumatic NIH 0.03
D000505 Alopecia NIH 0.02
D000070642 Brain Injuries, Traumatic NIH 0.02
D000690 Amyotrophic Lateral Sclerosis NIH 0.02
D012640 Seizures NIH 0.02
D000075902 Clinical Deterioration NIH 0.02
D012772 Shock, Septic NIH 0.02
D009101 Multiple Myeloma NIH 0.02
D007410 Intestinal Diseases NIH 0.02
D009205 Myocarditis NIH 0.02
D011618 Psychotic Disorders NIH 0.02
D016472 Motor Neuron Disease NIH 0.02
D058345 Asymptomatic Infections NIH 0.02
D014786 Vision Disorders NIH 0.02
D009410 Nerve Degeneration NIH 0.02
D006330 Heart Defects, Congenital NIH 0.02
D000208 Acute Disease NIH 0.02
D001528 Behcet Syndrome NIH 0.02
D006402 Hematologic Diseases NIH 0.02
D015354 Vision, Low NIH 0.02
D004700 Endocrine System Diseases NIH 0.02
D054990 Idiopathic Pulmonary Fibrosis NIH 0.02
D006526 Hepatitis C NIH 0.02
D054219 Neoplasms, Plasma Cell NIH 0.02
D013923 Thromboembolism NIH 0.02
D000066553 Problem Behavior NIH 0.02
D054556 Venous Thromboembolism NIH 0.02
D053717 Pneumonia, Ventilator-Associated NIH 0.02
D058186 Acute Kidney Injury NIH 0.02
D018450 Disease Progression NIH 0.02
D020246 Venous Thrombosis NIH 0.02
D040921 Stress Disorders, Traumatic NIH 0.02
D003680 Deglutition Disorders NIH 0.02
D025241 Spondylarthritis NIH 0.02
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.02
D004417 Dyspnea NIH 0.02
D011565 Psoriasis NIH 0.02
D012859 Sjogren's Syndrome NIH 0.02
D006470 Hemorrhage NIH 0.02
D000370 Ageusia NIH 0.02
D013651 Taste Disorders NIH 0.02
D001714 Bipolar Disorder NIH 0.02
D053120 Respiratory Aspiration NIH 0.02
D014947 Wounds and Injuries NIH 0.02
D020141 Hemostatic Disorders NIH 0.02
D001778 Blood Coagulation Disorders NIH 0.02
D005356 Fibromyalgia NIH 0.02
D000755 Anemia, Sickle Cell NIH 0.02
D012818 Signs and Symptoms, Respiratory NIH 0.02
D000163 Acquired Immunodeficiency Syndrome NIH 0.02
D003327 Coronary Disease NIH 0.02
D004617 Embolism NIH 0.02
D015535 Arthritis, Psoriatic NIH 0.02
D060085 Coinfection NIH 0.02
D006973 Hypertension NIH 0.02
D015658 HIV Infections NIH 0.02
D007154 Immune System Diseases NIH 0.02
D001930 Brain Injuries, NIH 0.02
D001927 Brain Diseases NIH 0.02
D009102 Multiple Organ Failure NIH 0.02
D001523 Mental Disorders NIH 0.02
D009765 Obesity NIH 0.01
D007153 Immunologic Deficiency Syndromes NIH 0.01
D000073496 Frailty NIH 0.01
D010300 Parkinsonian NIH 0.01
D008175 Lung Neoplasms NIH 0.01
D008180 Lupus Erythematosus, Systemic NIH 0.01
D009461 Neurologic Manifestations NIH 0.01
D019337 Hematologic Neoplasms NIH 0.01
D012769 Shock, NIH 0.01
D001327 Autoimmune Diseases NIH 0.01
D006331 Heart Diseases NIH 0.01
D008231 Lymphopenia NIH 0.01
D012598 Scoliosi NIH 0.01
D018805 Sepsis NIH 0.01
D009103 Multiple Sclerosis NIH 0.01
D002318 Cardiovascular Diseases NIH 0.01
D011248 Pregnancy Complications NIH 0.01
D059350 Chronic Pain NIH 0.01
D003095 Collagen Diseases NIH 0.01
D006333 Heart Failure NIH 0.01
D002055 Burnout, Professional NIH 0.01
D001008 Anxiety Disorders NIH 0.01
D001172 Arthritis, Rheumatoid NIH 0.01
D012216 Rheumatic Diseases NIH 0.01
D007251 Influenza, Human NIH 0.01
D017563 Lung Diseases, Interstitial NIH 0.01
D020521 Stroke NIH 0.01
D001168 Arthritis NIH 0.01
D011655 Pulmonary Embolism NIH 0.01
D011658 Pulmonary Fibrosis NIH 0.01
D003863 Depression, NIH 0.01
D000077062 Burnout, Psychological NIH 0.01
D009369 Neoplasms, NIH 0.01
D013315 Stress, Psychological NIH 0.01
D004630 Emergencies NIH 0.01

Correlated HPO Terms (74)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.15
HP:0011947 Respiratory tract infection HPO 0.08
HP:0100614 Myositis HPO 0.05
Name (Synonyms) Correlation
HP:0005978 Type II diabetes mellitus HPO 0.04
HP:0012418 Hypoxemia HPO 0.04
HP:0006536 Pulmonary obstruction HPO 0.04
HP:0002088 Abnormal lung morphology HPO 0.04
HP:0002905 Hyperphosphatemia HPO 0.03
HP:0002900 Hypokalemia HPO 0.03
HP:0000819 Diabetes mellitus HPO 0.03
HP:0000846 Adrenal insufficiency HPO 0.03
HP:0001618 Dysphonia HPO 0.03
HP:0001621 Weak voice HPO 0.03
HP:0100724 Hypercoagulability HPO 0.03
HP:0002355 Difficulty walking HPO 0.03
HP:0008711 Benign prostatic hyperplasia HPO 0.03
HP:0002789 Tachypnea HPO 0.03
HP:0000132 Menorrhagia HPO 0.03
HP:0003326 Myalgia HPO 0.03
HP:0002902 Hyponatremia HPO 0.03
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.03
HP:0000859 Hyperaldosteronism HPO 0.03
HP:0100280 Crohn's disease HPO 0.03
HP:0001609 Hoarse voice HPO 0.03
HP:0100512 Low levels of vitamin D HPO 0.03
HP:0000458 Anosmia HPO 0.03
HP:0001907 Thromboembolism HPO 0.03
HP:0006510 Chronic pulmonary obstruction HPO 0.03
HP:0002037 Inflammation of the large intestine HPO 0.03
HP:0010444 Pulmonary insufficiency HPO 0.03
HP:0006802 Abnormal anterior horn cell morphology HPO 0.02
HP:0001871 Abnormality of blood and blood-forming tissues HPO 0.02
HP:0000709 Psychosis HPO 0.02
HP:0000505 Visual impairment HPO 0.02
HP:0001627 Abnormal heart morphology HPO 0.02
HP:0012819 Myocarditis HPO 0.02
HP:0000224 Hypogeusia HPO 0.02
HP:0100754 Mania HPO 0.02
HP:0000818 Abnormality of the endocrine system HPO 0.02
HP:0002293 Alopecia of scalp HPO 0.02
HP:0007354 Amyotrophic lateral sclerosis HPO 0.02
HP:0002242 Abnormal intestine morphology HPO 0.02
HP:0012047 Hemeralopia HPO 0.02
HP:0002180 Neurodegeneration HPO 0.02
HP:0006775 Multiple myeloma HPO 0.02
HP:0000708 Behavioral abnormality HPO 0.02
HP:0001919 Acute kidney injury HPO 0.02
HP:0002098 Respiratory distress HPO 0.02
HP:0002625 Deep venous thrombosis HPO 0.02
HP:0003765 Psoriasiform dermatitis HPO 0.02
HP:0002015 Dysphagia HPO 0.02
HP:0001250 Seizure HPO 0.02
HP:0007018 Attention deficit hyperactivity disorder HPO 0.02
HP:0100785 Insomnia HPO 0.02
HP:0001928 Abnormality of coagulation HPO 0.02
HP:0001626 Abnormality of the cardiovascular system HPO 0.02
HP:0000822 Hypertension HPO 0.02
HP:0001513 Obesity HPO 0.02
HP:0001298 Encephalopathy HPO 0.02
HP:0002721 Immunodeficiency HPO 0.01
HP:0002725 Systemic lupus erythematosus HPO 0.01
HP:0100526 Neoplasm of the lung HPO 0.01
HP:0001888 Lymphopenia HPO 0.01
HP:0100806 Sepsis HPO 0.01
HP:0001635 Congestive heart failure HPO 0.01
HP:0012532 Chronic pain HPO 0.01
HP:0001370 Rheumatoid arthritis HPO 0.01
HP:0001909 Leukemia HPO 0.01
HP:0006515 Interstitial pneumonitis HPO 0.01
HP:0001297 Stroke HPO 0.01
HP:0001369 Arthritis HPO 0.01
HP:0002206 Pulmonary fibrosis HPO 0.01
HP:0002204 Pulmonary embolism HPO 0.01
HP:0002664 Neoplasm HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 820 clinical trials


1 An Adaptive Phase I/II Randomized Placebo-controlled Trial to Determine Safety, Immunogenicity and Efficacy of Non-replicating ChAdOx1 SARS-CoV-2 Vaccine in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.

NCT04444674
Conditions
  1. Coronavirus
Interventions
  1. Biological: ChAdOx1 nCoV-19
  2. Biological: Normal saline 0.9%
MeSH:Coronavirus Infect Coronavirus Infections

Primary Outcomes

Description: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination

Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-negative adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety)

Time: Up to 12 months post enrollment

Description: Virologically-confirmed COVID-19 clinical disease will be defined as an acute respiratory illness that is clinically consistent with COVID-19 disease, AND SARS-CoV-2 RT-PCR positivity.

Measure: Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults who receive candidate vaccine ChAdOx1 nCoV-19 compared to placebo recipients (efficacy)

Time: Up to 12 months post enrollment

Description: Number of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination, and unsolicited adverse events for 28 days following vaccination. Assess occurrence of disease enhancement episodes and serious adverse events in year post vaccination

Measure: Assess the incidence of adverse events (intervention-related and intervention-unrelated) in HIV-positive adults aged 18-65 year receiving candidate ChAdOx1 nCoV-19 vaccine or placebo (safety)

Time: Up to 12 months post enrollment

Description: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination

Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in people living with HIV (immunogenicity)

Time: Up to 12 months post enrollment

Description: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus

Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19 in people living with HIV

Time: Up to 12 months post enrollment

Secondary Outcomes

Description: Assessing Enzyme-linked immunosorbent assay (ELISA) or fluorescence based micro-bead immunosorbent assay on luminex platform to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) and Virus neutralising antibody (NAb) assays against live and/or pseudotyped SARS-CoV-2 virus

Measure: Assess humoral Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity)

Time: Up to 12 months post enrollment

Description: Assessing the Interferon-gamma (IFN-γ) enzyme- linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein and Th1 and Th2 cytokine response profile at 3-4 days after vaccination

Measure: Assess cellular Immunogenicity of ChAdOx1 nCoV-19 in HIV-negative adults (immunogenicity)

Time: Up to 12 months post enrollment

Other Outcomes

Description: Cellular Fc effector functionality assays to measure the ability of vaccine elicited antibodies to mediate cellular cytotoxicity, complement deposition, and phagocytosis.

Measure: Assess Fc effector functionality in participants who receive ChAdOx1 nCoV-19 vaccine or placebo

Time: Up to 12 months post enrollment

Description: Flow cytometric sorting of plasmablasts and memory B cells to using spike and receptor binding domain "baits" to isolate SARS-CoV-2 specific B cells, sequence their immunoglobulin genes and define their epitope specificity.

Measure: Assess B cell responses to SARS-CoV-2 spike trimer and/or the receptor binding domain in participants who receive ChAdOx1 nCoV-19 vaccine or placebo

Time: Up to 12 months post enrollment
2 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

NCT03331445
Conditions
  1. Respiratory Tract Infections
  2. Corona Virus Infection
Interventions
  1. Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: Measure the number of unanticipated adverse events over the duration of the study protocol

Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects

Time: 26 Days

Secondary Outcomes

Description: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy

Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects

Time: Day 5,12,19 and 26

Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy

Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum

Time: Day 19 and 26

Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)

Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score

Time: Day 19 and 26

Other Outcomes

Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.

Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions

Time: Day 26

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

Measure: Antiviral effect

Time: Day 26

Description: Time to clinical recovery as measured by resolution of clinical signs

Measure: Efficacy on clinical improvement

Time: Day 26

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26
3 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019

The primary objective of this study is to determine the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in Phase 1, to evaluate preliminary efficacy of TAK-981 in participants with select solid tumors or relapsed/refractory CD20-positive (CD20+) non-hodgkin lymphoma (NHL) indications in Phase 2, and to assess change in severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID-19 Expansion.

NCT03648372
Conditions
  1. Neoplasms
  2. Lymphoma
  3. Hematologic Neoplasms
  4. Coronavirus Disease
Interventions
  1. Drug: TAK-981
  2. Drug: Standard of care
MeSH:Coronavirus Infections Neoplasms Hematologic Neoplasms
HPO:Hematological neoplasm Leukemia Neoplasm

Primary Outcomes

Measure: Phase 1: Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

Time: Up to 48 months

Description: Severity grade will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which will be assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.

Measure: Phase 1: Number of Participants Based on Severity of TEAEs

Time: Up to 48 months

Measure: Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Time: Up to Cycle 1 (Cycle length is equal to [=] 21 days)

Measure: Phase 1: Number of Participants With Clinically Significant Laboratory Values

Time: Up to 48 months

Description: ORR is defined as percentage of participants who achieve complete response (CR) and partial response (PR), as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Overall Response Rate (ORR)

Time: From the first dose until best response is achieved (up to 4 years)

Measure: COVID-19 Expansion: Number of Participants With Greater Than or Equal to (>=) 2 log Reduction From Baseline in Viral Load or Below Level of Detection (Negative) in Nasopharyngeal or Oropharyngeal Samples

Time: Up to 9 months

Secondary Outcomes

Measure: Phase 2: Number of Participants Reporting one or More TEAEs

Time: Up to 48 months

Description: Severity grade will be evaluated as per the NCI CTCAE Version 5.0, except for CRS, which will be assessed by ASTCT consensus grading criteria.

Measure: Phase 2: Number of Participants Based on Severity of TEAEs

Time: Up to 48 months

Measure: Phase 2, Cmax: Maximum Observed Plasma Concentration for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length is equal to [=] 21 days)

Measure: Phase 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Phase 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Phase 2, AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Phase 2, Terminal Disposition Phase Half-life (t1/2z) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Phase 2, Total Clearance (CL) After Intravenous Administration for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Measure: Phase 2, Volume of Distribution at Steady State After Intravenous Administration (Vss) for TAK-981

Time: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post dose; Cycle 1 Day 8 pre-dose and at multiple time points (up to 24 hours) post dose (Cycle length =21 days)

Description: ORR is defined as percentage of participants who achieve CR and PR through the study (approximately 4 years), as determined by the investigator according to the RECIST V1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: ORR

Time: From the first dose until best response is achieved (up to 4 years)

Description: DOR is the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease for responders (PR or better) and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Duration of Response (DOR)

Time: From the time of documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to 4 years)

Description: DCR is defined as the percentage of participants who achieve stable disease (SD) or better (determined by the investigator according to RECIST v1.1 criteria for solid tumors or Lugano classification for lymphoma) greater than (>) 6 weeks during the study in the response-evaluable population.

Measure: Phase 2: Disease Control Rate (DCR)

Time: From the first dose until best response is achieved (up to 4 years)

Description: TTR is defined as the time from the date of first study drug administration to the date of first documented PR or better by the investigator for responders according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Time to Response (TTR)

Time: From the date of first study drug administration to the date of first documented PR or better (up to 4 years)

Description: TTP is defined as the time from the date of the first dose administration to the date of first documented progressive disease and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Time to Progression (TTP)

Time: From the date of first study drug administration to the date of first documented PD (up to 4 years)

Description: PFS is defined as the time from the date of the first dose administration to the date of first documentation of progressive disease or death due to any cause, whichever occurs first and will be determined by the investigator according to RECIST v1.1 for participants with solid tumors or Lugano classification for lymphoma.

Measure: Phase 2: Progression-free Survival (PFS)

Time: From the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to 4 years)

Description: OS is defined as the time from the date of the first dose administration to the date of death.

Measure: Phase 2: Overall Survival (OS)

Time: From the date of first study drug administration to the date of death (up to 4 years)

Measure: Phase 2: Number of Participants With TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation and SUMO Pathway Inhibition in Skin/Blood

Time: Up to 48 months

Measure: COVID-19 Expansion: Number of Participants Reporting one or More TEAEs

Time: Up to 9 months

Description: Severity Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 5.0.

Measure: COVID-19 Expansion: Number of Participants Based on Severity of TEAEs

Time: Up to 9 months

Measure: COVID-19 Expansion: Duration of TEAEs

Time: Up to 9 months

Description: NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

Measure: COVID-19 Expansion: Change from Baseline in National Early Warning Score (NEWS)

Time: Up to 9 months

Description: Percentage of participants will be reported based on severity rating on a 6-point ordinal scale, which will include: 1 (death); 2 (hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation, hospitalized); 3 (on non-invasive ventilation or high flow oxygen devices); 4 (hospitalized, requiring supplemental oxygen); 5 (hospitalized, not requiring supplemental oxygen); and 6 (not hospitalized).

Measure: COVID-19 Expansion: Percentage of Participants Reporting Each Hospitalization Severity Rating

Time: Up to 9 months

Description: Change from Baseline in SARS-CoV-2 viral Load in nasopharyngeal or oropharyngeal samples will be determined by viral response. The nasopharyngeal swab will be collected from both nostrils or from the same nostril every time.

Measure: COVID-19 Expansion: Change From Baseline in SARS-CoV-2 Viral Load in Nasopharyngeal or Oropharyngeal Samples

Time: Up to 9 months

Measure: COVID-19 Expansion: Percentage of Participants Requiring Oxygen Supplementation; Assisted or Positive Pressure Non-invasive Ventilation; and Invasive Ventilation, on Days 3, 5, 8, 11, 15, and 30

Time: Days 3, 5, 8, 11, 15, and 30

Measure: COVID-19 Expansion: Percentage of Participants That met Intensive Care Unit (ICU) Criteria

Time: Up to 9 months

Measure: COVID-19 Expansion: Duration of Hospitalization

Time: Up to 9 months

Description: Time from the first dose of TAK-981 to viral load negativity (below level of detection).

Measure: COVID-19 Expansion: Time to Viral Ribonucleic Acid (RNA) Negativity in Nasopharyngeal or Oropharyngeal Samples

Time: Up to 9 months

Description: Time from first dose of TAK-981 to participant's discharge or to NEWS score <=3. NEWS determines the degree of illness of participants and prompts critical care intervention. It will be based on the score allocated to respiratory rate, peripheral capillary oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness.

Measure: COVID-19 Expansion: Time to Discharge or to a NEWS of Less Than or Equal to (<=) 3 and Maintained for 24 Hours

Time: Up to 9 months

Measure: COVID-19 Expansion: Number of Deaths in Hospital due to any Cause in First 30 Days and in 90 Days

Time: Days 30 and 90
4 Lessening Organ Dysfunction With VITamin C (LOVIT)

LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.

NCT03680274
Conditions
  1. Sepsis
  2. Vitamin C
  3. Intensive Care Unit
  4. COVID-19
  5. Pandemic
  6. Coronavirus
Interventions
  1. Drug: Vitamin C
  2. Other: Control
MeSH:Coronavirus Infections

Primary Outcomes

Description: Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors

Measure: Number of deceased participants or with persistent organ dysfunction

Time: Both assessed at 28 days

Secondary Outcomes

Description: Persistent organ dysfunction-free days in intensive care unit

Measure: Number of participants with persistent organ dysfunction-free days in intensive care unit

Time: Up to day 28

Description: Mortality at 6 months

Measure: Number of participants deceased at 6 months

Time: 6 months

Description: Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Measure: Score of health related quality of life in 6-month survivors

Time: 6 months

Description: Assessed by serum lactate concentration

Measure: Global tissue dysoxia

Time: Days 1, 3, 7

Description: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).

Measure: Organ function (including renal function)

Time: Days 1, 2, 3, 4, 7, 10, 14, 28

Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)

Measure: Rate of inflammation

Time: Days 1, 3, 7

Description: Assessed by procalcitonin (PCT)

Measure: Rate of infection

Time: Days 1, 3, 7

Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)

Measure: Rate of endothelial injury

Time: Days 1, 3, 7

Description: Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria

Measure: Occurrence of stage 3 acute kidney injury

Time: Up to day 28

Description: clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells

Measure: Acute hemolysis

Time: Up to day 28

Description: Core lab-validated glucose level of less than 3.8 mmol/L

Measure: Hypoglycemia

Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C volume of distribution

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C clearance

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C plasma concentration

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)
5 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
6 Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV

In late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China. It is now confirmed that the etiology of this outbreak is a novel coronavirus, namely, 2019-nCoV. Of critical importance is rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of 2019-nCoV. Recombinase aided amplification (RAA) assay is a novel isothermal nucleic acid amplification technique in recent years, which has a variety of the advantages including high specificity and sensitivity, rapid detection (30 min), low cost, low equipment requirements and simple operation. The has successfully detected a variety of pathogens using this technique. To develop a RAA assay for 2019-nCoV with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. The investigators established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, The investigators also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference.

NCT04245631
Conditions
  1. New Coronavirus
Interventions
  1. Diagnostic Test: Recombinase aided amplification (RAA) assay
MeSH:Coronavirus Infections

Primary Outcomes

Description: Detection sensitivity is greater than 95%

Measure: Detection sensitivity is greater than 95%

Time: at baseline

Description: Detection specificity is greater than 95%

Measure: Detection specificity is greater than 95%

Time: at baseline

Secondary Outcomes

Description: Consistent with existing universal reagent detection rates greater than 95%

Measure: Consistent with existing universal reagent detection rates greater than 95%

Time: at baseline
7 Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

NCT04259892
Conditions
  1. Coronavirus
Interventions
  1. Biological: 2019-nCoV PCR
MeSH:Coronavirus Infections

Primary Outcomes

Description: PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

Measure: Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.

Time: 12 days (+/-2)

Secondary Outcomes

Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)

Measure: Time to apparition of any symptom suggestive of SARS-CoV-2 from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.

Time: 12 days (+/-2)

Description: nasopharyngeal excretion assessed by PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact

Measure: Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion

Time: 12 days (+/-2)

Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)

Measure: Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection

Time: 12 days (+/-2)

Description: Patient Reported Outcome assessed daily (fever > 38°C, asthenia/fatigue/malaise, headache, thrills/sweating, myalgia/aches, cough, dyspnea, Acute Respiratory Distress Syndrome, diarrhea, abdominal pain, ...)

Measure: Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection

Time: 12 days (+/-2)

Description: ELISA, microneutralisation essay

Measure: Proportion of contact subjects with positive serology defined as the presence of SARS-CoV-2 IgM or IgG at day 30 (+/-7) following last contact

Time: 30 days (+/-7)

Description: Whole exome sequencing

Measure: Host genetic variants

Time: 1 day

Description: ELISA, microneutralisation essay

Measure: The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.

Time: 365 days (+/-30)
8 A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.

NCT04261907
Conditions
  1. 2019-nCoV
Interventions
  1. Drug: ASC09/ritonavir group
  2. Drug: lopinavir/ritonavir group
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.

Measure: The incidence of composite adverse outcome

Time: 14 days

Secondary Outcomes

Description: Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.

Measure: Time to recovery

Time: 14 days

Measure: Rate of no fever

Time: 14 days

Measure: Rate of no cough

Time: 14 days

Measure: Rate of no dyspnea

Time: 14 days

Measure: Rate of no requring supplemental oxygen

Time: 14 days

Measure: Rate of undectable viral RNA

Time: 14 days

Measure: Rate of mechanical ventilation

Time: 14 days

Measure: Rate of ICU admission

Time: 14 days

Measure: Time and rate of laboratory indicators related to disease improvement to return to normal

Time: 14 days
9 Clinical Characterisation Protocol for Severe Emerging Infections

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.

NCT04262921
Conditions
  1. Coronavirus Infections
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the clinical features of the illness or syndrome (cardio-respiratory signs or symptoms, and laboratory results) and complications, and determinants of severity. Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.

Measure: Clinical features

Time: 6 months

Description: Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments. Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.

Measure: Response to treatment

Time: 6 months

Description: high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples. Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.

Measure: Pathogen replication, excretion and evolution, within the host

Time: 6 months

Description: Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood. Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.

Measure: Immune host responses to infection and therapy

Time: 6 months

Description: Identify host genetic variants associated with disease progression or severity

Measure: Host genetic variants

Time: Day 1
10 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
11 Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)

Compare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19). Random, open, group sequential design.

NCT04273763
Conditions
  1. Novel Coronavirus Pneumonia
  2. 2019-nCoV
Interventions
  1. Drug: Bromhexine Hydrochloride Tablets
  2. Drug: Arbidol Hydrochloride Granules
  3. Drug: Recombinant Human Interferon α2b Spray
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.

Measure: Time to clinical recovery after treatment

Time: within 14 days from the start of medication

Description: Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg

Measure: Rate of aggravation

Time: within 14 days from the start of medication

Secondary Outcomes

Description: Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.

Measure: Clinical remission rate

Time: within 14 days from the start of medication

Description: oxygenation index

Measure: Dynamic changes of oxygenation index

Time: within 14 days from the start of medication

Description: time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery

Measure: Time to cure

Time: within 14 days from the start of medication

Description: proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients

Measure: rate to cure

Time: within 14 days from the start of medication

Description: defervescence is defined as below 37 Celcius degrees(ear temperature)

Measure: Time to defervescence

Time: within 14 days from the start of medication

Measure: Time to cough remission

Time: within 14 days from the start of medication

Measure: Time to dyspnea remission

Time: within 14 days from the start of medication

Measure: Days of supplemental oxygenation

Time: within 14 days from the start of medication

Measure: Rate of patients with requring supplemental oxygen

Time: within 14 days from the start of medication

Measure: Rate of patients with mechanical ventilation

Time: within 14 days from the start of medication

Measure: Time of negative COVID-19 nucleic acid results

Time: within 14 days from the start of medication

Measure: Rate of negative COVID-19 nucleic acid results

Time: within 14 days from the start of medication

Measure: Rate of ICU admission

Time: within 14 days from the start of medication

Measure: 28-day mortality

Time: From the first day of screening to the day of follow-up (28 days)
12 Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool (COV_NUTRIC)

There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.

NCT04274322
Conditions
  1. Critically Ill
  2. Coronavirus Infections
Interventions
  1. Other: Nutrition support
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Measure: 28-day all cause mortality

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Secondary Outcomes

Measure: All cause infection

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: The rate of complications

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: Length of ICU stay

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: Duration of mechanical ventilation

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
13 Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.

NCT04275388
Conditions
  1. 2019 Novel Coronavirus Pneumonia
Interventions
  1. Drug: Xiyanping injection
  2. Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours

Measure: Clinical recovery time

Time: Up to Day 14

Secondary Outcomes

Description: From the beginning of research drug use to body temperature <37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more

Measure: Complete fever time

Time: Up to Day 14

Description: Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above

Measure: Cough relief time

Time: Up to Day 14

Description: From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)

Measure: Virus negative time

Time: Up to Day 14

Description: Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia

Measure: Incidence of severe or critical neocoronavirus pneumonia

Time: Up to Day 14
14 Effecacy and Safety of Bevacizumab in Severe Patients With Covid-19: a Pilot Study (BEST-CP)

The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental symptoms and usually presents in severe and critical coronavirus disease (COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is considered as the most potent vascular permeability inducers. Numerous studies have revealed that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab, an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary edema.

NCT04275414
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Bevacizumab Injection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Time: 24 hours

Description: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Measure: Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio

Time: 7 days

Secondary Outcomes

Description: The oxygen-support status includes 6 levels: mechanical ventilation, non-invasive ventilation, a transition status of alternate use of non-invasive ventilation and high-flow oxygen, high-flow oxygen, low-flow oxygen and ambient air. The improvement of oxygen-support status is defined as switch from a higher level of oxygen-support to a lower level.

Measure: Rate of improvement of oxygen-support status

Time: 28 days

Description: The areas of pulmonary lesions are analysised by a professional imaging software.

Measure: The change of areas of pulmonary lesions shown on chest radiological imaging (chest CT or X-ray)

Time: 7 days

Description: Blood lymphocyte counts

Measure: Blood lymphocyte counts

Time: 7 days

Description: Level of CRP

Measure: Level of CRP

Time: 7 days

Description: Level of hs-CRP

Measure: Level of hs-CRP

Time: 7 days

Description: All-cause mortality

Measure: All-cause mortality

Time: 28 days

Description: Discharge rate

Measure: Discharge rate

Time: 28 days
15 An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection

A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir

NCT04276688
Conditions
  1. Novel Coronavirus Infection
Interventions
  1. Drug: Lopinavir/ritonavir
  2. Drug: Ribavirin
  3. Drug: Interferon Beta-1B
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to negative NPS 2019-n-CoV RT-PCR

Measure: Time to negative NPS

Time: Up to 1 month

Secondary Outcomes

Description: Time to negative saliva 2019-n-CoV RT-PCR

Measure: Time to negative saliva

Time: Up to 1 month

Description: Time to NEWS of 0

Measure: Time to clinical improvement

Time: Up to 1 month

Description: Length of hospitalisation

Measure: Hospitalisation

Time: Up to 1 month

Description: 30-day mortality

Measure: Mortality

Time: Up to 1 month

Description: Cytokine/ chemokine changes

Measure: Immune reaction

Time: up to 1 month

Description: Adverse events during treatment

Measure: Adverse events

Time: up to 1 month

Description: Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR

Measure: Time to negative all clinical specimens

Time: up to 1 month
16 A Pilot Clinical Study on Aerosol Inhalation of the Exosomes Derived From Allogenic Adipose Mesenchymal Stem Cells in the Treatment of Severe Patients With Novel Coronavirus Pneumonia

In December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).

NCT04276987
Conditions
  1. Coronavirus
Interventions
  1. Biological: MSCs-derived exosomes
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Safety evaluation within 28 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)

Measure: Adverse reaction (AE) and severe adverse reaction (SAE)

Time: Up to 28 days

Description: Efficiency evaluation within 28 days, including time to clinical improvement (TTIC)

Measure: Time to clinical improvement (TTIC)

Time: Up to 28 days

Secondary Outcomes

Description: Number of patients weaning from mechanical ventilation within 28 days

Measure: Number of patients weaning from mechanical ventilation

Time: Up to 28 days

Description: Duration (days) of ICU monitoring within 28 days

Measure: Duration (days) of ICU monitoring

Time: Up to 28 days

Description: Duration (days) of vasoactive agents using within 28 days

Measure: Duration (days) of vasoactive agents usage

Time: Up to 28 days

Description: Duration (days) of mechanical ventilation supply among survivors

Measure: Duration (days) of mechanical ventilation supply

Time: Up to 28 days

Description: Number of patients with improved organ failure within 28 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs

Measure: Number of patients with improved organ failure

Time: Up to 28 days

Description: Rate of mortality within 28 days

Measure: Rate of mortality

Time: Up to 28 days

Other Outcomes

Description: Records of daily sequential organ failure assessment (SOFA) score (From 0 to 24 points, higher scores mean a worse outcome)

Measure: Sequential organ failure assessment (SOFA) score

Time: Every day for 28 days

Description: Records of Blood routine test

Measure: Lymphocyte Count (10E9/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Measure: C-reactive protein (CRP) (mg/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Measure: Lactate dehydrogenase (U/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Coagulation function

Measure: D-dimer (mg/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Records of heart failure

Measure: pro-type B natriuretic peptide (pro-BNP) (pg/ml)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-1β (pg/ml)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-2R (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-6 (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Record of serum cytokine

Measure: IL-8 (ng/L)

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Computed tomography or X-ray

Measure: Chest imaging

Time: Day0, Day3, Day7, Day14, Day21, Day28, indicated time points can be added if available

Description: Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimens

Measure: Time to SARS-CoV-2 RT-PCR negativity

Time: Up to 28 days
17 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404
Conditions
  1. Coronavirus Infection (COVID-19)
  2. Pulmonary Arterial Hypertension
  3. Urinary Tract Infections in Children
  4. Hypertension
  5. Pain
  6. Hyperphosphatemia
  7. Primary Hyperaldosteronism
  8. Edema
  9. Hypokalemia
  10. Heart Failure
  11. Hemophilia
  12. Menorrhagia
  13. Insomnia
  14. Pneumonia
  15. Skin Infection
  16. Arrythmia
  17. Asthma in Children
  18. Bronchopulmonary Dysplasia
  19. Adrenal Insufficiency
  20. Fibrinolysis; Hemorrhage
  21. Attention Deficit Hyperactivity Disorder
  22. Multisystem Inflammatory Syndrome in Children (MIS-C)
  23. Kawasaki Disease
  24. Coagulation Disorder
  25. Down Syndrome
Interventions
  1. Drug: 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:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
18 Investigation on Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection in Isolation Unit

Outbreak of 2019 Novel Coronavirus infection started in Wuhan and quickly spread to the world. Suspected patients were isolated and treated in our department. Clinical data was recorded to investigate the clinical features of patients confirmed and excluded diagnosed of 2019 Novel Coronavirus infection.

NCT04279782
Conditions
  1. Coronavirus
Interventions
  1. Other: Comprehensive treatment
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: If the patient will survive after comprehensive treatment

Measure: Survival rate

Time: 28 days

Secondary Outcomes

Description: Images of chest computed tomography are obtained to find out the changes in the course of treatment

Measure: Chest computed tomography

Time: 28 days

Description: Time for recovery from admission to discharged

Measure: Recovery Time

Time: 28 days

Description: A self-rating depression scale (SCL-90) will be finished from patients and medical staff. There are 90 questions. Each question scores from 1 to 5. Minimum score is 90, maximun score is 450. High scores indicate poor condition.

Measure: Depression evaluation

Time: 28 days
19 Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients

Outbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.

NCT04279795
Conditions
  1. Coronavirus
MeSH:Coronavirus Infections

Primary Outcomes

Description: rate of positive results of detection 2019 Novel Coronavirus nucleic acid from urine, blood, anal swabs and pharyngeal swabs samples

Measure: Positive rate of 2019 Novel Coronavirus RNA

Time: 28 days

Secondary Outcomes

Description: If the patient will survive after comprehensive treatment

Measure: Survival rate

Time: 28 days
20 Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus

Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.

NCT04280224
Conditions
  1. Novel Coronavirus Pneumonia
Interventions
  1. Biological: NK Cells
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of pneumonia improvement

Measure: Improvement of clinical symptoms including duration of fever

Time: Measured from day 0 through day 28

Description: Evaluation of pneumonia improvement

Measure: Improvement of clinical symptoms including respiratory frequency

Time: Measured from day 0 through day 28

Description: Safety evaluation

Measure: Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0

Time: Measured from day 0 through day 28

Secondary Outcomes

Description: Marker for 2019-nCoV

Measure: Time of virus nucleic acid test negative

Time: Measured from day 0 through day 28

Description: Marker of immunological function

Measure: CD4+ and CD8+ T cell count

Time: Measured from day 0 through day 28

Description: Marker for efficacy of treatment

Measure: Rate of mortality within 28-days

Time: Day 28

Description: Recovery of lung injury

Measure: Size of lesion area by thoracic imaging

Time: Measured from day 0 through day 28
21 Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)

Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).

NCT04280588
Conditions
  1. Coronavirus Disease (COVID-19)
Interventions
  1. Drug: Fingolimod 0.5 mg
MeSH:Coronavirus Infections

Primary Outcomes

Description: The lesion change on X-ray images from day 5 to baseline

Measure: The change of pneumonia severity on X-ray images

Time: 5 day after fingolimod treatment
22 Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

NCT04280913
Conditions
  1. Coronavirus Disease 2019
Interventions
  1. Other: retrospective analysis
MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary outcome is the time to negative conversion of coronavirus

Measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2

Time: 1 month

Secondary Outcomes

Description: The time of hospitalization.

Measure: Length of stay in hospital

Time: 1 month

Description: The rate of survival within hospitalization of these patients will be tracked.

Measure: Survival

Time: 1 month

Description: The rate of intubation within hospitalization of these patients will be tracked.

Measure: Intubation

Time: 1 month
23 Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.

NCT04281693
Conditions
  1. Novel Coronavirus Infection Pneumonia
Interventions
  1. Diagnostic Test: Standard screening strategy
  2. Diagnostic Test: New screening strategy
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The screening accuracy of the two screening strategies were calculated and compared.

Measure: Screening accuracy

Time: 1 month

Secondary Outcomes

Description: The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.

Measure: Cost-effectiveness analysis

Time: 1 month
24 A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)

This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.

NCT04285190
Conditions
  1. Coronavirus Disease 2019
  2. Novel Coronavirus Pneumonia
Interventions
  1. Drug: T89
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.

Measure: The time to oxygen saturation recovery to normal level (≥97%)

Time: Day -1 to 10

Description: The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.

Measure: The proportion of patients with normal level of oxygen saturation(≥97%)

Time: Day -1 to 10

Secondary Outcomes

Description: From screening to the end of treatment, for all patients randomized, the symptoms will be assessed 2 times daily, and the time to achievement of remission for each symptom will be calculated finally based on the record and compared between two groups.

Measure: The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc.

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.

Measure: The time to the myocardial enzyme spectrum recovery to normal after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with normal myocardial enzyme spectrum after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.

Measure: The time to the electrocardiogram recovery to normal level after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with normal electrocardiogram after treatment

Time: Day -1, 3, 7 and 10

Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.

Measure: The time to the hemodynamics recovery to normal after treatment

Time: Day -1 and 10

Description: From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with normal hemodynamics after treatment

Time: Day -1 and 10

Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.

Measure: The time to exacerbation or remission of the disease after treatment;

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.

Measure: The proportion of the patients with exacerbation or remission of disease after treatment

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.

Measure: The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders

Time: Day -1 to 10

Description: For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.

Measure: The all-cause mortality rate

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.

Measure: The proportion of patients with acidosis

Time: Day -1 and 10

Description: For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.

Measure: The total duration of the patients in-hospital

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.

Measure: The total duration of oxygen inhalation during treatment

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.

Measure: The oxygen flow rate during treatment

Time: Day -1 to 10

Description: From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups.

Measure: The oxygen concentration during treatment

Time: Day -1 to 10
25 The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.

NCT04286503
Conditions
  1. Novel Coronavirus Infectious Disease (COVID-19)
Interventions
  1. Drug: Carrimycin
  2. Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
  3. Drug: basic treatment
MeSH:Communicable Diseases Infection Coronavirus Infections

Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

Description: Pulmonary inflammation resolution time (HRCT) (day)

Measure: Pulmonary inflammation resolution time (HRCT) (day)

Time: 30 days

Description: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

Measure: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

Time: 30 days
26 A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Severe COVID-19 Patients

COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.

NCT04288102
Conditions
  1. Corona Virus Disease 2019(COVID-19)
Interventions
  1. Biological: UC-MSCs
  2. Biological: Saline containing 1% Human serum albumin(solution without UC-MSCs)
MeSH:Virus Diseases Coronavirus Infections

Primary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Change in lesion proportion (%) of full lung volume from baseline to day 28.

Time: Day 28

Secondary Outcomes

Description: Evaluation of Pneumonia Improvement

Measure: Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90

Time: Day 10, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening

Time: Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel)

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90.

Time: Day 10, Day 28, Day 90

Description: Clinical improvement defined as a one-point deduction from baseline in a 6 ordinal scale: Not hospitalized; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Time to clinical improvement in 28 days.

Time: Day 28

Description: Evaluation of Pneumonia Improvement

Measure: Oxygenation index( PaO2/FiO2)

Time: Day 6, Day 10, Day 28

Description: Evaluation of Pneumonia Improvement

Measure: Duration of oxygen therapy(days)

Time: Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Blood oxygen saturation

Time: Day 6, Day 10, Day 28

Description: Evaluation of Pneumonia Improvement

Measure: 6-minute walk test

Time: Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Maximum vital capacity (VCmax)

Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Diffusing Capacity (DLCO)

Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.

Measure: mMRC (Modified Medical Research Council) dyspnea scale

Time: Day 28, Day 90

Description: Marker of Immunological function

Measure: Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90.

Time: Day 6, Day 10, Day 28, Day 90

Description: Marker of Immunological function

Measure: Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90.

Time: Day 6, Day 10, Day 28, Day 90

Description: Safety endpoints

Measure: Adverse events

Time: Day 0 through Day 90

Description: Safety endpoints

Measure: Serious adverse events

Time: Day 0 through Day 90

Description: Safety endpoints

Measure: All-cause mortality

Time: Day 0 through Day 90
27 Soliris to Stop Immune Mediated Death In Covid 19 Infected Patients. A Trial of Distal Complement Inhibition.

Covid-19 has spread rapidly throughout the world causing widespread panic, death, and injury. While this virus is the provocateur, it is often the patient's own disproportionate immune response which deals the most devastating (and often fatal) damage. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care.

NCT04288713
Conditions
  1. Coronavirus
Interventions
  1. Drug: Eculizumab
MeSH:Coronavirus Infections

28 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04290858
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
  3. Dyspnea
Interventions
  1. Drug: Nitric Oxide
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Dyspnea
HPO:Dyspnea Pneumonia Respiratory distress

Primary Outcomes

Description: The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).

Measure: Time to clinical recovery

Time: 28 days
29 Nitric Oxide Gas Inhalation Therapy for Severe Acute Respiratory Syndrome Due to COVID-19.

The investigators will enroll 102 patients with a confirmed diagnosis of COVID-19. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or placebo. ICU Standards of care will be the institution's own protocols (such as ventilation strategies and use and dose of antivirals and antimicrobials, steroids, inotropic and vasopressor agents).

NCT04290871
Conditions
  1. Coronavirus
  2. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Drug: Nitric Oxide Gas
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Percentage of patients that have a PaO2/FiO2 ratio steadily > 300 in ambient air

Measure: SARS-free patients at 14 days

Time: 14 days since beginning of treatment

Secondary Outcomes

Measure: Survival at 28 days

Time: 28 days

Measure: Survival at 90 days

Time: 90 days

Description: Composite outcome in which: Death=0, Days of treatment =1

Measure: SARS-free days at 28 days

Time: 28 days

Description: Composite outcome in which: Death=0, Days of treatment =1

Measure: SARS -free days at 90 days

Time: 90 days

Description: Incidence

Measure: Renal Replacement Therapy

Time: 28 days

Description: Incidence

Measure: Liver Failure

Time: 28 days

Description: Incidence of patients requiring VA-ECMO, LVAD, IABP

Measure: Mechanical Support of Circulation

Time: 28 days

Description: In ambient air if possible

Measure: PaO2/FiO2 ratio in ambient air

Time: daily for 28 days
30 Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)

Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types. Method: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Outcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19. Conclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.

NCT04292327
Conditions
  1. Pneumonia Caused by Human Coronavirus
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The mortality of COVID-19 in 28 days

Measure: Mortality

Time: 28 day

Description: The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.

Measure: The time interval of Nucleic acid detection become negative

Time: 28 day
31 The Efficacy and Safety of Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of Novel Coronavirus Pneumonia Patient (COVID-19) : An Observational Study

There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.

NCT04292340
Conditions
  1. Coronavirus
MeSH:Coronavirus Infections

Primary Outcomes

Description: The SARS-CoV-2 nuclei acid was quantified using RT-PCR

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 1

Time: 1 day after receiving plasma transmission

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3

Time: 3 days after receiving plasma transmission

Measure: The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7

Time: 7 days after receiving plasma transmission

Description: Clinical outcomes include death, critical illness, recovery

Measure: Numbers of participants with different Clinical outcomes

Time: From receiving plasma transmission to 4 weeks

Secondary Outcomes

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: 4 weeks after receiving plasma transmission
32 Randomized, Open, Blank Control Study on the Efficacy and Safety of Recombinant Human Interferon α1β in the Treatment of Patients With New Type of Coronavirus Infection in Wuhan

New coronavirus infection is an important cause of public health emergencies at home and abroad, which seriously affects people's health and social stability. The outbreak of SRAR-COV in China in 2003 caused serious social impact. From January 2002 to August 7, 2003, there were a total of 8,422 cases worldwide, involving 32 countries and regions, of which 919 cases were fatal, with a fatality rate of nearly 11%. The fatality rate of elderly patients and patients with underlying diseases was even more high.There is no precise and effective treatment for coronavirus infection. In vitro, IFN-α2β has inhibitory effects on MERS-CoV and closely related coronavirus severe acute respiratory syndrome (SARS) -CoV. A study showed the effects of interferon-α2β and ribavirin on the replication of nCoV isolates hCoV-EMC / 2012 in Vero and LLC-MK2 cells. The combined application may be useful for the management of patients with nCoV infection in the future. At present, the combination therapy of interferon α2β and ribavirin has been successfully applied in the initial treatment and prevention of SARS and MERS.The purpose of this study was to evaluate the efficacy and safety of recombinant human interferon α1β in treating patients with new coronavirus infection in Wuhan.

NCT04293887
Conditions
  1. COVID-19
  2. Recombinant Human Interferon α1β
Interventions
  1. Drug: Recombinant human interferon α1β
MeSH:Coronavirus Infections

Primary Outcomes

Description: dyspnea

Measure: The incidence of side effects

Time: Within 14 days after enrollment

Description: SPO2≤94%

Measure: The incidence of side effects

Time: Within 14 days after enrollment

Description: respiratory rate ≥24 breaths/min in oxygen state)

Measure: The incidence of side effects

Time: Within 14 days after enrollment

Secondary Outcomes

Description: the patient had a normal body temperature of > for 24 hours (without taking antipyretic drugs or hormones) without self-consciousness Dyspnea or reduced dyspnea;

Measure: Time from patient enrollment to clinical remission

Time: Within 14 days after enrollment

Description: Proportion of patients with normal body

Measure: Proportion of patients with normal body

Time: Within 14 days after enrollment

Description: Proportion of patients without dyspnea

Measure: Proportion of patients without dyspnea

Time: Within 14 days after enrollment

Description: Proportion of patients without cough

Measure: Proportion of patients without cough

Time: Within 14 days after enrollment

Description: Proportion of patients without oxygen treatment

Measure: Proportion

Time: Within 14 days after enrollment

Description: The negative conversion rate of new coronavirus nucleic acid

Measure: The negative conversion rate of new coronavirus nucleic acid

Time: Within 14 days after enrollment

Description: Proportion of patients hospitalized/hospitalized in ICU

Measure: Proportion

Time: within 28 days after enrollment

Description: Frequency of serious adverse drug events.

Measure: Frequency of serious adverse drug events.

Time: within 28 days after enrollment
33 Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.

NCT04295551
Conditions
  1. COVID-19
Interventions
  1. Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection
  2. Drug: Lopinavir/ritonavir treatment
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The time from study drug use to complete fever reduction and cough recovery is measured in hours.

Measure: Clinical recovery time

Time: Up to Day 28
34 Medical Masks Versus N95 Respirators to Prevent 2019 Novel Coronavirus Disease (COVID-19) in Healthcare Workers: A Randomized Trial

A randomized controlled trial in which nurses will be randomized to either medical masks or N95 respirators when providing care to patients with COVID-19.

NCT04296643
Conditions
  1. Coronavirus
  2. N95
  3. Medical Mask
Interventions
  1. Device: Medical Mask
  2. Device: N95 respirator
MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of participants with RT-PCR confirmed COVID-19 infection

Measure: RT-PCR confirmed COVID-19 infection

Time: 6 months

Secondary Outcomes

Description: Number of participants with acute respiratory illness

Measure: Acute respiratory illness

Time: 6 months

Description: Number of participants with absenteeism

Measure: Absenteeism

Time: 6 months

Description: Number of participants with lower respiratory infection

Measure: Lower respiratory infection

Time: 6 months

Description: Number of participants with pneumonia

Measure: Pneumonia

Time: 6 months

Description: Number of participants with ICU admission

Measure: ICU admission

Time: 6 months

Description: Number of participants needing mechanical ventilation

Measure: Mechanical ventilation

Time: 6 months

Description: Number of participants that died

Measure: Death

Time: 6 months
35 Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.

NCT04299152
Conditions
  1. Severe Acute Respiratory Syndrome (SARS) Pneumonia
Interventions
  1. Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Inflammation
HPO:Pneumonia

Primary Outcomes

Description: The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.

Measure: Determine the number of Covid-19 patients who were unable to complete SCE Therapy

Time: 4 weeks

Secondary Outcomes

Description: Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.

Measure: Examine the percentage of activated T cells after SCE therapy by flow cytometry

Time: 4 weeks

Description: Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.

Measure: Assess the percentage of Th17 cells after SCE therapy by flow cytometry

Time: 4 weeks

Description: Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.

Measure: Chest imaging changes by computed tomography (CT) scan of the chest

Time: 4 weeks

Description: To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.

Measure: Quantification of the SARS-CoV-2 viral load by real time RT-PCR

Time: 4 weeks
36 Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

NCT04302766
Conditions
  1. Coronavirus Disease 2019
Interventions
  1. Drug: Remdesivir
MeSH:Coronavirus Infections

37 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
38 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID-19: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04305457
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: Nitric Oxide
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Proportion of deaths from all causes

Measure: Mortality

Time: 28 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.

Measure: Time to clinical recovery

Time: 28 days

Other Outcomes

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days
39 Nitric Oxide Gas Inhalation Therapy for Mechanically Ventilated Patients With Severe Acute Respiratory Syndrome Caused by SARS-CoV2: a Randomized Clinical Trial.

Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded randomized controlled trial with 1:1 individual allocation

NCT04306393
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
  2. Coronavirus
Interventions
  1. Drug: Nitric Oxide Gas
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Difference within groups in terms of PaO2/FiO2 ratio. If a patient dies during the first 48 hours of treatment, the last available blood gas analysis will be used.

Measure: Change of arterial oxygenation at 48 hours from enrollment

Time: 48 hours

Secondary Outcomes

Description: Time to recover gas exchange to a PaO2/FiO2 =/> 300 for at least 24 hours during the first 28 days after enrollment, within each group and comparison between groups. If the patient dies before day 28, the patient will be considered as "never recovered".

Measure: Time to reach normoxemia during the first 28 days after enrollment

Time: 28 days

Description: Daily proportion of patients with a PaO2/FiO2 ratio > 300 for at least 24 hours within each group and comparison between groups. If a patient dies before day 28, the patient will be considered as "never recovered".

Measure: Proportion of SARS-nCoV-2 free patients during the first 28 days after enrollment

Time: 28 days

Description: Proportion of patients surviving at 28 days within each group and comparison between groups.

Measure: Survival at 28 days from enrollment

Time: 28 days

Description: Proportion of patients surviving at 90 days within each group and comparison between groups.

Measure: Survival at 90 days from enrollment

Time: 90 days

Other Outcomes

Description: Expressed as PaO2/FiO2 ratio within each group and comparison between groups.

Measure: Daily oxygenation in the two groups until day 28

Time: 28 days

Description: Proportion of patients needing RRT within each group and comparison between groups.

Measure: Need for new renal replacement therapy during the first 28 days

Time: 28 days

Description: Proportion of patients needing (i.e., ECMO, intra-aortic balloon pump, VADs) within each group and comparison between groups.

Measure: Mechanical support of circulation during the first 28 days

Time: 28 days

Description: Average days without need for vasopressors within each group and comparison between groups.

Measure: Days free of vasopressors during the first 28 days

Time: 28 days

Description: Average days without need for mechanical ventilation within each group and comparison between groups.

Measure: Ventilator-free day at 28 days

Time: 28 days

Description: Time to obtain first negative upper respiratory trait sample in the 2019-nCoV rt-PCR assay. Average within groups and comparison between groups.

Measure: Time to SARS-CoV-2 rt-PCR negative in upper respiratory tract specimen

Time: 28 days

Description: Average days out of ICU within each group and comparison between groups.

Measure: ICU-free days at 28 days

Time: 28 days

Description: Average days of ICU admission within each group and comparison between groups.

Measure: ICU length of stay

Time: 90 days
40 Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation

In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe. No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19). The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.

NCT04307459
Conditions
  1. Coronavirus Infections
  2. Respiratory Failure
  3. Ventilator Lung
Interventions
  1. Other: standard operating procedures
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome

Measure: Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Time: 1-6 months

Secondary Outcomes

Description: How many patients died during the hospitalization

Measure: in-hospital mortality

Time: 1 month

Description: How many patients died 30 days after the discharge

Measure: 30 days mortality

Time: 1 month

Description: How many patients died 6 months after the discharge

Measure: 6 months mortality

Time: 6 months

Description: How many patients were intubated during the hospitalization

Measure: Intubation rate

Time: 7 days

Description: How many days/hours from admittance to intubation

Measure: Time to Intubation

Time: 7 days

Description: How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy

Measure: Time to ventilation

Time: 7 days

Description: How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation

Measure: Non invasive to Invasive time

Time: 7 days

Description: How many patients were healed from the infection and discharged

Measure: Recovery rate

Time: 1 month

Description: How many patients underwent re-infection after previous recovery from COVID19

Measure: Recurrence rate

Time: 1 month

Description: Assessment of the risk factors for the infection and the admission to the hospital

Measure: Risk factor for COVID19

Time: retrospective

Description: What serological parameter could be used as predictor of good or negative prognosis.

Measure: Blood tests and outcome

Time: 1 month

Description: Impact of antiviral therapy on the clinical course of the disease

Measure: Antiviral therapy

Time: 1 month

Description: Assessment of bacterial, fungal or other coinfections rate

Measure: Coinfections

Time: 1 month

Description: Impact of radiological findings on the clinical course and the outcome

Measure: Radiological findings

Time: 1 month

Description: Impact of ultrasound findings on the clinical course and the outcome

Measure: Ultrasound findings

Time: 1 month

Description: Assessment of the evidence of myocardial injury in covid19+ patients

Measure: Myocardial injury

Time: 1 month

Description: impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.

Measure: Medical management

Time: 1 month
41 Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.

NCT04307693
Conditions
  1. COVID-19
Interventions
  1. Drug: Lopinavir/ritonavir
  2. Drug: Hydroxychloroquine sulfate
MeSH:Coronavirus Infections

Primary Outcomes

Description: Area under the curve (AUC) of Ct value or viral copies number per mL

Measure: Viral load

Time: hospital day 3, 5, 7, 10, 14, 18

Secondary Outcomes

Description: Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)

Measure: Viral load change

Time: hospital day 3, 5, 7, 10, 14, 18

Description: Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours

Measure: Time to clinical improvement (TTCI)

Time: up to 28 days

Description: Percentage of progression to supplemental oxygen requirement by day 7

Measure: Percentage of progression to supplemental oxygen requirement by day 7

Time: hospital day 7

Description: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7

Measure: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7

Time: hospital day 7

Description: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission

Measure: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission

Time: up to 28 days

Description: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7

Measure: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7

Time: hospital day 7

Description: Safety and tolerability, as assessed by adverse effects

Measure: adverse effects

Time: up to 28 days

Description: Concentration of Lopinavir/ritonavir and hydroxychloroquine

Measure: Concentration of Lopinavir/ritonavir and hydroxychloroquine

Time: 1, 2, 4, 5, 12 hours after taking intervention medicine
42 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
43 Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study

The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.

NCT04310228
Conditions
  1. COVID-19
Interventions
  1. Drug: Favipiravir Combined With Tocilizumab
  2. Drug: Favipiravir
  3. Drug: Tocilizumab
MeSH:Virus Diseases Coronavirus Infections

Primary Outcomes

Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.

Measure: Clinical cure rate

Time: 3 months

Secondary Outcomes

Measure: Viral nucleic acid test negative conversion rate and days from positive to negative

Time: 14 days after taking medicine

Measure: Duration of fever

Time: 14 days after taking medicine

Measure: Lung imaging improvement time

Time: 14 days after taking medicine

Measure: Mortality rate because of Corona Virus Disease 2019

Time: 3 months

Measure: Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs

Time: 3 months

Measure: Mean in-hospital time

Time: 3 months
44 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
45 Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System

Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

NCT04311398
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: New QIAstat-Dx fully automatic multiple PCR detection platform
MeSH:Coronavirus Infections

Primary Outcomes

Measure: Sensitivity, spectivity turnaround time of the New QIAstat-Dx fully automatic multiple PCR detection platform

Time: 3 months
46 ZYESAMI (Aviptadil) for the Treatment of Critical COVID-19 With Respiratory Failure

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI (aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.

NCT04311697
Conditions
  1. Critical COVID-19 With Respiratory Failure
  2. Acute Respiratory Distress Syndrome (ARDS)
  3. Corona Virus Infection
  4. Acute Lung Injury
Interventions
  1. Drug: Aviptadil by intravenous infusion + standard of care
  2. Drug: Normal Saline Infusion + standard of care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Lung Injury

Primary Outcomes

Description: Cumulative distribution of the time to respiratory failure resolution with concurrent survival through day 28

Measure: Resolution of Respiratory Failure

Time: Day 0 through day 28

Secondary Outcomes

Description: Achievement of score 6-8 on NIAID Ordinal Scale through day 28

Measure: Improvement on NIAID Scale (key secondary measure)

Time: Day 0 through day 28

Description: Survival probability on Kaplan Meier lifetable through day 28 and day 60

Measure: Survival through day 28 and day 60

Time: Day 0 through day 28

Description: Time to discharge from Intensive Care Unit

Measure: Time to ICU discharge

Time: Day 0 through day 28

Description: Time on mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen

Measure: Time on ventilation

Time: Day 0 through day 28

Description: Time to extubation (for those initially on mechanical ventilation)

Measure: Time to extubation

Time: Day 0 through day 28

Description: Time to discharge alive

Measure: Time to discharge alive

Time: Day 0 through day 28 and day 60

Description: Days free of multisystem organ failure

Measure: Multi-organ failure free days

Time: Day 0 through day 28

Other Outcomes

Description: PaO2:FiO2 ratio

Measure: Respiratory Distress while on mechanical ventilation

Time: Day 0 through day 28

Description: Oxygenation index

Measure: Oxygenation index

Time: Day 0 through day 28

Description: Improvement in chest x-ray by RALES score

Measure: Improvement in chest x-ray

Time: Day 0 through day 28

Description: Improvement in IL-6, TNF alpha, and other inflammatory markers

Measure: Improvement in inflammatory markers

Time: Day 0 through day 28
47 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
48 Sequential Oxygen Therapy Strategy for Patients With COVID-19

All patients with COVID-19 were divided into three groups according to their illness: mild patient who receive conventional oxygen therapy, severe patients who receive nasal high flow oxygen inhalation or non-invasive positive pressure ventilation,all the oxygen therapy will be used as part of the standard of care. Each group will enroll 10 patients, the treatment of all patients will be continuously optimized during observation, and the incidence of respiratory failure, intubation rate, 28 day mortality rate, ICU hospitalization days, etc will be recorded and analyzed so to optimize the treatment time window of sequential oxygen therapy

NCT04312100
Conditions
  1. Coronavirus Disease-2019
Interventions
  1. Other: oxygen treatment
MeSH:Coronavirus Infections

Primary Outcomes

Description: Incidence of respiratory failure at day 28 after enrollment

Measure: Incidence of respiratory failure

Time: 28 day

Secondary Outcomes

Description: mortality rate at day 28 after enrollment

Measure: 28 day mortality rate

Time: 28 day
49 Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers

Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.

NCT04312243
Conditions
  1. Cor
  2. Coronavirus Infections
  3. Healthcare Associated Infection
Interventions
  1. Drug: Inhaled nitric oxide gas
MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of subjects with COVID-19 diagnosis in the two groups

Measure: COVID-19 diagnosis

Time: 14 days

Secondary Outcomes

Description: Percentage of subjects with a positive test in the two groups

Measure: Positive SARS-CoV-2 rt-PCR test

Time: 14 days

Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days
50 Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19

Covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.

NCT04314232
Conditions
  1. COVID
  2. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Combined outcome measure of either ICU admission or death

Measure: Number of participants with ICU admission or death

Time: From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)

Secondary Outcomes

Description: ICU admission

Measure: Number of participants with ICU admission

Time: From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)

Description: Hospital mortality

Measure: Number of participants with death from all causes

Time: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)

Description: Total time admitted to the ICU

Measure: Total duration of ICU stay

Time: From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)

Measure: Total duration of hospital stay

Time: From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)
51 Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.

NCT04315870
Conditions
  1. Infection Viral
Interventions
  1. Other: pregnant women with laboratory-confirmed 2019-n-CoV
MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission

Measure: Maternal and perinatal outcomes

Time: during gestation and at the time of delivery of the baby
52 Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

NCT04315896
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: incidence of all-cause mortality

Measure: All-cause hospital mortality

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Secondary Outcomes

Description: Days from ER admission to hospital discharge

Measure: Length of hospital stay

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: need of invasive or non invasive mechanical ventilation

Measure: Need of mechanical ventilation

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization

Measure: Ventilator free days

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: Adverse Reactions

Measure: Grade 3-4 adverse reaction

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days
53 Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults

This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. Adults (≥18 year-old) hospitalized for COVID-19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC (this treatment arm has been ceased since June 29, 2020) + Lopinavir/Ritonavir plus interferon ß-1a versus SoC (this treatment arm has been ceased since June 29, 2020) + Hydroxychloroquine (this treatment arm has been ceased since May 24, 2020). Randomization will be stratified by European region and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.

NCT04315948
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Remdesivir
  2. Drug: Lopinavir/ritonavir
  3. Drug: Interferon Beta-1A
  4. Drug: Hydroxychloroquine
  5. Other: Standard of care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Percentage of subjects reporting each severity rating on a 7-point ordinal scale

Time: Day 15

Secondary Outcomes

Description: Time to an improvement of one category from admission on an ordinal scale. Time to an improvement of two categories from admission on an ordinal scale. Time to discharge (categories 1 or 2 of ordinal scale) from admission. Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29. Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline.

Measure: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale

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

Description: • Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS.

Measure: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.

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

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

Time: 29 days

Measure: Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial.

Time: 29 days

Measure: Duration of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial.

Time: 29 days

Measure: Ventilator free days in the first 28 days

Time: 29 days

Measure: Incidence of new mechanical ventilation use during the trial.

Time: 29 days

Description: • Duration of hospitalization (days).

Measure: Hospitalization

Time: 29 days

Description: Rate of mortality

Measure: Mortality

Time: In hospital, Day 28, Day 90

Measure: Cumulative incidence of serious adverse events (SAEs)

Time: 29 days

Measure: Cumulative incidence of Grade 3 and 4 adverse events (AEs)

Time: 29 days

Measure: Number of participants with a discontinuation or temporary suspension of study drugs (for any reason)

Time: 29 days

Measure: Changes from baseline in blood white cell count

Time: 29 days

Measure: Changes from baseline in haemoglobin

Time: 29 days

Measure: Changes from baseline in platelets

Time: 29 days

Measure: Changes from baseline in creatinine

Time: 29 days

Measure: Changes from baseline in blood electrolytes (including kaliemia)

Time: 29 days

Measure: Changes from baseline in prothrombine time

Time: 29 days

Measure: Changes from baseline in international normalized ratio (INR)

Time: 29 days

Measure: Changes from baseline in glucose

Time: 29 days

Measure: Changes from baseline in total bilirubin

Time: 29 days

Measure: Changes from baseline in alanine aminotransferase (ALT)

Time: 29 days

Measure: Changes from baseline in aspartate aminotransferase (AST)

Time: 29 days

Other Outcomes

Measure: Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample

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

Measure: Quantitative SARS-CoV-2 virus in nasopharyngeal sample

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

Measure: Quantitative SARS-CoV-2 virus in blood

Time: Days 3, 5, 8 and 11

Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized

Measure: Plasma concentration of lopinavir

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

Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized

Measure: Plasma concentration of hydroxychloroquine

Time: Days 1, 3, 5, 8 and 11
54 Norwegian Coronavirus Disease 2019 Study: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Antiviral Effect of Chloroquine in Adult Patients With SARS-CoV-2 Infection

In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.

NCT04316377
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Hydroxychloroquine Sulfate
MeSH:Infection Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples

Measure: Rate of decline in SARS-CoV-2 viral load

Time: Baseline (at randomization) and at 96 hours

Secondary Outcomes

Description: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.

Measure: Change in National Early Warning Score score

Time: Baseline (at randomization) and at 96 hours

Description: Transfer from regular ward to intensive care unit during index admission

Measure: Admission to intensive care unit

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

Description: All-cause mortality during index admission

Measure: In-hospital mortality

Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)

Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)

Measure: Duration of hospital admission

Time: During index admission (between admission and discharge, approximately 21 days)

Description: All-cause mortality assessed at 30 and 90 days

Measure: Mortality at 30 and 90 days

Time: At follow-up 30 and 90 days

Description: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities

Measure: Clinical status

Time: 14 days after randomization

Description: Change in C-reactive protein concentrations from randomization to 96 hours after randomization

Measure: Change in C-reactive protein concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization

Measure: Change in alanine aminotransferase concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization

Measure: Change in aspartate aminotransferase concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in bilirubin concentrations from randomization to 96 hours after randomization

Measure: Change in bilirubin concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization

Measure: Change in estimated glomerular filtration rate

Time: Baseline (at randomization) and at 96 hours

Description: Change in cardiac troponin concentrations from randomization to 96 hours after randomization

Measure: Change in cardiac troponin concentrations

Time: Baseline (at randomization) and at 96 hours

Description: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization

Measure: Change in natriuretic peptide concentrations

Time: Baseline (at randomization) and at 96 hours
55 Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19

This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.

NCT04316728
Conditions
  1. Coronavirus Infections
Interventions
  1. Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test

Measure: Number of patients with constant negative results

Time: 30 days

Description: Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive

Measure: Number of patients with positive test with a positive PCR for COVID-19

Time: 30 days

Description: Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Overall Number of patients positive for COVID-19

Time: six months

Description: Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR

Measure: Overall Number of patients negative for COVID-19

Time: six months

Description: Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Number of patients with contrasting results

Time: 30 days

Secondary Outcomes

Description: Number of Invalid results

Measure: Reliability of the test

Time: 30 days

Description: Number of healthcare workers that become positive for COVID-19 IgM or IgG

Measure: Positive HCW

Time: 60 days

Description: Number of Chronic Patients that become positive for COVID-19 IgM or IgG

Measure: Number of Chronic Patients

Time: 60 days
56 Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

NCT04318015
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.

Measure: Symptomatic COVID-19 infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Secondary Outcomes

Description: Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.

Measure: Symptomatic non-COVID viral infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Description: Number of days absent from labor due to COVID-19 symptomatic infection

Measure: Days of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Absenteeism from labor rate due to COVID-19 symptomatic infection

Measure: Rate of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Rate of severe respiratory COVID-19 disease in healthcare personnel

Measure: Rate of severe respiratory COVID-19 disease in healthcare personnel

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start
57 COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2

Modelling repurposed from pandemic influenza is currently informing all strategies for SARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will be important to understand subsequent disease waves, vaccine development and therapeutics. For this reason, ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium) was set up in advance. This focuses on hospitalised and convalescent serum samples to understand severe illness and associated immune response. However, many subjects are seroconverting with mild or even subclinical disease. Information is needed about subclinical infection, the significance of baseline immune status and the earliest immune changes that may occur in mild disease to compare with those of SARS-CoV-2. There is also a need to understand the vulnerability and response to COVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort with likely higher exposure and seroconversion rates than the general population, but who can be followed up with potential for serial testing enabling an insight into early disease and markers of risk for disease severity. We have set up "COVID-19: Healthcare worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2". This urgent fieldwork aims to secure significant (n=400) sampling of healthcare workers (demographics, swabs, blood sampling) at baseline, and weekly whilst they are well and attending work, with acute sampling (if hospitalised, via ISARIC, if their admission hospital is part of the ISARIC network) and convalescent samples post illness. These will be used to address specific questions around the impact of baseline immune function, the earliest immune responses to infection, and the biology of those who get non-hospitalized disease for local research and as a national resource. The proposal links directly with other ongoing ISARIC and community COVID projects sampling in children and the older age population. Reasonable estimates suggest the usable window for baseline sampling of NHS HCW is closing fast (e.g. baseline sampling within 3 weeks).

NCT04318314
Conditions
  1. Health Care Worker Patient Transmission
  2. Coronavirus
  3. Coronavirus Infections
  4. Immunological Abnormality
Interventions
  1. Diagnostic Test: COPAN swabbing and blood sample collection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Home-isolation or hospital admission

Measure: Seroconversion to SARS-CoV-2 positivity

Time: Within 6 months
58 Study to Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Collection and analysis of demographic, clinical, radiographic and laboratory characteristics of CoViD-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions

NCT04318366
Conditions
  1. Coronavirus Infections
Interventions
  1. Other: Observational Study
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Measure: Characterize Patients With SARS-Cov-2 Infection and to Create a Biobank to Identify Predictors of Disease Severity, Mortality and Treatment Response

Time: Hospital stay (2-3 weeks)
59 Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial

The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.

NCT04318444
Conditions
  1. COVID-19
  2. Corona Virus Infection
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.

Measure: Number of participants with symptomatic, lab-confirmed COVID-19.

Time: Date of enrollment to 14 days post-enrollment date
60 Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients

The overall purpose of this project is to better understand the incidence, risk factors, etiology, clinical manifestations and outcome of tCOVID19 in solid organ transplant recipients. The results obtained will allow us to gain insight on the need of antiviral treatment, on the strategy for complications surveillance, on how to adjust the immunosuppressant therapy and on the level of care in which each patient should be treated. In order to attain the objectives previously described we will develop a multicenter prospective study of consecutive cases of COVID-19 among solid organ transplant recipients.

NCT04319172
Conditions
  1. Transplant Recipient
  2. Infections, Coronavirus
MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of Solid Organ Transplant Recipients positive to coronavirus

Measure: Incidence of coronavirus infection in Solid Organ Transplant Recipients

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients

Measure: Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Gathering possible risk factors in coronavirus infection in Solid Organ Transplant

Measure: Presence of other risk factors

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Establish the frequency and type of complications related to the net state of the patient immunosuppression

Measure: Establish the frequency and type of complications related to the net state of the patient immunosuppression

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Secondary Outcomes

Description: Another infections at the time of coronavirus positive infection will be gathered

Measure: Frequency of co-infections

Time: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Description: Number of deaths caused or complicated by coronavirus infection in patients who has recceived Solid Organ Transplant

Measure: Mortality

Time: From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up

Description: Biochemical analysis, hemogram,

Measure: Laboratory characteristics

Time: At inclusion and at 28 days of follow up

Description: Nasopharyngeal swabs

Measure: Determination of coronavirus viral load

Time: At inclusion at 14 days and at 28 days

Description: According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia

Measure: Microbiological testing

Time: At inclusion at 14 days and at 28 days
61 Investigation of Physical Activity, Quality of Life and Stress Levels of Individuals Who Live in Their Homes Isolated Because of Coronavirus (COVID-19) Disease

The aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.

NCT04319211
Conditions
  1. Healthy People
Interventions
  1. Other: Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.
MeSH:Coronavirus Infections

Primary Outcomes

Description: The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey validity and reliability studies have been conducted in Turkey by Ozturk. The survey consists of 27 questions and 5 parts.

Measure: International Physical Activity Questionnaire (IPAQ)

Time: 4 weeks

Description: Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. SF-12 is an easy-to-apply 12-question scale that has been validated and reliable and obtained by shortening and simplifying SF-36, which evaluates the last 4 weeks.

Measure: Health-Related Quality of Life SF-12 Scale

Time: 4 weeks

Description: The individuals participating in our study will be evaluated with the Beck Depression Scale developed in 1961 by Beck et al. The scale validity and reliability studies have been conducted in Turkey by Hisli. The scale is a likert-type scale consisting of 21 items, each scored between 0-3.

Measure: Beck Depression Scale

Time: 4 weeks
62 An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area

The investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.

NCT04320238
Conditions
  1. 2019 Novel Coronavirus Infection
Interventions
  1. Drug: recombinant human interferon Alpha-1b
  2. Drug: thymosin alpha 1
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: new-onset coronavirus disease-2019

Measure: new-onset COVID-19

Time: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.

Secondary Outcomes

Description: new-onset fever or respiratory symptoms but with negative pulmonary images evidence.

Measure: Number of Participants with coronavirus related symptoms

Time: during 28-day intervention.

Description: adverse effect of interferon α

Measure: Number of Participants with adverse effect

Time: during 28-day intervention.
63 COVID CT, Beaumont Quantitative Lung Function Imaging to Characterize Patients With SARS-COV 2

The goal of this study is to evaluate if CT (Computerized Tomography) can effectively and accurately predict disease progression in patients with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). You may be eligible if you have been diagnosed with SARS-CoV-2, are an inpatient at Beaumont Hospital-Royal Oak and meet eligibility criteria. After consent and determination of eligibility, enrolled patients will have a CT scanning session. After the CT scan, patients are followed for 30 days by reviewing their medical records and by phone after discharge from hospital.

NCT04320511
Conditions
  1. SARS-COV2
  2. Severe Acute Respiratory Syndrome
  3. COVID-19
Interventions
  1. Device: CT-V
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Disease progression will be characterized as requiring mechanical ventilator support, non-invasive positive pressure ventilation, high flow nasal cannula or mortality within 30 days.CT-V and PBM scores will be calculated at a voxel level from inhalation-exhalation CT scan. Several CT-V pulmonary function metrics, including the volume of identified "cold spots" (areas with decreased ventilation and perfusion), total ventilation and perfusion and radiographic fibrosis score will be calculated to assess regional ventilation/perfusion and compared to disease progression. The number of participants with correlation between these factors will be reported.

Measure: Predictive association between CT-V, PBM score and disease progression

Time: 30 days
64 Risk Factors for Community- and Workplace Transmission of COVID-19

The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.

NCT04320732
Conditions
  1. Coronavirus
Interventions
  1. Behavioral: Observation of behavior and COVID-19 infection will be conducted.
MeSH:Coronavirus Infections

Primary Outcomes

Description: Diagnosed with serology or direct viral detection

Measure: Rate of COVID-19 infection

Time: 1 year
65 The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial

SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.

NCT04321096
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Camostat Mesilate
  2. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale

Measure: Cohort 1: Days to clinical improvement from study enrolment

Time: 30 days

Description: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)

Measure: Cohort 2: Days to clinical improvement from study enrolment

Time: 30 days

Secondary Outcomes

Measure: Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)

Time: 30 days

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; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30

Time: 30 days

Description: Mortality

Measure: Cohort 1: Day 30 mortality

Time: 30 days

Description: NEWS2

Measure: Cohort 1: Change in NEW(2) score from baseline to day 30

Time: 30 days

Description: ICU

Measure: Cohort 1: Admission to ICU

Time: 30 days

Description: invasive mechanical ventilation or ECMO

Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO

Time: 30 days

Description: Nasal or high-flow oxygen

Measure: Cohort 1: Duration of supplemental oxygen (days)

Time: 30 days

Description: Subjective clinical improvement

Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30

Time: 30 days

Description: No of new COVID-19 infections in the household

Measure: Cohort 2: Number participant-reported secondary infection of housemates

Time: 30 days

Description: Hospital admission

Measure: Cohort 2: Time to hospital admission related to COVID-19 infection

Time: 30 days
66 COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir

COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.

NCT04321174
Conditions
  1. Coronavirus Infections
  2. Post-exposure Prophylaxis
Interventions
  1. Drug: Lopinavir/ritonavir
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.

Measure: Microbiologic evidence of infection

Time: 14 days

Secondary Outcomes

Description: a) Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 & 90 days

Measure: Adverse events

Time: 90 days

Description: fever, cough or other respiratory/ systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhea) by day 14 in a patient with laboratory confirmed infection, combined with microbiologic confirmation of COVID-19 infection in the participant.

Measure: Symptomatic COVID-19 disease

Time: 14 days

Description: Reactive serology to SARS-CoV-2

Measure: Seropositivity

Time: 28 days

Description: The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90

Measure: Days of hospitalization attributable to COVID-19 disease

Time: 90 days

Description: The number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation will be tabulated both at day 28 and day 90.

Measure: Respiratory failure requiring ventilatory support attributable to COVID-19 disease

Time: 90 days

Description: Death attributable to COVID-19 disease and all-cause mortality

Measure: Mortality

Time: 90 days

Description: Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16.

Measure: Short-term psychological impact of exposure to COVID-19 disease

Time: 28 days

Description: Long-term impact will be measured at day 90 using the Impact of Event Scale, a validated measure of traumatic stress response, using a standard cutoff score of ≥26

Measure: Long-term psychological impact of exposure to COVID-19 disease

Time: 90 days

Description: Health-related quality of life will be measured using the EQ-5D-5L (EuroQol-5D). The EQ-5D consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The tool will be administered to participants at 1, 14, 28 and 90 days.

Measure: Health-related quality of life

Time: 90 days
67 Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

NCT04321278
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
Interventions
  1. Drug: Hydroxychloroquine + azithromycin
  2. Drug: Hydroxychloroquine
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

Description: All-cause mortality rates at 29 days after randomization

Measure: All-cause mortality

Time: 29 days after randomization

Description: Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)

Measure: Evaluation of the clinical status

Time: 7 and 29 days after randomization

Description: Number of days free from mechanical ventilation at 29 days after randomization

Measure: Number of days free from mechanical ventilation

Time: 29 days after randomization

Description: Number of days that the patient was on mechanical ventilation after randomization

Measure: Duration of mechanical ventilation

Time: 29 days after randomization

Description: Length of hospital stay on survivors

Measure: Duration of hospitalization

Time: 29 days after randomization

Description: Presence of other secondary infections

Measure: Other secondary infections

Time: 29 days after randomization

Description: Time from treatment start to death

Measure: Time from treatment start to death

Time: 29 days after randomization

Description: Morbimortality, daily life activities, mental health, and quality of life

Measure: Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life

Time: 3, 6, 9 and 12 months

Description: Leucocyte transcriptome

Measure: Assess whether the tested therapies may be affected by leucocyte phenotype

Time: Baseline

Other Outcomes

Description: Occurrence of QT interval prolongation

Measure: QT interval prolongation

Time: 29 days after randomization

Description: Occurrence of gastrointestinal intolerance

Measure: Gastrointestinal intolerance

Time: 29 days after randomization

Description: Occurrence of laboratory hematimetric parameters, creatinine and bilirubin

Measure: Laboratory abnormalities

Time: 29 days after randomization

Description: Occurrence of adverse events related to the use of the investigational products

Measure: Adverse events

Time: 29 days after randomization
68 The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients

The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.

NCT04321616
Conditions
  1. SARS-CoV Infection
  2. COVID 19
  3. Acute Respiratory Distress Syndrome ARDS
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Remdesivir
  3. Other: (Standard of Care) SoC
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: All cause in-hospital mortality

Measure: In-hospital mortality

Time: 3 weeks

Secondary Outcomes

Measure: Occurrence and duration of mechanical ventilation

Time: 3 weeks

Measure: Occurrence and duration of intensive care unit (ICU) treatment

Time: 3 weeks

Measure: Duration of hospital admittance

Time: 1 month

Measure: 28 Day mortality

Time: 3 weeks

Measure: Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen

Time: 3 weeks

Measure: Occurrence of co-infections

Time: 3 weeks

Measure: Occurrence of organ dysfunction

Time: 3 months

Other Outcomes

Measure: Inflammatory and anti-inflammatory mediators as assessed in serum and plasma

Time: Throughout hospitalization

Measure: Markers of extracellular matrix remodeling

Time: Throughout hospitalization and 3 months after remission

Measure: Markers of endothelial activation

Time: Throughout hospitalization

Measure: Markers of platelet activation

Time: Throughout hospitalization
69 A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)

Background: During the current COVID-19 pandemic there is urgent need for information about the natural history of the infection in non-hospitalized patients, including the severity and duration of symptoms, and outcome from early in the infection, among different subgroups of patients. In addition, a large, real-world data registry can provide information about how different concomitant medications may differentially affect symptoms among patient subgroups. Such information can be invaluable for clinicians managing chronic diseases during this pandemic, as well as identify interventions undertaken in a naturalistic setting that have differential effects. Such factors may include patient diet, over the counter or prescription medications, and herbal and alternative treatments, among others. Identifying the natural disease history in patients from different demographic and disease subgroups will be important for identifying at-risk patients and effectiveness of interventions undertaken in the community. Objectives: The purpose of this study is to understand at the population level the symptomatic course of known or suspected COVID-19 patients while sheltering-in-place or under quarantine. Symptoms will be measured using a daily report derived from the CTCAE-PRO as well as free response. Outcomes will be assessed based on the duration and severity of infection, hospitalization, lost-to-follow-up, or death. As a patient-centric registry, patients themselves may propose, suggest, and/or submit evidence or ideas for relevant collection.

NCT04321811
Conditions
  1. Coronavirus
Interventions
  1. Other: Observation of patients with known, suspected, or at risk for COVID-19 infection
MeSH:Coronavirus Infections

Primary Outcomes

Description: Daily survey of symptoms known or reported to be associated with COVID-19 infection based including: Headache, Sore throat, Runny nose, Stuffy nose, Gritty/itch eyes, Watery eyes, Nausea, Vomiting, Diarrhea, Sneezing, Coughing, Shortness of breath, Difficulty breathing, Pain or pressure in your chest, Fever, Chills, Body aches, Fatigue, or other issues. Symptoms are rated by participants on a scale of none, mild, moderate, severe, or very severe.

Measure: Define Natural Symptom Course

Time: Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days)

Secondary Outcomes

Description: Time (in days) from onset of symptoms to hospitalization

Measure: Time to Hospitalization

Time: Realistic timeframe of 14 days

Description: Time (in days) from onset of symptoms to resolution of symptoms

Measure: Time to Symptomatic Recovery

Time: Realistic timeframe of 14 days
70 Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)

The additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.

NCT04321928
Conditions
  1. SARS-CoV-2
  2. Coronavirus
  3. COVID-19
  4. 2019-nCoV
  5. 2019nCoV
Interventions
  1. Behavioral: Personalized health education
  2. Behavioral: General health education
MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary endpoint will be the composite of the rate of the followings in COVID-19 positive cases (verified by an accredited laboratory): the number of pariticipants with ICU (intensive care unit) admission; 48 hours of hospitalisation and/or death. 48 hours of hospitalisation for the following reasons: (I) arrhythmia (causing hemodynamic instability and requiring continuous monitoring and/or cardiac support, as indicated by mean arterial pressure <65 mm Hg, and/or serum lactate >2 mmol/L) and/or (II) Acute Respiratory Distress Syndrome (ARDS): severe hypoxaemic respiratory failure indicated by a Partial Pressure of Oxygen (PaO2)/Fraction of inspired oxygen (FiO2) <300 mmHg according to the Berlin definition and/or (III) circulatory shock (the requirement of continuous vasopressor support to maintain mean arterial pressure <65 mmHg and/or serum lactate >2 mmol/L)

Measure: Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases

Time: 12 months

Secondary Outcomes

Description: The number of participants, who required general practitioner visit assessed by the investigator.

Measure: The number of general practitioner visits

Time: 12 months

Description: The number of participants, who required the admission to each type of level of care assessed by the investigator.

Measure: The number of emergency, hospital admission and intensive care admission

Time: 12 months

Description: The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.

Measure: Length of hospitalization and intensive care unit stay

Time: 12 months

Description: The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.

Measure: Organ dysfunction

Time: 12 months

Description: The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire. The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress. One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.

Measure: Lifestyle changes

Time: 12 months

Description: The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.

Measure: The cost of care

Time: 12 months
71 Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.

NCT04321993
Conditions
  1. COVID-19
Interventions
  1. Drug: Baricitinib (janus kinase inhibitor)
MeSH:Coronavirus Infections

Primary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Clinical status of subject at day 15 (on a 7 point ordinal scale).

Time: Up to 15 days

Secondary Outcomes

Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.

Time: Up to 180 days

Description: Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.

Measure: Length of time to clinical improvement

Time: Up to 29 days

Measure: Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29

Time: Up to 29 days

Measure: Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment

Time: Up to 24 weeks

Description: Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission

Measure: Length of time to clinical progression

Time: Up to 29 days

Measure: Cause of death (if applicable)

Time: Up to 24 weeks

Measure: Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)

Time: Up to 29 days

Description: Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours

Measure: Length of time to normalization of fever

Time: Up to 29 days

Description: Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.

Measure: Length of time to normalization of oxygen saturation

Time: Up to 29 days

Measure: Duration of supplemental oxygen (if applicable)

Time: Up to 29 days

Measure: Duration of mechanical ventilation (if applicable)

Time: Up to 29 days

Measure: Duration of hospitalization

Time: Up to 29 days

Measure: Adverse events

Time: Up to 180 days

Other Outcomes

Measure: Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm

Time: Up to 180 days

Measure: Percent of subjects with SARS-CoV-2 detectable in blood at days 3, 5, 8, 11, 15, 29 and 180.

Time: Up to 180 days

Measure: Quantitative SARS-CoV-2 viral load in blood at days 3, 5, 8, and 11, 15, 29, and 180.

Time: Up to 180 days
72 An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients

Coronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now spreading to several countries in the world, including Brazil. Hydroxychloroquine and azithromycin may be useful for treating those patients. COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19. COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal endpoint of status at 15 days will be the primary endpoint.

NCT04322123
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Hydroxychloroquine Oral Product
  2. Drug: Hydroxychloroquine + azithromycin
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 7th day after randomization defined by the Ordinal Scale of 7 points. Alive at home without limitations on activities Alive at home without limitations on activities In the hospital without oxygen In the hospital using oxygen In the hospital using high-flow nasal catheter or non-invasive ventilation In hospital, on mechanical ventilation Dead

Measure: Ordinal scale in 7 days

Time: 7 days after randomization

Description: Need of intubation and mechanical ventilation up to the 7th day after randomization

Measure: Need of intubation and mechanical ventilation

Time: 7 days after randomization

Description: Use of mechanical ventilation during hospital stay

Measure: Use of mechanical ventilation during hospital stay

Time: 15 days after randomization

Description: Use of non-invasive ventilation up to the 7th day after randomization

Measure: Use of non-invasive ventilation

Time: 7 days after randomization

Description: Hospital Length of Stay

Measure: Hospital Length of Stay

Time: 28 days after randomization

Description: All-cause mortality rates during hospital stay

Measure: All-cause mortality

Time: 28 days after randomization

Description: Occurrence of thromboembolic complications such as: Deep vein thrombosis Pulmonary Embolism Stroke

Measure: Thromboembolic complications

Time: 15 days after randomization

Description: Occurrence of renal dysfunction, defined as an increase in creatinine above 1.5 times the baseline value

Measure: Acute renal disfunction

Time: 15 days after randomization

Description: Number of days alive and free of respiratory support up to 15 days (DAFOR15), defined as the sum of days patients did not require supplementary oxygen, non-invasive ventilation, high-flow nasal catheter neither mechanical ventilation at 15 -days. Patients that perished during the 15-day window will receive zero DAFOR15.

Measure: Number of days alive and free of respiratory support up to 15 days

Time: 15 days

Other Outcomes

Description: Corrected QT interval

Measure: Safety outcome on corrected QT interval

Time: At day 3 and 7 after enrollment
73 An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications

This observational study will collect data from patients treated with siltuximab program for treatment of SARS-CoV-2 infection complicated with serious respiratory complications. This observational study will group the patients into two cohorts receiving siltuximab.. Outcome of patients will be compared to a cohort of patients receiving standard treatment without siltuximab. The patients will be divided into 2 cohorts. Those contained in Cohort A were treated after the use of continuous positive airways pressure (CPAP) or non-invasive ventilation (NIV). Patients in Cohort B were treated after intubation

NCT04322188
Conditions
  1. Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection
MeSH:Infection Communicable Diseases Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort

Measure: mortality in siltuximab treated patients

Time: 30 days

Secondary Outcomes

Description: Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort

Measure: the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support

Time: 30 days

Description: Describe the clinical course of patients treated with siltuximab (Cohort A and B) in terms of ventilatory support and compare the results with the control cohort

Measure: clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy

Time: 30 days

Description: Safety of siltuximab treatment

Measure: Safety Improvement of the lung function assessed by radiologic findings

Time: 30 days

Description: Evaluate the effect of siltuximab on inflammatory parameters (CRP)

Measure: the effect on inflammatory parameters

Time: 30 days

Description: Correlation of outcomes with IL-6 levels

Measure: Correlation of outcomes with IL-6 levels

Time: 30 days
74 Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)

In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020. Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital. Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action. Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection. In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers. The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition. This include both children and adult subjects, subject without social security, and healthcare workers.

NCT04322279
Conditions
  1. Coronavirus
Interventions
  1. Diagnostic Test: Serology
  2. Genetic: Sequencing
MeSH:Coronavirus Infections

Primary Outcomes

Description: Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

Measure: Proportion of subjects with SARS-CoV-2 positive serology at day 30 following the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.

Time: 30 days (+/-7)

Secondary Outcomes

Description: Positive serology defined as the presence of SARS-CoV-2 IgM or IgG and assessed by ELISA, microneutralisation assay

Measure: Factors associated with a SARS-CoV-2 positive serology at day 30 (+/-7);

Time: 30 days (+/-7)

Description: ELISA, microneutralisation assay

Measure: Time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.

Time: 365 days (+/-30)
75 Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients

In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.

NCT04322344
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Escin
  2. Drug: standard therapy
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: All cause mortality

Measure: Mortality rate

Time: up to 30 days

Description: mild type:no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2>93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm;b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation,c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ;4. Critically type:match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS

Measure: Clinical status evaluated in agreement with guidelines

Time: up to 30 days

Secondary Outcomes

Description: Pulse Oxygen Saturation(SpO2)>93%,1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation(oxygen concentration%,The oxygen flow rate:L/min);3. Mask oxygen inhalation(oxygen concentration%,The oxygen flow rate:L/min);4. Noninvasive ventilator oxygen supply(Ventilation mode,oxygen concentration%,The oxygen flow rate:L/min,);5. Invasive ventilator oxygen supply(Ventilation mode,oxygen concentration%,The oxygen flow rate:L/min,)

Measure: The differences in oxygen intake methods

Time: up to 30 days

Description: days

Measure: Time of hospitalization (days)

Time: up to 30 days

Description: days

Measure: Time of hospitalization in intensive care units

Time: up to 30 days

Description: forced expiratory volume at one second ,maximum voluntary ventilation at 1month,2month,3month after discharge

Measure: Pulmonary function

Time: up to 3 months after discharge
76 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396
Conditions
  1. Virus Diseases
  2. Infection Viral
  3. Corona Virus Infection
Interventions
  1. Drug: Azithromycin
  2. Drug: Hydroxychloroquine
  3. Drug: Placebo oral tablet
  4. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

Secondary Outcomes

Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Measure: Categorization of hospitalization status

Time: 14 days

Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

Measure: Mortality

Time: 30 days

Measure: Length of hospitalization

Time: 14 days

Measure: Days alive and discharged from hospital

Time: 30 days

Measure: Mortality

Time: 90 days

Measure: Mortality

Time: 365 days

Measure: Number of readmissions (all causes)

Time: 30 days

Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days
77 Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.

NCT04322513
Conditions
  1. Coronavirus
Interventions
  1. Diagnostic Test: Biomarkers expression
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients

Measure: Biomarkers expression

Time: up to 30 days

Description: Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy

Measure: Liver Biomarkers expression

Time: up to 30 days

Secondary Outcomes

Description: Changes in biomarkers in covid-19 patients before and after standard treatment

Measure: biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment

Time: 60 days
78 Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia

Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear. Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].

NCT04322565
Conditions
  1. Coronavirus Infections
  2. Pneumonia, Viral
Interventions
  1. Drug: Colchicine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale

Measure: Clinical improvement

Time: Day 28

Description: Live discharge from the hospital (whatever comes first)

Measure: Hospital discharge

Time: Day 28

Secondary Outcomes

Description: Number of death patients

Measure: Death

Time: Day 28

Description: 7-category ordinal scale

Measure: Clinical status

Time: Day 7, Day 14

Description: Number of patients with mechanical ventilhation

Measure: Mechanical ventilhation

Time: Day 28

Description: Days of hospitalization

Measure: Hospitalization

Time: Day 28

Description: Days to death from treatment initiation

Measure: Time from treatment initiation to death

Time: Day 28

Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart

Measure: Time to Negativization COVID 19

Time: Day 21

Description: Time to remission of fever in patients with T>37.5°C at enrollment

Measure: Fever

Time: Day 1,4,7,14,21,28
79 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

NCT04322682
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Colchicine
  2. Drug: Placebo oral tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.

Measure: Number of participants who die or require hospitalization due to COVID-19 infection

Time: 30 days post randomization

Secondary Outcomes

Description: The secondary endpoint is the occurrence of death in the 30 days following randomization.

Measure: Number of participants who die

Time: 30 days post randomization

Description: The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.

Measure: Number of participants requiring hospitalization due to COVID-19 infection

Time: 30 days post randomization

Description: The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.

Measure: Number of participants requiring mechanical ventilation

Time: 30 days post randomization
80 The Efficacy of Natural Honey in Patients Infected With Novel Coronavirus (COVID-19) : A Randomized, Controlled ,Single Masked , Investigator Initiated, Multi-center Trial

The novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) has been discovered recently in December 2019 from wuhan city in China to spread in more than 40 countries allover the world. This disease has gain the attention of all nations after it has been stated as a pandemic by the World Health Organization (WHO) in March 12, 2020. Currently no treatment has been proved to be efficient in the treatment of infected patients by COVID-19. Natural honey has been demonstrated as potent antimicrobial in many research investigations and has been considered a good alternative for antiviral drugs for the treatment of some viral infections. The investigators aim to study the efficacy of natural honey in the treatment of COVID-19 patients in this randomized , multicenter, controlled trial, comparing honey in one arm to standard care in the other arm.

NCT04323345
Conditions
  1. COVID-19
Interventions
  1. Dietary Supplement: Natural Honey
  2. Other: Standard Care
MeSH:Coronavirus Infections

Primary Outcomes

Description: Percentage of patients turned from positive to negative swaps at day 14

Measure: Rate of recovery from positive to negative swaps

Time: 14 days

Description: Number of days till no fever

Measure: Fever to normal temperature in days

Time: 14 days

Description: Number of days till lungs recovery in chest X ray or CT

Measure: Resolution of lung inflammation in CT or X ray

Time: 30 days

Secondary Outcomes

Description: mortality rate in each group at 30 days

Measure: 30 days mortality rate

Time: 30 days

Description: Number of days from initiation of intervention till changing of the swap test result from positive to negative

Measure: Number of days till reaching negative swab results

Time: 30 days
81 Efficacy and Safety of Chloroquine Diphosphate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV2: a Phase IIb, Double-blind, Randomized Adaptive Clinical Trial

In December 2019, the Municipal Health Committee of Wuhan, China, identified an outbreak of viral pneumonia of unknown cause. This new coronavirus was called SARS-CoV-2 and the disease caused by that virus, COVID-19. Recent numbers show that 222,643 infections have been diagnosed with 9115 deaths, worldwide. Currently, there are no approved therapeutic agents available for coronaviruses. In this scenario, the situation of a global public health emergency and evidence about the potential positive effect of chloroquine (CQ) in most coronaviruses, including SARS-CoV-1, and recent data on small trials on SARS-CoV-2, the investigators intend to investigate the efficacy and the safety of CQ diphosphate in the treatment of hospitalized patients with severe acute respiratory syndrome in the scenario of SARS-CoV2. Preliminary in vitro studies and uncontrolled trials with low number of patients of CQ repositioning in the treatment of COVID-19 have been encouraging. The main hypothesis is that CQ diphosphate will reduce mortality in 50% in those with severe acute respiratory syndrome infected by the SARS-COV2. Therefore, the main objective is to assess whether the use of chloroquine diphosphate reduces mortality by 50% in the study population. The primary outcome is mortality in day 28 of follow-up. According to local contingency plan, developed by local government for COVID-19 in the State of Amazonas, the Hospital Pronto-Socorro Delphina Aziz, located in Manaus, is the reference unit for the admission of serious cases of the new virus. The unit currently has 50 ICU beds, with the possibility of expanding to 335 beds, if needed. The hospital also has trained multiprofessional human resources and adequate infrastructure. In total, 440 participants (220 per arm) will receive either high dose chloroquine 600 mg bid regime (4x150 mg tablets, every 12 hours, D1-D10) or low dose chloroquine 450mg bid regime (3x150mg tablets + 1 placebo tablet every 12 hours on D1, 3x150mg tablets + 1 placebo followed by 4 placebo tablets 12h later from D2 to D5, and 4 placebo tablets every 12 hours, D6-D10). Placebo tablets were used to standardize treatment duration and blind research team and patients. All drugs administered orally (or via nasogastric tube in case of orotracheal intubation). Both intervention and placebo drugs will be produced by Farmanguinhos. Clinical and laboratory data during hospitalization will be used to assess efficacy and safety outcomes.

NCT04323527
Conditions
  1. SARS-CoV Infection
  2. Severe Acute Respiratory Syndrome (SARS) Pneumonia
Interventions
  1. Drug: Chloroquine diphosphate
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome
HPO:Pneumonia

Primary Outcomes

Description: proportion of deaths at day 28 between groups compared

Measure: Mortality rate reduction of 50% by day 28

Time: 28 days after randomization

Secondary Outcomes

Description: number of deaths at days 7 and 14 between groups compared

Measure: Absolute mortality on days 7 and 14

Time: 7 and 14 days after first dose

Description: clinical status

Measure: Improvement in overall subject's clinical status assessed in standardized clinical questionnaires on days 14 and 28

Time: 14 and 28 days after first dose

Description: clinical status

Measure: Improvement in daily clinical status assessed in standardized clinical questionnaires during hospitalization

Time: during and after intervention, up to 28 days

Description: supplemental oxygen

Measure: Duration of supplemental oxygen (if applicable)

Time: during and after intervention, up to 28 days

Description: mechanical ventilation

Measure: Duration of mechanical ventilation (if applicable)

Time: during and after intervention, up to 28 days

Description: hospitalization

Measure: Absolute duration of hospital stay in days

Time: during and after intervention, up to 28 days

Description: adverse events grade 3 and 4

Measure: Prevalence of grade 3 and 4 adverse events

Time: during and after intervention, up to 28 days

Description: adverse events

Measure: Prevalence of serious adverse events

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum creatinine compared to baseline

Measure: Change in serum creatinine level

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum troponin I compared to baseline

Measure: Change in serum troponin I level

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum aspartate aminotransferase compared to baseline

Measure: Change in serum aspartate aminotransferase level

Time: during and after intervention, up to 28 days

Description: increase or decrease in serum aspartate aminotransferase compared to baseline

Measure: Change in serum CK-MB level

Time: during and after intervention, up to 28 days

Description: virus clearance from respiratory tract secretion

Measure: Change in detectable viral load in respiratory tract swabs

Time: during and after intervention, up to 28 days

Description: viremia in blood detected through RT-PCR

Measure: Viral concentration in blood samples

Time: during and after intervention, up to 28 days

Description: death

Measure: Absolute number of causes leading to participant death (if applicable)

Time: during and after intervention, up to 28 days
82 Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day. A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg. The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).

NCT04323592
Conditions
  1. Severe Acute Respiratory Syndrome (SARS) Pneumonia
  2. Coronavirus Infections
  3. ARDS, Human
Interventions
  1. Drug: Methylprednisolone
  2. Other: standard care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Distress Syndrome, Adult Syndrome
HPO:Pneumonia

Primary Outcomes

Description: We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.

Measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

Time: 28 days

Description: We reported below the number of participants who died within 28 days, during the hospital stay.

Measure: In-hospital Death Within 28 Days

Time: 28 days

Description: We reported below the number of participants admitted to ICU within 28 days.

Measure: Admission to Intensive Care Unit (ICU)

Time: 28 days

Description: We reported below the number of participants who needed endotracheal intubation during ICU admission

Measure: Endotracheal Intubation (Invasive Mechanical Ventilation)

Time: 28 days

Secondary Outcomes

Description: Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.

Measure: Change in C-reactive Protein (CRP)

Time: 7 days

Description: number of days free from mechanical ventilation (both invasive and non-invasive) by day 28

Measure: Number of Days Free From Mechanical Ventilation

Time: 28 days
83 Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)

CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.

NCT04323644
Conditions
  1. COVID-19
  2. Coronavirus
  3. Surgery
Interventions
  1. Procedure: Surgery
MeSH:Coronavirus Infections

Primary Outcomes

Description: Death up to 30-days post surgery

Measure: 30-day mortality

Time: 30 days

Secondary Outcomes

Description: Death up to 7-days post surgery

Measure: 7-day mortality

Time: 7 days post surgery

Description: Reoperation up to 30-days post surgery

Measure: 30-day reoperation

Time: Up to 30-days post surgery

Description: Admission to ICU post surgery

Measure: Postoperative ICU admission

Time: Up to 30 days post surgery

Description: Respiratory failure post surgery

Measure: Postoperative respiratory failure

Time: Up to 30 days post surgery

Description: Acute respiratory distress syndrome post surgery

Measure: Postoperative acute respiratory distress syndrome (ARDS)

Time: Up to 30 days post surgery

Description: Sepsis post surgery

Measure: Postoperative sepsis

Time: Up to 30 days post surgery
84 Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

NCT04323800
Conditions
  1. Coronavirus
  2. Convalescence
Interventions
  1. Biological: Anti- SARS-CoV-2 Plasma
  2. Biological: SARS-CoV-2 non-immune Plasma
MeSH:Coronavirus Infections Convalescence

Primary Outcomes

Description: Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.

Measure: Efficacy of treatment at Day 28

Time: Day 28

Description: Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and Acute Respiratory Distress Syndrome during the study period.

Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 1

Time: Up to Day 28

Description: Cumulative incidence of grade 3 and 4 adverse events during the study period

Measure: Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 2

Time: Up to Day 28

Secondary Outcomes

Description: Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28): Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen; Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection

Measure: Cumulative incidence of disease severity

Time: up to Day 28

Other Outcomes

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day -1 or day 0 (baseline).

Measure: Anti-SARS-CoV-2 titers Day 0

Time: Day 0

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 1.

Measure: Anti-SARS-CoV-2 titers Day 1

Time: Day 1

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 7.

Measure: Anti-SARS-CoV-2 titers Day 7

Time: Day 7

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 14.

Measure: Anti-SARS-CoV-2 titers Day 14

Time: Day 14

Description: Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 90.

Measure: Anti-SARS-CoV-2 titers Day 90

Time: Day 90

Description: Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

Measure: Rates of SARS-CoV-2 PCR positivity

Time: Up to day 28

Description: Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

Measure: Duration of SARS-CoV-2 PCR positivity

Time: Up to day 28

Description: Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 1, 7, 14 and 28 days.

Measure: Peak quantity levels of SARS-CoV-2 RNA

Time: Up to day 28
85 PRIORITY (Pregnancy Coronavirus Outcomes Registry)

PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.

NCT04323839
Conditions
  1. Pregnancy
  2. Coronavirus
  3. COVID-19
Interventions
  1. Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19
  2. Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19
MeSH:Coronavirus Infections

Primary Outcomes

Description: presenting symptoms and testing

Measure: Clinical presentation

Time: Baseline to 12 months

Description: Clinical outcomes with resolution of illness

Measure: Disease prognosis outcomes

Time: Baseline to 12 months

Description: Pregnancy outcomes among women infected with COVID-19

Measure: Pregnancy outcomes

Time: Baseline to 12 months

Description: Obstetric outcomes among women infected with COVID-19

Measure: Obstetric outcomes

Time: Baseline to 12 months

Description: Neonatal outcomes among infants born to women with COVID-19

Measure: Neonatal outcomes

Time: Baseline to 12 months

Description: Transmission of COVID-19 from mother to infant

Measure: Modes of transmission of COVID-19

Time: Baseline to 12 months
86 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

The overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. The specific aims of this Covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with COVID-19 pneumonia. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design.

NCT04324047
Conditions
  1. Corona Virus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Overall Survival

Measure: Survival

Time: 14 days

Description: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale COVID 19

Time: 14 days
87 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

NCT04324073
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Sarilumab
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of ventilator utilization at day 14.

Time: 14 days

Description: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale <=5 at day 4

Time: 4 days

Description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14

Time: 14 days

Description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event. Scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9

Measure: WHO progression scale at day 4

Time: 4 days

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

Measure: respiratory acidosis at day 4

Time: 4 days

Description: evolution of PaO2/FiO2 ratio

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: time to oxygen supply independency

Measure: time to oxygen supply independency

Time: 14 days

Description: duration of hospitalization

Measure: duration of hospitalization

Time: 90 days

Description: time to negative viral excretion

Measure: time to negative viral excretion

Time: 90 days

Description: time to ICU discharge

Measure: time to ICU discharge

Time: 90 days

Description: time to hospital discharge

Measure: time to hospital discharge

Time: 90 days
88 Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

NCT04324463
Conditions
  1. Coronavirus
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Colchicine
  2. Drug: Interferon-Beta
  3. Drug: Aspirin
  4. Drug: Rivaroxaban
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: composite of hospitalization or death

Measure: Outpatient trial - Colchicine vs. control and Aspirin vs. control

Time: 45 days post randomization

Description: invasive mechanical ventilation or death

Measure: Inpatient trial - Interferon-β vs. control and Colchicine vs. control

Time: 45 days post randomization

Description: invasive mechanical ventilation or death

Measure: Inpatient trial - Aspirin and rivaroxaban vs. control

Time: 45 days post randomization

Secondary Outcomes

Description: disease progression by 2 points on a 7-point scale

Measure: Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control

Time: 45 days post randomization

Description: composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale

Measure: Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control

Time: 45 days post randomization
89 Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

NCT04324528
Conditions
  1. Coronavirus
  2. COVID-19
  3. SARS-CoV Infection
  4. Respiratory Failure
  5. Cytokine Storm
Interventions
  1. Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)
  2. Device: vv-ECMO only (no cytokine adsorption)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

Measure: interleukin-6 (IL-6) level after 72 hours

Time: 72 hours

Secondary Outcomes

Description: survival after 30 days

Measure: 30-day-survival

Time: 72 hours

Description: needed dosage of norepinephrine and other vasopressors

Measure: vasopressor dosage

Time: 72 hours

Description: fluid balance levels during cytokine adsorption

Measure: fluid balance

Time: 72 hours

Description: serum-lactate levels during cytokine adsorption

Measure: lactate

Time: 72 hours
90 A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm

NCT04324606
Conditions
  1. Coronavirus
Interventions
  1. Biological: ChAdOx1 nCoV-19
  2. Biological: MenACWY
  3. Biological: ChAdOx1 nCoV-19 full boost
  4. Biological: ChAdOx1 nCoV-19 half boost
  5. Biological: MenACWY boost
  6. Drug: Paracetamol
  7. Biological: ChAdOx1 nCoV-19 0.5mL boost
MeSH:Coronavirus Infections

Primary Outcomes

Description: Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases

Time: 6 months

Description: Occurrence of serious adverse events (SAEs) throughout the study duration

Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)

Time: 6 months

Secondary Outcomes

Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms

Time: 7 days following vaccination

Description: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms

Time: 7 days following vaccination

Description: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)

Time: 28 days following vaccination

Description: Change from baseline for safety laboratory measures (haematology and biochemistry blood results)

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests

Time: 6 months

Description: Occurrence of disease enhancement episodes

Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes

Time: 6 months

Description: Number of hospital admissions associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions

Time: 6 months

Description: Number of intensive care unit admissions associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions

Time: 6 months

Description: Number of deaths associated with COVID-19

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related deaths

Time: 6 months

Description: Occurrence of severe COVID-19 disease (defined according to clinical severity scales)

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19

Time: 6 months

Description: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study

Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates

Time: 6 months

Description: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays

Time: 6 months

Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19

Time: 6 months

Other Outcomes

Description: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus

Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays

Time: 6 months

Description: All safety, reactogenicity, immunogenicity and efficacy endpoints

Measure: Assess safety, reactogenicity, immunogenicity and efficacy endpoints, for participants receiving prophylactic paracetamol

Time: 6 months

Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates) post boost

Measure: Assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost

Time: 6 months

Description: Differences in viral shedding on stool between vaccine and comparator arms at 7 days and beyond post SARS-CoV-2 PCR or NAAT positivity

Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive individuals

Time: 6 months
91 "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death. Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies. This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

NCT04324736
Conditions
  1. Coronavirus
  2. Diabetes
Interventions
  1. Other: no interventional study
MeSH:Coronavirus Infections Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: Prevalence of severe forms among all COVID-19 patients with diabetes

Measure: Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19

Time: 1 month

Secondary Outcomes

Description: Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.

Measure: describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

Time: 1 month

Description: death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit

Measure: describe the prognosis of hospitalized subjects with diabetes and COVID-19

Time: 1 month

Description: care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7

Measure: describe the care management of hospitalized subjects with diabetes and COVID-19

Time: 1 month
92 Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.

NCT04324866
Conditions
  1. Coronavirus Infection
Interventions
  1. Diagnostic Test: Nasopharyngeal swab
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Psoriasis
HPO:Palmoplantar pustulosis Psoriasiform dermatitis

Primary Outcomes

Measure: Point prevalence of COVID-19 infection

Time: Baseline up to 6 months

Secondary Outcomes

Measure: Incidence of COVID-19 infection

Time: Baseline up to 6 months

Measure: Percentage of subjects presenting fever or respiratory symptoms

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and comorbid medical conditions

Time: Baseline up to 6 months
93 Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19

Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.

NCT04325048
Conditions
  1. Coronavirus Infection
Interventions
  1. Device: Cordio App
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patient voice that is recorded during the study will be anylaysis with specific algorithms

Measure: Voice anaysis

Time: 1-2 years
94 Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY

CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.

NCT04325412
Conditions
  1. COVID-19; Cardiovascular Diseases
MeSH:Coronavirus Infections Cardiovascular Diseases
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Measure: The incidence of cardiovascular complications in patients with COVID-19

Time: 30 days
95 Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples

On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests. Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development. This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2. As soon as it is available, serology will be performed on the collected samples.

NCT04325646
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
  2. COVID-19
Interventions
  1. Other: Human Biological samples
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Description of the serological status of individuals by different detection tests

Measure: Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.

Time: One year

Secondary Outcomes

Description: Proportion of asymptomatic subjects into seropositive population

Measure: Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies

Time: One year
96 Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19

Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

NCT04325672
Conditions
  1. Coronavirus
Interventions
  1. Biological: Convalescent Plasma
MeSH:Coronavirus Infections

Primary Outcomes

Description: Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.

Measure: RNA in SARS-CoV-2

Time: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion

Description: Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.

Measure: ICU Admissions

Time: 90 days after transfusion

Description: Total number of subject deaths.

Measure: Hospital Mortality

Time: 90 days after transfusion

Description: The total number of days subjects were admitted to the hospital.

Measure: Hospital Length of Stay (LOS)

Time: 90 days after transfusion

Secondary Outcomes

Description: The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.

Measure: Type of respiratory support

Time: 90 days after transfusion or until hospital discharge (whichever comes first)

Description: The total number of days subjects required respiratory support.

Measure: Duration of respiratory support

Time: 90 days after transfusion or until hospital discharge (whichever comes first)
97 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
98 Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.

NCT04325906
Conditions
  1. Prone Positioning
  2. High Flow Nasal Cannula
  3. Acute Respiratory Distress Syndrome
  4. Corona Virus Infection
Interventions
  1. Device: high flow nasal cannula (HFNC)
  2. Procedure: Prone positioning (PP)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: the treatment failure rate of HFNC/HFNC+PP support and clinical requirement for advanced respiratory support

Measure: Treatment failure

Time: 28 days

Measure: Intubation rate

Time: 28 days

Secondary Outcomes

Description: the improvement of SpO2/FIO2 or PaO2/FiO2 from HFNC alone to HFNC+PP

Measure: Efficacy of PP

Time: 28 days
99 Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)

COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19. Arm 1: We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate. Arm 2: The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study. Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls. Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.

NCT04325919
Conditions
  1. Coronavirus Infection
  2. Coronavirus Infections
Interventions
  1. Other: No intervention
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patients' treatment and management during hospitalization.

Measure: Clinical

Time: 6 months

Description: Serial viral load changes during hospitalization.

Measure: Virological

Time: 6 months

Description: Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.

Measure: Microbiological

Time: 6 months
100 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

NCT04326036
Conditions
  1. Pulmonary Alveolar Proteinosis
  2. COPD
  3. Idiopathic Pulmonary Fibrosis
  4. Viral Pneumonia
  5. Coronavirus Infection
  6. Interstitial Lung Disease
Interventions
  1. Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)
  2. Device: Centricyte 1000
  3. Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution
  4. Drug: Liberase Enzyme (Roche)
  5. Drug: Sterile Normal Saline for Intravenous Use
MeSH:Infection Communicable Diseases Coron Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis
HPO:Abnormal lung morphology Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Intraalveolar phospholipid accumulation Pulmonary fibrosis

Primary Outcomes

Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

Measure: Digital Oximetry

Time: 3 months, 6 months
101 Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

NCT04326309
Conditions
  1. COVID-19
  2. Coronavirus Infections
  3. Hay Fever
  4. Asthma
  5. Chronic Obstructive Pulmonary Disease
  6. Influenza
  7. Common Cold
  8. Respiratory Tract Infections
  9. Healthy
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Common Cold Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Chronic pulmonary obstruction Pulmonary obstruction Respiratory tract infection

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days
102 Evaluation of Novel Diagnostic Tests for 2019-nCOV

COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.

NCT04326387
Conditions
  1. Acute Disease
  2. Coronavirus
  3. Respiratory Viral Infection
Interventions
  1. Diagnostic Test: SAMBA II (Diagnostic for the Real World)
  2. Diagnostic Test: Public Health England Gold Standard
  3. Diagnostic Test: Cambridge Validated Viral Detection Method
  4. Diagnostic Test: Radiological Detection
MeSH:Coronavirus Infections Virus Diseases Acute Disease

Primary Outcomes

Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard

Measure: SAMBA COVID-19 POC PCR Test

Time: 28 days

Secondary Outcomes

Description: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale

Measure: Patient acceptability

Time: 28 days

Description: Time to positive IgM/IgG test positivity

Measure: Immune Response Positivity

Time: 40 days
103 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
104 The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection

This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

NCT04326452
Conditions
  1. Coronavirus Infection
Interventions
  1. Device: bidirectional oxygenation mouthpiece
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve

Measure: Pulse oximetry level

Time: Change from Baseline pulse oximetry level at 15 minutes post treatment

Secondary Outcomes

Measure: Respiratory rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Measure: Heart rate

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Measure: Blood pressure

Time: Change from Baseline clinical measurements at 15 minutes post treatment

Description: Venous and arterial blood gases, if available, will be combined to report systemic carbon dioxide.

Measure: Systemic carbon dioxide

Time: Change from Baseline clinical measurements at 15 minutes post treatment
105 Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins C, D and Zinc During COVID-19 Pandemia: An Observational Study

Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.

NCT04326725
Conditions
  1. Pneumonitis
  2. Coronavirus Infection
Interventions
  1. Drug: Plaquenil 200Mg Tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: persons who took this medication should not have an infection

Measure: Protection against COVID-19

Time: 4 months
106 BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial

Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.

NCT04327206
Conditions
  1. Coronavirus Disease 2019 (COVID-19)
  2. Respiratory Illness
  3. Corona Virus Infection
  4. COVID-19
Interventions
  1. Drug: BCG Vaccine
  2. Drug: 0.9%NaCl
MeSH:Coronavirus Infections Severe Acute Respiratory Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: COVID-19 disease incidence

Time: Measured over the 6 months following randomisation

Description: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant (*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. (*) "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities". (**) "I do not feel physically well enough to go to work"

Measure: Severe COVID-19 disease incidence

Time: Measured over the 6 months following randomisation

Secondary Outcomes

Description: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: COVID-19 incidence by 12 months

Time: Measured over the 12 months following randomisation

Description: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant(*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. * "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities" ** "I do not feel physically well enough to go to work"

Measure: Severe COVID-19 incidence by 12 months

Time: Measured over the 12 months following randomisation

Description: Time to first symptom of COVID-19 in a participant who subsequently meets the case definition: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Time to first symptom of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of episodes of COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Episodes of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of participants with asymptomatic SARS-CoV-2 infection defined as Evidence of SARS-CoV-2 infection (by PCR or seroconversion) Absence of respiratory illness (using self-reported questionnaire) No evidence of exposure prior to randomisation (inclusion serology negative)

Measure: Asymptomatic SARS-CoV-2 infection

Time: Measured over the 12 months following randomisation

Description: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Work absenteeism due to COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Bed confinement due to COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Symptom duration of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: SARS-CoV-2 pneumonia

Time: Measured over the 12 months following randomisation

Description: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Oxygen therapy with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Critical care admissions with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Measure: Critical care admission duration with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test

Measure: Mechanical ventilation with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of days that participants needed mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test

Measure: Mechanical ventilation duration with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).

Measure: Hospitalisation duration with COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of deaths (from death registry) associated with a positive SARS-CoV-2 test

Measure: Mortality with SARS-CoV-2

Time: Measured over the 12 months following randomisation

Description: Number of participants with fever or respiratory illness will be defined as: fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of episodes of fever or respiratory illness, defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Episodes of fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Work absenteeism due to fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days confined to bed (using self-reported questionnaire) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Bed confinement due to fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days with symptoms in any episode of illness that meets the case definition for fever or respiratory illness: fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)

Measure: Symptom duration of fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records)

Measure: Pneumonia

Time: Measured over the 12 months following randomisation

Description: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)

Measure: Oxygen therapy

Time: Measured over the 12 months following randomisation

Description: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)

Measure: Critical care admissions

Time: Measured over the 12 months following randomisation

Description: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)

Measure: Mechanical ventilation

Time: Measured over the 12 months following randomisation

Description: Number of deaths (from death registry)

Measure: Mortality

Time: Measured over the 12 months following randomisation

Description: Number of days of hospitalisation due to fever or respiratory illness (using self-reported questionnaire, medical/hospital records and/or government registries)

Measure: Hospitalisation duration with fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)

Measure: Unplanned work absenteeism

Time: Measured over the 12 months following randomisation

Description: Cost of hospitalisation due to COVID-19 will be reported and compared between groups (using hospital administrative linked costing records held by individual hospitals and state government routine costing data collections to provide an estimate of the cost to hospitals for each episode of COVID-19 care)

Measure: Hospitalisation cost to treat COVID-19

Time: Measured over the 12 months following randomisation

Description: Type and severity of local and systemic adverse events will be collected in self-reported questionnaire and graded using toxicity grading scale.

Measure: Local and systemic adverse events to BCG vaccination in healthcare workers

Time: Measured over the 3 months following randomisation
107 Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial

Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial

NCT04327349
Conditions
  1. Coronavirus Infections
Interventions
  1. Biological: Convalescent Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

Measure: Mortality changes in day 10

Time: 10 days after plasma transmission

Description: Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.

Measure: Mortality changes in day 30

Time: 30 days after plasma transmission

Description: Measurement of CRP

Measure: Changes of C-reactive protein

Time: Day 1

Description: Measurement of CRP

Measure: Changes of C-reactive protein

Time: Day 3

Description: Measurement of CRP

Measure: Changes of C-reactive protein

Time: Day 7

Description: Measurement of IL-6

Measure: Changes of Interleukin 6

Time: Day 1

Description: Measurement of IL-6

Measure: Changes of Interleukin 6

Time: Day 3

Description: Measurement of IL-6

Measure: Changes of Interleukin 6

Time: Day 7

Description: Measurement of TNF-α

Measure: Changes of tumor necrosis factor-α

Time: Day 1

Description: Measurement of TNF-α

Measure: Changes of tumor necrosis factor-α

Time: Day 3

Description: Measurement of TNF-α

Measure: Changes of tumor necrosis factor-α

Time: Day 7

Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen

Measure: Changes of PaO2/FiO2 Ratio

Time: Day 1

Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen

Measure: Changes of PaO2/FiO2 Ratio

Time: Day 3

Description: Partial pressure of arterial oxygen/Percentage of inspired oxygen

Measure: Changes of PaO2/FiO2 Ratio

Time: Day 7

Secondary Outcomes

Measure: Changes of CD3

Time: Day 1

Measure: Changes of CD3

Time: Day 3

Measure: Changes of CD3

Time: Day 7

Measure: Changes of CD4

Time: Day 1

Measure: Changes of CD4

Time: Day 3

Measure: Changes of CD4

Time: Day 7

Measure: Changes of CD8

Time: Day 1

Measure: Changes of CD8

Time: Day 3

Measure: Changes of CD8

Time: Day 7

Measure: Changes of CD4/CD8 ratio

Time: Day 1

Measure: Changes of CD4/CD8 ratio

Time: Day 3

Measure: Changes of CD4/CD8 ratio

Time: Day 7

Measure: Changes of lymphocyte count

Time: Day 1

Measure: Changes of lymphocyte count

Time: Day 3

Measure: Changes of lymphocyte count

Time: Day 7

Measure: Changes of leukocyte count

Time: Day 1

Measure: Changes of leukocyte count

Time: Day 3

Measure: Changes of leukocyte count

Time: Day 7

Measure: Changes of alanine transaminase (ALT)

Time: Day 1

Measure: Changes of alanine transaminase (ALT)

Time: Day 3

Measure: Changes of alanine transaminase (ALT)

Time: Day 7

Measure: Changes of aspartate transaminase (AST)

Time: Day 1

Measure: Changes of aspartate transaminase (AST)

Time: Day 3

Measure: Changes of aspartate transaminase (AST)

Time: Day 7

Measure: Changes of alkaline phosphatase (ALP)

Time: Day 1

Measure: Changes of alkaline phosphatase (ALP)

Time: Day 3

Measure: Changes of alkaline phosphatase (ALP)

Time: Day 7

Measure: Changes of lactate dehydrogenase (LDH)

Time: Day 1

Measure: Changes of lactate dehydrogenase (LDH)

Time: Day 3

Measure: Changes of lactate dehydrogenase (LDH)

Time: Day 7

Measure: Changes of creatine phosphokinase (CPK)

Time: Day 1

Measure: Changes of creatine phosphokinase (CPK)

Time: Day 3

Measure: Changes of creatine phosphokinase (CPK)

Time: Day 7

Measure: Changes of Creatine kinase-MB (CK-MB)

Time: Day 1

Measure: Changes of Creatine kinase-MB (CK-MB)

Time: Day 3

Measure: Changes of Creatine kinase-MB (CK-MB)

Time: Day 7

Measure: Changes of Specific IgG

Time: Day 1

Measure: Changes of Specific IgG

Time: Day 3

Measure: Changes of Specific IgG

Time: Day 7

Description: Computed tomography Scan and Chest X-Ray

Measure: Radiological findings

Time: Within 2 hours after admission

Description: Computed tomography Scan and Chest X-Ray

Measure: Radiological findings

Time: Day 14

Measure: Number of days ventilated

Time: Through study completion, an average of 2 weeks

Measure: Length of hospitalization

Time: Through study completion, an average of 2 weeks
108 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
109 COVID-19-associated ARDS Treated With DEXamethasone: an Open-label, Randomized, Controlled Trial: CoDEX (Alliance Covid-19 Brasil III)

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.

NCT04327401
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: Dexamethasone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.

Measure: Ventilator-free days

Time: 28 days after randomization

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.

Measure: Evaluation of the clinical status

Time: 15 days after randomization

Description: All-cause mortality rates at 28 days after randomization.

Measure: All-cause mortality

Time: 28 days after randomization

Description: Number of days of mechanical ventilation from randomization to day 28.

Measure: Mechanical ventilation duration

Time: 28 days after randomization

Description: Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: Score at 48 hours, 72 hours and 7 days after randomization

Other Outcomes

Description: Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.

Measure: Intensive Care Unit free days

Time: 28 days after randomization
110 A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19

COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality. The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.

NCT04327505
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
  2. Cytokine Storm
  3. ARDS, Human
  4. COVID-19
  5. Sars-CoV2
  6. Acute Respiratory Failure
Interventions
  1. Drug: Hyperbaric oxygen
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU

Measure: ICU admission

Time: Through study completion 30 days

Secondary Outcomes

Description: Proportion of subjects with 30-day mortality, all cause Mortality, from day 1 to day 30.

Measure: 30-day mortality

Time: Through study completion 30 days

Description: Time-to-Intubation, i.e. cumulative days free of invasive mechanical ventilation, from day 1 to day 30

Measure: Time-to-intubation

Time: Through study completion 30 days

Description: Time-to-ICU, i.e. cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30.

Measure: Time-to-ICU

Time: Through study completion 30 days

Description: Mean change in inflammatory response from day 1 to day 30. White cell count + differentiation Procalcitonin C-Reactive protein Cytokines (IL-6) (if available at local laboratory) Ferritin D-Dimer LDH

Measure: Inflammatory response

Time: Through study completion 30 days

Description: Overall survival (Kaplan-Meier)

Measure: Overall survival

Time: Through study completion 30 days

Other Outcomes

Description: Hospital mortality of any cause, proportion of subjects, from day 1 to day 30.

Measure: Hospital mortality

Time: Through study completion 30 days

Description: Proportion of subjects with ICU mortality, Mortality of any cause in ICU, from day 1 to day 30.

Measure: ICU mortality

Time: From ICU admission to study completion 30 days

Description: Time-to-stop of intubation/invasive mechanical ventilation, from ICU admission to day 30.

Measure: Time in Invasive Ventilation

Time: From ICU admission to study completion 30 days

Description: Mean daily NEWS from day 1 to day 30.

Measure: NEWS

Time: Through study completion 30 days

Description: Mean change in PaO2/FiO2 (PFI), from day 1 to day 2, … to day 30.

Measure: PaO2/FiO2 (PFI)

Time: Through study completion 30 days

Description: Proportion of HBO treatments given vs planned. Proportion of subjects with HBO treatment administered within 24h after enrolment.

Measure: HBO Compliance

Time: Day 1 to day 7

Description: Time-to-discharge from hospital

Measure: Hospital discharge

Time: Through study completion 30 days

Description: Mean oxygen dose per day including HBO and cumulative pulmonary oxygen toxicity expressed as Units of oxygen pulmonary toxicity dose (UPTD) and Cumulative pulmonary toxicity dose (CPTD) from day 1 to day 30.

Measure: Oxygen dose

Time: Through study completion 30 days

Description: Median number of HBO treatments and dose of HBO given, from day 1 to day 7

Measure: HBO dose

Time: Day 1 to day 7

Description: Change in expression of Micro RNA in plasma from day 1 to day 30

Measure: Micro RNA

Time: Through study completion 30 days

Description: Change in gene expression and Micro RNA interactions in Peripheral Blood Mononuclear Cells (PBMC) (20 Subjects) from day 1 to day 30

Measure: Hypoxic response

Time: Through study completion 30 days

Description: Immunological response (20 subjects) from day 1 to day 30 in the following. Cytokines extended including (IL-1β, IL-2, IL-6, IL33 and TNFα) Lymphocyte profile Flowcytometry with identification of monocyte/lymphocyte subsets including but not limited to CD3+/CD4+/CD8+ and CD4+/CD8+ ratio FITMaN panel/Flow cytometry, Interleukins (IL-1β, IL-2, IL-6, IL33 and TNFα), T-reg cells (CD3+/CD4+/CD25+/CD127+) Monocyte proliferation markers, Ex vivo monocyte function

Measure: Immunological response

Time: Through study completion 30 days

Description: Mean change in routine biomarkers for organ dysfunction, from day 1to day 30.

Measure: Multi organ dysfunction

Time: Through study completion 30 days

Description: Viral load, review of records from day 1 to day 30.

Measure: Viral load

Time: Through study completion 30 days

Description: Number of secondary infections, review of records, number of events and patients from day 1 to day 30.

Measure: Secondary infections

Time: Through study completion 30 days

Description: Diagnosed PE needing treatment, review of records, number of events and patients from day 1 to day 30.

Measure: Pulmonary embolism

Time: Through study completion 30 days

Description: Changes on Pulmonary CT, review of records from day 1 to day 30.

Measure: Pulmonary CT

Time: Through study completion 30 days

Description: Changes on Chest X-ray, review of records from day 1 to day 30.

Measure: Chest X-ray

Time: Through study completion 30 days

Description: Changes in Lung ultrasound, review of records from day 1 to day 30.

Measure: Lung ultrasound

Time: Through study completion 30 days
111 In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2

The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

NCT04327570
Conditions
  1. Coronavirus Infections
Interventions
  1. Other: Patient sampling
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Description of clinical, laboratory and radiological features of illness and complications.

Measure: Clinical Features

Time: 6 months

Description: Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.

Measure: Immune host response at systemic level

Time: 6 months

Description: Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).

Measure: Immune host response at local level

Time: 6 months

Description: Identification of host genetic variants that are associated with severity of disease.

Measure: Host genetic variation

Time: 6 months

Secondary Outcomes

Description: Differences in baseline factors

Measure: Comparison severe and non-severe COVID-19 hospitalised patients

Time: 6 months

Description: Differences in immune characteristics

Measure: Comparison severe and non-severe COVID-19 hospitalised patients

Time: 6 months

Description: Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy

Measure: Correlation of findings with outcome

Time: 6 months

Description: Correlation of immune profiling with microbiome analysis of patients

Measure: Correlation of immune profiling - microbiome

Time: 6 months
112 A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research

Minimal risk research study: 1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus; 2. Quantifying the development and trajectory of the disease through clinic visits and blood values.

NCT04327804
Conditions
  1. SARS-CoV Infection
Interventions
  1. Diagnostic Test: Odd/Even birth year intervention groups
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the agreement between the detection of SARS-CoV-2 virus using a foam nasal swab tested directly after collection, a polyester nasal swab tested directly after testing, and a polyester nasal swab stored at room temperature for four days without saline or VTM before being tested.

Measure: Detection of SARS-CoV-2 virus

Time: 42 days

Secondary Outcomes

Description: Longitudinal blood samples from SARS-CoV-2 patients to gain a better understanding of the trajectory of COVID-19 and antibody development

Measure: Trajectory of COVID-19 and antibody development

Time: 2 months
113 Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions

This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in tropical regions such as French Guiana, Guadeloupe and New-Caledonia.

NCT04328129
Conditions
  1. Coronavirus Infections
  2. Severe Acute Respiratory Syndrome
  3. SARS-CoV Infection
Interventions
  1. Procedure: Human biological samples
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus

Measure: Evaluation of the extent of the virus transmission within households

Time: 2 years

Secondary Outcomes

Description: The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household

Measure: Characterization of the secondary cases

Time: 2 years

Description: The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.

Measure: Characterization of the secondary cases

Time: 2 years

Description: The extent of the virus transmission within contact persons will be assessed by evaluating the rate of extended-contact secondary transmission of the virus

Measure: In New-Caledonia, evaluation of the extent of the virus transmission within contact persons

Time: 2 years
114 Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

NCT04328454
Conditions
  1. Coronavirus
Interventions
  1. Other: retrospective analysis
MeSH:Coronavirus Infections

Primary Outcomes

Description: The primary outcome is the time to negative conversion of coronavirus

Measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2

Time: 1 month

Secondary Outcomes

Description: The time of hospitalization

Measure: Length of stay in hospital

Time: 1 month

Description: The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked.

Measure: Survival

Time: 1 month

Description: The rate of intubation within hospitalization of these patients will be tracked

Measure: Intubation

Time: 1 month
115 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
116 Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study

This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).

NCT04328961
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. SARS-CoV-2
Interventions
  1. Drug: Hydroxychloroquine Sulfate
  2. Drug: Ascorbic Acid
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

Primary Outcomes

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 1 through Day 14 after enrolment

Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection

Time: Day 28 after enrolment

Secondary Outcomes

Description: Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Measure: Rate of participant-reported adverse events

Time: 28 days from start of Hydroxychloroquine therapy

Description: PCR-confirmed COVID-19 diagnosis

Measure: Incidence rates of COVID-19 through study completion

Time: 28 days from enrolment
117 The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial

Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.

NCT04330300
Conditions
  1. Hypertension
  2. COVID-19
Interventions
  1. Drug: Thiazide or Thiazide-like diuretics
  2. Drug: Calcium Channel Blockers
  3. Drug: ACE inhibitor
  4. Drug: Angiotensin receptor blocker
MeSH:Coronavirus Infections Hypertension
HPO:Hypertension

Primary Outcomes

Description: Time from randomization to the first occurrence of any of the clinical events above

Measure: Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

Secondary Outcomes

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who die

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require intubation in intensive care unit (ICU)

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of SARS-CoV-2 positive participants

Time: 12 months

Measure: Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization

Time: 12 months

Description: Performed in a random sub-sample of the cohort (both study arms)

Measure: 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: All-cause mortality

Time: 12 months
118 Impact of the Coronavirus (COVID-19) on Patients With Cancer

The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.

NCT04330521
Conditions
  1. Cancer
  2. COVID-19
MeSH:Coronavirus Infections

Primary Outcomes

Description: We will track the number of participants who fill out the survey for the 12 month duration of the study and the number of participants who participate in the semi-structured telephone interviews.

Measure: Number of participants who fill out the survey and participate in the semi-structured interviews.

Time: 12 Months
119 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

NCT04331808
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Tocilizumab
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Group 1. Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of ventilator utilization at day 14. Group 1

Time: 14 days

Description: Group 1. Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale <=5 at day 4. Group 1.

Time: 4 days

Description: Group 2. Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Group 2.

Time: 14 days

Description: Group 2 Early end point : proportion of patients with a decrease of WHO score of at least 1 point at day 4. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale at day 4. Group 2.

Time: 4 days

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

Measure: respiratory acidosis at day 4

Time: 4 days

Description: evolution of PaO2/FiO2 ratio

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: time to oxygen supply independency

Measure: time to oxygen supply independency

Time: 14 days

Description: duration of hospitalization

Measure: duration of hospitalization

Time: 90 days

Description: time to negative viral excretion

Measure: time to negative viral excretion

Time: 90 days

Description: time to ICU discharge

Measure: time to ICU discharge

Time: 90 days

Description: time to hospital discharge

Measure: time to hospital discharge

Time: 90 days
120 An Observational Study of Patients With Coronavirus Disease 2019

This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

NCT04331886
Conditions
  1. COVID-19
  2. Coronavirus
MeSH:Coronavirus Infections

Primary Outcomes

Measure: Natural history of COVID-19: Characteristics of COVID-19

Time: 12 months

Measure: Natural history of COVID-19: Participant demographics

Time: 12 months

Measure: Natural history of COVID-19: Treatment use

Time: 12 months

Measure: Time point of clinical response

Time: 12 months
121 Convalescent Plasma for Patients With COVID-19: A Pilot Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.

NCT04332380
Conditions
  1. Coronavirus
  2. Coronavirus Infection
Interventions
  1. Drug: Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Copies of COVID-19 per ml

Measure: Change in Viral Load

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin M COVID-19 antibodies

Measure: Change in Immunoglobulin M COVID-19 antibodies Titers

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin G COVID-19 antibodies

Measure: Change in Immunoglobulin G COVID-19 antibodies Titers

Time: Days 0, 4, 7, 14 and 28

Secondary Outcomes

Description: Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

Measure: Intensive Care Unit Admission

Time: Days 7, 14 and 28

Description: Days of Intensive Care Unit management (days 7, 14 and 28)

Measure: Length of Intensive Care Unit stay

Time: Days 7, 14 and 28

Description: Days of Hospitalization (days 7, 14 and 28)

Measure: Length of hospital stay (days)

Time: Days 7, 14 and 28

Description: Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Measure: Requirement of mechanical ventilation

Time: Days 7, 14 and 28

Description: Days with mechanical ventilation (days 7, 14 and 28)

Measure: Duration (days) of mechanical ventilation

Time: Days 7, 14 and 28

Description: 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)

Measure: Clinical status assessed according to the World Health Organization guideline

Time: Days 7, 14 and 28

Description: Proportión of death patients at days 7, 14 and 28

Measure: Mortality

Time: Days 7, 14 and 28
122 Angiotensin-(1,7) Treatment in COVID-19: the ATCO Trial

Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.

NCT04332666
Conditions
  1. Coronavirus
  2. Respiratory Failure
  3. Coronavirus Sars-Associated
  4. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
  5. SARS-CoV-2
Interventions
  1. Drug: Angiotensin 1-7
  2. Drug: Placebos
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: composite outcome of mortality and necessity of mechanical ventilation

Measure: ventilator free days

Time: 28 days

Secondary Outcomes

Description: number of days free from intensive care unit

Measure: ICU free days

Time: trough study completion, on average 40 days

Description: Hospital length of stay

Measure: Hospital length of stay

Time: through study completion, on average 60 days

Description: Time to wean from mechanical ventilation

Measure: Time to wean from mechanical ventilation

Time: through study completion, on average 14 days

Description: PaO2/FiO2 changes during drug administration

Measure: PaO2/FiO2 changes during drug administration

Time: 48 hours

Description: US confirmed deep vein thrombosis

Measure: Deep vein thrombosis incidence

Time: through study completion, on average 30 days

Description: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gamma

Measure: Changes in inflammatory markers

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Ang II and Ang-(1-7) plasmatic levels

Measure: RAS effectors levels

Time: at randomization, 48 hours after randomization and 72 hours after randomization

Description: Chest x-ray or CT scan changes

Measure: Radiological findings

Time: through study completion, on average 30 days

Other Outcomes

Description: phase 2b = principal safety outcome; phase 3 = secondary outcome

Measure: Rate of serious adverse events

Time: study drug administration/day 28 or ICU discharge or death
123 Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks

NCT04332835
Conditions
  1. Coronavirus
  2. Coronavirus Infection
Interventions
  1. Drug: Plasma
  2. Drug: Standard Therapy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Copies of COVID-19 per ml

Measure: Change in Viral Load

Time: Days 0, 4, 7, 14 and 28

Description: Immunoglobulin G COVID-19 antibodies

Measure: Change in Immunoglobulin G COVID-19 Titers

Time: Days 0, 4, 7, 14 and 28

Secondary Outcomes

Description: Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

Measure: Intensive Care Unit Admission

Time: Days 7, 14 and 28

Description: Days of Intensive Care Unit management (days 7, 14 and 28)

Measure: Length of Intensive Care Unit stay

Time: Days 7, 14 and 28

Description: Days of Hospitalization (days 7, 14 and 28)

Measure: Length of hospital stay (days)

Time: Days 7, 14 and 28

Description: Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Measure: Requirement of mechanical ventilation

Time: Days 7, 14 and 28

Description: Days with mechanical ventilation (days 7, 14 and 28)

Measure: Duration (days) of mechanical ventilation

Time: Days 7, 14 and 28

Description: 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)

Measure: Clinical status assessed according to the World Health Organization guideline

Time: Days 7, 14 and 28

Description: Proportion of death patients at days 7, 14 and 28

Measure: Mortality

Time: Days 7, 14 and 28
124 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
125 Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS

Whereas the pandemic due do Covid-19 continues to spread, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes Severe Acute Respiratory Distress Syndrome in 30% of patients with a 30%-60% mortality rate for those requiring hospitalization in an intensive care unit. The main physio-pathological hallmark is an acute pulmonary inflammation. Currently, there is no treatment. Mesenchymal stem cells (MSC) feature several attractive characteristics: ease of procurement, high proliferation potential, capacity to home to inflammatory sites, anti-inflammatory, anti-fibrotic and immunomodulatory properties. If all MSC share several characteristics regardless of the tissue source, the highest productions of bioactive molecules and the strongest immunomodulatory properties are yielded by those from the Wharton's jelly of the umbilical cord. An additional advantage is that they can be scaled-up to generate banks of cryofrozen and thus readily available products. These cells have already been tested in several clinical trials with an excellent safety record. The objective of this project is to treat intubated-ventilated patients presenting with a SARS-CoV2-related Acute Respiratory Distress Syndrome (ARDS) of less than 96 hours by three intravenous infusions of umbilical cord Wharton's jelly-derived mesenchymal stromal cells (UC-MSC) one every other day (duration of the treatment: one week). The primary endpoint is the PaO2/FiO2 ratio at day 7. The evolution of several inflammatory markers, T regulatory lymphocytes and donor-specific antibodies will also be monitored. The trial will include 40 patients, of whom 20 will be cell-treated while the remaining 20 patients will be injected with a placebo solution in addition to the standard of care. Given the pathophysiology of SARS-CoV2, it is thus sound to hypothesize that the intravenous administration of UC-MSC during the initial phase of ARDS could control inflammation, accelerate its recovery with improved oxygenation, reduced mechanical ventilation and ventilation weaning time and therefore reduced length of stay in intensive care. The feasibility of the project is supported by the expertise of the Meary Cell and Gene Therapy Center, which is approved for the production of Advanced Therapy Medicinal Products and has already successfully prepared the first batches of cells, as well as by the involvement of a cardiac surgery team which will leverage its experience with stem cells for the treatment of heart failure to make it relevant to the Stroma-Cov-2 project.

NCT04333368
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. Severe Acute Respiratory Distress Syndrome
Interventions
  1. Biological: Umbilical cord Wharton's jelly-derived human
  2. Other: NaCl 0.9%
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Measure: Respiratory efficacy evaluated by the increase in PaO2/FiO2 ratio from baseline to day 7 in the experimental group compared with the placebo group

Time: From baseline to day 7

Secondary Outcomes

Measure: Lung injury score

Time: From baseline to day 28

Measure: Oxygenation index

Time: From baseline to day 28

Measure: In-hospital mortality

Time: From baseline to day 28

Measure: Mortality

Time: At day 28

Measure: Ventilator-free days

Time: From baseline to day 28

Measure: Number of days between randomization and the first day the patient meets weaning criteria o Number of days between randomization and the first day the patient meets PaO2/FiO2 > 200 (out of a prone positioning session)

Time: From baseline to day 28

Measure: Cumulative use of sedatives

Time: From baseline to day 28

Measure: Cumulative duration of use of sedatives

Time: From baseline to day 28

Measure: Cumulative duration of use of neuromuscular blocking agents (other than used for intubation)

Time: From baseline to day 28

Measure: Cumulative use of neuromuscular blocking agents (other than used for intubation)

Time: From baseline to day 28

Measure: ICU-acquired weakness and delirium

Time: From baseline to day 28

Measure: Treatment-induced toxicity rate and adverse events up to day 28

Time: From baseline to day 28

Measure: Quality of life at one year (EQ5D-3L quality of life questionnaire)

Time: At 6 months and 12 months

Measure: Measurements of plasmatic cytokines (IL1, IL6, IL8, TNF-alpha, IL10, TGF-beta, sRAGE, Ang2) level

Time: At day 1, 3, 5, 7 and 14

Measure: Anti-HLA antibodies plasmatic dosage

Time: From baseline to day 14, and at 6 months
126 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
127 The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients W