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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) Colonic Neoplasms (4) Colorectal Neoplasms (4) Coronary Artery Disease (4) Coronary Disease (4) Death (4) Embolism and Thrombosis (4) Fibromyalgia (4) Headache (4) Heart Arrest (4) Leukemia (4) Musculoskeletal Pain (4) Mycobacterium Infections (4) Postoperative Complications (4) Signs and Symptoms, Respiratory (4) Sleep Initiation and Maintenance Disorders (4) Substance-Related Disorders (4) Tuberculosis (4) Ventricular Dysfunction (4) Ventricular Dysfunction, Left (4) Ageusia (3) Alcoholism (3) Asthma (3) Attention Deficit Disorder with Hyperactivity (3) Autistic Disorder (3) Bipolar Disorder (3) Bronchiectasis (3) Cardiomyopathies (3) Chilblains (3) Cystic Fibrosis (3) Deglutition Disorders (3) Digestive System Diseases (3) Dysgeusia (3) Ganglion Cysts (3) Gastrointestinal Diseases (3) Giant Cell Arteritis (3) Head and Neck Neoplasms (3) Hemorrhage (3) Hypersensitivity (3) Hypertension, Pulmonary (3) Leukemia, Lymphocytic, Chronic, B-Cell (3) Measles (3) Melanoma (3) Metabolic Diseases (3) Migraine Disorders (3) Muscle Weakness (3) Myeloproliferative Disorders (3) Myocardial Ischemia (3) Myofascial Pain Syndromes (3) Obesity, Morbid (3) Pancreatic Neoplasms (3) Polymyalgia Rheumatica (3) Pregnancy Complications, Infectious (3) Psoriasis (3) Pulmonary Edema (3) Rare Diseases (3) Renal Insufficiency, Chronic (3) Rheumatic Fever (3) Sjogren's Syndrome (3) Sleep Wake Disorders (3) Spinal Cord Injuries (3) Spondylarthritis (3) Systemic Inflammatory Response Syndrome (3) Taste Disorders (3) Acute Disease (2) Alcohol Drinking (2) Alopecia (2) Amyotrophic Lateral Sclerosis (2) Anorexia (2) Anorexia Nervosa (2) Arteritis (2) Asymptomatic Infections (2) Atrial Fibrillation (2) Atrophy (2) Bacteremia (2) Behcet Syndrome (2) Brain Injuries, Traumatic (2) Carcinoma, Renal Cell (2) Cerebral Palsy (2) Child Development Disorders, Pervasive (2) Cholangiocarcinoma (2) Cholangitis (2) Clinical Deterioration (2) Common Cold (2) Compassion Fatigue (2) Congenital Abnormalities (2) Conjunctivitis (2) Constriction, Pathologic (2) Coronavi (2) Dementia (2) Depressive Disorder, Major (2) Developmental Disabilities (2) Diarrhea (2) Drug-Related Side Effects and Adverse Reactions (2) Encephalitis (2) Endocrine System Diseases (2) Esophageal Neoplasms (2) Eye Diseases (2) Fever (2) Fractures, Bone (2) Fractures, Stress (2) Genetic Predisposition to Disease (2) Glucose Metabolism Disorders (2) Heart Defects, Congenital (2) Hematologic Diseases (2) Hepatitis C (2) Hypothermia (2) Idiopathic Pulmonary Fibrosis (2) Infertility, Male (2) Intestinal Diseases (2) Ischemia (2) Jaundice (2) Leukemia, Lymphoid (2) Liver Cirrhosis (2) Lymphoma, Mantle-Cell (2) Macular Edema (2) Motor Neuron Disease (2) Mouth Diseases (2) Multiple Myeloma (2) Muscular Atrophy (2) Myelodysplastic Syndromes (2) Myositis (2) Neoplasm Metastasis (2) Neoplasms, Plasma Cell (2) Nerve Degeneration (2) Neuroendocrine Tumors (2) Nidovirales Infections (2) Noncommunicable Diseases (2) Obstetric Labor, 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)

D045169: Severe Acute Respiratory Syndrome

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 (1278)

Name (Synonyms) Correlation
drug2490 Placebo Wiki 0.31
drug1507 Hydroxychloroquine Wiki 0.21
drug2557 Placebo oral tablet Wiki 0.18
Name (Synonyms) Correlation
drug1740 Ivermectin Wiki 0.17
drug3191 Standard of Care Wiki 0.12
drug2215 No intervention Wiki 0.11
drug2192 Nitazoxanide Wiki 0.10
drug2827 Remdesivir Wiki 0.10
drug341 Azithromycin Wiki 0.10
drug2985 Saline Wiki 0.09
drug899 Convalescent plasma Wiki 0.09
drug884 Convalescent Plasma Wiki 0.09
drug1861 Losartan Wiki 0.08
drug1508 Hydroxychloroquine (HCQ) Wiki 0.08
drug2730 Questionnaire Wiki 0.07
drug1527 Hydroxychloroquine Sulfate Wiki 0.07
drug2579 Plasma Wiki 0.07
drug1592 INO-4800 Wiki 0.07
drug4004 placebo Wiki 0.07
drug2892 Ruxolitinib Wiki 0.07
drug3628 Vitamin C Wiki 0.07
drug3199 Standard of care Wiki 0.06
drug3630 Vitamin D Wiki 0.06
drug2665 Prone positioning Wiki 0.06
drug2763 REGN10933+REGN10987 combination therapy Wiki 0.06
drug1672 Interferon Beta-1A Wiki 0.06
drug2903 SARS-CoV-2 Wiki 0.06
drug557 CELLECTRA® 2000 Wiki 0.06
drug2249 Normal Saline Wiki 0.06
drug4084 standard care Wiki 0.06
drug1292 Favipiravir Wiki 0.06
drug1023 Dexamethasone Wiki 0.06
drug3869 human monoclonal antibody DZIF-10c (Group 1A-2D) Wiki 0.06
drug1455 High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.06
drug170 Aeonose Wiki 0.06
drug2700 Pulmozyme Wiki 0.06
drug3029 Self Supportive Care (SSC) Alone Wiki 0.06
drug2186 Nigella Sativa / Black Cumin Wiki 0.06
drug3461 Tranexamic acid Wiki 0.06
drug1848 Lopinavir-Ritonavir Wiki 0.06
drug2426 Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki 0.06
drug2930 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.06
drug4142 vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki 0.06
drug4143 vv-ECMO only (no cytokine adsorption) Wiki 0.06
drug2449 Peripheral blood draw Wiki 0.06
drug678 CVnCoV Vaccine Wiki 0.06
drug2435 Peginterferon Lambda-1A Wiki 0.06
drug1866 Low Dose Radiation Therapy Wiki 0.06
drug1228 Exercise Wiki 0.06
drug1762 KB109 + Self Supportive Care (SSC) Wiki 0.06
drug3697 Zinc Wiki 0.06
drug3154 Spirometry Wiki 0.06
drug2301 Olokizumab 64 mg Wiki 0.06
drug1008 Deferoxamine Wiki 0.06
drug2553 Placebo on a 0- and 28-day schedule Wiki 0.06
drug1068 Disulfiram Wiki 0.06
drug2494 Placebo (NaCl 0.9%) (Group 2D) Wiki 0.06
drug3207 Standard of care treatment Wiki 0.06
drug2918 SARS-CoV-2 diagnostic rapid test Wiki 0.06
drug2908 SARS-CoV-2 PCR Wiki 0.06
drug2894 Ruxolitinib Oral Tablet Wiki 0.06
drug1141 Ebselen Wiki 0.06
drug1990 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.06
drug1755 Ivermectin and Doxycycline Wiki 0.06
drug890 Convalescent Plasma Transfusion Wiki 0.06
drug1104 Duvelisib Wiki 0.06
drug885 Convalescent Plasma (CP) Wiki 0.06
drug1969 Matching Placebo Wiki 0.06
drug1874 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.06
drug1513 Hydroxychloroquine + azithromycin Wiki 0.06
drug1496 Human biological samples Wiki 0.06
drug1751 Ivermectin Oral Product Wiki 0.06
drug3104 Single Dose of Hydroxychloroquine Wiki 0.06
drug1842 Lopinavir / Ritonavir Wiki 0.06
drug2805 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.06
drug3871 hydroxychloroquine Wiki 0.06
drug2135 Nafamostat Mesilate Wiki 0.06
drug1084 Doxycycline Wiki 0.06
drug808 Colchicine Wiki 0.06
drug3185 Standard care Wiki 0.06
drug686 Camostat Mesilate Wiki 0.05
drug1193 Enoxaparin Wiki 0.05
drug3015 Sarilumab Wiki 0.05
drug2879 Rivaroxaban Wiki 0.05
drug210 Anakinra Wiki 0.05
drug1673 Interferon Beta-1B Wiki 0.05
drug3065 Serological test Wiki 0.05
drug976 DWRX2003 Wiki 0.05
drug1642 Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki 0.05
drug119 AV-COVID-19 Wiki 0.05
drug1787 LY3832479 Wiki 0.05
drug3923 mRNA-1273 Wiki 0.05
drug3880 hzVSF-v13 Wiki 0.05
drug3637 Vitamin Super B-Complex Wiki 0.05
drug2495 Placebo (Normal saline solution) Wiki 0.05
drug2180 Niclosamide Wiki 0.05
drug2676 Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki 0.05
drug3043 Selinexor Wiki 0.05
drug2200 Nitric Oxide Gas Wiki 0.05
drug2555 Placebo oral capsule Wiki 0.05
drug2771 RT-PCR Wiki 0.05
drug2870 Ribavirin Wiki 0.05
drug3430 Tocilizumab Wiki 0.05
drug2152 Nasopharyngeal swab Wiki 0.05
drug1906 Lung ultrasound Wiki 0.05
drug1859 Lopinavir/ritonavir Wiki 0.04
drug1412 HCQ & AZ Wiki 0.04
drug2459 Personalized ambulatory training Wiki 0.04
drug2939 SARS-CoV-2 vaccine formulation 2 with adjuvant 1 Wiki 0.04
drug2766 RIA-device (Remote Investigation and Assessment) Wiki 0.04
drug2907 SARS-CoV-2 IgG Antibody Testing Kit Wiki 0.04
drug1404 Guided online support program Wiki 0.04
drug121 AVIGAN Wiki 0.04
drug887 Convalescent Plasma 1 Unit Wiki 0.04
drug1470 High-dose placebo (18-59 years) & Two dose regimen Wiki 0.04
drug1678 Interferon-Beta Wiki 0.04
drug1598 IV Dexamethasone Wiki 0.04
drug2113 NETosis markers Wiki 0.04
drug332 Aviptadil 67μg Wiki 0.04
drug1682 Interleukin 6 (IL6) Antagonist Wiki 0.04
drug936 Covid-19 swab PCR test Wiki 0.04
drug3106 Single high dose vitamin D Wiki 0.04
drug4128 urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic Wiki 0.04
drug188 Airwave Oscillometry Wiki 0.04
drug2257 Normal saline solution (NSS), Placebo, Day 189 - Phase 2 Wiki 0.04
drug279 ArtemiC Wiki 0.04
drug2207 Nitroglycerin Wiki 0.04
drug2334 Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East Wiki 0.04
drug2943 SARS-CoV-2-test Wiki 0.04
drug3639 Vitamins and Minerals Wiki 0.04
drug3850 glenzocimab Wiki 0.04
drug2008 Merimepodib Wiki 0.04
drug1097 Drugs and supportive care Wiki 0.04
drug2108 NA-831 Wiki 0.04
drug2364 P2Et (Caesalpinia spinosa extract) Wiki 0.04
drug1895 Low-dose placebo (60-85 years) & Two dose regimen Wiki 0.04
drug2830 Remdesivir-HU Wiki 0.04
drug2940 SARS-CoV-2 vaccine formulation 2 with adjuvant 2 Wiki 0.04
drug4028 pulmonary rehabilitation Wiki 0.04
drug2714 Quality of Life Wiki 0.04
drug1938 MVC-COV1901 Wiki 0.04
drug774 Clarithromycin Wiki 0.04
drug1593 INOpulse Wiki 0.04
drug1266 F-652 Wiki 0.04
drug676 CVnCoV 12μg Wiki 0.04
drug642 COVID-19 testing Wiki 0.04
drug2758 RDV Wiki 0.04
drug1396 Group B Control Wiki 0.04
drug1099 Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki 0.04
drug1117 EIT-Group Wiki 0.04
drug1780 LAU-7b Wiki 0.04
drug1443 Hepatitis A vaccine Wiki 0.04
drug2482 Piclidenoson Wiki 0.04
drug3428 To assess for development of IgG antibodies against SARS-CoV2 Wiki 0.04
drug1473 High-flow nasal cannula treatment Wiki 0.04
drug2857 Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki 0.04
drug1468 High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen Wiki 0.04
drug1746 Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets Wiki 0.04
drug1578 ID NOW vs. Accula Wiki 0.04
drug2078 Monitoring Visit - Baseline Wiki 0.04
drug2318 Online Survey about Dietary and Lifestyle Habits Wiki 0.04
drug1828 Linagliptin Wiki 0.04
drug3589 Vehicle + Heparin along with best supportive care Wiki 0.04
drug3202 Standard of care (SOC) plus placebo Wiki 0.04
drug2402 Pacritinib Wiki 0.04
drug2536 Placebo for "Deficiency of Qi and Yang" Wiki 0.04
drug3365 Test: Favipiravir 200 mg (LOQULAR) Wiki 0.04
drug1384 Glycine Wiki 0.04
drug2337 Oral Wiki 0.04
drug3465 Transcutaneous Auricular Vagus Nerve Stimulation Wiki 0.04
drug1157 Electrical Impedance tomography Wiki 0.04
drug2412 Particle measurement Wiki 0.04
drug1192 Enisamium Iodide Wiki 0.04
drug3525 UCMSCs Wiki 0.04
drug2552 Placebo on a 0- and 14-day schedule Wiki 0.04
drug3623 Viruxal Oral and Nasal Spray Wiki 0.04
drug1493 Human Biological samples Wiki 0.04
drug2454 Personal behaviours Wiki 0.04
drug2933 SARS-CoV-2 serological assessment (IgG) Wiki 0.04
drug2223 No intervention, this is an observational study that uses validated questionnaires and qualitative interviews.. Wiki 0.04
drug2862 Retrospective case-control analysis Wiki 0.04
drug322 Auricular neuromodulation Wiki 0.04
drug2787 Randomized booster Wiki 0.04
drug2924 SARS-CoV-2 rS/Matrix M1-Adjuvant Wiki 0.04
drug3238 Stool collection or fecal swab Wiki 0.04
drug2129 NP-120 (Ifenprodil) Wiki 0.04
drug2659 Prone Position (PP) Wiki 0.04
drug1820 Lidocaine 2% Wiki 0.04
drug3168 Standard Care Wiki 0.04
drug2612 Povidone-Iodine 0.6% NI Wiki 0.04
drug2914 SARS-CoV-2 antibody test Wiki 0.04
drug2022 MetaNeb® System Wiki 0.04
drug2096 Muscle ultrasound Wiki 0.04
drug4145 web based survey Wiki 0.04
drug1923 MR or M-M-R II ® vaccine Wiki 0.04
drug1070 Doctella telehealth monitoring Wiki 0.04
drug2097 MuscleSound Ultrasound Wiki 0.04
drug4147 zinc acetate Wiki 0.04
drug2138 Nanocovax Wiki 0.04
drug2037 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.04
drug2496 Placebo (PB0) Wiki 0.04
drug1362 GPs reports of potential patient safety incidents, non-COVID-19 related Wiki 0.04
drug2687 Psychological stress and adaptation at work score (PSAS) Wiki 0.04
drug2028 MethylPREDNISolone 80 Mg/mL Injectable Suspension Wiki 0.04
drug744 Chat-based support Wiki 0.04
drug1680 Interferon-β 1a Wiki 0.04
drug1826 Lift Wiki 0.04
drug2719 Quantitative analysis of SARS-CoV-2 antibodies Wiki 0.04
drug1743 Ivermectin + Doxycycline + Placebo Wiki 0.04
drug2590 Plitidepsin 1.5 mg/day Wiki 0.04
drug1887 Low-dose Chest CT Wiki 0.04
drug1444 Hesperidin and Diosmin mixture Wiki 0.04
drug2092 Multicapillary column coupled ion mobility spectrometry Wiki 0.04
drug1894 Low-dose placebo (60-85 years) & Three dose regimen Wiki 0.04
drug1761 Janus Kinase Inhibitor (ruxolitinib) Wiki 0.04
drug913 Core Warming Wiki 0.04
drug1522 Hydroxychloroquine Only Product in Oral Dose Form Wiki 0.04
drug3174 Standard Of Care (SOC) Wiki 0.04
drug1054 Digital oximeter monitoring Wiki 0.04
drug1908 LungFit™ Wiki 0.04
drug1837 Liver, lung, heart and kidney biopsy Wiki 0.04
drug2133 NaCl 0.9% Wiki 0.04
drug970 DECT Wiki 0.04
drug60 80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki 0.04
drug817 Colgate periogard mouthwash Wiki 0.04
drug2401 Pacebo: Calcium citrate Wiki 0.04
drug2959 SCTA01 Placebo Wiki 0.04
drug1846 Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki 0.04
drug3012 Sampling of tissue Wiki 0.04
drug2024 Metformin Glycinate Wiki 0.04
drug406 Base therapy Wiki 0.04
drug1392 Group A HCQ Wiki 0.04
drug2366 PCR Wiki 0.04
drug1819 Licorice extract Wiki 0.04
drug1615 IgM and IgG antibodies assay Wiki 0.04
drug3872 hydroxychloroquine + azithromycin Wiki 0.04
drug1187 Endoscopic procedure Wiki 0.04
drug3656 Web Based Questionnaire Wiki 0.04
drug2994 Saline-sodium citrate (SSC) buffer Wiki 0.04
drug2380 PHR160 Spray Wiki 0.04
drug1926 MRI Wiki 0.04
drug2030 Methylene Blue 5 MG/ML Wiki 0.04
drug2872 Ringer's lactate Wiki 0.04
drug1597 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.04
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drug1601 Ibrutinib Wiki 0.02
drug53 3D Telemedicine Wiki 0.02
drug193 Allocetra-OTS Wiki 0.02
drug1288 Famotidine Wiki 0.02
drug2958 SCTA01 Wiki 0.02
drug16 0.9% saline Wiki 0.02
drug4092 standard therapy Wiki 0.02
drug1116 EIDD-2801 Wiki 0.02
drug3273 Survey Wiki 0.02
drug139 Acalabrutinib Wiki 0.02
drug3274 Survey Administration Wiki 0.02
drug812 Colchicine Tablets Wiki 0.02
drug2916 SARS-CoV-2 convalescent plasma Wiki 0.02
drug3014 Sargramostim Wiki 0.02
drug2278 Observation Wiki 0.02
drug1411 HCQ Wiki 0.02
drug2511 Placebo Administration Wiki 0.02
drug1853 Lopinavir/Ritonavir Wiki 0.02
drug2354 Oxygen Wiki 0.02
drug425 Best Practice Wiki 0.02
drug769 Cholecalciferol Wiki 0.02
drug594 COVID-19 Wiki 0.02
drug2322 Online questionnaire Wiki 0.02
drug2325 Online survey Wiki 0.02
drug3173 Standard Medical Treatment Wiki 0.02
drug965 DAS181 Wiki 0.02
drug2998 Saliva collection Wiki 0.02
drug3802 convalescent plasma Wiki 0.02
drug2717 Quality-of-Life Assessment Wiki 0.02
drug401 Baricitinib Wiki 0.01
drug4099 survey Wiki 0.01
drug2744 Questionnaires Wiki 0.01
drug3762 blood sample Wiki 0.01
drug3958 no intervention Wiki 0.01
drug3557 Usual Care Wiki 0.01
drug2732 Questionnaire Administration Wiki 0.01

Correlated MeSH Terms (165)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.83
D003141 Communicable Diseases NIH 0.35
D007239 Infection NIH 0.32
Name (Synonyms) Correlation
D013577 Syndrome NIH 0.18
D011014 Pneumonia NIH 0.16
D011024 Pneumonia, Viral NIH 0.13
D012127 Respiratory Distress Syndrome, Newborn NIH 0.13
D012128 Respiratory Distress Syndrome, Adult NIH 0.12
D014777 Virus Diseases NIH 0.12
D055371 Acute Lung Injury NIH 0.11
D003333 Coronaviridae Infections NIH 0.09
D012141 Respiratory Tract Infections NIH 0.09
D012327 RNA Virus Infections NIH 0.09
D012140 Respiratory Tract Diseases NIH 0.08
D016638 Critical Illness NIH 0.06
D030341 Nidovirales Infections NIH 0.06
D009220 Myositis NIH 0.06
D003139 Common Cold NIH 0.06
D044882 Glucose Metabolism Disorders NIH 0.06
D012120 Respiration Disorders NIH 0.06
D008659 Metabolic Diseases NIH 0.05
D004408 Dysgeusia NIH 0.05
D003924 Diabetes Mellitus, Type 2 NIH 0.05
D000860 Hypoxia NIH 0.05
D008173 Lung Diseases, Obstructive NIH 0.04
D008171 Lung Diseases, NIH 0.04
D006685 Hoarseness NIH 0.04
D019965 Neurocognitive Disorders NIH 0.04
D012507 Sarcoidosis NIH 0.04
D000070627 Chronic Traumatic Encephalopathy NIH 0.04
D059246 Tachypnea NIH 0.04
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.04
D051346 Mobility Limitation NIH 0.04
D001997 Bronchopulmonary Dysplasia NIH 0.04
D008595 Menorrhagia NIH 0.04
D013166 Spondylitis NIH 0.04
D013167 Spondylitis, Ankylosing NIH 0.04
D006929 Hyperaldosteronism NIH 0.04
D014552 Urinary Tract Infections NIH 0.04
D058070 Asymptomatic Diseases NIH 0.04
D011470 Prostatic Hyperplasia NIH 0.04
D054559 Hyperphosphatemia NIH 0.04
D019446 Endotoxemia NIH 0.04
D055154 Dysphonia NIH 0.04
D006965 Hyperplasia NIH 0.04
D004314 Down Syndrome NIH 0.04
D000073436 Microvascular Rarefaction NIH 0.04
D024821 Metabolic Syndrome NIH 0.04
D015163 Superinfection NIH 0.04
D001424 Bacterial Infections NIH 0.04
D011649 Pulmonary Alveolar Proteinosis NIH 0.04
D063806 Myalgia NIH 0.04
D005879 Tourette Syndrome NIH 0.04
D014832 Voice Disorders NIH 0.04
D020767 Intracranial Thrombosis NIH 0.04
D018410 Pneumonia, Bacterial NIH 0.04
D003424 Crohn Disease NIH 0.04
D000309 Adrenal Insufficiency NIH 0.04
D007008 Hypokalemia NIH 0.04
D007010 Hyponatremia NIH 0.04
D010608 Pharyngeal Diseases NIH 0.04
D006562 Herpes Zoster NIH 0.04
D016769 Embolism and Thrombosis NIH 0.04
D055501 Macrophage Activation Syndrome NIH 0.04
D000857 Olfaction Disorders NIH 0.04
D003428 Cross Infection NIH 0.04
D019851 Thrombophilia NIH 0.04
D004194 Disease NIH 0.03
D003920 Diabetes Mellitus, 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
D055370 Lung Injury NIH 0.03
D000505 Alopecia NIH 0.03
D000070642 Brain Injuries, Traumatic NIH 0.03
D000690 Amyotrophic Lateral Sclerosis NIH 0.03
D012640 Seizures NIH 0.03
D012772 Shock, Septic NIH 0.03
D009101 Multiple Myeloma NIH 0.03
D007410 Intestinal Diseases NIH 0.03
D011618 Psychotic Disorders NIH 0.03
D016472 Motor Neuron Disease NIH 0.03
D058345 Asymptomatic Infections NIH 0.03
D009410 Nerve Degeneration NIH 0.03
D001528 Behcet Syndrome NIH 0.03
D006402 Hematologic Diseases NIH 0.03
D004700 Endocrine System Diseases NIH 0.03
D054990 Idiopathic Pulmonary Fibrosis NIH 0.03
D006526 Hepatitis C NIH 0.03
D054219 Neoplasms, Plasma Cell NIH 0.03
D013923 Thromboembolism NIH 0.03
D000066553 Problem Behavior NIH 0.03
D054556 Venous Thromboembolism NIH 0.03
D053717 Pneumonia, Ventilator-Associated NIH 0.03
D058186 Acute Kidney Injury NIH 0.03
D018450 Disease Progression NIH 0.03
D014808 Vitamin D Deficiency NIH 0.03
D020246 Venous Thrombosis NIH 0.03
D040921 Stress Disorders, Traumatic NIH 0.03
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
D007249 Inflammation 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
D007319 Sleep Initiation and Maintenance Disorders 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
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
D000073397 Occupational Stress NIH 0.02
D009102 Multiple Organ Failure NIH 0.02
D001523 Mental Disorders NIH 0.02
D009765 Obesity NIH 0.02
D007153 Immunologic Deficiency Syndromes NIH 0.02
D000073496 Frailty NIH 0.02
D010300 Parkinsonian NIH 0.02
D008175 Lung Neoplasms NIH 0.02
D008180 Lupus Erythematosus, Systemic NIH 0.02
D012769 Shock, NIH 0.02
D006331 Heart Diseases NIH 0.02
D003289 Convalescence NIH 0.02
D008231 Lymphopenia NIH 0.02
D012598 Scoliosi NIH 0.01
D018805 Sepsis NIH 0.01
D009103 Multiple Sclerosis NIH 0.01
D009205 Myocarditis 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
D006973 Hypertension NIH 0.01
D000077062 Burnout, Psychological NIH 0.01
D013315 Stress, Psychological NIH 0.01
D002318 Cardiovascular Diseases NIH 0.01
D004630 Emergencies NIH 0.01

Correlated HPO Terms (68)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.16
HP:0011947 Respiratory tract infection HPO 0.09
HP:0100614 Myositis HPO 0.06
Name (Synonyms) Correlation
HP:0005978 Type II diabetes mellitus HPO 0.05
HP:0006536 Pulmonary obstruction HPO 0.05
HP:0012418 Hypoxemia HPO 0.05
HP:0002088 Abnormal lung morphology HPO 0.05
HP:0002905 Hyperphosphatemia HPO 0.04
HP:0002900 Hypokalemia HPO 0.04
HP:0000846 Adrenal insufficiency HPO 0.04
HP:0001618 Dysphonia HPO 0.04
HP:0001621 Weak voice HPO 0.04
HP:0100724 Hypercoagulability HPO 0.04
HP:0002355 Difficulty walking HPO 0.04
HP:0008711 Benign prostatic hyperplasia HPO 0.04
HP:0002789 Tachypnea HPO 0.04
HP:0000132 Menorrhagia HPO 0.04
HP:0003326 Myalgia HPO 0.04
HP:0002902 Hyponatremia HPO 0.04
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.04
HP:0000859 Hyperaldosteronism HPO 0.04
HP:0100280 Crohn's disease HPO 0.04
HP:0001609 Hoarse voice HPO 0.04
HP:0000458 Anosmia HPO 0.04
HP:0001907 Thromboembolism HPO 0.04
HP:0006510 Chronic pulmonary obstruction HPO 0.03
HP:0000819 Diabetes mellitus 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 0.03
HP:0001871 Abnormality of blood and blood-forming tissues HPO 0.03
HP:0000709 Psychosis HPO 0.03
HP:0000224 Hypogeusia HPO 0.03
HP:0100754 Mania HPO 0.03
HP:0000818 Abnormality of the endocrine system HPO 0.03
HP:0002293 Alopecia of scalp HPO 0.03
HP:0007354 Amyotrophic lateral sclerosis HPO 0.03
HP:0002242 Abnormal intestine morphology HPO 0.03
HP:0002180 Neurodegeneration HPO 0.03
HP:0006775 Multiple myeloma HPO 0.03
HP:0000708 Behavioral abnormality HPO 0.03
HP:0001919 Acute kidney injury HPO 0.03
HP:0100512 Low levels of vitamin D HPO 0.03
HP:0002098 Respiratory distress HPO 0.03
HP:0002625 Deep venous thrombosis HPO 0.03
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:0001928 Abnormality of coagulation HPO 0.02
HP:0001513 Obesity HPO 0.02
HP:0001298 Encephalopathy HPO 0.02
HP:0002721 Immunodeficiency HPO 0.02
HP:0002725 Systemic lupus erythematosus HPO 0.02
HP:0100526 Neoplasm of the lung HPO 0.02
HP:0001888 Lymphopenia HPO 0.02
HP:0100806 Sepsis HPO 0.01
HP:0001635 Congestive heart failure HPO 0.01
HP:0012819 Myocarditis HPO 0.01
HP:0012532 Chronic pain HPO 0.01
HP:0001370 Rheumatoid arthritis 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:0000822 Hypertension HPO 0.01
HP:0001626 Abnormality of the cardiovascular system HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 567 clinical trials

1 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
2 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
3 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
4 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
5 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
6 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
7 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
8 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.
9 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
10 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
11 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
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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
23 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)
24 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
25 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
26 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
27 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
28 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
29 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
30 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)
31 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
32 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.
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 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
49 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
50 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
51 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
52 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
53 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
54 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
55 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
56 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
57 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
58 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
59 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
60 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
61 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
62 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
63 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
64 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
65 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
66 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
67 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
68 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
69 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
70 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
71 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
72 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
73 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
74 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
75 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
76 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
77 A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

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

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

Primary Outcomes

Description: Viral load assessed by PCR from a nasopharyngeal swab

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

Time: Baseline to Day 3

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

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

Time: Baseline to Day 3

Secondary Outcomes

Description: Viral load assessed by PCR from a nasopharyngeal swab

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

Time: Baseline to Day 5

Description: Viral load assessed by PCR from a nasopharyngeal swab

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

Time: Baseline to end of study (Day14)

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

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

Time: Baseline to end of study (Day14)

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

Measure: Time to resolution of COVID-19 Symptoms

Time: Baseline to end of study (Day14)

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

Measure: Time to resolution of fever

Time: Baseline to end of study (Day14)

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

Measure: Percentage of participants with resolution of fever

Time: Baseline to end of study (Day14)

Measure: Percentage of participants hospitalized

Time: Baseline to end of study (Day14)

Measure: Number of participants with Adverse Events

Time: Baseline to end of study (Day14)
78 Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib

In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α. Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells. This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.

NCT04334044
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Ruxolitinib Oral Tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndr Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Presence of recovery of pneumonia characterized by cease of respiratory symptoms

Measure: Recovery of Pneumonia

Time: 14 days

Secondary Outcomes

Description: Increment or decrease in mg/ml of C-reactive protein

Measure: Response of C-reactive protein

Time: 14 days

Description: Increment or decrease in ng/ml of ferritin

Measure: Response of Ferritin

Time: 14 days

Description: Increment or decrease in mg/ml of D-dimer

Measure: Response of D-dimer

Time: 14 days

Description: Requirement of Intensive Care Unit on the patients under treatment

Measure: Rate of ICU admission

Time: 14 days

Description: Requirement of mechanical ventilation on the patients under treatment

Measure: Rate of mechanical ventilation

Time: 14 days

Description: Time since the diagnosis to the last follow up (recovery or death)

Measure: Overall Survival

Time: 1 month

Description: Rate of adverse events associated with ruxolitinib

Measure: Toxicity Rate

Time: 1 month
79 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

NCT04334512
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. Coronavirus-19
  4. Sars-CoV2
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Azithromycin
  3. Dietary Supplement: Vitamin C
  4. Dietary Supplement: Vitamin D
  5. Dietary Supplement: Zinc
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy

Time: 12 weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

Description: Assess the symptom response to study therapy as measured by the survey in the EDC

Measure: Assess the safety of Quintuple Therapy

Time: 12 weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

Description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks
80 Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial

The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.

NCT04334629
Conditions
  1. Coronavirus
  2. Respiratory Distress Syndrome
  3. SARS-CoV Infection
Interventions
  1. Drug: Ibuprofen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]

Measure: Disease progression

Time: 14 days

Description: Time to mechanical ventilation (or need of)

Measure: Time to mechanical ventilation

Time: 14 days

Secondary Outcomes

Measure: Overall survival

Time: 28 days

Measure: Reduction in proportion of patients who require ventilation

Time: 28 days

Measure: Reduction in length of Critical Care stay

Time: 28 days

Measure: Reduction in length of Hospital stay

Time: 28 days

Measure: Modulation of serum pro- and anti-inflammatory cytokines

Time: 28 days

Measure: Reduction in duration of ventilation

Time: 28 days

Measure: Increase in ventilator-free days

Time: 28 days
81 Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo

Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.

NCT04334928
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Emtricitabine/tenofovir disoproxil
  2. Drug: Hydroxychloroquine
  3. Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo
  4. Drug: Placebo: Hydroxychloroquine
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of confirmed symptomatic infections of SARS-CoV-2 (COVID-19)

Time: 12 weeks

Secondary Outcomes

Description: assessed by: No symptoms Mild symptoms: general malaise, fever, cough, myalgia, asthenia. Moderate symptoms: mild symptoms plus shortness of breath, Severe symptoms: mild symptoms plus respiratory insufficiency that requires admission in intensive care unit and mechanical ventilation

Measure: Severity of disease in confirmed infected participants of SARS-CoV-2 (COVID-19)

Time: 12 weeks

Measure: Duration of symptoms in confirmed infected participants of SARS-CoV-2 (COVID-19) measured in days

Time: 12 weeks
82 Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

NCT04334967
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS-CoV-2
  4. 2019-nCoV
  5. 2019 Novel Coronavirus
Interventions
  1. Drug: Hydroxychloroquine
  2. Dietary Supplement: Vitamin C
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This outcome will be assessed by comparing the percentages of enrolled patients that are hospitalized in the treatment and control arms.

Measure: Total Hospitalization

Time: 14 days

Description: This outcome will be assessed by comparing the percentages of enrolled patients that have received mechanical ventilation in the treatment and control arms.

Measure: Total Mechanical Ventilation

Time: 14 days

Secondary Outcomes

Description: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.

Measure: Fever intensity measure

Time: 2 days

Description: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.

Measure: Fever intensity measure

Time: 5 days

Description: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.

Measure: Fever intensity measure

Time: 10 days

Description: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.

Measure: Fever intensity measure

Time: 14 days

Description: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.

Measure: Shortness of breath measure

Time: 2 days

Description: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.

Measure: Shortness of breath measure

Time: 5 days

Description: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.

Measure: Shortness of breath measure

Time: 10 days

Description: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.

Measure: Shortness of breath measure

Time: 14 days

Description: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in daytime cough measure

Time: 2 days

Description: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in daytime cough measure

Time: 5 days

Description: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in daytime cough measure

Time: 10 days

Description: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in daytime cough measure

Time: 14 days

Description: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in nighttime cough measure

Time: 2 days

Description: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in nighttime cough measure

Time: 5 days

Description: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in nighttime cough measure

Time: 10 days

Description: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.

Measure: Changes in nighttime cough measure

Time: 14 days

Description: Number of enrolled patients who have died within the specified time frame

Measure: Total mortality

Time: 28 days
83 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

NCT04335084
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Sars-CoV2
  4. Corona Vi
  5. Corona Virus Infection
  6. COVID
  7. Coronavirus
  8. Coronavirus-19
  9. Coronavirus 19
Interventions
  1. Drug: Hydroxychloroquine
  2. Dietary Supplement: Vitamin C
  3. Dietary Supplement: Vitamin D
  4. Dietary Supplement: Zinc
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.

Measure: Prevention of COVID-19 symptoms as recorded in a daily diary

Time: 24 weeks

Description: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.

Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

Time: 24 weeks
84 PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease

Rationale: The current SARS-CoV-2 pandemic has a high burden of morbidity and mortality due to development of the so-called acute respiratory distress syndrome (ARDS). The renin-angiotensin-system (RAS) plays an important role in the development of ARDS. ACE2 is one of the enzymes involved in the RAS cascade. Virus spike protein binds to ACE2 to form a complex suitable for cellular internalization. The downregulation of ACE2 results in the excessive accumulation of angiotensin II, and it has been demonstrated that the stimulation of the angiotensin II type 1a receptor (AT1R) increases pulmonary vascular permeability, explaining the increased lung pathology when activity of ACE2 is decreased. Currently available AT1R blockers (ARBs) such as valsartan, have the potential to block this pathological process mediated by angiotensin II. There are presently two complementary mechanisms suggested: 1) ARBs block the excessive angiotensin-mediated AT1R activation, and 2) they upregulate ACE2, which reduces angiotensin II concentrations and increases the production of the protective vasodilator angiotensin 1-7. In light of the above, ARBs may prevent the development of ARDS and avert morbidity (admission to intensive care unit (ICU) and mechanical ventilation) and mortality. Objective: To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Death. Study design: A double-blind, placebo-controlled 1:1 randomized clinical trial Study population: Adult hospitalized SARS-CoV-2-infected patients (n=651). Intervention: The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160mg b.i.d. and the placebo arm will receive a matching placebo also titrated to blood pressure. Treatment duration will be 14 days or up to hospital discharge < 14 days or occurrence of the primary endpoint if < 14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death.

NCT04335786
Conditions
  1. Acute Respiratory Distress Syndrome
  2. SARS-CoV-2
  3. CO
  4. COVID
  5. COVID-19
  6. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Valsartan (Diovan)
  2. Drug: Placebo oral tablet
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Death is defined as all-cause mortality

Measure: first occurrence of intensive care unit admission, mechanical ventilation or death

Time: within 14 days

Secondary Outcomes

Description: All-cause mortality; and time to all-cause mortality

Measure: Death

Time: Within 14 days, 30 days, 90 days and at 1 year

Description: Occurrence of mechanical ventilation and time to ventilation

Measure: Mechanical ventilation

Time: within 14 days

Description: Occurrence of ICU admission and time to admission

Measure: Intensive care unit admission

Time: within 14 days

Description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2

Measure: Occurrence of acute kidney injury

Time: Within 14 days
85 Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit. A Multicenter Observational Study.

NCT04336345
Conditions
  1. Coronavirus Infections
  2. COVID-19
  3. Viral Pneumonia Human Coronavirus
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Mortality 30 days following hospital admission

Measure: Hospital mortality

Time: 30 days

Secondary Outcomes

Description: The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge

Measure: Length of stay in the intensive care unit

Time: Through study completion, an average of 30 days
86 Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

NCT04336410
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: INO-4800
  2. Device: CELLECTRA® 2000
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Participants with Adverse Events (AEs)

Time: Baseline up to Week 52

Measure: Percentage of Participants with Administration (Injection) Site Reactions

Time: Day 0 up to Week 52

Measure: Percentage of Participants with Adverse Events of Special Interest (AESIs)

Time: Baseline up to Week 52

Measure: Change from Baseline in Antigen-Specific Binding Antibody Titers

Time: Baseline up to Week 52

Measure: Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response

Time: Baseline up to Week 52
87 Determination Of Physical Activity, Sleep And Stress Level Of Pregnant Women In The Covıd-19 Quarantine Period

We hypothesized: During the COVID-19 pandemic, the sleep quality of pregnant women decreases. During the COVID-19 epidemic, the stress level of pregnant women increases. During the COVID-19 epidemic, the level of physical activity of pregnant women decreases. Aims: The aim of the study is to determine the sleep quality, stress level and physical activity level of pregnant women who maintain the home quarantine during the COVID-19 pandemic.

NCT04336787
Conditions
  1. Covid-19
  2. Coronavirus Infection
  3. Pregnancy Related
Interventions
  1. Other: Survey
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days) 1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week

Measure: International Physical Activity Questionnaire

Time: Baseline of the study

Description: The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.

Measure: Pittsburgh Sleep Quality Index

Time: Baseline of the study

Description: The Perceived Stress Scale (PSS) is a 14-item self-report measure designed to assess "the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) and summed to create a total score. PSS-14 has strong internal consistency (α = .84 to .86) and good test-retest reliability (r = .85 over a 2-day period, r = .55 over a 6-week period.

Measure: Perceived Stress Scale

Time: Baseline of the study

Description: The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale rates the pain from 0 (no pain) to 10 (worst pain).

Measure: Numerical Pain Rating Scale

Time: Baseline of the study
88 Gerontological Telemonitoring of Older Adults Living in Nursing Homes With Symptoms of Confirmed or Probable COVID-19 Disease

Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020. Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.

NCT04337788
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: telehealth applications
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Impact of Gerontological telemonitoring on healthcare management for older adults living in Nursing Homes with symptoms of confirmed or probable COVID-19 disease (Death within 30 days).

Time: day 30
89 Multi-Center, Randomized, Controlled, Phase II Clinical Efficacy Study Evaluating Nitric Oxide Releasing Solution Treatment for the Prevention and Treatment of COVID-19 in Healthcare Workers and Individuals at Risk of Infection

This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.

NCT04337918
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: NORS (Nitric Oxide Releasing Solution)
  2. Drug: NORS (Nitric Oxide Releasing Solution)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the proportion of subjects with either swab positive COVID-19 or presentation of clinical symptoms as measured by fatigue with either fever >37.2 (oral)and/or a persistent cough.

Measure: Prevention Study: Measure the effect of NORS on the prevention of COVID-19 infection among health care professionals at risk of exposure to COVID-19

Time: 14 days

Description: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.

Measure: Treatment Sub Study: Measure the efficacy of NORS at reducing the progression of COVID- 19

Time: 21 days

Secondary Outcomes

Description: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.

Measure: Prevention Study: Measure the effect of NORS on the prevention of progression of COVID- 19

Time: 21 days

Description: Measure the tolerability of the NORS treatments as determined by number of adverse events, pain, discomfort or discontinuations of treatment.

Measure: Prevention Study: Measure the tolerability of NORS treatments

Time: 21 days

Description: Measure the median number of days to negative conversion of SARS-CoV-2 RT-PCR from a nasopharyngeal swabs.

Measure: Treatment Sub Study: Measure the virucidal effect of NORS Treatments

Time: 21 days

Description: Determine the time to clinical recovery in participants with COVID-19 by measuring the median number of days from enrollment to discharge (if admitted), or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air).

Measure: Treatment Sub Study: Determine effect of NORS on the speed of clinical recovery

Time: 21 days

Description: Measure the reduction clinical symptoms in participants with COVID- 19 by the magnitude of the change in Modified Jackson Cold Score Diary Score (5-unit change is a substantial clinical benefit).

Measure: Treatment Sub Study: Determine the reduction in clinical symptoms

Time: 21 days

Description: Measure the proportion of participants that have a positive sero-conversion for SARS-CoV-2

Measure: Treatment & Sub Study: Determine positive sero-conversion for SARS-CoV-2

Time: 21 days
90 Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study

COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue. While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation. Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients. Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date. Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

NCT04338100
Conditions
  1. COVID
  2. Coronavirus Infection
Interventions
  1. Procedure: Follow-up at 14 days
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14. Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion. We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.

Measure: Risk of unfavourable outcome at D14

Time: 14 days

Secondary Outcomes

Description: To evaluate, in patients with a confirmed or probable SARS-CoV-2 infection, whether POCUS score performances vary as a function of time, between D1 and D14, and, if so, until which time horizon its performances are clinically relevant. In this purpose, we will determine the time period for which the lower limit of the 95% confidence interval of the AUC of the POCUS score ROC curve is at least 0.7.

Measure: Risk of unfavourable outcome over time

Time: 14 days

Description: To identify the threshold values of POCUS score to perform risk-stratification in three groups of patients: low-risk patients, intermediate-risk patients, high-risk patients. In this purpose, we will determine two threshold values on the inflection points of the ROC curve: maximizing the specificity for a sensitivity of at least 95%, maximizing the sensitivity for a specificity of at least 95%.

Measure: Risk-stratification threshold values

Time: 14 days

Description: To study the impact of adding the result of POCUS evaluation to several risk-stratification clinical rules for pulmonary infection or sepsis: qSOFA, CRB 65 and CURB 65 In this purpose, we will attribute 0, 1 or 2 points to POCUS score according to the predefined threshold values and will assess : sensitivities of qSOFA with and without addition of POCUS score result, specificities of qSOFA with and without addition of POCUS score result; sensitivities of CRB 65 with and without addition of POCUS score result, specificities of CRB 65 with and without addition of POCUS score result; sensitivities of CRB 65 with and without addition of POCUS score result, specificities of CRB 65 with and without addition of POCUS score result.

Measure: Adding value of POCUS score to previous risk-stratification clinical rules

Time: 14 days

Description: To assess, the capacity of POCUS score at D0 to predict patient clinical status at D14 In this purpose, we will determine the correlation coefficient between the POCUS score at D0 and the clinical status of patients at day 14 according to the WHO Ordinal Scale for Clinical Improvement for COVID-19 patients.

Measure: POCUS score and patient clinical status at D14

Time: 14 days

Description: To study the correlation between POCUS and CT scan assessment of lung damage. In this purpose, we will determine the intra-class correlation coefficient between POCUS assessment according to the number of affected areas among 12 and CT scan assessment according to the quantification proposed by the French Society of Radiology: 0 - normal; 1 - minor (< 10%), 2 - moderate (10-25%), 3 - important (25-50%), 4 - severe (50-75%), 5 - critical (> 75%)

Measure: POCUS and CT scan correlation

Time: 14 days

Description: To compare the diagnostic performances of POCUS with that of chest computed tomography to identify patients with unfavourable outcome. In this purpose, we will compare the AUC of the ROC curves of POCUS score and CT scan quantification of lung damage to identify patients with unfavourable outcome (intubation and mechanical ventilation requirement or death)

Measure: POCUS versus CT scan risk-stratification performances

Time: 14 days

Description: To evaluate, in the subgroup of hospitalized patients having a second chest ultrasonography at Day 5 +/- 3 of inclusion, the performances of the evolution of the POCUS score between the first and the second assessment to identify patients with unfavourable outcome. In this purpose, we will calculate the delta between the first and second POCUS score and determine the AUC of the ROC curve and its 95% confidence interval.

Measure: POCUS score evolution performances

Time: 14 days
91 HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

NCT04338841
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: HOME-CoV rule implementation
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.

Measure: the composite rate of adverse outcomes

Time: day 7

Description: The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission. It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.

Measure: The rate of hospitalization

Time: 24 hours
92 COVID-19 Risk Stratification

The investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

NCT04339387
Conditions
  1. Coronavirus
  2. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die.

Measure: Suitable for discharge

Time: Duration of participation in cohort, expected to be between 1 day and 20 days.
93 Efficiency in Management of Organ Dysfunction Associated With Infection by the Novel SARS-CoV-2 Virus (COVID-19) Through a Personalized Immunotherapy Approach: the ESCAPE Clinical Trial

Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.

NCT04339712
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Macrophage Activation Syndrome
  4. Corona Virus Infection
Interventions
  1. Drug: Anakinra
  2. Drug: Tocilizumab
MeSH:Infection Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Macrophage Activation Syndrome

Primary Outcomes

Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8

Measure: Change of baseline total sequential organ failure assessment (SOFA) score

Time: Visit study day 8

Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8

Measure: Improvement of lung involvement measurements

Time: Visit study day 8

Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8

Measure: Increase of pO2/FiO2 ratio

Time: Visit Study Day 8

Secondary Outcomes

Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of sequential organ failure assessment (SOFA) score

Time: Day 28

Description: Mortality on day 28

Measure: Rate of Mortality

Time: Day 28

Description: Mortality on day 90

Measure: Rate of Mortality

Time: Day 90

Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Cytokine stimulation

Time: Screening, Day 4

Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Gene expression

Time: Screening, Day 4

Description: Change of serum/plasma proteins between days 0 and 4

Measure: Serum/plasma proteins

Time: Screening, Day 4

Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation

Measure: Classification of the immune function

Time: Screening
94 Assessment of Exam Findings in Coronavirus Disease 2019 (COVID-19) With Point-of-Care Ultrasonography (POCUS)

Specific Aims: 1. The investigators will prospectively evaluate and analyze changes in the appearance of the lungs and heart through serial acquisition of focused point-of-care ultrasound images in a cohort of patients with or under investigation for COVID-19. 2. The investigators will correlate changes noted in ultrasound with clinical course and diagnostic evaluation to ascertain whether changes on ultrasound could improve care through earlier diagnosis or identification of patients at high risk of disease progression.

NCT04339998
Conditions
  1. Coronavirus Infection
  2. COVID
  3. Covid-19
  4. SARS-CoV-2
Interventions
  1. Diagnostic Test: Point-of-Care Ultrasonography (POCUS)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the lungs. Higher scores indicate greater malady. Pulmonary POCUS Evaluation: B lines: absent (< 3 lines), present (> 3 lines), fused Consolidation: yes or no a. Bilateral: yes or no Pleural Effusion: yes or no Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities

Measure: POCUS Score - Lungs

Time: up to 14 days

Description: POCUS is a 6-point scale evaluating the degree of abnormalities and number of sites with abnormalities in ultrasound images of the heart. Higher scores indicate greater malady. Cardiac POCUS Evaluation: Parasternal long axis Parasternal short axis Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm) Left ventricular (LV) mass approximation by septal thickness Left Ventricular Chamber Size by internal diameter at diastole Score each finding based on degree of abnormalities and number of sites with abnormalities

Measure: POCUS Score - Heart

Time: up to 14 days
95 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.

NCT04340466
Conditions
  1. Pneumonia, Viral
  2. Critically Ill
  3. Corona Virus Infection
Interventions
  1. Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Cr Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28
96 Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection

The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.

NCT04340557
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Losartan
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure

Measure: Mechanical ventilation

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Secondary Outcomes

Description: Number of subjects transferred from non-ICU bed to an ICU bed

Measure: ICU transfer

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Description: Number of days requiring oxygen therapy

Measure: Oxygen therapy

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
97 Randomized Double Blinded Monocentric Clinical Trial to Assess the Impact of Auricular Vagus Nerve Neuromodulation in COVID-19 Positive Inpatients Outcome.

The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

NCT04341415
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Procedure: Auricular neuromodulation
  2. Procedure: Control
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Inpatients are considered as clinically improved if they have gained at least 2 points on the following clinical evaluation scale, or if they went back home Clinical evaluation scale :1. Outpatient back to normal activities / 2. Outpatient without normal activities / 3. Inpatient without oxygen therapy / 4. Inpatient with oxygen therapy/ 5. Inpatient requiring either nasal high-flow oxygen therapy or non-invasive respirator or both / 6. Inpatient, requiring either ExtraCorporeal Membrane Oxygenation (ECMO) or invasive artificial respirator, or both / 7. Deceased.

Measure: Comparison of the percentage of clinically improved inpatients between D0 and D14

Time: 14 day after intervention
98 Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study

This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.

NCT04341441
Conditions
  1. COVID-19
  2. Coronavirus
  3. Coronavirus Infections
  4. SARS-CoV 2
Interventions
  1. Drug: Hydroxychloroquine - Daily Dosing
  2. Drug: Hydroxychloroquine - Weekly Dosing
  3. Other: Placebo oral tablet
  4. Diagnostic Test: Monitoring Visit - Baseline
  5. Diagnostic Test: Monitoring Visit - Week 4
  6. Diagnostic Test: Monitoring Visit - Week 8
  7. Other: Weekly Assessment
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: We will measure the difference in new cases of COVID-19 disease between randomized treatment arms. Plan statistical analyses will include the assumption that up 10% of HCW at risk will become infected if no prophylactic treatment is provided. Therefore we expect that HCQ treatment arm will provide a reduction in the number of SARS-CoV 2 infections by 30%, with an expected study retention rate of 90%, a sample size of ~1500 participants per group, will have an 80% power to detect the difference at p=0.05.

Measure: To determine if the use of hydroxychloroquine as preventive therapy decreases the rate of acquisition of SARS-CoV 2 infections and clinical COVID-19 disease in Study Participants for each randomized treatment arm as compared to placebo.

Time: 8 Weeks

Secondary Outcomes

Description: Compare the rates of SARS-CoV 2 infections between the randomized treatment arms and the control arms to determine the effect of HCQ dose in the prevention of COVID-19 viremia and disease as determined by study visits, weekly questionnaires, and blood samples.

Measure: Determine the effect of hydroxychloroquine dose in the prevention of COVID-19 viremia and disease.

Time: 8 Weeks

Description: Comparison of the rates of SARS-CoV 2 infections in the non-randomized comparator arm to the randomized groups to assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention via weekly questionnaire and/or blood samples.

Measure: Assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention.

Time: 8 Weeks

Description: Measurement of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo via blood samples.

Measure: Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo.

Time: 8 Weeks

Description: Measurement of the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo via blood samples.

Measure: Compare the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo.

Time: 8 Weeks

Description: Measurement of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm and via weekly questionnaire and/or blood samples.

Measure: Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.

Time: 8 Weeks

Description: Review of the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care via weekly questionnaire.

Measure: To examine the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care.

Time: 8 Weeks

Description: Measurement of the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events reported via weekly questionnaire.

Measure: Determine the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events.

Time: 8 Weeks

Description: Examination of other clinical determinants contributing to the risk of SARS-CoV 2 infection including demographics, work type and location, positive COVID-19 partners, possible exposures and clinical symptoms via study visits and weekly questionnaire.

Measure: To examine other clinical determinants contributing to the risk of SARS-CoV 2 infection in healthcare workers and first responders.

Time: 8 Weeks

Description: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results via weekly questionnaire and/or blood samples.

Measure: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results.

Time: 8 Weeks

Description: Identification of immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease via study visits, weekly questionnaire, and blood samples.

Measure: identify immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease.

Time: 8 weeks
99 Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome

Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.

NCT04341493
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Nitazoxanide 500 MG
  2. Drug: Hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of patients COVID-19 positive that required mechanical ventilation

Measure: Mechanical ventilation requirement

Time: Since the diagnosis until two weeks after
100 "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).

NCT04341519
Conditions
  1. Corona Virus Infection
  2. Post-traumatic Stress Disorder
Interventions
  1. Behavioral: PTSD
  2. Behavioral: Burnout
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Stress Disorders, Traumatic Stress Disorders, Post-Traumatic
HPO:Pneumonia

Primary Outcomes

Description: Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411

Measure: PTSD Family members sup 22

Time: 90 days

Secondary Outcomes

Description: Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Family members

Time: 90 days

Description: Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD Patients

Time: 90 days

Description: Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)

Measure: PTSD healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among Family members Symptoms of anxiety and depression using the HADS scale

Measure: HADS Family members

Time: 90 days

Description: Among Patients Symptoms of anxiety and depression using the HADS scale

Measure: HADS Patients

Time: 90 days

Description: Among Patients Mental and physical health-related quality of life as assessed by the SF36

Measure: SF36 Patients

Time: 90 days

Description: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Family members

Time: 90 days

Description: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Patients

Time: 90 days

Description: Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers

Measure: MBI healthcare providers

Time: 2 months after official end of the Covid-19 peak

Description: Job Strain as assessed by the Karasec instrument

Measure: Karasec instrument healthcare providers

Time: 2 months after official end of the Covid-19 peak
101 CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection, Nested In The CORIMUNO-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

NCT04341584
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Anakinra
MeSH:Infection Communicable Diseases 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.

Measure: WHO progression scale ≤ 5

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) or withdrawal of NIV or high flow (for > 48h), at day 14

Time: 14 days

Description: Proportion of patients with a decrease of WHO score of at least 1 point at day 4

Measure: Decrease of at least one point in WHO progression scale score

Time: 4 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

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
102 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

NCT04341727
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Hydroxychloroquine Sulfate
  2. Drug: Azithromycin
  3. Drug: Chloroquine Sulfate
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: 42 days
103 Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes

The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection

NCT04341935
Conditions
  1. Coronavirus Infection
  2. Type 2 Diabetes
Interventions
  1. Drug: Linagliptin
  2. Drug: Insulin regimen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus, Type 2
HPO:Type II diabetes mellitus

Primary Outcomes

Description: Change in glucose control will be assessed via glucose levels obtained from blood serum samples

Measure: Changes in Glucose Llevels

Time: Baseline, up to 2 weeks

Secondary Outcomes

Description: changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method

Measure: Changes in SpO2 levels

Time: Baseline, up to 2 weeks

Description: Changes in IL 6 will be assessed from blood serum samples

Measure: Changes in Interleukin 6 (IL6)

Time: Baseline, up to 2 weeks

Description: Changes in Chest radiography (X-ray)

Measure: Changes in chest structures

Time: Baseline, up to 2 weeks
104 Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)

The Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed cases, there is still no effective way to contain the disease. The transmission of COVID-19 occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of confirmed cases is about 4%. These at-risk individuals are identified through contact tracing and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has yet to be a single effective, safe, and affordable pharmacological agent with such capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the invasion and intracellular replication of the virus. Existing studies have reported efficacy of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of patients suffering from significant side effects. However, existing studies are largely limited by their small sample sizes. Furthermore, there has yet to be a published trial on HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP (treatment group) and no treatment (control group). Subjects will be followed up over a course of 28 days, with daily symptom monitoring conducted over phone calls. Positive outcomes from this study will provide a means for us to battle the COVID-19 pandemic.

NCT04342156
Conditions
  1. Coronavirus Infection
  2. Hydroxychloroquine Adverse Reaction
Interventions
  1. Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: COVID-19 infection

Measure: positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.

Time: Until day 28

Secondary Outcomes

Description: Serology

Measure: Positive serology at day 28.

Time: 28 days

Description: COVID-19

Measure: Symptoms of COVID-19.

Time: Until day 28
105 Hydroxychloroquine for Outpatients With Confirmed COVID-19

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

NCT04342169
Conditions
  1. Coronavirus Infection
  2. Coronavirus
  3. Infectious Disease
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Duration of viral shedding

Time: Days 1-14

Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: Everyday through 6 months

Measure: Hospitalization

Time: within 14 days of enrollment

Measure: Duration of viral shedding

Time: Days 1-14 and Day 28

Measure: Adult household contact viral acquisition

Time: Days 1-14 and Day 28
106 Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19

Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.

NCT04342195
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Corona Virus Infection
Interventions
  1. Procedure: Blood draw
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.

Measure: Number of antibodies against coronaviruses isolated and identified from patient samples

Time: Up to 12 months after collection visit
107 Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial

This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).

NCT04342650
Conditions
  1. COVID-19
  2. SARS-CoV Infection
  3. Severe Acute Respiratory Syndrome (SARS) Pneumonia
  4. Clinical Trial
Interventions
  1. Drug: Chloroquine Diphosphate
  2. Drug: Placebo oral tablet
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome
HPO:Pneumonia

Primary Outcomes

Description: Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.

Measure: Proportion of patients with onset of severe acute respiratory syndrome (SARS)

Time: 7 days after randomization

Secondary Outcomes

Description: Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization

Measure: Mortality rate

Time: after randomization, up to 28 days

Description: Proportion of participants in need and duration of intensive care support after randomization

Measure: Number of participants in need of intensive care support

Time: during and after intervention, up to 28 days

Description: Viral load change in blood and oropharyngeal swab samples

Measure: Viral concentration

Time: After randomization, up to 7 days

Description: Incidence of serious adverse events during and after treatment

Measure: Cumulative incidence of serious adverse events

Time: During and after intervention, up to 28 days

Description: Incidence of grade 3 and 4 adverse events during and after treatment

Measure: Cumulative incidence of grade 3 and 4 adverse events

Time: During and after intervention, up to 28 days

Description: proportion of discontinuation or temporary suspension of treatment (for any reason)

Measure: Proportion of patients with discontinued treatment

Time: after randomization, up to 28 days

Description: proportion of patients with increased levels of troponin I

Measure: Incidence of cardiac lesions

Time: after randomization, up to 120 days

Description: proportion and magnitude of QTcF interval increases higher than 500ms

Measure: Incidence of cardiac disfunctions

Time: after randomization, up to 120 days

Description: Changes measured on day 120 will be compared to baseline, through spirometry.

Measure: Change in respiratory capacity

Time: Day 120 after randomization
108 Coronavirus Disease 2019- Using Ascorbic Acid and Zinc Supplementation (COVIDAtoZ) Research Study A Randomized, Open Label Single Center Study

The purpose of this study is to examine the impact of ascorbic acid (vitamin c) and zinc gluconate in reducing duration of symptoms in patients diagnosed with coronavirus disease 2019 (COVID-19). Patients above the age of 18 who present to the Cleveland Clinic outpatient testing and receive a positive test for COVID-19 will be invited to participate.

NCT04342728
Conditions
  1. COVID
  2. Corona Virus Infection
Interventions
  1. Dietary Supplement: Ascorbic Acid
  2. Dietary Supplement: Zinc Gluconate
  3. Dietary Supplement: Ascorbic Acid and Zinc Gluconate
  4. Other: Standard of Care
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days to reach a 50 percent reduction in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Assessed symptoms are Fever, Cough, Shortness of Breath, Fatigue, Muscle or body aches, Headache, New loss of taste, New loss of smell, Congestion or runny nose, Nausea, Vomiting, Diarrhea. Each patient will have a composite score ranging from 0-36/day

Measure: Symptom Reduction

Time: 28 days

Secondary Outcomes

Description: The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102.6

Measure: Symptom Resolution: Fever

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe

Measure: Symptom Resolution: Cough

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities

Measure: Symptom Resolution: Shortness of Breath

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale: 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.

Measure: Symptom Resolution: Fatigue

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of muscle/body aches based on a 0-3 scale: 1=mild muscle/body aches, 2=moderate muscle/body aches , 3=severe muscle/body aches.

Measure: Symptom Resolution: Muscle/body aches

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale: 1=mild headache, 2=moderate headache, 3=severe headache.

Measure: Symptom Resolution: Headache

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a 0-3 scale: 1=mild loss of taste, 2=moderate loss of taste, 3=severe loss of taste.

Measure: Symptom Resolution: New loss of taste

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a 0-3 scale: 1=mild loss of smell, 2=moderate loss of smell, 3=severe loss of smell.

Measure: Symptom Resolution: New loss of smell

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of congestion/runny nose on a 0-3 scale: 1=mild congestion/runny nose , 2=moderate congestion/runny nose , 3=severe congestion/runny nose .

Measure: Symptom Resolution: Congestion/ runny nose

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale: 1=mild nausea, 2=moderate nausea, 3=severe nausea.

Measure: Symptom Resolution: Nausea

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale: 1=mild vomiting, 2=moderate vomiting, 3=severe vomiting.

Measure: Symptom Resolution: Vomiting

Time: 28 days

Description: The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale: 1=mild diarrhea, 2=moderate diarrhea, 3=severe diarrhea.

Measure: Symptom Resolution: Diarrhea

Time: 28 days

Description: Total symptom composite score at day 5 of study supplementation: Symptom categories of fever based on a 0-3 scale: 0 = ≤98.6, 1 = >98.6- 100.6, 2 = > 100.6 - 102.6, 3 = >102; Cough on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe; Shortness of Breath on a 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = with walking on flat surface 3 = short of breath with getting dressed or daily activities; and Fatigue on a 0-3 scale: 0 = No fatigue/energetic, 1=mild fatigue, 2=moderate fatigue, 3=severe fatigue.

Measure: Day 5 Symptoms

Time: 5 days

Description: Differences in hospitalization events between the study arms

Measure: Hospitalizations

Time: 28 days

Description: Differences in severity of symptoms between study arms

Measure: Severity of Symptoms

Time: 28 days

Description: Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms

Measure: Adjunctive Medications

Time: 28 days

Description: Differences in number of patients in study arms who experienced side effects from the supplements.

Measure: Supplementation Side Effects

Time: 28 days
109 Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients With SARS-Cov-2 Infection

The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes

NCT04343053
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Other: SARS-Cov-2 infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

Measure: on-treatment platelet reactivity

Time: early stage of disease (first 96 hours)

Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

Measure: on-treatment platelet reactivity

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

Measure: on-treatment platelet reactivity

Time: late stage of disease (>14 days)

Secondary Outcomes

Description: patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.

Measure: apoptosis rate in human umbilical vein endothelial cells (HUVEC)

Time: early stage of disease (first 96 hours)

Description: patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.

Measure: apoptosis rate in human umbilical vein endothelial cells (HUVEC)

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

Measure: Nitric oxide (NO) intracellular levels

Time: late stage of disease (>14 days)

Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

Measure: Nitric oxide (NO) intracellular levels

Time: early stage of disease (first 96 hours)

Description: patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

Measure: Nitric oxide (NO) intracellular levels

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of ROS

Measure: reactive oxygen species (ROS) levels

Time: early stage of disease (first 96 hours)

Description: patterns and changes of ROS

Measure: reactive oxygen species (ROS) levels

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of ROS

Measure: reactive oxygen species (ROS) levels

Time: late stage of disease (>14 days)

Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

Measure: coagulation factors levels

Time: early stage of disease (first 96 hours)

Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

Measure: coagulation factors levels

Time: mid stage of disease (96 hours - 14 days)

Description: patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

Measure: coagulation factors levels

Time: late stage of disease (>14 days)

Description: values of FEV1% as assessed by spirometry

Measure: respiratory function

Time: 6-month

Description: values of FEV1% as assessed by spirometry

Measure: respiratory function

Time: 12-month

Description: values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

Measure: cardiac function

Time: 6-month

Description: values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

Measure: cardiac function

Time: 12-month

Description: occurrence of death, myocardial infarction, stroke and other major adverse events

Measure: clinical outcome

Time: 12-month
110 Convalescent Plasma in the Treatment of COVID 19

The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

NCT04343261
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus
  2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  3. COVID
  4. Coronavirus
Interventions
  1. Biological: Convalescent Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Mortality within 28 days

Measure: Mortality

Time: Up to 28 days

Description: Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).

Measure: Viral Load

Time: Day 0, Day 3, Day 5, and Day 7

Description: Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)

Measure: Serum Antibody Titers

Time: Day 0, Day 3, Day 5, and Day 7
111 Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial.

This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).

NCT04343729
Conditions
  1. SARS-CoV Infection
  2. Severe Acute Respiratory Syndrome (SARS) Pneumonia
Interventions
  1. Drug: Methylprednisolone Sodium Succinate
  2. Drug: Placebo solution
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome
HPO:Pneumonia

Primary Outcomes

Description: Mortality rate on day 28, after randomization

Measure: Mortality rate at day 28

Time: on day 28, after randomization

Secondary Outcomes

Description: Proportion of patient that died on days 7, 14 and 28.

Measure: Mortality rate on days 7, 14 and 28

Time: after randomization, up to 28 days.

Description: proportion of patients requiring orotracheal intubation

Measure: Incidence of orotracheal intubation

Time: after randomization, up to 7 days.

Description: Proportion of patients with oxygenation index (PaO2 / FiO2) < 100 in 7 days.

Measure: Change in oxygenation index

Time: after randomization, up to 7 days.
112 Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

NCT04343898
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: No intervention
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: 28-Day Mortality

Time: 28-days from the day of ICU admission

Secondary Outcomes

Measure: 60-Day Mortality

Time: 60-days from the day of ICU admission

Measure: 90-Day Mortality

Time: 90-days from the day of ICU admission
113 Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study (ProCov)

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

NCT04344106
Conditions
  1. Coronavirus Infection
  2. Oxygen Deficiency
Interventions
  1. Procedure: Prone positioning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients.

Measure: Proportion of "responder" patients to prone position

Time: 1 hour

Secondary Outcomes

Description: PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position.

Measure: proportion of "persistent responders" patients after prone position

Time: 1 day

Description: PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position.

Measure: Evolution of PaO2

Time: 1 day

Description: Look for an association between the time spent in Prone positione and persistent responder or not;

Measure: Duration of prone positioning and PaO2 evolution

Time: 2 days

Description: proportion of patients improving their arterial saturation within 1 hour of Prone Position

Measure: Evolution of Spo2

Time: 1 hour

Description: evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position

Measure: EVA Dyspnea

Time: 1 day

Description: proportion of patients intolerant to prone position (Prone Position <1h);

Measure: Intolerance to prone positioning

Time: 1 day

Description: proportion of patients who can maintain prone position for more than 3 h.

Measure: Tolerance to prone positioning

Time: 1 day
114 Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

NCT04345289
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Viral Pneumonia
Interventions
  1. Biological: Convalescent anti-SARS-CoV-2 plasma
  2. Other: Infusion placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Composite outcome

Measure: All-cause mortality or need of invasive mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Number of participants with adverse events with possible relation to study drug

Measure: Frequency of adverse events

Time: 90 days

Description: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines

Measure: Frequency of severe adverse events

Time: 90 days

Description: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities

Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status

Time: 90 days

Description: Number of days without mechanical ventilation

Measure: Ventilator-free days

Time: 28 days

Description: Number of days without organ-failure

Measure: Organ failure-free days

Time: 28 days

Description: Number of days in ICU

Measure: Duration of ICU stay

Time: 90 days

Description: Number of deaths by any cause

Measure: Mortality rate

Time: 7, 14, 21, 28 and 90 days

Description: Days from the date of hospital admission for COVID-19 to the date of discharge

Measure: Length of hospital stay

Time: 90 days

Description: Days requiring supplement oxygen

Measure: Duration of supplemental oxygen

Time: 90 days
115 Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia

Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.

NCT04345861
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
Interventions
  1. Drug: Hydroxychloroquine + placebo
  2. Drug: hydroxychloroquine + azithromycin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)

Measure: Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).

Time: up to Day 11

Secondary Outcomes

Description: Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29

Measure: Clinical status assessed by ordinal scale

Time: up to Day 29

Description: Necessity for transfer to Intensive care unit

Measure: transfer to ICU

Time: up to Day 29

Description: days from admission to hospital discharge

Measure: Length of hospital day

Time: up to Day 29

Description: incidence of all-cause mortality

Measure: Hospital Mortality

Time: Day 29

Description: Need to mechanical ventilation

Measure: Need to Mechanical Ventilation

Time: up to Day 29

Description: adverse reactions

Measure: Occurence of grade 3-4 adverse event

Time: up to Day 29

Description: ECG

Measure: QTc Lengthening

Time: up to Day 11

Description: Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework

Measure: Evolution of pulmonary CT scan images

Time: up to Day 11
116 A Pilot Study to Explore the Efficacy and Safety of Rescue Theraphy With Antibodies From Convalescent Patients Obtained With Double -Filtration Plasmapheresis (DFPP) and Infused in Critically Ill Ventilated Patients With Coronavirus Disease 2019 (COVID-19)

The 2019 outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID 19), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite any attempted treatment.. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. The use of solutions enriched of antiviral antibodies has several important advantages over the convalescent plasma including the high level of neutralizing antibodies supplied. Plasma-exchange is expensive and requires large volumes of substitution fluid. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. With either albumin or fresh frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia. The aforementioned limitations of plasma therapy can be overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP).DFPP is a modality of plasma purification that performs an initial plasma separation from blood, and the subsequent separation of specific molecules, on the basis of their specific molecular weight (cut-off), by using a fractionation filter. The Fractionation Filter 2A20, because of its membrane sieving cut-off, retains larger molecules and returns plasma along with smaller molecules to the circulation, including the major part of the albumin. The selection of the membrane 2A20 is related to the appropriate Sieving Coefficient for IgG that allows to efficiently collect antibodies from patients which are recovered from COVID-19, with negligible fluid losses and limited removal of albumin. The total amount of antibodies obtained during one DFPP session exceeds by three to four times the total amount provided to recipients with one unit of plasma obtained during one plasma-exchange session from one COVID-19 convalescent donor. This should result in more effective viral inhibition and larger benefit for the patient achieved with one unit of enriched immunoglobulin solution obtained with DFPP than with one unit of plasma obtained with plasma exchange. These observations provide the background for a pilot study aimed to explore whether the infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent donors could offer an effective and safe therapeutic option for critically ill patients with severe coronavirus (COVID-19) pneumonia requiring mechanical ventilation.

NCT04346589
Conditions
  1. Pneumonia, Ventilator-Associated
  2. Coronavirus Infection
Interventions
  1. Biological: Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients
MeSH:Pneumonia, Ventilator-Associated Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Number of mechanical ventilation days.

Time: Through study completion, an average of 6 months.

Secondary Outcomes

Measure: Survival

Time: Through study completion, an average of 6 months.

Measure: Shift to Continuous Positive Airway Pressure (CPAP) ventilation

Time: Through study completion, an average of 6 months.

Measure: Referral to a sub-intensive care unit or discharge

Time: Through study completion, an average of 6 months.

Measure: Viral titer

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.

Measure: Anti COVID 19 IgG antibodies

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.

Measure: Anti COVID 19 IgM antibodies

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.

Description: Marker of complement activation in plasma.

Measure: C5a concentration

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.

Description: Marker of complement activation in plasma.

Measure: C3a concentration

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.

Description: Marker of complement activation in plasma.

Measure: Serum C5b-9 concentration

Time: Changes from before Ig administration, one day and one week after Ig administration and every week after discharge from the intensive care unit through study completion, an average of 6 months.
117 Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate

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

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

Primary Outcomes

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

Measure: RT-PCR negative status

Time: 6-7 days

Secondary Outcomes

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

Measure: Progression of symptoms

Time: 7 days

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

Measure: Development of Symptoms

Time: 7 days

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

Measure: Adverse events

Time: 7 days
118 The Role of Honey and Nigella Sativa in the Management of COVID-19; A Randomized Controlled, Open-label, Add-on Trial in Pakistan

To evaluate the effectiveness of Nigella Sativa and honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).

NCT04347382
Conditions
  1. Coronavirus Infection
  2. Sars-CoV2
Interventions
  1. Drug: Honey
  2. Drug: Nigella Sativa / Black Cumin
  3. Drug: Placebos
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Days required to get a positive COVID-19 PCR to negative

Time: upto max 14 days

Description: Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.

Measure: Severity of symptoms progression

Time: upto max 14 days

Description: Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.

Measure: Duration of Hospital Saty

Time: upto max 14 day

Description: 30 days mortality rate in each arm

Measure: 30 day mortality

Time: 30 days

Description: grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death).

Measure: Clinical Grade Status

Time: 0, 4, 6, 8, 10 and 12 day

Description: Degree of fever

Measure: Fever

Time: 13 days

Secondary Outcomes

Measure: Oxygen Saturation at room air

Time: upto max of 14 days
119 Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study

It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.

NCT04347408
Conditions
  1. COVID
  2. Corona Virus Infection
Interventions
  1. Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Immunoglobulins (G and M) to SARS-Cov2 in plasma

Time: 6 months
120 Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

NCT04348370
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Coronavirus as the Cause of Diseases Classified Elsewhere
Interventions
  1. Biological: BCG Vaccine
  2. Biological: Placebo Vaccine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period

Measure: Incidence of COVID 19 Infection

Time: 6 months

Secondary Outcomes

Description: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.

Measure: Disease Severity

Time: up to 6 months
121 Randomized Phase II Clinical Trial of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19.Ruxo-Sim-20 Clinical Trial.

COVID-19's mechanism to enter the cell is initiated by its interaction with its cellular receptor, the angiotensin-converting enzyme. As a result of this union, a clathrin-mediated endocytosis process begins. This route is one of the therapeutic targets for which available drugs are being investigated in order to treat COVID-19 infection. This is one of the mechanisms blocked by drugs like ruxolitinib and chloroquine. Various drugs approved for clinical use that block the clathrin-mediated endocytosis pathway have been explored. It has been found that the best in vitro and in vivo results were obtained with statins, which also allowed generating a greater potent adaptive immune response. Therefore, statins and specifically simvastatin make it possible to block the entry process used by COVID-19, block inflammation by various mechanisms and increase the adaptive immune response. All of these processes are desirable in patients infected with COVID-19. Statins have been proposed to have beneficial effects in patients infected with MERS-COV, another coronavirus similar to COVID-19, but there have been no randomized studies supporting the use of statins in patients with COVID-19 infection. In this project we propose the combined use of one of these drugs, ruxolitinib with simvastatin, looking for a synergistic effect in the inhibition of viral entry and in the anti-inflammatory effect.

NCT04348695
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Ruxolitinib plus simvastatin
  2. Other: Standard of Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 7 from randomization.

Measure: Percentage of patients who develop severe respiratory failure.

Time: 7 days

Secondary Outcomes

Description: Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID at day 14 from randomization.

Measure: Percentage of patients who develop severe respiratory failure.

Time: 14 days

Description: Time from ICU admision to ICU discharge.

Measure: Length of ICU stay.

Time: 28 days

Description: Time from hospital admision to hospital discharge.

Measure: Length of hospital stay

Time: 28 days

Description: Percentage of patients alive at 6 months

Measure: Survival rate at 6 months

Time: 6 months

Description: Percentage of patients alive at 12 months

Measure: Survival rate at 12 months

Time: 12 months

Description: Percentage of patients who died from any cause 28 days after inclusion in the study

Measure: Survival rate at 28 days

Time: 28 days

Description: Percentage of patients with each AE by grade in relation with total number of treated patients

Measure: Percentage of patients with each AE by grade

Time: 28 days

Description: Percentage of patients who discontinued due to AEs in relation with total number of treated patients

Measure: Percentage of patients who discontinued due to AEs

Time: 28 days
122 A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo.

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

Primary Outcomes

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

Time: Baseline to Day 14

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI)

Time: Up to Day 28

Measure: Overall Death Rate

Time: Day 14, Day 28

Measure: Rate of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Mechanical Ventilation

Time: Up to Day 28

Measure: Overall Survival

Time: Up to Day 28

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

Time: Baseline, Day 28

Measure: Time to Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Rate of Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Length of Stay in Hospital

Time: Up to Day 28

Measure: Percentage of Participants Discharged from Hospital

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Duration of Oxygen Supplementation

Time: Up to Day 28

Measure: Duration of Mechanical Ventilation

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Change in Oxygenation Index

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Change from Baseline in Ferritin Levels

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Changes from Baseline in Blood Plasma Cytokines Levels

Time: Up to Day 28

Measure: Number of Participants with Adverse Events (AE)

Time: From start of study drug administration up to Day 28
123 Beaumont Health Large-scale Automated Serologic Testing for COVID-19

The purpose of this study is to determine how peoples' bodies respond to exposure to COVID-19. Employees of Beaumont Health in Michigan who are older than 18 years may be eligible to participate. Participants from other high-risk groups who are not Beaumont employees may also be recruited, as may family members of Beaumont employees who have tested positive for COVID-19. Participants will have blood drawn two or more times for serology testing. This serology test will determine if participants have detectable levels of the antibodies that our bodies develop to fight COVID-19 infection. Participants will fill out a questionnaire each time they provide a blood sample. The questionnaires include questions about participants' personal traits; their health; general questions about their risk to exposure; job and risk of exposure; symptoms, diagnosis, treatment of COVID-19 since last blood draw. Researchers will monitor participants' medical records in a confidential manner for one year after the last blood draw to help determine if people who develop antibodies to COVID-19 are protected against developing a COVID-19 infection in the future.There may be no direct benefits for participants; however, information from this study may benefit other people by increasing our understanding of COVID-19, how it spreads from person to person, and how people respond to fight off the infection.The results of the serology test are used for research only and will not affect clinical decisions regarding participants' treatment or quarantine

NCT04349202
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Diagnostic Test: EUROIMMUN assay
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants testing positive for the presence of IgG or IgA antibodies to SARS-CoV-2 using the EUROIMMUN Serology testing platform. Serology testing of Beaumont Health employees will allow an estimation of asymptomatic carriage and help determine level of nosocomial spread of COVID-19 within our institution among its employees. All participants will provide a minimum of 2 blood draws between 2 and 4 weeks apart to determine the presence of antibodies to COVID-19. Participants at medium risk for exposure in their job function at Beaumont will have 3 draws 2-4 weeks apart and people considered the highest risk, those who provide the direct patient care to COVID-19 patients, will be tested 2-4 weeks apart until the pandemic in Michigan is under control (estimated to be 8 blood draws).

Measure: Prevalence COVID antibodies in employees of Beaumont Health

Time: 1 year

Secondary Outcomes

Description: Number of participants with positive detection of anti-SARS-CoV-2 antibodies using the EUROIMMUN Serology testing platform, who later develop a COVID-19 infection as documented in Beaumont Health electronic medical records

Measure: COVID-19 re-infection in participants positive for antibodies to SARS-CoV-2

Time: 1 year

Description: Number of participants with positive SARS-CoV-2 serum IgG antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test positive for anti-SARS-CoV-2 IgG antibodies using dried blood spot samples

Measure: Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgG antibodies

Time: 1 yr

Description: Number of participants with negative SARS-CoV-2 serum IgG antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test negative for anti-SARS-CoV-2 IgG antibodies using dried blood spot samples

Measure: Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgG antibodies

Time: 1 yr

Description: Number of participants with positive SARS-CoV-2 serum IgA antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test positive for anti-SARS-CoV-2 IgA antibodies using dried blood spot samples

Measure: Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgA antibodies

Time: 1 yr

Description: Number of participants with negative SARS-CoV-2 serum IgA antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test negative for anti-SARS-CoV-2 IgA antibodies using dried blood spot samples

Measure: Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgA antibodies

Time: 1 yr

Description: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from separate blood spot samples collected on the same day

Measure: Reproducibility of SARS-CoV-2 IgG antibody detection from dried blood spots

Time: 1 yr

Description: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from blood spots collected on the same day but tested after 7 to 28 days of storage

Measure: Stability of dried blood spots for SARS-CoV-2 IgG antibody detection

Time: 1 year

Description: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from dried blood spot samples processed at Beaumont Health and those shipped to EUROIMMUN (Lubeck, Germany) for testing

Measure: Effect of shipping on dried blood spot samples for SARS-CoV-2 IgG antibody detection

Time: 1 yr

Description: Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from dried blood spot samples collected by a phlebotomist and those self-collected by the participant using an instructional information sheet

Measure: Accuracy of participant-performed blood spot collection for SARS-CoV-2 IgG antibody detection

Time: 1 yr

Description: Ease of following an instructional information sheet to self-collect blood spots will be rated by the participant on a 10 point scale where 1 indicates complete comfort and understanding the collection procedure and 10= extreme difficulty with understand the information sheet and collecting blood spots

Measure: Ease of participant-performed blood spot collection

Time: 1 yr

Description: Number of immediate family member participants testing positive for SARS-CoV-2 IgG antibodies using the EUROIMMUN Serology testing platform following a SARS-CoV-2 IgG antibody positive assay in a Beaumont Health employee participant

Measure: Correlation of SARS-CoV-2 antibodies between immediate family members

Time: 1 yr
124 Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial

The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.

NCT04350723
Conditions
  1. Corona Virus Infection
  2. Covid19
Interventions
  1. Procedure: Awake Proning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.

Measure: Endotracheal intubation

Time: within 30 days of randomization

Secondary Outcomes

Description: Death

Measure: Mortality

Time: 60 days

Description: Number of days not receiving mechanical ventilation

Measure: Invasive mechanical ventilation free days

Time: 30 Days

Description: Number of days not receiving non-invasive mechanical ventilation

Measure: Non-invasive ventilation free days

Time: 30 days

Description: Number of days admitted to ICU

Measure: ICU length of stay

Time: 30 Days

Description: Number of days admitted to the hospital

Measure: Hospital length of stay

Time: 30 days

Description: defined as the difference in SpO2: FiO2 ratio. The difference in SpO2: FiO2 ratio.

Measure: Change in oxygenation

Time: 30 days

Description: Includes any of the following: accidental removal of intravenous access, vomiting, falls from bed, pressure injuries, or cardiac arrest.

Measure: Complications from proning,

Time: 30 days
125 Registry for Clinical Presentation and Management of Patients With COVID-19 in the Emergency Room

Patients with COVID-19 usually present in the ED and receive their initial medical check-up here. We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED. The course of the disease prior to admission as well as the momentary health status at presentation to the ED are of interest because they influence risk stratification and decision-making of treating physicians. The ratio of patients with mild or moderate to severe symptoms will help to calculate the need for hospital beds including beds on Intensive Care Units (ICU) and Intermediate Care Units (IMC), as well as the need for other hospital resources.

NCT04351854
Conditions
  1. Corona Virus Infection
  2. SARS-CoV 2
Interventions
  1. Other: Retrospective data collection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Emergencies

Primary Outcomes

Description: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

Measure: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

Time: 6 months

Secondary Outcomes

Description: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

Measure: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

Time: 6 months

Description: Identification of the ratio of patients with mild or moderate to severe disease

Measure: Identification of the ratio of patients with mild or moderate to severe disease

Time: 6 months
126 Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock

NCT04352985
Conditions
  1. Septic Shock
  2. Endoto
  3. Endotoxemia
  4. COVID
  5. Corona Virus Infection
  6. Sepsis, Severe
Interventions
  1. Device: Toraymyxin PMX-20R (PMX Cartridge)
MeSH:Shock, Septic Endotoxemia Sepsis Coronavirus Infections Severe Acute Respiratory Syndrome Shock
HPO:Sepsis

127 PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) An Open Label Multi-arm Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19

The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.

NCT04353037
Conditions
  1. Coronavirus
  2. Corona Virus Infection
Interventions
  1. Drug: Group A HCQ
  2. Drug: Group B Control
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of hospitalization

Measure: Sub Study 1: Patients

Time: 21 days

Description: Rate of COVID-19 infection (confirmed by accepted testing methods) at 2 months

Measure: Sub Study 2: Health Care Workers

Time: 2 months

Secondary Outcomes

Description: any house hold member who has reported symptoms or test positive for COVID 19 during their 14 day active participation

Measure: Sub Study 1: Patients: Rate of secondary infection of co-inhabitants

Time: 14 days after enrollment of the household

Description: Assessment of any medical events that occur during the 14 day active period that is felt to be related to receipt of HCQ

Measure: Sub Study 1: Patients: Adverse Events

Time: 14 day active period

Description: If a test comes back negative, participant would be notified as such and told to destroy their pills as they are withdrawn

Measure: Sub Study 1: Patients: Negative for COVID-19

Time: up to 5 days after enrolling

Description: Any work time missed because the participant experienced COVID-like symptoms during their active 2 month period

Measure: Sub Study 2:Health Care Workers:Number of shifts missed

Time: up to ~60 days after enrollment

Description: Assessment of any medical events that occur during the ~60 day active period that is felt to be related to receipt of HCQ

Measure: Sub Study 2:Health Care Workers:Rate of adverse events

Time: up to ~60 days after enrollment

Description: if the participant gets COVID and has severe symptoms and hospitalized, end point reached if before the end of the 2 month period

Measure: Sub Study 2:Health Care Workers:Rate of hospitalization

Time: up to ~60 days after enrollment
128 Multicenter Randomized Controlled Trial of the Efficacy of Melatonin in the Prophylaxis of SARS-coronavirus-2 Infection Among High Risk Contacts.

There is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.

NCT04353128
Conditions
  1. Covid19
  2. SARS-CoV 2
  3. Coronavirus Infection
Interventions
  1. Drug: Melatonin 2mg
  2. Drug: Placebo oral tablet
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of confirmed (positive CRP) symptomatic infections in each treatment group

Measure: SARS-CoV 2 infection rate

Time: up to 12 weeks
129 Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.

NCT04353245
Conditions
  1. COVID19
  2. Corona Virus Infection
  3. Myocardial Injury
  4. Pneumonia
Interventions
  1. Other: BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM
MeSH:Infection Communicable Diseases Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry

Measure: Fibrosis

Time: 12 months

Description: Decreased functional capacity on ergospirometers

Measure: Ergospirometers

Time: 12 monthes
130 A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics

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

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

Primary Outcomes

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

Measure: Percentage of virus free subjects

Time: 7 days after initiation of trial

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

Measure: Disease severity

Time: 6 days

Secondary Outcomes

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

Measure: Incidence of hospitalization

Time: 14 days

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

Measure: Incidence of Death

Time: 70 Days (10 weeks)

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

Measure: Incidence of confirmed SARS-CoV-2 Detection

Time: 14 days

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

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

Time: 14 days

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

Measure: Immunity to Covid-19

Time: 70 days (10 weeks)
131 Clinical Study Evaluating the Efficacy of Chloroquine or Hydroxychloroquine in COVID-19 Treatment

Chloroquine or hydroxychloroquine in COVID-19 treatment

NCT04353336
Conditions
  1. COVID-19
  2. Coronavirus Infection
Interventions
  1. Drug: Chloroquine or Hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: the number of patients with cure or death

Measure: Number of patients with cure or death

Time: 1 month
132 Whole-Genome Sequencing Analysis of COVID-19 Positive Patients

We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.

NCT04353401
Conditions
  1. Coronavirus Infection
  2. COVID-19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical associations with human and viral genetics

Measure: Associations with severity and outcomes

Time: next 6 months
133 Renal Outcome in Patients With Coronavirus Disease 2019 (COVID-19)

Acute kidney injury (AKI) is reported to occur in 0.5-9% of severe acute respiratory distress coronavirus 2-positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of renal outcome of in-hospital patients diagnosed with COVID-19.

NCT04353583
Conditions
  1. Acute Kidney Injury
  2. Corona Virus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury
HPO:Acute kidney injury

Primary Outcomes

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

Measure: Incidence of chronic kidney disease

Time: 6 months post-hospital admission

Secondary Outcomes

Description: Serial biomarker assessment

Measure: Renal function changes during hospital stay

Time: from hospital admission til discharge up to 3 months

Description: As determined by KDIGO criteria

Measure: Incidence of AKI

Time: Within 7 days after admission
134 Antikörperseroprävalenz Und Hintergrundinfektionsrate Von SARS-CoV-2 in Einem österreichischen Schlüsselkollektiv an Arbeitnehmer*Innen

Context: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.

NCT04354779
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. SARS-CoV 2
  3. Coronavirus Infection
  4. Covid19
Interventions
  1. Diagnostic Test: a specifically designed self-administered questionnaire
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.

Measure: Antibody status in HCW

Time: 4 months

Description: To determine how many are actively infected with or without showing symptoms.

Measure: Active virus carriers in HCW

Time: 4 months

Description: To determine how many employees are in their incubation period during study time.

Measure: Incubation time

Time: 4 months

Secondary Outcomes

Description: To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population.

Measure: Background incidence rate

Time: 4 months

Description: To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees.

Measure: Occupation associated infection risk

Time: 4 months
135 Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study

Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.

NCT04355429
Conditions
  1. Pneumonia
  2. Coronavirus Infection
  3. COVID-19
Interventions
  1. Drug: captopril 25mg
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To assess determine the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival

Measure: Efficacy of captopril nebulization addition to standard of care compared to standard of care.

Time: 14 Days
136 Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.

NCT04355637
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Inhaled budesonide
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) at day 15 after initiation of therapeutic intervention

Measure: Proportion of patients in both arms fulfilling the criteria for treatment failure

Time: 15 days after treatment

Secondary Outcomes

Description: Yes/no

Measure: ICU admission

Time: baseline, day 3, day 7, day 15, day 30

Description: yes/no and reason

Measure: ICU refusal

Time: baseline, day3, day 7, day 15, day 30

Description: infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.

Measure: Occurrence of complications

Time: baseline, day3, day 7, day 15, day 30

Description: U/L

Measure: lactate dehydrogenase (LDH)

Time: at baseline, day 3, day 7, day 15, day 30

Description: mg/dL

Measure: C Reactive Protein (CRP)

Time: at baseline, day 3, day 7, day 15, day 30

Description: ng/mL

Measure: ferritin

Time: at baseline, day 3, day 7, day 15, day 30

Description: ng/mL

Measure: D-dimer

Time: at baseline, day 3, day 7, day 15, day 30

Description: x10^9/L

Measure: leukocyte counts

Time: at baseline, day 3, day 7, day 15, day 30
137 A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Patients With Moderate or Severe COVID-19

The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19.

NCT04355676
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Selinexor
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

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

Time: Baseline to Day 14

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI)

Time: Up to Day 28

Measure: Overall Death Rate

Time: Day 14, Day 28

Measure: Rate of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Mechanical Ventilation

Time: Up to Day 28

Measure: Overall Survival

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Time to Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Rate of Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Length of Stay in Hospital

Time: Up to Day 28

Measure: Percentage of Participants Discharged From Hospital

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Duration of Oxygen Supplementation

Time: Up to Day 28

Measure: Duration of Mechanical Ventilation

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Change in Oxygenation Index

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Change from Baseline in Ferritin Levels

Time: Up to Day 28

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

Time: Up to Day 28

Measure: Number of Participants with Adverse Events (AE)

Time: From start of study drug administration up to follow-up (Day 30)
138 Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)

The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).

NCT04355728
Conditions
  1. Corona Virus Infection
  2. ARDS
  3. ARDS, Human
  4. Acute Respiratory Distress Syndrome
  5. COVID-19
Interventions
  1. Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.
  2. Other: Vehicle + Heparin along with best supportive care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Safety will be defined by the incidence of pre-specified infusion associated adverse events as assessed by treating physician

Measure: Incidence of pre-specified infusion associated adverse events

Time: Day 5

Description: Safety will be defined by the incidence of severe adverse events as assessed by treating physician

Measure: Incidence of Severe Adverse Events

Time: 90 days

Secondary Outcomes

Description: Number of participants that are alive at 90 days post first infusion follow up.

Measure: Survival rate after 90 days post first infusion

Time: 90 days

Description: Number of days participants were off ventilators within up to 28 days of hospitalization

Measure: Ventilator-Free Days

Time: 28 days or hospital discharge, whichever is earlier

Description: Measure the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy).

Measure: Change in Oxygenation Index (OI)

Time: 28 days

Description: Measuring respiratory mechanics in ventilated patients [plateau pressure (Pplat)-positive end-expiratory pressure]

Measure: Plat-PEEP

Time: 28 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)

Measure: Sequential Organ Failure Assessment (SOFA) Scores

Time: 28 days

Description: The SIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The test has a total score ranging from 0-40 Follows scoring key for evaluation. The higher score indicates better outcome.

Measure: Small Identification Test (SIT) scores

Time: At baseline, day 18 and day 28.

Description: As assessed via serum blood samples.

Measure: Troponin I levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: C-Reactive Protein levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Arachidonic Acid (AA)/Eicosapentaenoic Acid (EPA) Ratio

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: D-dimer levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: 25-Hydroxy Vitamin D levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Alloantibodies levels

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Blood white cell count

Time: Baseline, 28 days

Description: As assessed via serum blood samples.

Measure: Platelets count

Time: Baseline, 28 days
139 Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France)

In adults with COVID-19 without criteria for hospitalization or oxygen therapy but with risk factors for aggravation, early treatment may avoid hospitalization, indication for oxygen therapy or death. No treatment is currently validated for this indication.

NCT04356495
Conditions
  1. Corona Virus Infection
  2. Sars-CoV2
Interventions
  1. Dietary Supplement: Vitamins
  2. Drug: Telmisartan
  3. Drug: Ciclesonide
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event

Time: From inclusion (day0) to day 14

Description: Proportion of participants with an occurrence of death

Measure: Efficacy phase: Death

Time: From inclusion (day0) to day 14

Description: Proportion of participants who had an indication for oxygen therapy

Measure: Efficacy phase: oxygen therapy

Time: From inclusion (day0) to day 14

Description: Proportion of participants who had an indication for hospitalization

Measure: Efficacy phase: hospitalization

Time: From inclusion (day0) to day 14

Secondary Outcomes

Measure: Proportion of hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Description: Proportion of deaths, overall and by cause, in each group

Measure: Death and causes of death

Time: From inclusion (day0) to day 28

Measure: Proportion of intensive care hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Measure: Proportion of participants with negative SARS-CoV-2 RT-PCR

Time: day 7

Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

Measure: Haematological markers evolution

Time: from inclusion (day 0) to day 7

Description: Evolution of Inflammatory markers in each group : PCT, CRP

Measure: Inflammatory markers evolution

Time: from inclusion (day 0) to day 7

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse events

Time: from inclusion (day 0) to day 28

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse reactions

Time: from inclusion (day 0) to day 28

Description: Acceptability of the treatment by participant will be assessed with an interview

Measure: Acceptability of the treatment

Time: from inclusion (day 0) to day 10

Description: Proportion of participants who received at least one day of antibiotic therapy

Measure: Antibiotic consumption

Time: from inclusion (day 0) to day 28

Description: Proportion of participants who experienced a worsening of oxygen saturation

Measure: Oxygen saturation worsening

Time: from inclusion (day 0) to day 28

Description: Proportion of participants who completed the prescribed protocol treatment

Measure: protocol follow-up

Time: from inclusion (day 0) to day 10
140 COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

NCT04357106
Conditions
  1. COVID-19
Interventions
  1. Biological: Convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: PaO2/FiO2 relation

Measure: Lung injury

Time: 7 days

Description: Patients survival after therapy

Measure: Overall survival

Time: 15-30 days

Secondary Outcomes

Description: Determine the incidence of side effects from plasma administration

Measure: Adverse reactions to plasma

Time: 7 days
141 Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study

The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100. The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis. Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available. The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).

NCT04357327
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Corona Virus Infection
Interventions
  1. Diagnostic Test: rapid salivary test
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: TP/TP+FN (TP= True Positive; FN = False Negative)

Measure: Sensibility

Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.

Description: TN/TN+FP (TN= True Negative; FP= False Positive)

Measure: Specificity

Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.
142 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.

NCT04357366
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Corona Virus Infection
  4. Lower Respiratory Tract Infection Viral
Interventions
  1. Drug: Anakinra
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency
HPO:Respiratory tract infection

Primary Outcomes

Description: The primary study endpoint is the ratio of patients who will develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered achieving the primary endpoint.

Measure: The ratio of patients who will develop serious respiratory failure (SRF)

Time: Visit study day 14

Secondary Outcomes

Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment

Time: Visit study day 14

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of SOFA score in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of peripheral mononuclear blood cells' (PBMCs) functionality of enrolled subjects will be compared between days 1 and 7

Measure: Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7

Measure: Change of plasma inflammatory mediators levels between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Mortality on day 30

Measure: Rate of Mortality

Time: Visit study day 30

Description: Mortality on day 90

Measure: Rate of Mortality

Time: Visit study day 90

Description: Transcriptional, proteomic and metabolomic change will be compared between days 1 and 7

Measure: Change of gene expression between days 1 nad 7

Time: days 1 and 7
143 Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection: A Phase 2a Clinical Trial

The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of COVID-19 ARDS is projected to exceed the number of available ventilators. Reports from China and Italy indicate that 22-64% of critically ill COVID-19 patients with ARDS will die. ARDS currently has no evidence-based treatments other than low tidal ventilation to limit mechanical stress on the lung and prone positioning. A new therapeutic approach capable of rapidly treating and attenuating ARDS secondary to COVID-19 is urgently needed. The dominant pathologic feature of viral-induced ARDS is fibrin accumulation in the microvasculature and airspaces. Substantial preclinical work suggests antifibrinolytic therapy attenuates infection provoked ARDS. In 2001, a phase I trial 7 demonstrated the urokinase and streptokinase were effective in patients with terminal ARDS, markedly improving oxygen delivery and reducing an expected mortality in that specific patient cohort from 100% to 70%. A more contemporary approach to thrombolytic therapy is tissue plasminogen activator (tPA) due to its higher efficacy of clot lysis with comparable bleeding risk 8. We therefore propose a phase IIa clinical trial with two intravenous (IV) tPA treatment arms and a control arm to test the efficacy and safety of IV tPA in improving respiratory function and oxygenation, and consequently, successful extubation, duration of mechanical ventilation and survival.

NCT04357730
Conditions
  1. Severe Acute Respiratory Syndrome
  2. Respiratory Failure
  3. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: Alteplase 50 MG [Activase]
  2. Drug: Alteplase 50 MG [Activase]
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome

Primary Outcomes

Description: Ideally, the PaO2/FiO2 will be measured with the patient in the same prone/supine position as in baseline, as change in positions may artificially reduce the improvement attributable to the study drug. However, given the pragmatic nature of the trial, the prone/supine position will be determined by the attending physician, in which case, we will use as an outcome the PaO2/FiO2 closest to the 48 hours obtained prior to the change in position as the outcome.

Measure: PaO2/FiO2 improvement from pre-to-post intervention

Time: at 48 hours post randomization

Secondary Outcomes

Description: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2 (whatever is lower)

Measure: Achievement of PaO2/FiO2 ≥ 200 or 50% increase in PaO2/FiO2

Time: at 48 hours post randomization

Description: This score is based on seven clinical features (respiration rate, hypercapnic respiratory failure, any supplemental oxygen, temperature, systolic blood pressure, heart rate and level of consciousness) and determines the degree of illness of a patient and prompts critical care intervention.

Measure: National Early Warning Score 2 (NEWS2)

Time: at 48 hours post randomization

Description: The ordinal scale is an assessment of the clinical status as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. (combined items 7 and 8 as our study is limited to hospital).

Measure: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale

Time: at 48 hours post randomization

Description: 48 hour mortality for hospitalized patients

Measure: 48 hour in-hospital mortality

Time: at 48 hours post randomization

Description: 14 days mortality for hospitalized patients

Measure: 14 days in-hospital mortality

Time: 14 days post randomization

Description: 28 days mortality for hospitalized patients

Measure: 28 days in-hospital mortality

Time: 28 days post randomization

Description: ICU-free days will be calculated based on (28 - number of days spent in the ICU) formula

Measure: ICU-free days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: In-hospital coagulation-related events include bleeding, stroke, myocardial infarction and venous thromboembolism (VTE). In-hospital coagulation-related event-free (arterial and venous) days will be calculated based on (28 - number of days without coagulation-related event) formula.

Measure: In-hospital coagulation-related event-free (arterial and venous) days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: Ventilator-free days will be calculated based on (28 - number of days on mechanical ventilation) formula.

Measure: Ventilator-free days

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)

Description: Calculated for patients who was on a mechanical ventilation any period of time during hospitalization. The extubation will be considered successful if no re-intubation occurred for more than 3 days have passed after the initial extubation.

Measure: Successful extubation

Time: Day 4 after initial extubation

Description: Calculated for patients who was on paralytics at the time of randomization. The weaning will be considered successful if no paralytics were used for more than 3 days have passed after termination of paralytics.

Measure: Successful weaning from paralysis

Time: Day 4 after initial termination of paralytics

Description: Is counted for the patients who was alive at the time of discharge.

Measure: Survival to discharge

Time: 28 days of hospital stay or until hospital discharge (whichever comes first)
144 Administration of Intravenous Vitamin C in Novel Coronavirus Infection and Decreased Oxygenation (AVoCaDO): A Phase I/II Safety, Tolerability, and Efficacy Clinical Trial

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS. We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

NCT04357782
Conditions
  1. COVID-19
  2. Hypoxia
Interventions
  1. Drug: L-ascorbic acid
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Occurrence of adverse events during study drug infusion

Measure: Incidence of adverse events

Time: Days 1-4

Description: Occurrence of serious adverse events during study drug infusion

Measure: Incidence of serious adverse reactions

Time: Days 1-4

Description: Occurrence of adverse reactions during study drug infusion

Measure: Incidence of adverse reactions

Time: Days 1-4

Secondary Outcomes

Description: Documented days free off mechanical ventilation the first 28 days post enrollment

Measure: Ventilator-free days

Time: Days 1-28

Description: Documented days free of ICU admission the first 28 days post enrollment

Measure: ICU-free days

Time: Days 1-28

Description: Documented days free of hospital admission the first 28 days post enrollment

Measure: Hospital-free days

Time: Days 1-28

Description: Incidence of mortality at 28 days by all causes

Measure: All-cause mortality

Time: Days 1-28

Description: SpO2 (% peripheral oxygenation saturation) will be divided by fraction of inspired oxygen (FiO2) at start of study infusion and compared with S/F ratio at end of study infusion

Measure: Change in S/F ratio during HDIVC infusion

Time: Days 1-4

Description: The difference in serum CRP during HDIVC infusion reported in mg/dL

Measure: C-reactive protein (CRP)

Time: Days 1-4

Description: The difference in LDH during HDIVC infusion will be reported in IU/L

Measure: Lactate dehydrogenase (LDH)

Time: Days 1-4

Description: The difference in D-dimer during HDIVC infusion will be reported in ug/mL

Measure: D-dimer

Time: Days 1-4

Description: The difference in lymphocyte count during HDIVC infusion will be reported in 10e3/uL

Measure: Lymphocyte count

Time: Days 1-4

Description: The NLR will be calculated by dividing the absolute neutrophil count (10e3/uL) over the absolute lymphocyte count (10e3/uL) and ratio compared with Day 1 versus Day 4

Measure: Neutrophil to Lymphocyte ratio (NLR)

Time: Days 1-4

Description: The difference in serum ferritin will be calculated from the start of HDIVC infusion to day 4 and reported as ng/mL

Measure: Serum Ferritin

Time: Days 1-4
145 Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission

The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.

NCT04357938
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Device: CT-imaging
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)

Measure: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Time: At hospital admission

Secondary Outcomes

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with pulmonary comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with pulmonary comorbidities

Time: At hospital admission

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with cardiovascular comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities

Time: At hospital admission

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with malignancy who are to be admitted to hospital and who are rt-PCR negative for infection with SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with malignancy

Time: At hospital admission

Description: Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with immunodeficiency who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.

Measure: Sensitivity and specificity of chest CT in patients with immunodeficiency

Time: At hospital admission

Other Outcomes

Description: Predictive value of chest CT

Measure: Predictive value of specific chest CT findings for detection of SARS-CoV-2

Time: At hospital admission
146 Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)

The search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support. Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.

NCT04358588
Conditions
  1. Coronavirus Infection
  2. COVID-19
  3. Pneumonia, Viral
Interventions
  1. Drug: iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

147 Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed

NCT04358640
Conditions
  1. Critical Illness
  2. Sars-CoV2
  3. SARS Pneumonia
  4. Coronavirus Infection
  5. Stress Disorders, Post-Traumatic
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Critical Illness Stress Disorders, Post-Traumatic
HPO:Pneumonia

Primary Outcomes

Description: Mesured by STAY Scale

Measure: Anxiety

Time: 15 to 45 days after the beginning of the outbreak

Secondary Outcomes

Description: Participant suffering of Insomnia

Measure: Insomnia

Time: 15 to 45 days after the beginning of the outbreak

Description: Participant suffering of catastrophism

Measure: Catastrophism

Time: 15 to 45 days after the beginning of the outbreak
148 Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia

In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern. According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown. Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19. The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.

NCT04358783
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: Plasma
  2. Other: Best Available Therapy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: any cause mortality during the first 14 days of treatment

Measure: Early all-cause mortality

Time: 14 days

Secondary Outcomes

Description: (48-hour sampling interval from day 3 of hospitalization to two consecutive negatives).

Measure: Time in days for SARS-CoV-2 RT-PCR negatives

Time: 90 days

Description: In subjects of both arms at day 0, 3, 7, 14 and 90.

Measure: The serum anti-SARS-CoV-2 antibody titres

Time: 90 days

Description: Comparison of anti-SARS-CoV-2 antibody titers

Measure: Detection of serum antibodies

Time: days 0, 3, 7, 14 and 90.
149 The Effect of Prone Positioning on Lung Aeration and Ventilation-perfusion Matching in Mechanically Ventilated Patients With Coronavirus Disease Related Acute Respiratory Distress Syndrome

The consensus therapeutic strategy implies that COVID patients with acute lung injury due to coronavirus are routinely placed in prone position in an attempt to improve oxygenation by increasing ventilation homogeneity. The purpose of the study is to quantify with the electrical impedance tomography (EIT) the changes in the ventilation and aeration in the dorsal regions of the lung when the patient is placed in prone position.

NCT04359407
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. Electric Impedance
  3. Prone Positioning
Interventions
  1. Other: Prone positioning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Change in the ratio of tidal electrical impedance variation in the dorsal and total lung areas

Measure: Tidal electrical Impedance

Time: One hour before turning to prone or supine positioning

Secondary Outcomes

Description: Changes in intrapulmonary shunt fraction

Measure: Intrapulmonary shunt

Time: One hour before turning to prone or supine positioning

Description: Changes in the phase three slope of the volumetric capnogram

Measure: Volumetric capnography

Time: One hour before turning to prone or supine positioning
150 A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

NCT04359836
Conditions
  1. Gut Microbiome
  2. Gastrointestinal Microbiome
  3. COVID
  4. COVID-19
  5. Corona Virus Infection
  6. Coronavirus
  7. Coronaviridae Infections
  8. Coronavirus 19
  9. Coronavirus-19
  10. COVID 19
Interventions
  1. Other: There is no intervention in this study
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections

Primary Outcomes

Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Time: One year

Secondary Outcomes

Description: To validate the methods used to sequence samples

Measure: Validation of Sequencing Methods

Time: One year
151 Sequencing and Tracking of Phylogeny in COVID-19 Study

We plan to generate a database of viral RNA sequences for SARS-CoV-2 within the Wessex region. Such whole genome data can be used to monitor mutation rates in real time and, through comparison with global databases of SARS-CoV-2 genome sequences, can be used to map transmission of the virus

NCT04359849
Conditions
  1. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Generated using Nanopore-based whole genome sequencing techniques

Measure: To produce whole genome sequences for the SARS-CoV-2 virus from viral RNA samples

Time: 2 years

Secondary Outcomes

Description: Identify mutations and viral strains prevalent within the Wessex region

Measure: To develop a phylogenetic map of the SARS-CoV-2 virus

Time: 2 years
152 Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This treatment protocol is designed to provide a treatment option for patients diagnosed with severe or life-threatening COVID-19 or judged by the subinvestigator (treating physician) to be at high risk of progressing to severe or life threatening disease

NCT04360486
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Biological: Anti-Sars-CoV-2 Convalescent Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

153 Long Term Outcomes of Patients With COVID-19

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

NCT04360538
Conditions
  1. Critical Illness
  2. Corona Virus Infection
  3. Respiratory Failure
  4. Covid-19
Interventions
  1. Other: Quality of Life
  2. Other: Impact Event Score
  3. Other: Hospital anxiety and depression scale
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Critical Illness

Primary Outcomes

Description: SF-36 score

Measure: Quality of Life score

Time: up to 12 months after discharge

Secondary Outcomes

Description: Montreal Cognitive Assessment (MoCA) score

Measure: cognitive dysfunction

Time: up to 12 months after discharge

Description: (FSS-ICU)

Measure: Functional Status Score

Time: up to 12 months after discharge

Description: MRC neuromuscular Assessment

Measure: Physical Disability

Time: up to 12 months after discharge

Description: Impact Event Score

Measure: Psychological Sequelae

Time: up to 12 months after discharge

Other Outcomes

Description: hospital anxiety and depression scale

Measure: hospital anxiety and depression

Time: up to 12 months after discharge

Description: including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness

Measure: ICU related complications

Time: hospitalization up to 6 weeks

Description: measure the location (home, rehabilitation center, nursing home

Measure: hospital discharge location

Time: hospital discharge up to 6 weeks

Description: number of days admitted to the ICU

Measure: lCU length of stay

Time: hospitalization up to 6 weeks

Description: number of days admitted to the hospital

Measure: hospital length of stay

Time: hospitalization up to 6 weeks
154 Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum During an Emergency Laparoscopy Conducted on Confirmed or Suspected COVID-19 Patients

The purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.

NCT04361396
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: Collection of samples
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneum at the end of the surgical procedure with exsufflation (T4) in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T4

Time: After surgery, an average of half a day

Secondary Outcomes

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR immediately after creation of the pneumoperitoneum just before intraperitoneal surgical exploration (T1) in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T1

Time: After surgery, an average of half a day

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the peritoneal effusion found during surgical exploration (T2) or in the peritoneal lavage fluid at the end of the surgical procedure before exsufflation (T4) in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus in the peritoneal effusion at T2 or T4

Time: After surgery, an average of half a day

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the pneumoperitoneum during intraperitoneal surgical dissection (T2) with straight blunt/sharp or any kind of energy devices in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T3

Time: After surgery, an average of half a day

Description: Assessment of the presence of the SARS-COV-2 virus by RT-PCR in the bile at the end of the intervention after specimen extraction (T5), in case a cholecystectomy is performed in COVID-19 patients

Measure: Assessment of the presence of the SARS-COV-2 virus at T5

Time: After surgery, an average of half a day
155 Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.

NCT04361461
Conditions
  1. Coronavirus Infections
  2. SARS-CoV 2
  3. SARS (Severe Acute Respiratory Syndrome)
  4. Pulmonary Disease
Interventions
  1. Drug: Hydroxychloroquine Sulfate
  2. Drug: Hydroxychloroquine Sulfate + Azythromycin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.

Measure: Individual response rate

Time: 14 days after randomization

Secondary Outcomes

Description: All-cause mortality rates at Day 28th after randomization

Measure: All-cause mortality

Time: 28 days after randomization

Description: Number of days that the patient was on mechanical ventilation which was under ventilation from basal line

Measure: Duration of mechanical ventilation

Time: baseline

Description: Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.

Measure: Proportion of patients which needed mechanical ventilation during study

Time: hospitalization within 28 days

Description: The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: World Health Organization (WHO) Ordinal scale

Time: 28 days after inclusion and compared to baseline

Description: Length of hospital stay in days for hospitalization

Measure: Duration of hospitalization

Time: hospitalization within 28 days

Description: Rates of drug discontinuation in all causes under study

Measure: Rates of drug discontinuation

Time: hospitalization within 28 days

Other Outcomes

Description: Rates of serious adverse events

Measure: Rates of serious adverse events

Time: Day 14th
156 Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)

Background: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS). Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.

NCT04361526
Conditions
  1. Coronavirus Infection
  2. Acute Respiratory Distress Syndrome
  3. COVID
Interventions
  1. Device: Cytokine Adsorption
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Number of ventilator-free days (VFDs) at day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment. For patients ventilated 28 days or longer and for ventilated subjects who die, VFD is 0

Measure: Mechanical ventilation-free days

Time: up to 28days

Secondary Outcomes

Measure: 30-day mortality

Time: up to 30 days

Measure: length of ICU stay (days)

Time: up to 30 days

Measure: length of hospital stay

Time: up to 30 days

Measure: Duration of renal replacement and cathecolamines therapies

Time: up to 30 days

Measure: Need for extracorporeal membrane oxygenation (ECMO) support

Time: up to 30 days

Measure: multi-organ failure measured by the Sequential Organ Failure Assessment (SOFA) score

Time: up to 30 days (measured on days 0, 1, 2, 3, 4, 5, 6, and the last day of mechanical ventilation)
157 Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection

This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.

NCT04361838
Conditions
  1. Coronavirus Infection
Interventions
  1. Behavioral: prayer
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.

Measure: Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Secondary Outcomes

Description: APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.

Measure: Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.

Description: The higher the SOFA score the increased likelihood of organ failure.

Measure: Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time in ICU increases mortality.

Measure: Difference in patient outcomes - Length of stay in ICU.

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time with ventilator support increases mortality.

Measure: Difference in patient outcomes - Length of ventilator support

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Description: A prolonged length of time with vasopressor support increases recovery time.

Measure: Difference in patient outcomes - length of vasopressor support

Time: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
158 COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study

It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

NCT04361903
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Ruxolitinib Oral Tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Syndrome

Primary Outcomes

Description: Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours

Measure: Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19

Time: 15 days

Secondary Outcomes

Description: ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pH

Time: 15 days

Description: ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2

Time: 15 days

Description: ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2

Time: 15 days

Description: PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations.

Measure: Improvement of respiratory performance - ratio values

Time: 15 days

Description: every 24 hours D-Dimer value in mgr/ml

Measure: Evaluation of known adverse events related to the use of the drug - D-Dimer

Time: 15 days

Description: every 24 hours fibrinogen value in mg/dl

Measure: Evaluation of known adverse events related to the use of the drug - fibrinogen

Time: 15 days

Description: every 24 hours transaminases value in U/L

Measure: Evaluation of known adverse events related to the use of the drug - transaminases

Time: 15 days

Description: every 24 hours aPTT value in seconds

Measure: Evaluation of known adverse events related to the use of the drug - aPTT

Time: 15 days

Description: every 24 hours INR value in %

Measure: Evaluation of known adverse events related to the use of the drug - INR

Time: 15 days

Description: every 24 hours glycemia value in mg/dl

Measure: Evaluation of known adverse events related to the use of the drug - glycemia

Time: 15 days

Description: every 24 hours creatinine serum value in mg/dl

Measure: Evaluation of known adverse events related to the use of the drug - creatinine

Time: 15 days

Description: Total leucocyte as CBC x10e)/L

Measure: Evaluation of known adverse events related to the use of the drug - Leucocytes count

Time: 15 days

Description: formula % on total leucocyte

Measure: Evaluation of known adverse events related to the use of the drug - Leucocytes formula

Time: 15 days

Description: Thoracic imaging, every 48 h: presence, extension and dimension on lung thickening - Chest CT at start and end of treatment, Time elapsed between the onset of clinical symptoms and hospitalization.

Measure: Evaluation of the epidemiological parameters: Chest CT

Time: 15 days

Description: Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization.

Measure: Evaluation of the epidemiological parameters: Eco Chest

Time: 15 days

Description: Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.

Measure: Evaluation of the epidemiological parameters: CHEST X-ray

Time: 15 days

Description: Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h

Measure: Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment

Time: 15 days

Description: Number of AE grade 1 to 4

Measure: Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy

Time: 15 days
159 SJTRC-St. Jude Tracking of Viral and Host Factors Associated With COVID-19: A Prospective Adaptive Cohort Study

This is a prospective adaptive cohort study of St. Jude employees to determine the rate of SARS-CoV-2 infections that are asymptomatic and to evaluate immunological responses to SARS-CoV-2 infection. Primary Objectives - To estimate the proportion of asymptomatic infection with SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees - To comprehensively map CD4 and CD8 T cell epitopes and response magnitudes to SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees who acquire SARS-CoV-2 infection Secondary Objectives - To establish seroprevalence of SARS-CoV-2-specific antibodies at baseline, and identify the rate of seroconversion to SARS-CoV-2 in a population of presumably naïve adult St. Jude employees - To identify features of T cell responses at baseline and during SARS-CoV-2 infection that are associated with protection against symptomatic or severe COVID-19 disease in a population of adult St. Jude employees Exploratory Objectives - To establish additional immunological features including host immune or receptor polymorphisms associated with response to SARS-CoV-2 infection - To explore SARS-CoV-2 diversity and specific features in a circumscribed population - To describe the presence, characteristics, and proportion of short-term re-infection - To determine if an association between SARS-CoV-2 viral load in nasal swab specimens and COVID-19 symptoms can be identified in a population of adult St. Jude employees who acquire SARS-CoV-2

NCT04362995
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Coronavirus
  4. SARS-CoV-2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.

Measure: Proportion of asymptomatic subjects

Time: 1 year from enrollment

Description: A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.

Measure: Positive CD4 and CD8 cell epitope positive response

Time: at enrollment, 3 months, 6 months, 9 months and 1 year

Secondary Outcomes

Description: The proportion of participants at each time point who have detectable antibodies that recognize SARS-COV-2.

Measure: Proportion of seroprevalence

Time: Baseline, 3 months, 6 months, 9 months and 1 year

Description: For CD8s, T cell responses will be categorized as cytolytic, cytokine producing, or exhausted. For CD4s they will be grouped as Th1, Th2, Tfh, or Th17. Percentages of cells in each category will be summarized at baseline and during SARS-CoV-2 infection.

Measure: T-cell response

Time: Baseline, 3 months, 6 months, 9months and 1 year
160 ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19

ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.

NCT04363268
Conditions
  1. Coronavirus
  2. COVID
  3. COVID-19
  4. COVID19
  5. Corona Virus Infection
  6. Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.

Measure: Development of population-based models of disease risk

Time: Up to 10 years

Description: To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at t