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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 the community, state and national levels.

Measure: Relation between disease burden and geolocation

Time: Up to 10 years

Description: To specifically identify medications and regimens that address disease symptoms

Measure: Effect of medications on symptoms of COVID19

Time: Up to 10 years

Description: To specifically identify medications and regimens that treat and reduce disease severity.

Measure: Effect of medications on disease severity of COVID19

Time: Up to 10 years

Secondary Outcomes

Description: To identify regional variations in disease incidence and outcomes.

Measure: Rate of COVID19 infection and disease outcomes

Time: Up to 10 years

Description: To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.

Measure: Effect of COVID19 on health outcomes

Time: Up to 10 years

Description: To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.

Measure: Long-term follow up and recontact

Time: Up to 10 years
161 COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study)

The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.

NCT04363437
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Colchicine
  2. Drug: Usual Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Patients requiring supplemental oxygen beyond 8L nasal cannula

Time: through study completion, estimated 2 months

Secondary Outcomes

Measure: Percentage of patients who will require mechanical ventillation

Time: through study completion, estimated 2 months

Measure: Hospital length of stay

Time: through study completion, estimated 2 months

Measure: Mortality

Time: through study completion, estimated 2 months

Measure: Maximum CRP

Time: through study completion, estimated 2 months

Measure: Maximum troponin elevation

Time: through study completion, estimated 2 months
162 Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

NCT04363450
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. Wuhan Coronavirus
  4. Prophylaxis
  5. Healthcare Worker
  6. Sars-CoV2
  7. Hydroxychloroquine
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay

Measure: Incidence of symptomatic COVID-19 infection in healthcare workers

Time: 12 weeks

Secondary Outcomes

Description: Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection

Measure: Absenteeism from work due to COVID-19

Time: 12 weeks

Description: Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging >50% lung involvement, respiratory failure, end organ damage or shock)

Measure: Severity of COVID-19 infection

Time: 12 weeks
163 Serology COVID-19 From the Cornwall Hospital Union

Coronavirus (COVID-19) is a pandemic-like disease caused by a new coronavirus called Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) isolated in China in 2019. Clinical manifestations vary widely from one individual to another, from asymptomatic carrier to a febrile cough that can rapidly lead to acute respiratory distress syndrome. Since the beginning of the COVID-19 epidemic, screening by chest X-ray (RT) and polymerase chain reaction (PCR) SARS-CoV-2 conducted by the Cornwall Hospital Union laboratory has shown that among symptomatic patients and hospital staff suspected of being COVID-19, only 7.8% were attributable to COVID-19. Two nosocomial clusters were also identified, in the emergency department (10 carers) and in the cardiology department (6 carers and one patient). However, direct diagnosis by RT-PCR has sensitivity limits and can lead to false negative results when the subject is indeed suffering from COVID-19. This lack of sensitivity is inherent to the technique on the one hand, but also to the quality of the sample and the kinetics of the infection. Indeed, the virological window during which the virus is present in the respiratory mucous membranes sampled seems relatively narrow, hence a progressive negativation of the respiratory samples as the disease progresses. Moreover, clinical symptoms vary from one individual to another, and it is now recognized that some infected persons are asymptomatic but carry the virus. Thus, the use of a second diagnostic technique is a necessity, and serology could be a relevant diagnostic support. In the literature, several publications report the performance of COVID-19 serology in clusters of cases or cohorts of subjects. The serological techniques employed are variable (target epitopes in particular) and frequently homemade. Serology is mainly studied in comparison or association with RT-PCR in order to highlight the increased performance of COVID-19 diagnosis when the two techniques are combined. Correlation with chest CT imaging data is also encountered. Numerous serological tests are therefore being tested to determine retrospectively whether the individual has been exposed to the virus by looking for specific antibodies to the virus. The supreme health authority has drawn up specifications dated 16 April 2020, defining the methods for evaluating the performance of serological tests detecting antibodies directed against SARSCoV-2 in order to provide a framework for these practices. Several clinical studies are also underway, in particular to assess the kinetics of the appearance of the antibodies, whether these specific antibodies would be protective and whether their appearance would coincide with a cessation of contagiousness. Thus, the main objective of this study is to evaluate the diagnostic performance of the COVID-19 immunoglobulin (IgG) Dia-Pro serological test, in view of its deployment at the Cornish Hospital Union Laboratory. Subsequently, given the low prevalence of COVID-19 in Brittany and the risk of a second epidemic wave when the confinement is lifted, the evaluation of the seroprevalence of the staff of the Cornish Hospital Union is necessary in order to assess the attack rate of COVID-19 within the establishment and particularly within departments where nosocomial clusters have been reported; and to prevent the impact of deconfinement. Indeed, knowledge of the proportion of immunized personnel and its distribution according to services will make it possible to establish internal recommendations and to effectively manage personal protective equipment inventories, in conjunction with the deconfinement strategy that will be implemented by the government. The goal is to protect hospital staff from overexposure to the virus;

NCT04363593
Conditions
  1. Corona Virus Infection
Interventions
  1. Biological: Serological test
  2. Biological: Serum test
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The performance of the COVID-19 IgG Dia-Pro serological test is evaluated in terms of sensitivity/specificity.

Measure: Serological test evaluation

Time: 1 day

Secondary Outcomes

Description: Population seroprevalence among hospital staff (caregivers and non-caregivers) in Quimper Hospital is assessed

Measure: Population seroprevalence

Time: 1 month
164 CONTAIN COVID-19: Convalescent Plasma to Limit Coronavirus Associated Complications: a Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV2 Plasma to Placebo in COVID-19 Hospitalized Patients

This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

NCT04364737
Conditions
  1. COVID-19
  2. Coronavirus
  3. Coronavirus Infection
Interventions
  1. Biological: Convalescent Plasma
  2. Other: Saline solution
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead

Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 14 days

Time: 14 days post randomization

Secondary Outcomes

Description: Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation & Mechanical ventilation; pO2/FIO2 >/= 150 or SpO2/FIO2 >/=200 8 Mechanical ventilation pO2/FIO2 < 150 (SpO2/FIO2 <200) or vasopressors 9 Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis or ECMO Death 10 Dead

Measure: Score on the WHO 11-point ordinal scale for clinical improvement at 28 days

Time: 28 days post randomization

Other Outcomes

Description: Anti-SARS-CoV-2 titers (IgM, IgG, IgA)

Measure: Comparison in Anti-SARS-CoV-2 antibody titers

Time: 0, 1, 7, 14, 28, 90 days post randomization

Description: SARS-CoV-2 PCR in nasopharyngeal swabs

Measure: Proportion positive in SARS-CoV-2 RNA

Time: 0, 7, 14, 28 days post randomization

Description: Rate of mortality

Measure: Mortality

Time: 7, 14, 28 days post randomization

Description: Percentage of patients requiring Intensive Care Unit admission

Measure: Rates of Intensive Care Unit admission

Time: 7, 14, 28 days post randomization

Description: Lymphocyte counts

Measure: Changes from baseline in lymphocyte

Time: 0, 1, 3, 7, 14 days post randomization

Description: Neutrophil counts

Measure: Changes from baseline in neutrophils

Time: 0, 1, 3, 7, 14 days post randomization

Description: D-dimer level

Measure: Changes from baseline in D-dimer

Time: 0, 1, 3, 7, 14 days post randomization

Description: Fibrinogen level

Measure: Changes from baseline in fibrinogen

Time: 0, 1, 3, 7, 14 days post randomization

Description: T cell subsets

Measure: Changes from baseline in T lymphocyte subsets

Time: 0, 7, 28 days post randomization

Description: B cell subsets

Measure: Changes from baseline in B lymphocyte subsets

Time: 0, 1, 3, 7, 14 days post randomization
165 Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection (COVID-19). A Randomized Trial

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

NCT04364893
Conditions
  1. Corona Virus Infection
  2. COVID-19
Interventions
  1. Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.

Measure: Median days alive and out of the hospital

Time: 30 days

Secondary Outcomes

Description: Cardiovascular outcomes such as progression of COVID-19, mortality (general and cardiovascular), acute myocardial infarction, stroke / TIA, new heart failure or worsening of pre-existing HF, myocarditis, pericarditis, arrhythmias requiring treatment, phenomena thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure. All events will be reported according to CTCAE 4.0

Measure: Number of participants with adverse cardiovascular outcomes and new worsening heart failure

Time: 30 days

Description: Evaluate levels of biomarkers [troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics].

Measure: Cardiovascular biomarkers related to COVID-19

Time: up to 30 days
166 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

NCT04365101
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Severe Acute Respiratory Syndrome Coronavirus 2
  4. Pneumonia
  5. Pneumonia, Viral
  6. Lung Diseases
  7. Respiratory Tract Disease
  8. Respiratory Tract Infections
  9. Coronaviridae Infections
  10. Nidovirales Infections
  11. RNA Virus Infections
  12. Virus Disease
  13. Immunologic Disease
  14. ARDS
  15. Immunologic Factors
  16. Physiological Effects of Drugs
  17. Antiviral Agents
  18. Anti-infective Agents
  19. Analgesics
  20. Antimetabolites, Antineoplastic
Interventions
  1. Biological: CYNK-001
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus I Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral RNA Virus Infections Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 6 months

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Phase 1: Rate of clearance of SARS-CoV-2

Time: Up to 6 months

Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.

Measure: Phase 1: Rate of clinical improvement

Time: Up to 6 months

Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.

Measure: Phase 2: Time to Clearance of SARS-CoV-2

Time: Up to 28 days

Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.

Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score

Time: Up to 28 days

Secondary Outcomes

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 6 months

Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 6 months

Description: Time to medical discharge as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 6 months

Description: Hospital utilization will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 6 months

Description: Mortality rate will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 6 months

Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.

Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score

Time: Up to 28 days

Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).

Measure: Time to Pulmonary Clearance

Time: Up to 28 days

Description: For ventilatory support subjects, the days with supplemental oxygen-free.

Measure: Supplemental oxygen-free days

Time: Up to 28 days

Description: Proportion of subjects who need invasive or non-invasive ventilation

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days
167 Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.

NCT04365985
Conditions
  1. COVID-19
  2. Acute Respiratory Distress Syndrome
  3. Severe Acute Respiratory Syndrome (SARS)
  4. Coronavirus Infections
Interventions
  1. Drug: Naltrexone
  2. Drug: Ketamine
  3. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation)

Measure: Progression of oxygenation needs

Time: up to 1 month

Secondary Outcomes

Description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.

Measure: Renal failure

Time: up to 1 month

Description: Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits

Measure: Liver failure

Time: up to 1 month

Description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)

Measure: Cytokine Storm

Time: up to 1 month

Description: Count of participants who die from COVID-19

Measure: Mortality

Time: up to 1 month post hospital discharge

Description: Length of hospital stay in days

Measure: Length of hospital stay

Time: up to 1 month

Description: Count of patients admitted to the ICU at any time during index hospitalization

Measure: Intensive Care Unit (ICU) admission

Time: up to 1 month

Description: Length of ICU stay in days

Measure: Intensive Care Unit (ICU) duration

Time: up to 1 month

Description: Count of participants requiring intubation

Measure: Intubation

Time: up to 1 month

Description: Length of intubation, measured in days

Measure: Intubation duration

Time: up to 1 month

Description: Time measured in days from hospital admission to determination patient is stable for discharge

Measure: Time until recovery

Time: up to 1 month
168 Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora

Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.

NCT04366089
Conditions
  1. COVID
  2. SARS-CoV 2
  3. Pneumonia, Viral
  4. Coronavirus Infection
Interventions
  1. Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care
  2. Dietary Supplement: SivoMixx (200 billion)
  3. Drug: Azithromycin
  4. Drug: hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 90 days

Description: Comparison between the two groups

Measure: delta in the value of interleukin (IL)-1

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-6

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-10

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of CD8+ CD38/ HLA-DR

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of fecal calprotectin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of lipopolysaccharide (LPS)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of zonulin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of alpha1-antitrypsin

Time: 21 days
169 The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19

This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.

NCT04366791
Conditions
  1. Pneumonia
  2. Coronavirus Infection in 2019 (COVID-19)
  3. Severe Acute Respiratory Syndrome (SARS) Pneumonia
Interventions
  1. Radiation: Low Dose Radiation Therapy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level.

Measure: Rate of extubation (for intubated patients)

Time: Screening up to 28 days after radiation therapy

Secondary Outcomes

Description: Temperature in degrees (F)

Measure: Clinical outcome - Temperature

Time: Screening up to 28 days after radiation therapy

Description: Heart rate in beats per minutes

Measure: Clinical outcome - Heart Rate

Time: Screening up to 28 days after radiation therapy

Description: Systolic blood pressure in mm Hg

Measure: Clinical outcome - Systolic blood pressure

Time: Screening up to 28 days after radiation therapy

Description: Oxygen saturation in percentage

Measure: Clinical outcome - Oxygenation

Time: Screening up to 28 days after radiation therapy

Description: Respiratory rate in breaths per minute

Measure: Clinical outcome - Respirations

Time: Screening up to 28 days after radiation therapy

Description: FI02 in percentage

Measure: Clinical outcome - FiO2

Time: Screening up to 28 days after radiation therapy

Description: Positive end expiratory pressure (PEEP) in cm H20

Measure: Clinical outcome - PEEP

Time: Screening up to 28 days after radiation therapy

Description: Tidal volume in mL

Measure: Clinical outcome - Tidal volume

Time: Screening up to 28 days after radiation therapy

Description: Extubation/intubation events in percentage

Measure: Clinical outcome - Intubation/Extubation events

Time: Screening up to 28 days after radiation therapy

Description: Survival in percentage

Measure: Clinical outcome - Overall survival

Time: Screening up to 28 days after radiation therapy

Description: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.

Measure: Radiographic outcome - Chest xray

Time: Screening up to 28 days after radiation therapy

Description: CT scans with volume of consolidation measured in cubic centimeters.

Measure: Radiographic outcome - CT can

Time: Screening up to 28 days after radiation therapy

Description: White blood cell count in cell count x 10^3/mcL

Measure: Serologic outcome - WBC

Time: Screening up to 28 days after radiation therapy

Description: Hemoglobin in gm/dL

Measure: Serologic outcome - Hgb

Time: Screening up to 28 days after radiation therapy

Description: Procalcitonin in ng/mL

Measure: Serologic outcome - Procalcitonin

Time: Screening up to 28 days after radiation therapy

Description: Absolute neutrophil count in cell count x 10^3/mcL

Measure: Serologic outcome - ANC

Time: Screening up to 28 days after radiation therapy

Description: Creatine kinase in units/L

Measure: Serologic outcome - Creatine kinase

Time: Screening up to 28 days after radiation therapy

Description: Myoglobin in ng/mL

Measure: Serologic outcome - Myoglobin

Time: Screening up to 28 days after radiation therapy

Description: Albumin in gm/dL

Measure: Serologic outcome - Albumin

Time: Screening up to 28 days after radiation therapy

Description: Coagulation pathway time in seconds

Measure: Serologic outcome - PT/PTT

Time: Screening up to 28 days after radiation therapy

Description: D-Dimer in ng/mL

Measure: Serologic outcome - D-Dimer

Time: Screening up to 28 days after radiation therapy

Description: Gamma-glutamyl transferase in units/L

Measure: Serologic outcome - GGT

Time: Screening up to 28 days after radiation therapy

Description: Trygliciericdes in mg/dL

Measure: Serologic outcome -Triglycerides

Time: Screening up to 28 days after radiation therapy

Description: Ferritin in ng/mL

Measure: Serologic outcome -Ferritin

Time: Screening up to 28 days after radiation therapy

Description: Fibrinogen in mg/dL

Measure: Serologic outcome -Fibrinogen

Time: Screening up to 28 days after radiation therapy

Description: Immune marker flow cytometry (refractive index)

Measure: Serologic Immune markers flow cytometry

Time: Screening up to 28 days after radiation therapy

Description: Bilirubin in mg/dL

Measure: Serologic outcome -Bilirubin

Time: Screening up to 28 days after radiation therapy

Description: Lactate Dehydrogenase in units/L

Measure: Serologic outcome - LDH

Time: Screening up to 28 days after radiation therapy

Description: Creatinine in mg/dL

Measure: Serologic outcome - Creatinine

Time: Screening up to 28 days after radiation therapy

Description: Estimated Glomerular Filtration Rate in mL/min/m2

Measure: Serologic outcome - EGFR

Time: Screening up to 28 days after radiation therapy

Description: C-Reactive Protein in mg/L

Measure: Serologic outcome - CRP

Time: Screening up to 28 days after radiation therapy

Description: Alanine Aminotransferase in units/L

Measure: Serologic outcome - ALT

Time: Screening up to 28 days after radiation therapy

Description: Asparatate Aminotransferase in units/L

Measure: Serologic outcome - AST

Time: Screening up to 28 days after radiation therapy

Description: Troponin-I in ng/mL

Measure: Serologic outcome - Troponin-I

Time: Screening up to 28 days after radiation therapy

Description: B-Natriuretic Peptid in pg/mL

Measure: Serologic outcome - BNP

Time: Screening up to 28 days after radiation therapy

Description: pH (no unit)

Measure: Serologic outcome - Blood Gases pH

Time: Screening up to 28 days after radiation therapy

Description: pressure of O2 in mm Hg

Measure: Serologic outcome - Blood Gases pO2

Time: Screening up to 28 days after radiation therapy

Description: pressure of CO2 in mm Hg

Measure: Serologic outcome - Blood Gases pCO2

Time: Screening up to 28 days after radiation therapy

Description: Lactic Acid in mmol/L

Measure: Serologic outcome - Lactic Acid

Time: Screening up to 28 days after radiation therapy

Description: Interleukin-6 in pg/mL

Measure: Serologic outcome - IL-6

Time: Screening up to 28 days after radiation therapy

Description: Potassium in mmol/L

Measure: Serologic outcome - Potassium

Time: Screening up to 28 days after radiation therapy
170 Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)

The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness. As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.

NCT04366908
Conditions
  1. SARS-CoV 2
  2. COVID19
  3. SARS (Severe Acute Respiratory Syndrome)
  4. Cytokine Release Syndrome
  5. Cytokine Storm
Interventions
  1. Drug: BAT + Calcifediol
  2. Drug: BAT
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

Primary Outcomes

Description: Proportion of subjects who enter the Intensive Care Unit

Measure: Admission to Intensive Care Unit

Time: At day 28.

Description: Proportion of subjects who die.

Measure: Death

Time: At day 28.

Secondary Outcomes

Description: Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.

Measure: Time from onset of symptoms to discharge of patients in conventional hospitalization

Time: At day 28.

Description: In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit

Measure: ICU - Time until admission

Time: At day 28.

Description: In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.

Measure: ICU - Time mechanical ventilation is removed

Time: At day 28.

Description: Evaluation of the inflammatory markers related to IL disease. Blood samples will be collected and assessed in order to evaluate interleukins related with the interleukin storm using immunological tests.

Measure: Evaluation of the inflammatory markers related with the disease

Time: At day 28.

Description: Evaluation of the Vitamin D metabolites.

Measure: Vitamin D metabolites

Time: At day 28.

Description: Compare the evolution in SatO2

Measure: Evolution in SatO2

Time: At day 28.

Description: Compare the evolution in the Sat O2/FiO2 ratio

Measure: Evolution in the Sat O2/FiO2 ratio.

Time: At day 28.

Description: Compare the evolution in the degree of dyspnea using the analog Borg scale

Measure: Evolution in the degree of dyspnea

Time: At day 28.

Description: Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial

Measure: Evolution of the improvement of radiological findings by simple radiology

Time: At day 28.

Description: Incidence of adverse events related to medication and its administration.

Measure: Incidence of adverse events

Time: At day 28.

Description: Incidence in the appearance of hemorrhagic or thrombotic phenomena.

Measure: Appearance of hemorrhagic or thrombotic phenomena

Time: At day 28.
171 Study of the Pathogenesis of Olfactory Disorders in COVID-19

This study is a case-control study to characterize the molecular and cellular anomalies of the olfactory epithelium of COVID-19 patients with isolated anosmia, by comparison with the olfactory epithelium of non-infected subjects.

NCT04366934
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Syndrome
  3. Sars-CoV2
Interventions
  1. Other: Nasal swab
  2. Other: Taste and olfactory function evaluation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Ratio of olfactory sensory cells in the nasal cytological sample

Measure: Molecular and cellular defects in olfactory epithelium

Time: 30 months

Secondary Outcomes

Description: Multiple measurements will be analyzed to characterize the immune and inflamatory status of the olfactory mucosa (presence of infiltrated immune cells, activation state of the immune cells in the epithelium, cytokine and interleukin level)

Measure: Biological mechanisms involved in the pathogenesis of the disease

Time: 30 months

Description: Demographic variables (sex, age, blood type), risk factors (tobacco, overweight, diabetes, rhinosinusitis disease, respiratory allergy)

Measure: Epidemiological characteristics

Time: 30 months

Description: Self-questionnaire taste and smell survey (TTS)

Measure: Olfactory and taste dysfunction

Time: 30 months

Description: Visual analogue scale (VAS) (units from 0 normal perception to 100 no perception)

Measure: Olfactory and taste dysfunction

Time: 30 months
172 Electrocardiogram Analysis in COVID-19 Patients

Electrocardiographic (ECG) evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infection. The present study involves three different phases of evaluation of the ECG traces of hospitalized patients with SARS-CoV-2 infection. - Phase 1: it is proposed to collect and retrospectively analyze the ECGs of hospitalized patients with severe SARS-CoV-2 infection which led to invasive ventilation or patient death as a consequence and, if available, also possible troponin dosage; - Phase 2: aims to collect and analyze the ECGs of consecutive hospitalized patients with SARS-CoV-2 infection and evaluate their relationship with the course of the disease, cardiac involvement and prognosis; - Phase 3: it is proposed to repeat ECG and to carry out echocardiogram to patients with SARS-CoV-2 infection after 3 months from hospital discharge by simultaneously performing, if deemed clinically indicated, also cardiac magnetic resonance. In this phase, any evolutions of ECG alterations of the acute phase will be described and the relationship with cardiac involvement will be assessed.

NCT04367129
Conditions
  1. SARS-CoV Infection
Interventions
  1. Diagnostic Test: ECG
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection

Measure: Phase 1: ECG characteristics in patients presenting with severe form of SARS-CoV-2 infection

Time: 1 month

Description: To evaluate the correlation between ECG signs and cardiac involvement in the acute phase • Assess the correlation between ECG signs and mortality in the acute phase

Measure: Phase 2: Correlation between ECG signs and needs for invasive mechanical ventilation and/or mortality in the acute phase

Time: 6 months

Description: To evaluate the correlation between acute phase ECG signs and chronic phase cardiac involvement • evaluate the appearance, in the short-term follow-up, of signs of cardiac involvement (cardiomyopathies and conduction disorders in particular)

Measure: Phase 3: Correlation between ECG signs and cardiac involvement and mortality in the chronic phase

Time: 12 months
173 African Covid-19 Critical Care Outcomes Study: An African, Multi-centre Evaluation of Patient Care and Clinical Outcomes for Patients With COVID-19 Admitted to High-care or Intensive Care Units

The infectious disease COVID-19, caused by coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has been declared a pandemic and an international healthcare emergency by the World Health Organization (WHO). It has spread across the globe, overwhelming healthcare systems by causing high rates of critical illness. Mortality from COVID-19 exceeds 4%, with older people with comorbidities being extremely vulnerable. It is expected that between 50-80% of the world's population may contract SARS-CoV-2 over the next two years. It is expected that the outcomes will be potentially worse in Africa, because firstly, there is a limited workforce, and secondly there are limited intensive care facilities and critical care resources across Africa to provide sufficient care. It is important therefore to establish what resources, comorbidities and interventions are potentially associated with either mortality or survival in patients with COVID-19 who are referred for critical care in Africa. Rapid dissemination of these findings may help mitigate mortality from COVID-19 in critical care patients in Africa. These points provide the rationale for the African COVID-19 Critical Care Outcomes Study (ACCCOS).

NCT04367207
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome is in-hospital mortality in adult patients referred to intensive care or high-care units following suspected or known COVID-19 infection in Africa.

Measure: In-hospital mortality

Time: 8-12 months

Secondary Outcomes

Description: To determine the risk factors (resources, comorbidities and interventions) associated with mortality in adult patients with suspected or known COVID-19 infection in Africa.

Measure: Risk factors (resources, comorbidities and interventions) associated with mortality

Time: 8-12 months
174 Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.

NCT04367350
Conditions
  1. COVID
  2. Sars-CoV2
  3. Corona Virus Infection
  4. Myositis
  5. Myocarditis
Interventions
  1. Diagnostic Test: laboratory biomarkers
  2. Diagnostic Test: muscle ultrasound
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Myositis Myocarditis
HPO:Inflammatory myopathy Myocarditis Myositis

Primary Outcomes

Description: Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)

Measure: Rate of elevated creatine kinase in hyperacute phase

Time: 1 week

Secondary Outcomes

Description: Elevation of creatine kinase during hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Rate of elevated creatine kinase

Time: 24 months

Description: Two-peak elevation of creatine kinase during acute phase of corona virus disease 2019 (Covid-19)

Measure: Rate of two-peak elevation of creatine kinase during acute phase

Time: 30 days

Description: Presence of myositis-specific antibodies on admission, at two weeks, and at end of follow-up

Measure: Rate of myositis-specific antibodies

Time: 24 months

Description: Presence of antimyocardial antibodies on admission, at two weeks, and at end of follow-up

Measure: Rate of antimyocardial antibodies

Time: 24 months

Description: Level of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19) assessed by the area under the curve (AUC)

Measure: Area under the curve (AUC) of elevated creatine kinase

Time: 24 months

Description: Maximal value of creatine kinase elevation in the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Peak-levels of elevated creatine kinase

Time: 24 months

Description: Maximal value of troponin in the acute phase of corona virus disease 2019 (Covid-19)

Measure: Peak-levels of troponin

Time: 30 days

Description: Maximal value of urine myoglobin in the acute of corona virus disease 2019 (Covid-19)

Measure: Peak-levels of urine myoglobin

Time: 30 days

Description: Muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Rate of muscle hyperechogenicity

Time: 24 months

Description: Peak-muscle hyperechogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score) during the hyperacute, acute, subacute and chronic phase of corona virus disease 2019 (Covid-19)

Measure: Peak-muscle hyperechogenicity

Time: 24 months
175 Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19

Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation. The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation. On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis. The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.

NCT04367662
Conditions
  1. COVID-19
Interventions
  1. Procedure: blood sampling
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Thrombophilia
HPO:Hypercoagulability

Primary Outcomes

Measure: Clinical worsening (yes/no) of the patient during hospitalization

Time: in the 15 days from admission

Description: Biological analysis using initial blood sampling

Measure: D-DIMERS plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Fibrin monomers plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Antithrombin plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Prothrombin Fragment 1 plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Prothrombin Fragment 2 plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Thrombin generation test plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Microvesicles of platelet plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Cross-linked platelets plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Willebrand Factor plasma levels in blood

Time: 1 hour after admission

Description: Biological analysis using initial blood sampling

Measure: Factor VIII plasma levels in blood

Time: 1 hour after admission
176 ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection

Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19

NCT04367740
Conditions
  1. Asymptomatic Condition
  2. Infection Viral
  3. Coronavirus Infections
  4. Severe Acute Respiratory Syndrome Coronavirus 2
  5. Coronaviridae Infections
  6. RNA Virus Infections
  7. Virus Diseases
  8. Communicable Disease
Interventions
  1. Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Asymptomatic Diseases

Primary Outcomes

Description: Presence or absence of IgG antibodies to SARS-CoV2

Measure: Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection.

Time: at enrollment

Secondary Outcomes

Description: swab for presence of SARS-CoV-2 virus

Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.

Time: at enrollment
177 SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project

The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.

NCT04367857
Conditions
  1. Covid-19
  2. Coronavirus Infection
  3. Coronavirus
Interventions
  1. Other: COVID-19 Serology
  2. Behavioral: Health Care Worker Survey
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.

Measure: Proportion seropositive

Time: Up to 12 months after collection visit
178 COVID-19 Immune Repertoire Sequencing

This concerns a single-center prospective interventional cohort study. Laboratory-confirmed COVID-19 patients will be asked to donate blood at at least two different timepoints. This will allow us to investigate T and B cell evolutions during the course of infection and recovery. The expected duration of the study is four months or the total duration of the SARS-CoV-2 circulation in Belgium (whichever is shortest).

NCT04368143
Conditions
  1. COVID
  2. SARS-CoV 2
  3. Corona Virus Infection
  4. RDT
  5. B Cell
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: provide proof-of-concept that (longitudinal) B cell repertoire mining allows identification of emerging virus specific B cell receptor variable regions.

Time: 4 months

Secondary Outcomes

Measure: study evolutions in B and T cell repertoires to understand COVID-19 specific immune responses fundamentally.

Time: every 7 days during hospitalization a bloodsample is taken

Measure: clinical and epidemiological description of UZA hospitalized COVID-19 patients

Time: at hospitalization
179 Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol

This is a compassionate use, proof of concept, phase IIb, prospective, interventional, pilot study in which the investigators will evaluate the effects of compassionate-use treatment with IV tirofiban 25 mcg/kg, associated with acetylsalicylic acid IV, clopidogrel PO and fondaparinux 2.5 mg s/c, in patients affected by severe respiratory failure in Covid-19 associated pneumonia who underwent treatment with continuous positive airway pressure (CPAP).

NCT04368377
Conditions
  1. Pneumonia, Viral
  2. Corona Virus Infection
  3. Respiratory Failure
  4. Embolism and Thrombosis
Interventions
  1. Drug: Tirofiban Injection
  2. Drug: Clopidogrel
  3. Drug: Acetylsalicylic acid
  4. Drug: Fondaparinux
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency Thrombosis Embolism Embolism and Thrombosis
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: Change in ratio between partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, and inspired oxygen fraction at baseline and after study treatment

Measure: P/F ratio

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Change in partial pressure of oxygen in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: PaO2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Change in alveolar-arterial gradient of oxygen at baseline and after study treatment. Arterial alveolar gradient will be calculated using the following parameters derived from arterial blood gas analysis: partial pressure of oxygen in arterial blood and partial pressure of carbon dioxide in arterial blood.

Measure: A-a O2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Secondary Outcomes

Description: Number of days on continuous positive end expiratory pressure (CPAP)

Measure: CPAP duration

Time: From the first day of study drugs administration (T0) until day 7 post study drugs administration

Description: Difference in intensity of the respiratory support (non invasive mechanical ventilation, CPAP, high flow nasal cannula (HFNC), Venturi Mask, nasal cannula, from higher to lower intensity, respectively) employed at baseline and at 72 and 168 hours after study treatment initiation

Measure: In-hospital change in intensity of the respiratory support

Time: At baseline and 72 and 168 hours after treatment initiation

Description: Difference in partial pressure of carbon dioxide in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: PaCO2 difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in concentration of bicarbonate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: HCO3- difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in concentration of lactate in arterial blood, measured by means of arterial blood gas analysis, at baseline and after study treatment

Measure: Lactate difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in hemoglobin concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.

Measure: Hb difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Difference in platelet concentration in blood samples, measured by means of blood chemistry test, at baseline and after study treatment.

Measure: Plt difference

Time: At baseline and 24, 48 and 168 hours after treatment initiation

Description: Any major or minor adverse effect occuring during and after the administration of the study drug (e.g. bleeding)

Measure: Adverse effects

Time: From the first day of study drugs administration until day 30 post study drugs administration
180 Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients

SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome. To test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.

NCT04369456
Conditions
  1. Kidney Transplant; Complications
  2. Coronavirus Infection
Interventions
  1. Other: blood sample
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Disease Progression

Primary Outcomes

Description: quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 kidney transplant patients.

Measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation

Time: 10 months
181 Observational Study of COVID-19 Treatment Efficacy

To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.

NCT04369989
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Corona Virus Infection
  4. COVID
  5. Sars-CoV2
  6. Coronavirus as the Cause of Diseases Classified Elsewhere
  7. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  8. COVID-19
  9. Coronavirus Disease
  10. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
Interventions
  1. Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Mortality during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

Measure: ICU admission during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

Measure: Ventilator use during the COVID-19 treatment hospital encounter

Time: up to 6 weeks
182 Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19. Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children.. Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

NCT04371315
Conditions
  1. Corona Virus Infection
  2. Pediatric Cancer
  3. Adult Children
  4. Cancer
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.

Measure: Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.

Time: Baseline-Day 60

Description: Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.

Measure: Clinical risk factors of acute respiratory infection due to COVID-19 in children.

Time: Baseline-day 60

Secondary Outcomes

Description: Immunological (Absolute lymphocyte/monocyte counts (mm3) and Immunoglobin level (mg/dL) response measures, will be summarized with mean, standard deviation, median and range.

Measure: Immunologic response to acute respiratory infection due to COVID-19 in children.

Time: Baseline-day 60

Description: The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.

Measure: Duration of viral shedding and evolution in children longitudinally.

Time: Baseline-Day 60
183 Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial

The objectives of PROVIDE are to: 1. Determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from SARS-2-CoVnasopharyngeal swab negative to positive 2. To determine if weekly prophylactic hydroxychloroquine reduced the severity of COVID-19 symptoms 3. To determine the safety of taking weekly prophylactic hydroxychloroquine

NCT04371523
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Apo-Hydroxychloroquine
  2. Drug: Matched Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The number of HCW that tested positive for SARS-CoV-2

Measure: Positive for SARS-CoV-2

Time: 8 weeks

Secondary Outcomes

Description: The number of HCW that required hospital admission secondary to SARS-CoV-2

Measure: Hospital admissions

Time: at any time after first dose to hospital discharge, truncated at 60 days

Description: The number of HCW that required intensive care unit admission

Measure: Intensive care unit admissions

Time: at any time after first dose to hospital discharge, truncated at 60 days

Description: The number of HCW that required intubation and mechanical ventilation

Measure: Intubation and mechanical ventilation

Time: at any time after first dose, truncated at 60 days

Description: number of days admitted to the ICU

Measure: ICU length of stay

Time: from randomization to hospital discharge, truncated at 60 days

Description: number of days admitted to the hospital

Measure: Hospital length of stay

Time: from randomization to hospital discharge, truncated at 60 days

Description: Death

Measure: Mortality

Time: from randomization to 60 days

Description: Gastrointestinal symptoms (abdominal pain, diarrhea, nausea, vomiting), Hypoglycemia, Abdominal LFTs, Angioedema, Opthalmic (corneal changes, decreased visual acuity, macular degeneration, retinal changes), Bronchospasm

Measure: Incidence of adverse events

Time: from randomization to 60 days
184 COVID-19 in People Living With HIV: Evaluation of Risk Factors and Outcomes in Resource-limited Settings. A Pooled Substudy of ADVANCE, D²EFT, DolPHIN2 and NAMSAL

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

NCT04371835
Conditions
  1. HIV-infection/Aids
  2. Coronavirus Infection
MeSH:Infection Communicable Diseases HIV Infections Coronavirus Infections Severe Acute Respiratory Syndrome Acquired Immunodeficiency Syndrome

Primary Outcomes

Description: To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status.

Measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH)

Time: At baseline

Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.

Measure: Clinical outcomes of symptomatic COVID-19 in PLWH

Time: At Day 28

Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.

Measure: Clinical outcomes of symptomatic COVID-19 in PLWH

Time: At Month 3

Secondary Outcomes

Description: To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.

Measure: Seroprevalence of COVID-19 in all parent study participants

Time: Through study completion, an average of one year
185 Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.

NCT04371978
Conditions
  1. COVID 19
  2. Coronavirus
  3. Diabetes Mellitus, Type 2
  4. Diabetes Mellitus
  5. Glucose Metabolism Disorders
  6. Metabolic Disease
  7. Endocrine System Diseases
  8. Dipeptidyl-Peptidase IV Inhibitors
  9. Linagliptin
  10. Severe Acute Respiratory Syndrome Coronavirus 2
  11. Sars-CoV2
  12. Hypoglycemic Agents
  13. Respiratory Tract Diseases
  14. Incretins
  15. Hormones
Interventions
  1. Drug: Linagliptin 5 MG
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Tract Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases
HPO:Abnormality of the endocrine system Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.

Measure: Time to clinical change

Time: 28 days

Secondary Outcomes

Measure: Percent of serious adverse events and premature discontinuation of treatment.

Time: 28 days

Description: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.

Measure: Percent of patients with clinical improvement.

Time: 28 days

Measure: Length of hospitalization.

Time: 28 days

Measure: All-cause mortality.

Time: 28 days

Measure: Percent of supplemental oxygen use.

Time: 28 days

Measure: Supplemental oxygen-free days.

Time: 28 days

Measure: Percent of mechanical ventilation use.

Time: 28 days

Measure: Ventilator-free days.

Time: 28 days

Measure: Percent of ICU admissions.

Time: 28 days

Measure: ICU-free days.

Time: 28 days

Measure: Percent of 50% decrease in C-reactive protein (CRP) levels

Time: Up to 28 days

Measure: Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test.

Time: 28 days
186 Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients

The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.

NCT04372576
Conditions
  1. Ventilator Associated Pneumonia
  2. Corona Virus Infection
Interventions
  1. Diagnostic Test: Assessment of ventilator-associated pneumonia criteria
MeSH:Pneumonia, Ventilator-Associated Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: 28-day all-cause mortality

Time: at study completion, anticipated 5 months

Secondary Outcomes

Measure: Days of mechanical ventilation

Time: average time frame expected 2-3 weeks

Measure: ICU length-of-stay

Time: average time frame expected 3-4 weeks

Measure: Antibiotic utilization

Time: average time frame expected 3-4 weeks (at discharge from ICU)

Measure: Ventilator-associated pneumonia rate

Time: at study completion, anticipated 5 months
187 A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir and StaNdard Care vErsEs Standard CaRe

Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.

NCT04373733
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Favipiravir
  2. Other: Standard of care management
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time from randomisation to clinical improvement by two points on a seven-category ordinal scale: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both Death

Measure: Time to improvement by two points on a seven-category ordinal scale

Time: Up to 28 days from randomisation

Secondary Outcomes

Description: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

Measure: Clinical status on a seven-category ordinal scale (Day 7)

Time: Day 7 from randomisation

Description: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

Measure: Clinical status on a seven-category ordinal scale (Day 14)

Time: Day 14 from randomisation

Description: Survival of patients to end of study

Measure: Overall survival

Time: 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS score

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for temperature

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for heartrate

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for respiratory rate

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for oxygen saturation.

Time: Up to 28 days from randomisation

Description: Frequency of admission of patients to intensive care

Measure: Admission to intensive care

Time: Up to 28 days from randomisation

Description: Frequency of requirement to administer mechanical ventilation to patients

Measure: Requirement for mechanical ventilation

Time: Up to 28 days from randomisation

Description: Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients

Measure: Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen

Time: Up to 28 days from randomisation

Description: Frequency of culture-confirmed bacterial or fungal infection in patients

Measure: Incidence of bacterial or fungal infection

Time: Up to 28 days from randomisation

Description: Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.

Measure: Incidence of adverse events not directly caused by COVID-19 infection.

Time: Up to 28 days from randomisation.

Other Outcomes

Description: Frequency of readmission to inpatient care of patients discharged from hospital.

Measure: Readmission to inpatient care

Time: Up to 28 days from randomisation
188 Triage Strategies Based on C-reactive Protein Levels Among Individuals With COVID-19: A Prospective Cohort Study

The primary objective of this multi-center study is to clarify the value of a CRP measurement for triage of patients initially presenting with light symptoms of the COVID-19 infection. Current recommendations of management of COVID-19 include large-scale tests for virus. Such tests reveal whether an individual is infected with the virus, however, the demonstration of virus per se has no prognostic value for the ensuing course of the COVID-19 disease. Publications of possible treatments strategies increase exponentially, while evidence of triage of the affected individuals is mainly based on the level of pulmonary affection as measured by the Oxygen saturation. To inform decision making for which patients are to be hospitalized due to risk of developing more severe affection, this study addresses the question, whether triage may be performed with the aid of a simple CRP measurement.

NCT04373798
Conditions
  1. Coronavirus Infection
Interventions
  1. Diagnostic Test: C-reactive protein
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Admission to a hospital. Reason for admission is recorded.

Measure: Hospitalisation

Time: within 28 days

Secondary Outcomes

Measure: Death

Time: within 28 days

Measure: Transfer to Intensive Care Unit

Time: within 28 days

Measure: Oxygen treatment during hospitalisation

Time: within 28 days
189 Efficacy and Safety of High-Titer Anti-SARS-CoV-2 (COVID19) Convalescent Plasma for Hospitalized Patients With Infection Due to COVID-19 to Decrease Complications: A Phase II Trial

This is a single arm phase II trial to assess efficacy and confirm safety of infusions of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms,with or without confirmed interstitial COVID-19 pneumonia by chest Xray or CT. A total of 29 eligible subjects will be enrolled to receive anti-SARS-CoV-2 plasma.Outcomes will be compared to hospitalized controls with confirmed COVID-19 disease through retrospective chart review.

NCT04374565
Conditions
  1. Corona Virus Infection
  2. SARS-CoV 2
  3. SARS Pneumonia
  4. Pneumonia
Interventions
  1. Drug: High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Will be done by comparing the admission rate to the ICU between patients who received convalescent plasma and a control group who did not enroll in the study, or receive another experimental therapy.

Measure: Transfer to ICU

Time: Days 0 - 60

Description: Will be done by comparing the 28 day mortality rate between enrolled subjects and the control group.

Measure: 28 day mortality

Time: Days 0 - 60

Secondary Outcomes

Description: Will be collected from time of enrollment until completion of the study. The adverse events will be evaluated by CTCAE V5.0 and MedDRA.

Measure: Cumulative incidence of serious adverse events

Time: Days 0 - 60

Description: Will be done by collecting respiratory tract swabs and testing for SARS-CoV-2 positivity.

Measure: Rates and duration of SARS-CoV-2

Time: Days 0, 7, 14, and 21

Description: Serum or plasma will be collected and analyzed for SARS-CoV-2 antibody.

Measure: Serum of plasma antibody titer to SARS-CoV-2

Time: Days 0, 7, 14, and 28

Description: Blood will be collected and analyzed for cellular and humoral response.

Measure: Cellular and humoral immune response

Time: Days 0, 7, 14, 28

Description: All days where a supplemental oxygen is needed will be recorded as a concomitant medication and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the supplemental oxygen free days.

Measure: Supplemental oxygen free days

Time: Days 0-28

Description: All days where a ventilator is needed will be recorded as a concomitant procedure and will be subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ventilator free days.

Measure: Ventilator free days

Time: Days 0 - 28

Description: All days where the participant is admitted to the ICU will be recorded and subtracted from total days the participant is alive and enrolled in the study up to day 28 to determine the ICU free days.

Measure: ICU free days

Time: Days 0 - 28

Description: The patient will be evaluated throughout their enrollment in the study. The score will be evaluated to see if the score improved or worsened throughout their admission.

Measure: Sequential organ failure assessment score

Time: days 0, 1, 4, 7, 14, 21, 28

Description: Concomitant medications will be recorded throughout the patients participation in the study and vasopressors will be recorded, if they are needed.

Measure: Need for vasopressors

Time: Days 0 - 60

Description: Renal function will be assessed throughout the patients participation in the study. If renal replacement therapy is needed, it will be captured as a concomitant procedure.

Measure: Need for renal replacement therapy

Time: Days 0 - 60

Description: Respiratory function will be assessed throughout the patients participation in the study. If ECMO is needed, it will be captured as a concomitant procedure.

Measure: Need for extracorporeal membrane oxygenation (ECMO)

Time: Days 0 - 60

Description: Will be calculated from the date the patient entered the hospital until they were discharged.

Measure: Hospital length of stay (LOS)

Time: Days 0-60

Description: Will be calculated from the date the patient entered the ICU until they were discharged from the ICU.

Measure: ICU LOS

Time: days 0 - 60

Description: All adverse events will be recorded and evaluated by CTCAE v.5.0. All grade 3 and 4 AEs will be calculated to determine safety of convalescent plasma.

Measure: Grade 3 or 4 Adverse Events (AEs)

Time: days 0 - 60
190 Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

NCT04374617
Conditions
  1. COVID-19
  2. Critical Illness
  3. Venous Thromboembolism
  4. Venous Thromboses
  5. Venous Thromboses, Deep
  6. Venous Thrombosis Pulmonary
  7. Pulmonary Embolism
  8. Pulmonary Embolism and Thrombosis
  9. Sars-CoV2
  10. SARS-CoV Infection
Interventions
  1. Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Critical Illness
HPO:Deep venous thrombosis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"

Measure: Venous thromboembolisms

Time: 7 days

Secondary Outcomes

Description: Deaths from all causes during the follow-up

Measure: Deaths

Time: 7 days
191 Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial

Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

NCT04375098
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Biological: COVID-19 convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization

Time: 1 year follow up

Secondary Outcomes

Description: Days

Measure: Median duration of fever

Time: 1 year

Description: Days

Measure: Median duration of mechanical ventilation

Time: 1 year follow up

Description: Days

Measure: Median length of ICU stay

Time: 1 year follow up

Description: Days

Measure: Median length of admission

Time: 1 year follow up

Measure: Hospital mortality rate (percentage)

Time: 1 year follow up

Measure: 30-day mortality (percentage)

Time: 1 year follow up

Measure: Readmission rate (percentage)

Time: 1 year follow up

Description: days

Measure: Median length of viral clearance

Time: 1 year follow up
192 Study of Immune-mediated Mechanisms in Patients Tested Positive for SARS-CoV-2: Phenotypic and Functional Analysis of Monocytes and NK Cells in the Blood of Subjects Affected by Covid 19

SARS-CoV-2 belong to beta-coronavirus family and its transmission route and symptoms follow those of all community-acquired coronaviruses. The main difference of the novel Coronavirus is the higher mortality rate, that is around 3%. Death rate is over 1% only for patients over 50 years old, whereas until 40 years old is under 0,4%. No fatalities are declared among children under 10 years old to date. Death rate is almost double for male rather than female. This distribution of mortality rate according to age of infected patients could be only partially ascribed to other comorbidities in addition to great age. In fact, patients with no pre-existing conditions have however a case fatality rate of 0,9%. The almost null rate of severe illness in children and generally in patients younger than 40 years old is quite un-explicable. Infant, children and young people could be infected but infection is rapidly self-limited or without symptoms. Older patients undergo severe lung injury as consequence of an immune response that is late in coming. Possible explanation of these phenomena could be something, which assure ability to prompt response to SARS-CoV-2 in younger people independently from the novelty of the virus itself. It would seem to be that younger people are already sensitized to the antigens of the virus without a previous contact. This immunity is not really specific, but "partially specific" for many antigens of the virus, however able to limit the infection in the organism. Something stimulated the immune system and it scattered immunity against more and more antigens present. Children are the age group mostly exposed to all community-circulating viruses. This immunity is not persistent but progressively fade out. It protects from the age of two, when the hypothetical stimulation occurs, to the fifth decade because of its slow decrease. The only external stimulation, which healthy people receive are vaccines. All vaccinations and especially tetanic, diphtheria toxoids and inactivated bacteria as pertussis could stimulate immune system. They develop the specific immunity but generate also a sprouting immunity against antigens in transit, as coronaviruses and other community-circulating viruses. The developed immunity gives some protection against multiple viral infection for years until the natural fade out. After the fifth decade, that immunity is slower to be recall and reactivated. Additionally, transplant recipients and HIV infected patients, which have an immune system inhibited, unexpectedly, do not seem to suffer the worst complications of SARS-CoV-2 infection. An immune system imbalance could be play a pivotal role during the reaction to the virus, limiting destructive consequences of excessive inflammation. According to the medical hypothesis on which the protocol is based on, young people could benefit from a functional adaptation of innate immune cells induced through epigenetic reprogramming and, especially, a pre-existing "partially specific" immunity to the community viruses caused by "bystander effect" of preceding vaccinations. In this study, we will explore the main differences existing among patients infected by SARS-CoV-2 who experience the illness at different degree of severity. We suppose to recognize different populations of patients, each one with a specific immunological pattern. It could differ in terms of cytokines, soluble factors serum level and immune cells activity both of the innate compartment and of the acquired one. The proof of a role of these immunological phenomena in the pathogenesis of Covid-19 are bases for implementation of therapeutic immunomodulatory treatments. In addition, the definition of an immunological risk profile could tailor established therapies to each kind of patient.

NCT04375176
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome Coronavirus 2
  3. Immunomodulation
Interventions
  1. Diagnostic Test: Study of immune-mediated mechanisms in patients tested positive for SARS-CoV-2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Scientists' hypothesis is that monocytes, NK, CD4 AND CD8 T cells, in patients with severe infection to SARS-CoV-2, show an impairment in their function: cells reveal an overpowering hyperactivity that provokes a pathologic inflammatory response with a massive production of proinflammatory cytokine, edema and pulmonary fibrosis.

Measure: Immune cells activity

Time: 6 months

Secondary Outcomes

Description: The secondary objectives are to correlate clinical data and vaccination history with laboratory immune pattern to identify protective factors for Covid 19 and open paths for new therapeutic strategies.

Measure: Protective factors and new therapeutic strategies

Time: 6 months
193 IbrutiNib in SARS CoV-2 Induced Pulmonary Injury and Respiratory Failure (iNSPIRE)

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection. Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States. Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.

NCT04375397
Conditions
  1. CoronaVirus Induced Disease-2019 (COVID-19)
Interventions
  1. Drug: Ibrutinib
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Lung Injury

Primary Outcomes

Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.

Measure: Percentage of Participants Alive and Without Respiratory Failure

Time: Day 28

Secondary Outcomes

Description: WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).

Measure: Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline

Time: Day 14

Description: Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.

Measure: Median Reduction in Days Spent on Supplemental Oxygen

Time: Up to Day 28

Description: Percentage of participants with mortality from any cause.

Measure: All-Cause Mortality

Time: Up to Day 28

Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.

Measure: Percentage of Participants Experiencing Respiratory Failure or Death

Time: Up to Day 28

Description: Percentage of participants alive and not requiring mechanical ventilation.

Measure: Mechanical Ventilation-Free Survival

Time: Up to Day 56

Description: Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.

Measure: Days on Mechanical Ventilation

Time: Up to Day 56

Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.

Measure: Duration of hospitalization

Time: Up to Day 56

Description: Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.

Measure: Time to Discharge

Time: Up to Day 56

Description: PaO2:FiO2 ratio is an index of respiratory distress.

Measure: Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio

Time: Up to Day 56

Description: Oxygenation Index is a parameter of pulmonary function of participants.

Measure: Oxygenation Index

Time: Up to Day 56

Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Measure: Number of Participants With Adverse Events

Time: Up to Day 56

Description: Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Measure: Number of Participants With Abnormal Laboratory Findings

Time: Up to Day 56
194 Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.

NCT04376034
Conditions
  1. COVID19
  2. Coronavirus Infection
  3. Coronavirus
  4. Virus Diseases
  5. RNA Virus Infections
Interventions
  1. Biological: Convalescent Plasma 1 Unit
  2. Biological: Convalescent Plasma 2 Units
  3. Other: Standard of Care
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections

Primary Outcomes

Description: Time it takes to identify eligible donors whom are willing to donate

Measure: Plasma Donor

Time: Measured in days for 365 days

Description: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma

Measure: Plasma Donor

Time: Measured in days for 365 days

Description: Time from consent to infusion

Measure: Plasma Recipient

Time: Measured evey 24 hours up to 30 days

Description: Survival

Measure: Plasma Recipient

Time: Measured in days with 30 day from discharge follow-up

Secondary Outcomes

Description: Time until plasma is donated

Measure: Plasma Donor

Time: Measured every 24 hours up to 1 year

Description: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]

Measure: Plasma Recipient

Time: Day 1, 2, 3, 4, 7, and 30 day

Description: Morbidity reduction

Measure: Plasma Recipient

Time: Day 1, 2, 3, 4, 7, and 30 day

Description: Reduced Length of Stay in hospital

Measure: Plasma Recipient

Time: Measured every 24 hours until patient discharged from hospital up to 1 year

Description: Reduced Length of Stay on Advance Respiratory Support

Measure: Plasma Recipient

Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 year
195 Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

NCT04376476
Conditions
  1. Infection, Coronavirus
  2. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Biological: Blood sample
  2. Biological: Low or upper respiratory tract sample
  3. Biological: Stool collection or fecal swab
  4. Genetic: Blood sample for whole genome sequencing
  5. Other: phone call
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.

Measure: Initial biological profile of children and adults with COVID-19 infection

Time: Day 0

Description: measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.

Measure: Initial immunological profile of children and adults with COVID-19 infection

Time: Day 0

Secondary Outcomes

Description: Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection

Measure: Clinical worsening

Time: Within 21 days following inclusion

Description: measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening

Measure: Evolution of the immunological profile of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation

Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19

Time: Day 0

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation

Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19

Time: Day 0

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation

Measure: titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19

Time: Day 0

Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.

Measure: Genetic profile of adults with COVID-19 infection

Time: Day 0

Description: Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening

Measure: Genetic profile of adults with COVID-19 infection

Time: Within 21 days following inclusion
196 Assessment of Health-related Quality of Life and Patient-centered Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study

The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton & Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised. Four sets of variables (1-demographic characteristics, 2-pre-morbid state of health, 3-characteristics of acute illness, and 4- specific Covid-19 treatments received) will be assessed as potential risk factors for health-related quality of life and secondary outcomes.

NCT04376658
Conditions
  1. Quality of Life
  2. Long-term Outcomes
  3. Coronavirus Infection
Interventions
  1. Other: COVID-19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Measure: One-year utility score of health-related quality of life

Time: The outcome will be assessed 12 months after enrollment.

Secondary Outcomes

Description: Incidence of all-cause mortality.

Measure: Incidence of all-cause mortality

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: Incidence of all-cause rehospitalizations.

Measure: Incidence of rehospitalizations

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: Percentage of return to work or study among patients that were working or studying at the moment of hospitalization.

Measure: Percentage of return to work or study

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence).

Measure: Score of Instrumental Activities of Daily Living

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms.

Measure: Score of dyspnea

Time: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.

Description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.

Measure: Percentage of long-term ventilatory support need

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).

Measure: Symptoms of anxiety and depression

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).

Measure: Symptoms of posttraumatic stress disorder

Time: The outcome will be assessed 3, 6, 9 and 12 months after enrollment.

Description: The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Measure: Utility score of health-related quality of life at 3, 6, and 9 months

Time: The outcome will be assessed 3, 6, and 9 months after enrollment.

Description: The outcome will be assessed using the visual analogue scale of the Brazilian version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).

Measure: Score of self-rated health

Time: The outcome will be assessed 3, 6, 9, and 12 months after enrollment.
197 A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of participants with severe COVID-19 related pulmonary disease. The study population will consist of hospitalized participants with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.

NCT04376684
Conditions
  1. Severe Acute Respiratory Syndrome
Interventions
  1. Biological: Otilimab
  2. Biological: Placebo
  3. Drug: Standard of care
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Participants are alive and free of respiratory failure if they are in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

Measure: Proportion of participants alive and free of respiratory failure at Day 28

Time: Day 28

Secondary Outcomes

Description: Number of deaths due to all causes will be assessed.

Measure: Number of deaths due to all causes at Day 60

Time: Day 60

Description: Time to death due to all causes will be assessed.

Measure: Time to number of deaths due to all causes up to Day 60

Time: Up to Day 60

Description: Participants alive and free of respiratory failure if they are in category 1, 2, 3 or 4 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

Measure: Proportion of participants alive and free of respiratory failure at Days 7, 14, 42 and 60

Time: Days 7, 14, 42, and 60

Description: Time will be recorded from dosing to recovery from respiratory failure. Participants are in respiratory failure if they are in category 5 or above from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

Measure: Time to recovery from respiratory failure

Time: Up to Day 28

Description: Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

Measure: Proportion of participants alive and independent of supplementary oxygen at Days 7, 14, 28, 42, and 60

Time: Days 7, 14, 28, 42, and 60

Description: Participants are independent of supplementary oxygen if they are in category 1, 2 or 3 from the GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. The 8-point scale is as follows: 1) Non-hospitalized, no limitation of activity; 2) Non-hospitalized, limitation of activity; 3) Hospitalized, no oxygen therapy; 4) Hospitalized, low-flow oxygen by mask or nasal prongs; 5) Hospitalized, high-flow oxygen (≥15L/min), continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), non-invasive ventilation; 6) Hospitalized, intubation and mechanical ventilation; 7) Hospitalized, mechanical ventilation plus additional organ support; 8) Death.

Measure: Time to last dependence on supplementary oxygen

Time: Up to Day 28

Description: For participants not in ICU at time of dosing, the proportion of participants admitted to the ICU prior to Day 28.

Measure: Proportion of participants admitted to Intensive Care Unit (ICU)

Time: Up to Day 28

Description: Defined as the time from dosing to when the participant is discharged from the ICU.

Measure: Time to final ICU discharge

Time: Up to Day 28

Description: Time from dosing to when a participant is discharged from the hospital.

Measure: Time to final hospital discharge

Time: Up to Day 28

Description: AEs and SAEs will be collected.

Measure: Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)

Time: Up to Day 60
198 COVID-19 Health Messaging Efficacy and Its Impact on Public Perception, Anxiety, and Behavior

Effective communication is a critical component of managing pandemic outbreaks like COVID-19. This study explores COVID-19 related public knowledge, perceptions, belief in public health recommendations, intent to comply with public health recommendations, trust in information sources and preferred information sources. Participants are invited to include detailed free-text answers to make sure their COVID-19 experiences are heard.

NCT04377581
Conditions
  1. Public Health
  2. Demography
  3. Pandemics
  4. Corona Virus Infection
  5. News
  6. Global Health
  7. Perception
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Binary knowledge measures (true/false questions pertaining to COVID-19) each have a corresponding 5-point confidence score, the inverse of which generates a weighting variable. Weighted knowledge scores will be analyzed via a generalized linear mixed-methods effects model with a logistic link function and a random effect for the participant, generating a probability of correct response from 0 to 1.0.

Measure: Knowledge and Confidence in Knowledge of COVID-19

Time: Through study completion, an average of 3 months.

Description: Participants are asked, "Do you think that following these CDC recommendations will decrease the spread of COVID-19 in your community?" and select from a 5-point scale, Minimum: 1=certainly not; Maximum: 5 = most certainly.

Measure: Beliefs about the effectiveness of public health recommendations

Time: Through study completion, an average of 3 months.

Description: Participants are asked, "Will you follow these recommendations?" and select from a 5-point scale, Minimum: 1=certainly not; Maximum: 5 = most certainly.

Measure: Intent to comply with public health recommendations

Time: Through study completion, an average of 3 months.

Description: Participants are asked, "How likely is it that you will be diagnosed with any of the following diseases over the next year?" and rate their perceived likelihood of diagnosis for Measles, Flu, Lung Cancer, Ebola and COVID-19 on a 5 point scale. Minimum: 1, very unlikely; Maximum: 5, very likely. Participants are asked, "How serious do you think infection with any of the following diseases would be (or is) to your own personal health?" and rate their perceived seriousness of diagnosis for Measles, Flu, Lung Cancer, Ebola and COVID-19 on a 5 point scale. Minimum: 1, Not at all Serious; Maximum: 5, Very Serious

Measure: Perception of Risk of COVID-19 and other health threats

Time: Through study completion, an average of 3 months.

Description: Participants are asked the extent to which they trust common information sources: The World Health Organization, The U.S. Centers for Disease Control and Prevention, the European Commission, the participant's national government, the participant's local government, and the participant's personal healthcare provider. Participants rate on a 5 point scale. Minimum: 1, Not at all; Maximum: 2, Completely. (As these sources are not recognized in all places, participants may select "Not Applicable" in lieu of ranking.

Measure: Perceptions of trust in common health information sources

Time: Through study completion, an average of 3 months.

Description: Participants are asked to identify their single most trusted source of news through selection from a pre-generated list or via free-text.

Measure: Single most trusted news source

Time: Through study completion, an average of 3 months.

Secondary Outcomes

Description: Participants are asked if COVID-19 will change how they consume news (y/n)

Measure: Intention to change consumption of news because of COVID-19 (yes/no)

Time: Through study completion, an average of 3 months.

Description: Participants who answer, "Yes" to Outcome 7 are asked to provide a free-text response to describe how their consumption of news will change.

Measure: For participants who will change their news consumption, in what way will they change?

Time: Through study completion, an average of 3 months.

Description: Participants are asked to identify all other sources of information via selection from pre-generated menu or free-text.

Measure: Secondary information sources

Time: Through study completion, an average of 3 months.

Description: Free-text response invited to describe their concerns regarding COVID-19.

Measure: Concerns about COVID-19

Time: Through study completion, an average of 3 months.
199 An Important Index on Severity of Coronavirus Disease: Erythrocyte Haemoglobin Concentration

A rapid oxygen desaturation has observed in patients with COVID-19 which have seriously respiratory failure and most of them have intubated and connected to the mechanical ventilator. Finally, many of them have died during the process. ORF8 and superficial glycoproteins of a novel coronavirus bind to porphyrin on haemoglobin molecules and inhibit heme metabolism in an erythrocyte. However, it is not clarify the effects of the novel coronavirus on mean corpuscular volume (MCV), mean corpuscular of haemoglobin (MCH) and mean corpuscular haemoglobin concentration (MCHC).

NCT04377607
Conditions
  1. Corona Virus Infection
Interventions
  1. Other: File scanning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The severity of disease can decrease haemoglobin concentration and destroy oxygen transport.

Measure: Relationship between severity of disease and values of erythrocyte indices

Time: 5 days

Secondary Outcomes

Description: Detecting of cut-off value of haemoglobine indices can predict severity of the disease

Measure: Sensitivity of haemoglobin concentration on severity of the disease

Time: 5 days
200 Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

The purpose of this study is to evaluate the safety of administration of plasma containing antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent disease or lessen the severity of disease in individuals who are at high risk of developing COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent plasma.

NCT04377672
Conditions
  1. Corona Virus Infection
Interventions
  1. Biological: Anti-SARS-CoV-2 Human Convalescent Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of subjects with grade 3 and 4 adverse events during the study period

Measure: Safety of treatment with high-titer anti-SARS-CoV-2 plasma as assessed by adverse events

Time: 28 days

Secondary Outcomes

Description: Descriptive analysis of these outcomes, e.g. disease worsening as defined by hospitalization, need for supplemental oxygenation, respiratory distress, requirement for mechanical ventilation, and death

Measure: Proportion of subjects with disease worsening event

Time: 28 days

Description: Anti-SARS-CoV-2 antibody titer changes

Measure: Pharmacokinetics of anti-SARS-CoV-2 antibodies as defined by changes in antibody titers

Time: Up to 28 days

Description: This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers. Antibody titer will be collected one time between 60-120 days.

Measure: Proportion of subjects with a natural antibody response to SARS-CoV-2 infection

Time: 60-120 days
201 Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU

This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively. The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

NCT04378582
Conditions
  1. SARS-CoV 2
  2. Respiratory Distress Syndrome, Adult
  3. Corona Virus Infection
  4. Critical Illness
Interventions
  1. Other: risk factors
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Critical Illness

Primary Outcomes

Description: the proportion of patients who survive to ICU discharge or for 28 days in the ICU

Measure: ICU survival at 28 days

Time: 28 days

Secondary Outcomes

Description: the proportion of patients who survive to hospital discharge or for 60 days in the hospital

Measure: Hospital survival at 60 days

Time: 60 days

Description: Number of days under invasive ventilatory support

Measure: Duration of mechanical ventilation

Time: 28 days

Description: Proportion of patients who received renal replacement therapy during the ICU stay

Measure: Need for renal replacement therapy

Time: 28 days

Description: percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications

Measure: Complications during the ICU stay

Time: 28 days
202 The Role of Social Media as an Information Source in Covid19 Pandemic

According to the data of February 2020, in Turkey with a population of 83.9 million, internet and social media usage percentage to population are 74% and 64% respectively. Although previous researches have investigated the effect of social media on different medical situations, there is no study focused role of social media on patients' behavior and information source during the COVID-19 pandemic. In the present study, it is aimed to reveal the impact of social media on patients' attitudes and information sources during the COVID-19 pandemic.

NCT04378738
Conditions
  1. Social Media
  2. Corona Virus Infection
Interventions
  1. Behavioral: survey
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: applying a custom made survey to examine the role of social media and which type of research module is more effective

Measure: the role of social media

Time: 1 week
203 Vagus Nerve Stimulation ARDS Prevention Trial for COVID-19 Hospitalized Patients

This trial is designed to determine if the inflammation modulating effect of vagus nerve stimulation can improve pulmonary function and limit progression to ARDS in hospitalized COVID-19 hospitalized patients.

NCT04379037
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Device: Transcutaneous Auricular Vagus Nerve Stimulation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Survival

Measure: Survival without need of mechanical ventilation

Time: Day 14 since symptom onset

Description: WHO Progression Scale

Measure: WHO progression scale ≤ 5 at day 4 since admission.

Time: Score on day 4 since admission

Description: Successful tracheal extubation

Measure: Cumulative incidence of successful tracheal extubation at day 14 since symptom onset.

Time: Day 14 since symptom onset

Description: WHO Progression Scale

Measure: WHO progression scale ≤ 7 at day 4 since admission.

Time: Score on day 7 since admission

Secondary Outcomes

Description: Survival

Measure: Survival at day 14 of hospitalization

Time: Day 14

Description: Duration of hospitalization

Measure: Duration of hospitalization

Time: Day 28

Description: Time to hospital discharge

Measure: Time to hospital discharge

Time: Day 28
204 Low-dose Computed Tomography in COVID-19 Pneumonia: a Prospective Moscow Study

Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled in the study. Each patient will have 2 studies (routine chest CT and low-dose chest CT) sequentially during one visit to the computed tomography room.

NCT04379531
Conditions
  1. Pneumonia
  2. Coronavirus Infection
Interventions
  1. Diagnostic Test: Low-dose Chest CT
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: A standardized scale CT1-CT4 will be used. The expected correlation percentage is 90%.

Measure: Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia.

Time: Upon completion, up to 1 year

Secondary Outcomes

Description: Expected threshold - 10 mm.

Measure: Threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan.

Time: Upon completion, up to 1 year

Description: Expected number - more than two zones.

Measure: Number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan.

Time: Upon completion, up to 1 year
205 An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)

The primary objective of the study is to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study

NCT04380519
Conditions
  1. COVID-19
Interventions
  1. Biological: RPH-104 80 mg
  2. Drug: Olokizumab 64 mg
  3. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients, responded to the study therapy, in each of the treatment groups. The patient can be considered as the therapy responder, in case tocilizumab or sarilumab were not administered and there is an improvement of a clinical status at least by 1 point on a 6-points COVID-19 scale, where 1 point means most favorable outcome, 6 points means most undesirable outcome.

Measure: Proportion of patients, responded to the study therapy, in each of the treatment groups

Time: Day 15

Secondary Outcomes

Description: Changes of patients' clinical status on a 6 points ordinal scale over time

Measure: Changes of patients' clinical status on a 6 points ordinal scale over time

Time: from Day 2 until Day 15, Day 29

Description: Mortality rate over the follow-up period

Measure: Mortality rate over the follow-up period

Time: from Day 1 until Day 29

Description: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.

Measure: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.

Time: on screening and then from Day 1 until Day 29

Description: Proportion of patients received tocilizumab or sarilumab due to COVID-19

Measure: Proportion of patients received tocilizumab or sarilumab due to COVID-19

Time: from Day 1 until the Day 29

Other Outcomes

Description: Proportion of patients having National Early Warning Score 2 (NEWS2) of ≤ 4 maintained for 2 consecutive days

Measure: Proportion of patients having National Early Warning Score 2 of ≤ 4 maintained for 2 consecutive days

Time: from day 3 until day 15

Description: Time to a NEWS2 of ≤ 2 maintained for two consecutive days

Measure: Time to a NEWS2 of ≤ 2 maintained for two consecutive days

Time: from day 1 until day 15

Description: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, CRP, ferritin (if applicable), D-dimer (if applicable)

Measure: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, C-Reactive protein (CRP), ferritin (if applicable), D-dimer (if applicable)

Time: Day 2, Day 3, Day5, Day 7, Day 15

Description: Mortality during an ICU stay, on days 7, 15, 29 of the study

Measure: Mortality during an ICU stay, on days 7, 15, 29 of the study

Time: On Day 7, Day 15, Day 29

Description: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days

Measure: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days

Time: from Day 2 until Day 15

Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period

Measure: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period

Time: On Day 1 and from Day 2 until Day 15

Description: Duration of ICU stay measured in days

Measure: Duration of ICU stay measured in days

Time: from Day 2 until Day 15

Description: Changes from baseline (if applicable) in severity of ARDS according to WHO criteria

Measure: Changes from baseline (if applicable) in severity of Acute Respiratory Distress Syndrome (ARDS) according to World Health Organization (WHO) criteria

Time: from Day 1 until Day 15

Description: Duration of mechanical ventilation and EMO (if applicable) measured in days

Measure: Duration of mechanical ventilation and Extracorporeal Membrane Oxygenation (EMO) (if applicable) measured in days

Time: from Day 2 until Day 15

Description: Duration of oxygen support (if applicable) measured in days

Measure: Duration of oxygen support (if applicable) measured in days

Time: from Day 1 until Day 15

Description: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days

Measure: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days

Time: from day 3 until day 15

Description: Time to a NEWS2 of ≤ 4 maintained for two consecutive days

Measure: Time to a NEWS2 of ≤ 4 maintained for two consecutive days

Time: from day 1 until day 15

Description: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)

Measure: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)

Time: On Day 1 and from Day 2 until Day 15

Description: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)

Measure: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)

Time: from day 1 until day 15

Description: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale

Measure: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale

Time: from day 1 until day 29

Description: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale

Measure: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale

Time: from day 1 until day 29

Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study

Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study

Time: from Day 1 until Day 29

Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable

Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable

Time: from Day 1 until Day 29

Description: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)

Measure: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)

Time: from Day 1 until Day 29
206 Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study

The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.

NCT04380870
Conditions
  1. Coronavirus Infection
Interventions
  1. Dietary Supplement: Chinese Herbal Medicine
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patient reported change

Measure: Patient reported main complaint

Time: 24 hours

Description: Patient reported change

Measure: Patient reported main complaint

Time: 48 hours

Description: Patient reported change

Measure: Patient reported main complaint

Time: 3 months

Description: Patient reported change

Measure: Patient reported main complaint

Time: 12 months

Secondary Outcomes

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 24 hours

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 48 hours

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 3 months

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 12 months
207 Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study

Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).

NCT04381819
Conditions
  1. SARS Virus
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Diagnostic Test: SARS-CoV-2 PCR
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Fatal outcome from COVID-19

Measure: Death

Time: From date of randomization until the date of death from any cause assessed up to 3 months.

Description: Resolved infection

Measure: Recovery from COVID-19

Time: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.

Description: Percentage of patients requiring intensive care admission or ventilation

Measure: Progression to ICU care or ventilation

Time: 30 days

Secondary Outcomes

Description: The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days

Measure: Clearance of SARS-CoV-2 from respiratory specimen

Time: The number of calendar days from date of PCR positive test (counted as 1 day) in respiratory specimen until date of such test first become negative in the respiratory specimen assessed up to 3 months

Description: Cell-mediated and humoral immunity

Measure: Immune response to COVID-19

Time: From date of randomization until the date of clinical follow-up assessed up to 3 months.
208 High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia

The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.

NCT04381923
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. Hypoxemic Respiratory Failure
  3. Pneumonia, Viral
  4. COVID
Interventions
  1. Device: Helmet Continuous Positive Airway Pressure (CPAP)
  2. Device: High Flow Nasal Oxygen (HFNO)
MeSH:Coronavirus Infec Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: VFD is the number of days alive and free of mechanical ventilation in the first 28 days after study enrollment. Death before 28 days will be assigned a VFD equal to 0 to penalize non-survival. In cases of repeated intubation and extubation, periods free from invasive ventilation and lasting at least 24 consecutive hours will be calculated and summed. Timing of intubation and extubation will be captured in hours, and the number of hours a patient received invasive ventilation will be used to calculate duration of ventilation.

Measure: Ventilator-Free Days (VFD)

Time: 28 days

Secondary Outcomes

Description: Days spent in the ICU and hospital after time of enrollment

Measure: ICU and Hospital Length of Stay

Time: 28 days

Description: Incidence and time to intubation in days after the time of enrollment

Measure: Intubation

Time: 28 days

Description: Incidence of RRT after the time of enrollment

Measure: Renal Replacement Therapy (RRT)

Time: 28 days

Description: Death from any cause during after the time of enrollment

Measure: Mortality

Time: 28 days, 90 days
209 Randomised Evaluation of COVID-19 Therapy

RECOVERY is a randomised trial investigating whether treatment with Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Synthetic neutralizing antibodies (REGN-COV2), Tocilizumab or Aspirin prevents death in patients with COVID-19.

NCT04381936
Conditions
  1. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Lopinavir-Ritonavir
  2. Drug: Corticosteroid
  3. Drug: Hydroxychloroquine
  4. Drug: Azithromycin
  5. Biological: Convalescent plasma
  6. Drug: Tocilizumab
  7. Biological: Immunoglobulin
  8. Drug: Synthetic neutralising antibodies
  9. Drug: Aspirin
  10. Drug: Colchicine
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.

Measure: All-cause mortality

Time: Within 28 days after randomisation

Secondary Outcomes

Description: To assess the effects of study treatment on number of days stay in hospital

Measure: Duration of hospital stay

Time: Within 28 days and up to 6 months after the main randomisation

Description: Among patients not on invasive mechanical ventilation at baseline, the number of patients with a composite endpoint of death or need for invasive mechanical ventilation or ECMO.

Measure: Composite endpoint of death or need for mechanical ventilation or ECMO

Time: Within 28 days and up to 6 months after the main randomisation

Other Outcomes

Description: To assess the effects of study treatment on number of patients who needed ventilation and the number of days it was required

Measure: Need for (and duration of) ventilation

Time: Within 28 days and up to 6 months after the main randomisation

Description: To assess the effects of study treatment on number of patients who needed renal replacement therapy

Measure: Need for renal replacement

Time: Within 28 days and up to 6 months after the main randomisation

Description: To assess the effects of study treatment on number of patients who develop new major cardiac arrythmias

Measure: Development of new major cardiac arrythmias

Time: Within 28 days and up to 6 months after the main randomisation
210 A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19

Agent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2. Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events. Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy. Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2. Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities. Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19. Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19. Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.

NCT04382040
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS-CoV 2
  4. Coronavirus
  5. Coronavirus Infection
Interventions
  1. Drug: ArtemiC
  2. Drug: Placebo
MeSH:Infection Com Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patient will be assessed using a scoring table for changes in clinical signs

Measure: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of Time: 24 hours

Description: Adverse events caused by the study drug will be assessed

Measure: Percentage of participants with definite or probable drug related adverse events

Time: 14 days

Secondary Outcomes

Measure: Time to negative COVID-19 PCR

Time: 14 days

Measure: Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

Time: 14 days

Measure: COVID-19 related survival

Time: 14 days

Measure: Incidence and duration of mechanical ventilation

Time: 14 days

Measure: Incidence of Intensive Care Init (ICU) stay

Time: 14 days

Measure: Duration of ICU stay

Time: 14 days

Measure: Duration of time on supplemental oxygen

Time: 14 days
211 A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)

The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The active and control groups will be diseased and severity matched. The primary objective is to reduce initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Secondary objectives are to evaluate cytokine trends/prevent cytokine storms, evaluate supplemental oxygen requirements, decrease mortality of CoViD-19 patients and to delay the onset of mechanical ventilation.

NCT04382391
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Respiratory Failure
  4. Respiratory Distress Syndrome, Adult
  5. ARDS, Human
  6. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Device: gammaCore® Sapphire (non-invasive vagus nerve stimulator)
  2. Other: Standard of care therapies
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome Signs and Symptoms, Respiratory

Primary Outcomes

Description: measure the change (in hours) between the control group and treatment group

Measure: change in initiation of mechanical ventilation in patients with CoViD-19 compared to the control group.

Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first, assessed up to 3 months

Secondary Outcomes

Description: measure the changes in the serum/plasma concentrations of TH1 and TH2-type cytokines

Measure: evaluate cytokine trends

Time: From the time of initial blood draw until the time of final blood draw, assessed up to date of mechanical ventilation, death, or discharge from hospital, whichever occurs first,assessed up to 3 months

Description: compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19.

Measure: evaluate supplemental oxygen requirements

Time: From the time of randomization, assessed up to time of mechanical ventilation, day of discharge or death, whichever occurs first,assessed up to 3 months

Description: measure the change (in hours) to death between control group and treatment group

Measure: decrease mortality of CoViD-19 patients

Time: From the time or randomization until the date of death from any cause, assessed up to day of discharge or death,assessed up to 3 months

Description: measure the change (in hours) to time of mechanical ventilation between control group and treatment group

Measure: delay onset of ventilation

Time: From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first,assessed up to 3 months
212 Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.

NCT04382508
Conditions
  1. Immune Suppression
  2. Immune Deficiency
  3. Infection
  4. COVID
  5. Children, Adult
Interventions
  1. Other: Questionnaire
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Primary Outcomes

Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year

Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting

Time: 1 year

Secondary Outcomes

Description: Patient/parent reported positive tests for COVID19

Measure: Number of children/adults tested positive for COVID19

Time: 1 year

Description: Patient/parent reported admissions in hospital because of COVID19

Measure: Number of children/adults admitted in hospital because of COVID19

Time: 1 year

Description: Patient/parent reported effect of COVID19 on daily activities

Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children

Time: 1 year
213 Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.

The study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.

NCT04382768
Conditions
  1. Coronavirus Infection
  2. Respiratory Disease
  3. SARS (Disease)
Interventions
  1. Drug: Inhaled Hypertonic ibuprofen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale

Measure: Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen.

Time: 7, 14 and 28 days

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

Measure: Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen.

Time: 7, 14 and 28 days

Secondary Outcomes

Measure: Chage in length of Hospital stay

Time: 28 days

Measure: Chage in duration of ventilation

Time: 28 days

Measure: Chage in length of Critical Care stay

Time: 28 days

Description: NEWS2 score 20 points is the maximum and indicates that the patient needs emergent assessment by a clinical team or critical care team and usually transfer to higher level of care.

Measure: Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28.

Time: 1, 7, 14 and 28

Description: qSOFA, score for sepsis, a maximum value of 3 indicates high risk qSOFA Scores 2-3 are associated with a 3- to 14-fold increase in in-hospital mortality. Assess for evidence of organ dysfunction with blood testing including serum lactate and calculation of the full SOFA Score. Patients meeting these qSOFA criteria should have infection considered even if it was previously not.

Measure: Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28.

Time: 1, 7, 14 and 28 days

Measure: Time from first dose to conversion to normal or mild pneumonia

Time: 28 days

Measure: Antibiotic requirement

Time: 28 days

Measure: Glucocorticoids requirement

Time: 28 days

Measure: Incidence of adverse event

Time: 28 days

Measure: Incidence of serious adverse event

Time: 28 days

Measure: Number of deaths from any cause at 28 days

Time: 28 days

Measure: Lymphocyte count

Time: 28 days
214 Nitazoxanide in Treatment of COVID-19

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

NCT04382846
Conditions
  1. COVID
  2. Corona Virus Infection
Interventions
  1. Drug: Nitazoxanide
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: the number of patients with virological cure

Measure: Number of patients with virological cure

Time: 6 months
215 Covid-19 Triage Using Camera-based AI

The vital signs are critical in assessing the severity and prognosis of infections, such as Covid-19. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). This project aims to evaluate a new camera-based system for contactless measurement of vital signs as well as an artificial intelligence (AI) predicting hospitalization or death within 30 days. This particular study will evaluate the new system's ability without interfering with standard care of the patient.

NCT04383457
Conditions
  1. Coronavirus Infections
Interventions
  1. Device: RIA-device (Remote Investigation and Assessment)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Body temperature will be measured with the new camera based method as well as with a conventional ear thermometer. Both measurements will estimate the body temperature in degrees Celsius. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

Measure: Agreement between the new camera based method and reference standard to estimate body temperature

Time: Two minutes between measurements

Description: Heart rate will be measured with the new camera based method as well as with a conventional apparatus for measuring pulse rate. Both measurements will estimate the heart rate in beats per minute. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

Measure: Agreement between the new camera based method and reference standard to estimate heart rate

Time: Two minutes between measurements

Description: Blood oxygen saturation will be measured with the new camera based method as well as with a conventional apparatus for measuring blood oxygen saturation. Both measurements will estimate the blood oxygen saturation in percent (ranging from 0-100%). The agreement between blood oxygen saturation estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

Measure: Agreement between the new camera based method and reference standard to estimate blood oxygen saturation

Time: Two minutes between measurements

Description: Systolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring systolic blood pressure. Both measurements will estimate the systolic blood pressure in mm Hg. The agreement between systolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

Measure: Agreement between the new camera based method and reference standard to estimate systolic blood pressure

Time: Two minutes between measurements

Description: Diastolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring diastolic blood pressure. Both measurements will estimate the diastolic blood pressure in mm Hg. The agreement between diastolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

Measure: Agreement between the new camera based method and reference standard to estimate diastolic blood pressure

Time: Two minutes between measurements

Description: Respiratory rate will be measured with the new camera based method as well as manually using a stethoscope. Both measurements will estimate the respiratory rate in breath per minute. The agreement between respiratory rate estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

Measure: Agreement between the new camera based method and reference standard to estimate respiratory rate

Time: Two minutes between measurements

Secondary Outcomes

Description: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.

Measure: Prediction of hospital admission using vital signs estimated using reference standard methods

Time: Hospital admission for any cause up until 30 days after inclusion

Description: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for death within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.

Measure: Prediction of death using vital signs estimated using reference standard methods

Time: Death for any cause up until 30 days after inclusion

Description: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.

Measure: Prediction of hospital admission using vital signs estimated using the new camera based method

Time: Hospital admission for any cause up until 30 days after inclusion

Description: An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for hospitalization within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.

Measure: Prediction of death using vital signs estimated using the new camera based method

Time: Death for any cause up until 30 days after inclusion

Description: An artificial intelligence (AI) algorithm will use 75% of patient observations of raw camera data for training and raw data from the remaining 25% of patients will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.

Measure: Prediction of hospital admission using raw camera data

Time: Hospital admission for any cause up until 30 days after inclusion

Description: An artificial intelligence (AI) algorithm will use 75% of patient observations of raw camera data for training and raw data from the remaining 25% of patients will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for death within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.

Measure: Prediction of death using raw camera data

Time: Death for any cause up until 30 days after inclusion
216 Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019 (COVID-19) Infections: a Case-control Study

It has been suggested that ibuprofen might be associated with more severe cases of coronavirus infections, based on the observation that severe COVID cases had been exposed to ibuprofen, resulting in a warning by the French authorities. This was attributed to: 1. a suggestion that ibuprofen might upregulate ACE-2 thereby increasing the entrance of COVID-19 into the cells, 2. an analogy with bacterial soft-tissue infections where more severe infections on NSAIDs are attributed to an immune-depressive action of NSAIDs, or to belated treatment because of initial symptom suppression, 3. fever is a natural response to viral infection, and reduces virus activity: antipyretic activity might reduce natural defenses against viruses. However fever reduction in critically ill patients had no effect on survival. However, these assertions are unclear: upregulation of ACEII would increase the risk of infection, not necessarily its severity, and would only apply to the use of NSAIDs before the infection, i.e. chronic exposure. It would be irrelevant to the infection once the patients are infected, i.e., to symptomatic treatment of COVID-19 infection. Anti-inflammatory effect masking the early symptoms of bacterial infections resulting in later antibiotic or other treatment is not applicable: there is no treatment of the virus that might be affected by masking symptoms. Antipyretic effect increasing the risk or the severity of infection would apply equally to all antipyretic agents including paracetamol, which share the same mechanism of action for fever reduction. EMA remains prudent about this assertion In addition, excess reliance on paracetamol while discouraging the use of ibuprofen might increase the risk of hepatic injury from paracetamol overdose. Paracetamol is the prime drug associated with liver injury and transplantation, in voluntary and inadvertent overdose or even at normal doses. This might be increased by COVID-related liver function alterations. It is therefore proposed to conduct a case-control study in a cohort of patients admitted to hospital in France with COVID-19 infection.

NCT04383899
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: Questionnaire
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions on existing pathology, drugs administrated symptom onset and when, hospitalisation. Each questions have a multiple choice.

Measure: Describe medications used prior to admission associated with worse infection in COVID-19 patients in France.

Time: At inclusion day

Description: Quantify medications including ibuprofen used prior to admission associated with worse infection in COVID-19 patients in France. Thanks to a questionnaire created for the study, with 5 questions: existing pathology, drugs administrated symptoms onset and when, hospitalisation. Each questions have a multiple choice.

Measure: Quantify medications used prior to admission associated with worse infection in COVID-19 patients in France.

Time: At inclusion day

Secondary Outcomes

Description: Describe patient characteristics thanks to the same questionnaire.

Measure: Describe other patient characteristics with worse infection in COVID-19 patients in France.

Time: At inclusion day

Description: Quantify patient characteristics thanks to the same questionnaire.

Measure: Quantify other patient characteristics with worse infection in COVID-19 patients in France.

Time: At inclusion day
217 Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Case-Control Study

The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The case-control study is described here (the cross-sectional study is described in a separate ClinicalTrials.gov record).

NCT04384042
Conditions
  1. SARS-CoV Infection
  2. COVID-19
  3. Anosmia
  4. Dysgeusia
Interventions
  1. Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Olfaction Disorders Dysgeusia
HPO:Anosmia

Primary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances

Measure: Presence or absence of olfactory and taste disturbances in study participants

Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Description: The relationship between case & control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.

Measure: Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection

Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Secondary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19/within the past 2 weeks of answering the questionnaire (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)

Measure: Clinical manifestations of study participants

Time: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)

Measure: Other pre-existing health conditions

Time: Baseline

Description: PPV reflects the probability that the presence of olfactory and taste disturbances will have a positive diagnosis of COVID-19. This is derived from dividing the number of patients with olfactory & taste disturbances with COVID-19 infection over the total number of patients with olfactory and taste disturbances, and multiplying by 100%

Measure: Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection

Time: Baseline

Description: NPV reflects the probability that the absence of olfactory and taste disturbances will have a negative diagnosis of COVID-19. This is derived from dividing the number of patients without olfactory & taste disturbances and without COVID-19 infection over the total number of patients with no olfactory and taste disturbances, and multiplying by 100%

Measure: Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection

Time: Baseline

Description: The percentage of true positives, i.e. the proportion of patients with olfactory and taste disorders with COVID-19 infection. This can be calculated by dividing the number of subjects with olfactory & taste disturbances who have COVID-19 infection with the number of patients with olfactory & taste disturbances, and multiplying by 100%

Measure: Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection

Time: Baseline

Description: The percentage of true negatives, i.e. the proportion of patients without olfactory and taste disorders who do not have COVID-19 infection. This can be calculated by dividing the number of subjects without olfactory & taste disturbances who do not have COVID-19 infection with the number of patients without olfactory & taste disturbances, and multiplying by 100%

Measure: Specificity of olfactory and taste disturbances in predicting COVID-19 infection

Time: Baseline
218 A Multi-center, Randomized, Open-label, Controlled Trial to Evaluate the Efficacy and Tolerability of Hydroxychloroquine (HCQ) in Adult Patients With Mild to Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment

The effective medical treatment against COVID-19 infection is still unknown. Chloroquine phosphate is a well-known antimalarial drug which has been on the market for many years. Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also an immune-modifier and could distribute to the whole body including lung. Also, chloroquine is cheap and safe, and could be a promising agent against COVID-19 infection. However, only hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore, hydroxychloroquine instead become the best choice for the treatment candidate, since it shows higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the original effect which compared with chloroquine.

NCT04384380
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To evaluate the efficacy of HCQ, with respect to the time to negatively RT-PCR assessments in COVID-19 patients.

Measure: Time to negatively RT-PCR

Time: 14 days

Secondary Outcomes

Description: To evaluate the efficacy of HCQ in the aspect of virologic assessments in COVID-19 patients

Measure: Virologic assessment

Time: 14 days

Description: To evaluate the safety and tolerability of HCQ

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time: 28 days
219 A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Moderate to SARS Related to COVID-19 Infection vs Placebo

The purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.

NCT04384445
Conditions
  1. Corona Virus Infection
  2. COVID-19
  3. SARS
  4. Acute Respiratory Distress Syndrome
Interventions
  1. Biological: Zofin
  2. Other: Placebo
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

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

Measure: Incidence of any infusion associated adverse events

Time: 60 Days

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

Measure: Incidence of Severe Adverse Events

Time: 60 Days

Secondary Outcomes

Description: Measured at day 60 or at hospital discharge, whichever comes first.

Measure: All Cause Mortality

Time: 60 Days

Description: Number of participants that are alive at 60 days post first infusion follow up

Measure: Survival Rate

Time: 60 Days

Description: Measure IL-6, TNF-alpha from serum of blood samples

Measure: Cytokine Levels

Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Description: D-dimer from serum of blood samples methodology using blood samples or nose / throat swab

Measure: D-dimer Levels

Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Description: CRP from serum of blood samples

Measure: C-reactive protein Levels

Time: Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Description: Viral load by real time RT methodology using blood samples or nose / throat swab

Measure: Quantification of the COVID-19

Time: Day 0, Day 4, Day 8

Description: Improved organ failure within 30 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs using Sequential Organ Failure Assessment (SOFA) score.

Measure: Improved Organ Failure

Time: Day 30

Description: Chest imaging changes for 30 days compare to placebo: 1) Ground-glass opacity, - 2) Local patchy shadowing, 3) Bilateral patchy shadowing, and 4) Interstitial abnormalities.

Measure: Chest Imaging Changes

Time: Day o, Day 30
220 Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of COVID-19?

NCT04384458
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Ivermectin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of participants in whom there was a a positivity for SARS-CoV-2 through specific examination (RT-PCR) or by serology for antibodies specific (IgM and IgG), corroborated or not with clinical finding of COVID-19, defined as the occurrence of signs and symptoms suggestive of this disease.

Measure: Proportion of participants in whom there was a positivity for SARS-CoV-2.

Time: Post-intervention at day 52

Secondary Outcomes

Description: Proportion of participants who developed mild, moderate, or severe forms of COVID-19.

Measure: Participants who developed mild, moderate, or severe forms of COVID-19.

Time: Post-intervention at day 52.

Description: Measurement of the QT interval through electrocardiogram evaluation.

Measure: Measurement of the QT interval.

Time: Baseline, 3, 15 and 45 days post-intervention.

Description: Proportion of participants who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.

Measure: Widening of the corrected QT interval or with changes in heart rate on the ECG.

Time: Day 52.

Description: Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.

Measure: Comparison of hematological and biochemical parameters.

Time: Day 52.

Description: Proportion of occurrence of adverse events reported by participants or verified by the attending physician, or even observed in laboratory tests.

Measure: Occurrence of adverse events.

Time: Post-intervention at day 52.

Description: Severity of symptoms of COVID-19 measured by a visual analog scale (VAS), with scores ranging from zero to 10, where zero represents the absence of the symptom and 10 corresponds to the most intense manifestation of symptoms (severe dyspnoea).

Measure: Assessment of COVID-19 symptom severity.

Time: Post-intervention at day 52.

Description: Proportion of participants who discontinue study intervention,

Measure: Proportion of participants who discontinue study intervention.

Time: Post-intervention at day 52.

Description: Proportion of participants who required hospital care.

Measure: Proportion of participants who required hospital care.

Time: Post-intervention at day 52.

Description: Proportion of participants who required mechanical ventilation.

Measure: Proportion of participants who required mechanical ventilation.

Time: Post-intervention at day 52.
221 HDL Target of CoViD19 ? Analysis on the Caregivers of the Reunion University Hospital

Since December 2019, the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic has spread around the world. The people most exposed to this virus remain the healthcare personnel who are on the front line in the fight against this pandemic. Due to the delayed nature of the pandemic in Reunion island and its insular geographical situation, the study of the voluntary medical personnel will allow the investigators to establish a longitudinal follow-up of the anomalies of the lipidic balance in relation to the exposure to the SARS-Cov virus. 2. During bacterial infections, the lipid profiles are profoundly modified with very significant reductions in plasma cholesterol levels, LDL-C but especially HDL-C whose concentrations are particularly low. Lipid profiles are altered during viral infections, for example, the severity of dengue is inversely correlated with total cholesterol and LDL-C but not with HDL-C levels, according to a recent meta-analysis. The hepatitis C virus circulates in serum linked to lipoproteins rich in triglycerides and HDL can facilitate its entry into cells via Scavenger receptor class B type 1 (SRB1). Likewise, it has been shown that apoA1 can bind to the dengue virus and increase its infectivity by promoting its entry into cells, also via SRB1. At the moment, nothing is known about the lipid profiles in subjects with SARS-CoV-2. The investigator hypothesize that a drop in plasma HDL-C levels and a change in their size during infection could justify future therapeutic approaches aimed at supplementing the subjects most at risk of pulmonary complications. In a model of Pseudomonas aeruginosa pneumonia in mice, investigators have shown that the injection of reconstituted HDL allowed to limit the pulmonary inflammation and the deleterious consequences of the infection. The investigator propose to study not only the lipid profiles in subjects who are infected with SARS-CoV-2 but also the polymorphisms of genes involved in the regulation of lipoprotein levels like that of Cholesterol Ester-Transfer Protein (CETP) depending on the developed forms, symptomatic or not.

NCT04384705
Conditions
  1. SARS-CoV Infection
Interventions
  1. Other: research specific blood sample
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: lipid profile

Measure: Change of lipid profile during exposure to SARS-Cov-2

Time: at the end of the study, maximum 1 year

Secondary Outcomes

Description: HDL-cholesterol size

Measure: HDL-cholesterol size

Time: at the end of the study, maximum 1 year

Description: circulating plasma cytokine levels

Measure: circulating plasma cytokine levels

Time: at the end of the study, maximum 1 year

Description: ACE2 gene polymorphisms

Measure: ACE2 gene polymorphisms

Time: at the end of the study, maximum 1 year
222 The Use of Convalescent Plasma for Patients Hospitalized With COVID-19 Disease

Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.

NCT04385199
Conditions
  1. Coronavirus Infection
  2. Coronavirus
  3. COVID
Interventions
  1. Biological: Convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: For intubated patients improvement in PaO2/FiO2

Measure: Improvement in respiratory disease

Time: day 1 post transfusion

Description: For intubated patients improvement in PaO2/FiO2

Measure: Improvement in respiratory disease

Time: day 3 post transfusion

Description: For intubated patients improvement in PaO2/FiO2

Measure: Improvement in respiratory disease

Time: day 5 post transfusion

Description: For intubated patients improvement in PaO2/FiO2

Measure: Improvement in respiratory disease

Time: day 7 post transfusion

Description: For intubated patients improvement in PaO2/FiO2

Measure: Improvement in respiratory disease

Time: day 14 post transfusion

Description: For intubated patients improvement in PaO2/FiO2

Measure: Improvement in respiratory disease

Time: day 28 post transfusion

Description: For non intubated patients time to intubation post transfusion

Measure: Improvement in respiratory disease

Time: 7 days

Secondary Outcomes

Description: ICU length of stay

Measure: ICU Length of Stay

Time: 28 days

Description: Hospital length of stay

Measure: Length of Stay

Time: 28 days

Description: Duration of time on ventilator

Measure: Ventilator days

Time: 28

Description: Adverse transfusion events

Measure: Tolerability of convalescent plasma

Time: During transfusion, 1 day post-transfusion

Description: Improvement in Chest X Ray

Measure: Radiographic improvement

Time: 3 days post transfusion

Description: Improvement in Chest X Ray

Measure: Radiographic improvement

Time: 28 days post transfusion
223 COVIDAge Study- Hospital Des Trois-Chêne

In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.

NCT04385212
Conditions
  1. Coronavirus Infection
  2. Sars-CoV2
  3. Elderly Infection
  4. Old Age; Debility
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: We measure functional score of comorbidities

Measure: To evaluate the relative contributions of comorbidities on intra-hospitalized death

Time: 1 month

Secondary Outcomes

Description: We measure Functional Independence Measure scale

Measure: To evaluate the relative contributions of functional characteristics on intra-hospitalized death

Time: 1 month

Description: We describe the role fo geriatric syndrome such as delirium, falls

Measure: To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes

Time: 1 month
224 Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)

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. The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.

NCT04385771
Conditions
  1. Coronavirus Infection
  2. COVID
  3. SARS-CoV 2
  4. Respiratory Failure
  5. Cytokine Storm
  6. Extracorporeal Membrane Oxygenation
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: IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement

Time: 72 hours

Description: time to successful ECMO-explantation within 30 days after randomization

Measure: time to successful ECMO-explantation

Time: 30 days

Secondary Outcomes

Description: Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization

Measure: Ventilator free days (VFD)

Time: 30 days

Description: Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last visit for surviving patients under ventilation and/or ECMO.

Measure: Time to extubation from ventilation and explantation from ECMO

Time: 30 days

Description: Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients.

Measure: Overall survival time

Time: 30 days

Description: Days on intensive care unit (ICU)

Measure: Days on intensive care unit (ICU)

Time: 30 days

Description: Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h

Measure: Vasopressor dosage

Time: 24, 48, 72 hours

Description: Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h

Measure: Fluid substitution and fluid balance

Time: 24, 48, 72 hours

Description: Serum lactate at 24, 48, 72 h

Measure: Serum lactate

Time: 24, 48, 72 hours

Description: Urine output at 24, 48, 72 h

Measure: Urine output

Time: 24, 48, 72 hours

Description: Willebrand factor at 24, 48, 72 h

Measure: Willebrand factor

Time: 24, 48, 72 hours

Description: d-dimers at 24, 48, 72 h

Measure: d-dimers

Time: 24, 48, 72 hours

Description: interleukin-6 levels at 24, 48, 72 h

Measure: interleukin-6 levels

Time: 24, 48, 72 hours

Description: Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)

Measure: SOFA-Score

Time: 24, 48, 72 hours

Description: serious complications or malfunctions related to the CytoSorb device

Measure: serious adverse device effects

Time: 30 days

Description: unintended air in the ECMO system during operation of the device

Measure: adverse event of special interest: air in the ECMO system

Time: 30 days

Description: unintended blood-clotting in the ECMO system during operation of the device

Measure: adverse event of special interest: blood-clotting in the ECMO system

Time: 30 days

Description: major bleeding events

Measure: adverse event of special interest: bleeding complications

Time: 30 days
225 Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study

Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

NCT04385823
Conditions
  1. Respiratory Syndrome, Acute, Severe
  2. Hypoxic Respiratory Failure
  3. Viral Pneumonia
Interventions
  1. Device: patients receiving nasal high flow
MeSH:Pneumonia, Viral Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: values of ROX index during ICU stay

Measure: Changes in ROX index

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Secondary Outcomes

Description: percentage of patients requiring intubation

Measure: NHF failure

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: level of flow used with NHF

Measure: NHF flow

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: level of inspired fraction in oxygen used with NHF

Measure: NHF inspired fraction in oxygen

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: level of pulse oxymetry during NHF therapy

Measure: oxygenation

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: respiratory rate during NHF therapy

Measure: respiratory status

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: defining the values of ROX index associated with intubation

Measure: prediction of intubation

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

Description: defining the values of ROX index associated with NHF success (no intubation required)

Measure: prediction of NHF success

Time: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months
226 Trial of Alpha One Antitrypsin Inhalation in Treating Patient With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

It is clear now that SARS-CoV-2 could use angiotensin-converting enzyme 2 (ACE2), the same receptor as SARS-CoV Transmembrane protease serine type 2 (TMPRSS2), a protease belonging to the type II transmembrane serine protease family, cleaves the coronavirus spike protein Serine proteases are inhibited by a diverse group of inhibitors, The best-studied serpins are antithrombin and alpha 1-antitrypsin

NCT04385836
Conditions
  1. Coronavirus
Interventions
  1. Drug: alpha one antitrypsin inhalation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to clinical improvement, from the point of randomization to two-point improvement on a seven-point ordinal scale or discharged alive from hospital, whichever comes first. Ordinal Scale - 1, Ambulatory with normal activities; 2, Ambulatory with limitation of normal activities; 3, not requiring supplemental oxygen; 4, requiring supplemental oxygen by mask or nasal prongs; 5, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, requiring ECMO, invasive mechanical ventilation, or both; and 7, death

Measure: clinical improvement

Time: we will follow the patient daily starting from the day 0 which is the first day of giving drug for 3 weeks or till clinical improvement and discharge from the hospital or till death whichever comes first.
227 Demographics and Outcomes of Pregnant COVID 19 Positive Women in a Community Health System

Demographics of pregnant COVID persons under investigation and those who were positive from March-May 2020. Looking at demographics including age, socio-economic status and pregnancy outcomes in these groups.

NCT04385914
Conditions
  1. Corona Virus Infection
Interventions
  1. Other: COVID positive via testing
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: increased risk of preterm birth, preeclampsia, etc.

Measure: Pregnancy Outcome

Time: through study completion, approximately 1 year
228 Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19

The aim of this study is to reduce COVID-19 related pulmonary complications in adult patients undergoing all types of elective or emergency surgery in a COVID-19 exposed environment. A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)

NCT04386070
Conditions
  1. Pulmonary Complications in Sur
  2. Pulmonary Complications in Surgical Patients
  3. COVID
  4. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Lopinavir-Ritonavir
  2. Drug: Hydroxychloroquine
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The primary outcome is any one of the following COVID-19 specific, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death

Measure: Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death

Time: From randomisation until discharge from hospital, average less than 30 days

Secondary Outcomes

Description: Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.

Measure: Rate of Pneumonia

Time: From randomisation until discharge from hospital, average less than 30 days

Description: ARDs will be presented and analysed separately as a secondary outcome measure

Measure: Rate of ARDs

Time: From randomisation until discharge from hospital, average less than 30 days

Description: Death will be presented and analysed separately as a secondary outcome measure

Measure: Death rate

Time: From randomisation until discharge from hospital, average less than 30 days

Description: Unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation by 30 days after surgery

Measure: Rate of unexpected ventilation

Time: From operation until 30 days post operation

Description: Postoperative diagnosis of proven COVID-19 pulmonary complications

Measure: COVID-19 pulmonary complications

Time: 30 days post-surgery

Description: Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic)

Measure: Overall SARS-CoV-2 infected rate

Time: 30 days post-surgery

Description: Duration of hospital stay (including time spent in intensive care, time ventilated)

Measure: Duration of hospital stay

Time: 30 days post-surgery

Description: Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale

Measure: Pulmonary function

Time: 30 days post-surgery
229 Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19

Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis

NCT04386447
Conditions
  1. Covid-19
  2. Corona Virus Infection
  3. SARS-CoV 2
Interventions
  1. Drug: Oxytocin
  2. Drug: Standard of Care
MeSH:Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of cases who during 14 days exhibit one of the following conditions (the most severe): respiratory failure that requires mechanical ventilation organ failure that requires intensive care monitoring and treatment death

Measure: Proportion of cases who during 14 exhibit one of the following conditions

Time: 14 days

Secondary Outcomes

Description: Mortality 28 days after randomization

Measure: Mortality 28 days after randomization

Time: 28 days
230 Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections. In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,

NCT04387240
Conditions
  1. Covid 19 Positive
  2. Corona Virus Infection
Interventions
  1. Drug: Artemisinin / Artesunate
  2. Other: placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: absence of the virus shedding evidenced by negative swabs

Measure: length of stay in hospital

Time: within the first 6 days intervention

Secondary Outcomes

Description: reduction of morbidity and mortality

Measure: number of ICU admission

Time: 14 days

Description: finding the time that the symptoms disappear

Measure: resolution of symptoms

Time: 6 days - 10 day
231 Major Determinants of COVID-19 Associated Pneumonia

Molecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases. Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal. Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies. In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.

NCT04387799
Conditions
  1. Pneumonia, Viral
  2. Pneumonia, Bacterial
  3. Coronavirus Infection
  4. Obstructive Lung Disease
Interventions
  1. Diagnostic Test: Serology for Covid-19
MeSH:Pneumonia, Bacterial Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive
HPO:Abnormal lung morphology Pneumonia Pulmonary obstruction

Primary Outcomes

Description: assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.

Measure: Serology

Time: 3 weeks

Secondary Outcomes

Description: to find if the combination of CT scan and serology could help us in the identification of those patients who were initially negative at laboratory testing alone.

Measure: Efficacy of CT scan and Serology

Time: 3 weeks

Description: the efficacy of different pharmaceutical treatments against Covid-19

Measure: Efficacy of different pharmaceutical treatments

Time: 3 weeks
232 Epidemiological Study of the Covid-19 Presto Test Among Agents of the Local Authorities of CCTVL, Region Centre Val de Loire and Orleans Métropole. Correlation of IgM Level According to Contact With the Public

The "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community

NCT04387968
Conditions
  1. Coronavirus Infection
Interventions
  1. Diagnostic Test: Covid-19 presto test
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures

Measure: Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city

Time: 15 minutes

Secondary Outcomes

Description: Search for a correlation of covid-19 immunity based on the officer's position, if he is in contact with the public.

Measure: Determine if there is a relationship between the profession carried out by the agents of the territorial community of Orleans metropolitan city, the Loire Valley Region, the CCTVL and contamination by covid-19

Time: 6 months
233 Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study

Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.

NCT04388605
Conditions
  1. Corona Virus Infection
  2. COVID
  3. Pregnancy Related
  4. Early Pregnancy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Determine the prevalence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.

Measure: Prevalence of SARS-CoV-2 infection throughout pregnancy in women

Time: Up to 9 months

Description: Determine the incidence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.

Measure: Incidence of SARS-CoV-2 infection throughout pregnancy in women

Time: Up to 9 months

Secondary Outcomes

Description: Determine risk ratios of adverse obstetric outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.

Measure: Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women

Time: Up to 9 months

Description: Determine risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.

Measure: Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women

Time: Up to 1.5 years

Description: Identify clinical, behavioral and sociodemographic determinants that predict risk of (a) maternal infection during pregnancy and (b) severe infection symptomatology (hospitalization, ICU admission). Deliverable: The investigators will provide novel findings that identify high-risk groups warranting more aggressive social avoidance measures during pregnancy.

Measure: Clinical, behavioral, and sociodemographic determinants

Time: Up to 27 months
234 Investigating Anosmia and Ageusia in COVID-19 Adult Patients in Saudi Arabia

COVID-19 has adversely affected the healthcare system across the world. The world was not prepared for global outbreak of infectious diseases. The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is enabling researchers worldwide to acquire a large amount of clinical data regarding coronavirus disease (COVID-19). The COVID-19 infection severely affects the respiratory system in the critical cases and results in mortalities. The affected people experience a dry cough, fever, breathing problems, diarrhea, muscle pain, and sore throat. Besides that, some of the evidence from Italy, South Korea, China, and Spain suggest that the COVID-19 cases also lose their senses of smell and taste resulting in alterations in those patients. The objective of this proposed study is to determine whether COVID-19 cases have Olfactory and gustatory dysfunctions as a hallmark indicator and can be used as diagnostic tools for the isolation of suspected people. Investigators are presenting a prospective proportional case-control study that is conducted to investigate the COVID-19 cases with anosmia and /or Ageusia in a university hospital in Riyadh, Saudi Arabia. The sample size of this case series would be 250 cases of suspected COVID-19 patients. The cases included in the study are analyzed prospectively to determine if the cases had a history of anosmia and /or Ageusia, and then tested for the alteration of these senses through a panel of standardized odors/taste strips. That is looked at statistically allowing us to confirm the proposed effectiveness of these tests as a diagnostic tool.

NCT04388618
Conditions
  1. Anosmia
  2. Ageusia
  3. Covid19
  4. Corona Virus Infection
Interventions
  1. Other: NHANES smell and taste tests
MeSH:Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Olfaction Disorders Ageusia
HPO:Anosmia Hypogeusia

Primary Outcomes

Description: to how extent alteration of smell and taste senses is related to covid19 status

Measure: correlation of anosmia and ageusia to covid19 positive patients

Time: from 1/06/2020 to 31/12/2020

Secondary Outcomes

Description: to determine the range of sense affection ranging from total loss to mild form

Measure: objective assessment of severity of smell and taste senses alterations in covid19 patients

Time: from 1/06/2020 to 31/12/2020
235 Department of Chinese Medicine, Branch of Linsen, Chinese Medicine, and Kunming, Taipei City Hospital, Taipei, Taiwan Institute of Traditional Medicine, National Yang-Ming University, Taipei, Taiwan.

the retrospective observation study, the first line to care CAVID-19

NCT04388644
Conditions
  1. Corona Virus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The isolated person and first-line care person who taking JGF

Measure: the number confirmed COVID-19 cases

Time: 8 weeks

Description: The isolated person and first-line care person who taking JGF

Measure: The person with COVID-19 like symptoms

Time: 8 weeks

Secondary Outcomes

Description: The isolated person and first-line care person who taking JGF

Measure: The improving rate of COVID-19 like symptoms

Time: 8 weeks

Description: The isolated person and first-line care person who taking JGF

Measure: The satisfaction% to taking JGF

Time: 8 weeks
236 Randomized, Placebo-Controlled, Phase 2 Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).

NCT04388826
Conditions
  1. Respiratory Distress Syndrome, Adult
Interventions
  1. Drug: Veru-111
MeSH:Severe Acute Resp Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 29. Respiratory failure is defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation

Measure: Proportion of subjects that are alive without respiratory failure at Day 29.

Time: Day 29

Secondary Outcomes

Description: Improvement on the WHO Ordinal Scale for Clinical Improvement (8-point ordinal scale)

Measure: WHO clinical Improvement

Time: Day15 Day 22 and Day 29

Description: Proportion of subjects with normalization of fever and oxygen saturation through

Measure: Normalization of Fever and Oxygen

Time: Day 15, Day 22, and Day 29

Description: Percentage of subjects discharged from hospital

Measure: Discharge from Hospital

Time: Day 15 and Day 22

Description: Proportion of patients alive and free of respiratory failure

Measure: Patients alive and free of respiratory failure

Time: Day 15, and Day 22
237 Aerosol Inhalation of the Exosomes Derived From Allogenic COVID-19 T Cell in the Treatment of Early Stage Novel Coronavirus Pneumonia

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused mass mortality in the last 3 months that necessitates urgent development of new therapeutical agents. So far there is no effective anti-viral drug to reduce viral load that has critical importance to prevent progress into severe viral pneumonia and systemic hyper inflammation state. This project is to offer a biologic agent based on T cell derived exosomes. This is a novel approach using our proprietary protocols for drug development. This clinical trial is to test the safety and efficacy of this new agent following targeted delivery by metered dose inhaler. The project have received proper approvals from the Turkish Ministry of Health and Erciyes University, Kayseri Turkey. Turk-Patent Application Number: PCT/TR2020/050302

NCT04389385
Conditions
  1. Corona Virus Infection
  2. Pneumonia
Interventions
  1. Biological: COVID-19 Specific T Cell derived exosomes (CSTC-Exo)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Safety Assessment

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

Time: 28 days

Description: Time to Clinical Recovery (TTCR)

Measure: Efficacy Assessment

Time: 28 days

Description: Efficacy Assessment

Measure: The Rate of Recovery Without Mechanical Ventilator

Time: 28 days
238 Combination Therapy With Isotretinoin and Tamoxifen Expected to Provide Complete Protection Against Severe Acute Respiratory Syndrome Coronavirus

Combination Therapy with Isotretinoin and Tamoxifen expected to provide Complete Protection against Severe Acute Respiratory Syndrome Coronavirus Abstract: The COVID-19 pandemic caused by SARS-COV-2 has infected over 2,000,000 people causing over 150,000 deaths.Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 and for which there are currently no approved treatments.The principal investigator reported according to previous research data that combination therapy with Isotretinoin and tamoxifen expected to provide Complete Protection against Severe Acute Respiratory Syndrome Coronavirus, ACE2-expressing cells can act as home cells and are prone to SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry and replication. A study demonestrated that patients with hypertension and diabetes mellitus may be at higher risk of SARS-CoV-2 infection, as these patients are often treated with ACE inhibitors (ACEIs) or angiotensin II type-I receptor blockers (ARBs), which have been previously suggested to increase ACE2 expression, In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are currently being investigated in clinical trials for treating COVID-19 (chloroquine, thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov), none of which was found to significantly alter ACE2 expression (P>0.1) Moreover, another study demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment by performing target-based virtual ligand screening. As Investigators discussed before in their previous clinical trial (NCT04353180) that Isotretinoin is the strongest down-regulator of ACE2. and the principal investigator expects that Isotretinoin can inhibit or downrgulat ACE2 by direct interaction and binding with the transmembrane ACE2, Suggesting its therapeutic potential in preventing the entry of COVID 2019 to the host cell. The second combined drug is tamoxifen, A study demonstrated that tamoxifen causes redistribution of weak base chemotherapeutics from acidic organelles to the nucleus in drug-resistant cells. Agents that disrupt organelle acidification (e.g., monensin, bafilomycin A1) cause a similar redistribution. Measurement of cellular pH in several cell lines reveals that tamoxifen inhibits acidification of endosomes and lysosomes without affecting cytoplasmic pH, Tamoxifen decreased the rate of vesicular transport though the recycling and secretory pathways. Organellar acidification is required for many cellular functions, and its disruption could account for many of the side effects of tamoxifen. A sudy demonstrated that the phagocytosis is inhabited by tamoxifen and chloroquine in retinal epithelial cells and Also, a study demonstrated that Tamoxifen have weak base property and increase endolysosomal pH and alter endosomal dynamics. Importantly, TAM treatment enhanced survival of mice injected with a lethal dose of STx1 or STx2,The protective effect was independent of estrogen receptors but dependent on the weak base property of TAM, which allowed TAM to increase endolysosomal pH and alter endosomal dynamics. A study demonstrated that Tamoxifen have antimalarial effect via treating mice infected with P. berghei, which show lower levels of parasitaemia and do not develop signs of cerebral malaria, Tamoxifen is found to prevent lung fibrosis and reduce serum TGFβ-1 levels. A study Reported that Tamoxifen have endosomal and lysosomal cysteine proteases inhibitory effect better than chloroquine , Cathepsins are endosomal and lysosomal cysteine proteases that play important roles in protein degradation in various cellular processes including both the endocytic pathway and autophagy. The role of cathepsins in viral infection was first identified by Huang et al and they found that one cysteine proteases inhibitor E64d and a specific cathepsin L inhibitor Z-FY(t-Bu)-DMK are able to block the SARS-CoV infection. A study demonestrated that Cathepsin D was more sensitive to tamoxifen than to chloroquine. Tamoxifen exposures decreased the cathepsin D activity at less than 10 pM concentrations. The effect of chloroquine started at concentration of 15 pM, Finally, the principal investigator expects strong inhibition of COVID-19 by this combination therapy. Keywords: COVID 2019 , Isotretinoin , Tamoxofin, ACE2,.Endosomal and Lysosomal pH.

NCT04389580
Conditions
  1. COVID-19
Interventions
  1. Drug: Drug: Isotretinoin plus Tamoxifen
  2. Drug: Aerosolized Isotretinoin plus Tamoxifen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of lung injury score decreased or increased after treatment

Measure: lung injury score

Time: at 7 days

Secondary Outcomes

Description: lymphocyte counts

Measure: Absolute lymphocyte counts

Time: at day 7 and 14

Description: Serum levels of CRP, ESR ,IL-1,IL-6,TNF and Type I interferon

Measure: Serum levels of CRP, ESR ,IL-1,IL-6,TNF and Type I interferon

Time: at day 7 and 14

Description: Serum level of COVID19 RNA

Measure: Serum level of COVID19 RNA

Time: at day 7 and 14

Measure: All cause mortality rate

Time: at day 7 and 14

Measure: Ventilation free days

Time: at 14 days

Measure: ICU free days

Time: at 14 days

Description: less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample

Measure: d-dimers

Time: at 3-5 days

Description: (if pos. at baseline)

Measure: Time to first negative SARS-CoV-2 PCR in NP swap

Time: 14 days
239 Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.

NCT04390022
Conditions
  1. Covid-19
  2. Coronavirus Infection
  3. SARS-CoV-2 Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. PCRs were performed using two target genes (E and N).

Measure: Proportion of Patients With a Positive SARS-CoV-2 PCR

Time: 7 days post-treatment

Secondary Outcomes

Description: Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).

Measure: Median Viral Load

Time: Baseline and on days 4, 7, 14 and 21

Description: Proportion of patients with fever and cough

Measure: Fever and Cough Progression

Time: Days 4, 7, 14 and 21

Description: Proportion of participants with positive IgG at day 21

Measure: Seroconversion at Day 21

Time: Up to and including day 21

Description: Proportion of drug-related adverse events

Measure: Proportion of Drug-related Adverse Events

Time: 7 days post treatment

Description: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay. [Results not yet available]

Measure: Levels of IgG, IgM and IgA

Time: Up to and including day 28

Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry. [Results not yet available]

Measure: Frequency of Innate Immune Cells

Time: Up to and including day 7

Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry. [Results not yet available]

Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells

Time: Up to and including day 7

Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher). [Results not yet available]

Measure: Results From Cytokine Human Magnetic 30-Plex Panel

Time: Up to and including day 28
240 Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Cross-Sectional Study

The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection. This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).

NCT04390165
Conditions
  1. SARS-CoV Infection
  2. COVID-19
  3. Anosmia
  4. Dysgeusia
Interventions
  1. Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Olfaction Disorders Dysgeusia
HPO:Anosmia

Primary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances

Measure: Presence or absence of olfactory and taste disturbances in COVID-19 patients

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)

Measure: Prevalence of olfactory disturbances in COVID-19 patients

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: Percentage of COVID-19 patients experiencing taste disturbances

Measure: Prevalence of taste disturbances in COVID-19 patients

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Secondary Outcomes

Description: In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19 (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)

Measure: Clinical manifestations of study participants

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.)

Measure: Other pre-existing health conditions

Time: Prior to diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste before their diagnosis of COVID-19 infection

Measure: Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection

Time: Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)

Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of diagnosis of COVID-19 infection

Measure: Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection

Time: Within 2 weeks preceding the diagnosis of COVID-19 infection

Description: In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of answering questionnaire survey

Measure: Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey

Time: Up to 6 months
241 Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial

Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.

NCT04390412
Conditions
  1. COVID
  2. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Radiation: Low Dose Radiotherapy
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: O2 saturation

Measure: Change from baseline blood oxygenation

Time: 28 days

Description: Total days the patient is admitted to hospital

Measure: Number of Hospital stay days

Time: 28 days

Description: Total days the patient is admitted to ICU

Measure: Number of ICU stay days

Time: 28 days

Description: Total number of intubations performed after the treatment

Measure: Number of intubation events

Time: 28 days

Secondary Outcomes

Description: Changes in WBC count if base-line is abnormal

Measure: WBC

Time: 28 days

Description: Changes in Platelets count if base-line is abnormal

Measure: Platelets

Time: 28 days

Description: Changes in CRP serum level

Measure: CRP

Time: Day 1

Description: Changes in CRP serum level

Measure: CRP

Time: Day 2

Description: Changes in CRP serum level

Measure: CRP

Time: Day 3

Description: Changes in CRP serum level

Measure: CRP

Time: Day 4

Description: Changes in CRP serum level

Measure: CRP

Time: Day 5

Description: Changes in IL-6 serum level

Measure: IL-6

Time: Day 1

Description: Changes in IL-6 serum level

Measure: IL-6

Time: Day 2

Description: Changes in IL-6 serum level

Measure: IL-6

Time: Day 3

Description: Changes in IL-6 serum level

Measure: IL-6

Time: Day 4

Description: Changes in IL-6 serum level

Measure: IL-6

Time: Day 5
242 The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection

A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.

NCT04390477
Conditions
  1. COVID-19
  2. Coronavirus Infection
Interventions
  1. Dietary Supplement: Probiotic
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of patients with discharge to ICU.

Measure: Cases with discharge to ICU.

Time: 30-days

Secondary Outcomes

Description: Percentage of patients with home discharge.

Measure: Patients with home discharge.

Time: 30-days

Description: Percentage of deaths.

Measure: Mortality.

Time: 30-days

Description: Number of adverse events that occur during the treatment period, attributable or not to the intervention product.

Measure: Treatment safety assessed by number of adverse events.

Time: 30-days

Description: Number of new cases of positive SARS-Cov-2 infection by PCR analysis.

Measure: New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.

Time: 30-days

Description: Percentage of patients with negative PCR for SARS-CoV-2.

Measure: Patients with negative PCR result for SARS-CoV-2 infection.

Time: 30-days
243 Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS

Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation. Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation. Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care. Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.

NCT04391140
Conditions
  1. COVID
  2. ARDS
  3. Acute Respiratory Distress Syndrome
  4. Acute Respiratory Failure
  5. Corona Virus Infection
Interventions
  1. Other: Prone position
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury

Primary Outcomes

Description: Therapeutic failure: death or intubation

Measure: Therapeutic failure death or intubation

Time: 28 days within randomization

Secondary Outcomes

Description: Comfort measurement using a visual-analog scale. Presence of complications related with prone position and the use of high-flow nasal cannula: Skin ulcers. Intravascular lines displacement HFNC related events (hot air feeling, nasal lesions)

Measure: Feasibility and safety of prone position in HFNC patients

Time: 28 days within randomization

Description: Evolution of the oxygenation (SpO2/FiO2) in prone position. Efficacy Length of HFNC therapy Length of ICU stay Length of mechanical ventilation (in those who require intubation) ICU and hospital mortality

Measure: Efficacy of prone position in HFNC patients

Time: 28 days within randomization
244 Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

NCT04391179
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Covid-19
  4. SARS-CoV-2 Infection
Interventions
  1. Drug: Dipyridamole 100 Milligram(mg)
  2. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Increase in plasma D-dimer level compared with baseline at enrollment.

Measure: Change in D-dimer

Time: baseline, up to approximately 28 days after last study drug administration

Secondary Outcomes

Description: Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.

Measure: Global composite rank score

Time: up to approximately 28 days after last study drug administration
245 Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males

The objectives of the study, are to describe detection of SARS-CoV-2 in the semen of COVID-19 positive patients, the duration of positive semen and to investigate the impact on semen quality, thereby providing insights into the early impact on male reproductive function.

NCT04391829
Conditions
  1. COVID-19
  2. Sars-CoV2
  3. Corona Virus Infection
  4. Semen
Interventions
  1. Diagnostic Test: Ejaculated semen sample
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: detection of SARS-CoV-2 in the semen of men positive for SARS-CoV-2 on nasopharyngeal swab

Measure: detection of SARS-CoV-2 in the semen

Time: within 7 days after positive testing for SARS-CoV-2

Secondary Outcomes

Description: in case of a positive SARS-CoV-2 semen sample, for how long stays the virus present in semen

Measure: duration of SARS-CoV-2 presence in semen

Time: from first positive semen testing until first negative semen testing, upto 15 weeks

Description: viscosity of semen will be assessed macroscopically

Measure: semen viscosity

Time: from first until last semen analysis, upto 15 weeks

Description: semen volume

Measure: semen volume

Time: from first until last semen analysis, upto 15 weeks

Description: semen pH

Measure: semen pH

Time: from first until last semen analysis, upto 15 weeks

Description: Sperm motility assesment, according to the WHO guidelines of 2010

Measure: Sperm motility

Time: from first until last semen analysis, upto 15 weeks

Description: Sperm morphology assesment, according to the WHO guidelines of 2010

Measure: Sperm morphology

Time: from first until last semen analysis, upto 15 weeks

Description: Sperm density assesment, according to the WHO guidelines of 2010

Measure: Sperm density

Time: from first until last semen analysis, upto 15 weeks
246 What is the Effect of Mesenchymal Stem Cell Therapy on Seriously Ill Patients With Covid 19 in Intensive Care? (Prospective Double Controlled Study)

This study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery.

NCT04392778
Conditions
  1. Covid19
  2. Pneumonia
  3. Multiple Organ Failure
  4. Corona Virus Infection
Interventions
  1. Biological: MSC Treatment
  2. Biological: Saline Control
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Multiple Organ Failure
HPO:Pneumonia

Primary Outcomes

Description: Improvement of clinical symptoms related to Covid-19 infection (fever, pneumonia, shortness of breath)

Measure: Clinical improvement

Time: 3 months

Secondary Outcomes

Description: Improvement of lungs assessed by CT Scan

Measure: Lung damage improvement

Time: 3 months

Description: Negative, measured by RT-PCR laboratory tests for the virus

Measure: Sars-Cov-2 viral infection laboratory test

Time: 3 months

Description: Cell types and numbers

Measure: Blood test

Time: 3 months
247 Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19

SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed.

NCT04393142
Conditions
  1. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with Polymerase Chain Reaction for detected SARS-CoV-2 .

Measure: Identify antibodies

Time: 1 day

Secondary Outcomes

Description: Determine the sensitivity of IgM and IgG antibody detection by ELISA in direct eastern contacts of patients with PCR for detected SARS-CoV-2.

Measure: Determine antibody sensitivity

Time: 1 day

Description: Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Measure: IgM determination

Time: 1 day

Description: Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Measure: IgG determination

Time: 1 day
248 Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?

COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.

NCT04393792
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Povidone-Iodine
  2. Drug: Normal saline
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: viral load as measured by real time polymerase chain reaction (PCR)

Measure: Change in viral load in the oral and nasopharyngeal cavity

Time: Day 0, 2, 3, 7, 14

Secondary Outcomes

Description: Visual analogue score 1-5 per symptom via a smartphone app

Measure: Symptom severity in primary participants and co-residents

Time: Days 0 to 14
249 sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?

Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

NCT04394195
Conditions
  1. CORONAVIRUS INFECTIONS
Interventions
  1. Other: measurement of circulating sFlt1 concentration
MeSH:Cor Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Association between concentration of circulating sFlt1 and use of vasopressor

Time: 14 days
250 Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial

Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer. Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation

NCT04394377
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed
  2. Drug: Group 2: control group with enoxaparin 40mg/d
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner.

Measure: Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.

Time: In 30 days

Secondary Outcomes

Measure: Incidence of Venous thromboembolism

Time: In 30 days

Measure: Incidence of acute myocardial infarction

Time: In 30 days

Measure: Incidence of stroke

Time: In 30 days

Measure: Number of days using oxygen therapy

Time: In 30 days

Measure: Peak of troponin

Time: In 30 days

Measure: Peak of D-dimer

Time: In 30 days

Description: It will be considered the main safety endpoint

Measure: Incidence of Major bleeding and clinically relevant non-major bleeding by the ISTH criteria

Time: In 30 days
251 Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19

Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.

NCT04395144
Conditions
  1. Coronavirus Infection
  2. COVID
  3. Severe Acute Respiratory Syndrome
  4. Respiratory Failure
  5. Respiratory Insufficiency
  6. Respiratory Distress Syndrome
  7. ARDS
  8. Lung Diseases
Interventions
  1. Procedure: Awake Prone Positioning
  2. Procedure: Standard care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Pulmonary Valve Insufficiency Syndrome
HPO:Abnormal lung morphology Pulmonary insufficiency

Primary Outcomes

Measure: Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death

Time: Up to 28 days after randomization

Secondary Outcomes

Measure: Intubation rate

Time: Up to 28 days after randomization

Measure: Mortality

Time: Up to 28 days after randomization

Measure: Days spent on mechanical ventilation

Time: Until discharge, up to 24 weeks after randomization

Measure: Days spent in the ICU

Time: Until discharge, up to 24 weeks after randomization

Measure: Hospital stay (in days)

Time: From admission to discharge, up to 24 weeks after randomization

Other Outcomes

Description: Total time spent in prone position, as recorded by nursing or respiratory therapists

Measure: Time in prone position

Time: Up to 28 days post randomization

Description: Daily evolution of oxygenation

Measure: Oxygenation (SpO2/FiO2 ratio)

Time: Until HFNC weaning, or up to 14 days after randomization, whichever is first
252 A Phase I Study of ResCure™ to Treat COVID-19 Infection

This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.

NCT04395716
Conditions
  1. COVID
  2. Covid-19
  3. Corona Virus Infection
  4. Sars-CoV2
  5. Coronavirus-19
  6. SARS Pneumonia
  7. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Interventions
  1. Biological: ResCure™
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

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 ResCure™

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: Pulse from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via pulse

Time: 12 Weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via oxygen saturation

Time: 12 Weeks

Description: EKG from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via EKG

Time: 12 Weeks

Description: Assess Adverse Events and Serious Adverse Events due to ResCure™

Measure: Assess Tolerability of ResCure™

Time: 12 Weeks
253 The Impact of EXercise TRAining, Physical Activity and Sedentary Lifestyle on Clinical Outcomes in Surviving Patients Infected With the Severe Acute Respiratory Syndrome Coronavirus 2: Cross-sectional Study

The present study aims to assess the impact of exercise training, physical activity, and sedentary lifestyle on clinical outcomes in surviving patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, this study will evaluate cross-sectionally and through a questionnaire in Portuguese and English on the internet, whether physically active patients have better outcomes for the disease such as shorter hospital stay, lesser symptoms, lesser need for mechanical ventilation, and medications.

NCT04396353
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Corona Virus Infection
  4. Sedentary Behavior
Interventions
  1. Other: Electronic questionnaire
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of hospitalizations required due to COVID-19

Measure: Number of hospitalizations

Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Secondary Outcomes

Description: Symptoms such as fever, cough, shortness of breathe, and muscle pain due to COVID-19

Measure: Percentage of symptoms of the disease

Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Description: Length of hospital stay required due to COVID-19

Measure: Length of hospital stay

Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)

Description: Need for mechanical ventilation during hospitalization due to COVID-19

Measure: Percentage of mechanical ventilation

Time: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
254 Characterization of ARDS, Critical Illness Myopathy and Their Long-term Consequences in Patients With Covid-19 Disease: Effects of Inflammation, Mitochondrial Dysfunction and Plasma Concentrations of Various Sedative Drugs

COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements. The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.

NCT04397172
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Sars-CoV2
Interventions
  1. Procedure: Study Arm
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Short Form (36) Health Survey (SF-36)

Measure: Short Form (36) Health Survey (SF-36)

Time: 3 months

Secondary Outcomes

Description: Mortality

Measure: Mortality

Time: 90 days

Description: Modified Rankin Scale (mRS); (0=no Symptoms at all, 6=dead)

Measure: Modified Rankin Scale (mRS)

Time: 90 days

Description: Duration of mechanical ventilation in days

Measure: Duration of mechanical ventilation in days

Time: 3 months

Description: Barthel Index (80-100= patient should be able to live independently, <20=total dependence)

Measure: Barthel Index

Time: 3 months

Description: Beck's Depression Inventory II (BDI-II)

Measure: Beck's Depression Inventory II (BDI-II)

Time: 3 months

Description: Essener Questionnaire for Coping with a Disease (EFK); (0=no burden of disease, 180-strong burden of disease)

Measure: Essener Questionnaire for Coping with a Disease (EFK)

Time: 3 months

Description: Number of patients with Critical Illness Myopathy

Measure: Number of patients with Critical Illness Myopathy

Time: day 10
255 Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

NCT04397588
Conditions
  1. ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2
  2. Acute Refrac
  3. Acute Refractory Heart Failure Related to SARS-CoV 2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Heart Failure
HPO:Abnormal left ventricular function Congestive heart failure Right ventricular failure

Primary Outcomes

Description: Hospital mortality

Measure: Hospital mortality

Time: up to 90 days

Secondary Outcomes

Description: Mortality Day 28

Measure: Mortality Day 28

Time: Day 28

Description: Mortality Day 90

Measure: Mortality Day 90

Time: Day 90

Description: Ventilator-free days

Measure: Ventilator-free days

Time: Day 28

Description: ICU-free days

Measure: Intensive care unit-free days

Time: Day 28

Description: Hospital-free days

Measure: Hospital-free days

Time: Day 28
256 RT-PCR on Conjunctival Sample for the Detection of SARS-Cov-2 in Patients With Covid-19

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients

NCT04397666
Conditions
  1. SARS-CoV Infection
  2. Pinkeye
Interventions
  1. Diagnostic Test: conjunctival RT PCR
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: to assess the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis

Measure: the SARS-Cov-2 positivity rate in patients with Covid-19 with or without signs of conjunctivitis

Time: 3 months
257 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04397692
Conditions
  1. Corona Virus Infection
  2. COVID-19
  3. SARS-CoV 2
  4. Nitric Oxide
  5. Respiratory Disease
  6. Pneumonia, Viral
  7. Inhaled Nitric Oxide
Interventions
  1. Device: Nitric Oxide delivered via LungFit™ system
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disord Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration measured by need for NIV, HFNC or intubation

Measure: Time to deterioration

Time: 14 Days

Secondary Outcomes

Description: Time to non-invasive ventilation

Measure: Time to NIV

Time: 14 Days

Description: Time to high flow nasal cannula

Measure: Time to HFNC

Time: 14 Days

Description: Time to intubation

Measure: Time to intubation

Time: 14 days

Description: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

Time: 14 days

Other Outcomes

Description: Need for supplemental oxygen

Measure: Need for supplemental oxygen

Time: 14 days

Description: Change in viral load

Measure: Change in viral load

Time: 30 days

Description: Duration of the Hospital Length of Stay (LOS)

Measure: Duration of the Hospital Length of Stay (LOS)

Time: 14 days

Description: Mortality rate at Day 30

Measure: Mortality rate at Day 30

Time: 30 days
258 Anti-inflammatory Clarithromycin to Improve SARS-CoV-2 (COVID-19) Infection Early: The ACHIEVE Open-label Non-randomized Clinical Trial

Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.

NCT04398004
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Corona Virus Infection
Interventions
  1. Drug: Clarithromycin
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.

Measure: Clinical outcome negative for two parameters(hospital admission/disease progression)

Time: Day 1 to Day 8

Description: This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).

Measure: At least 50% change of the score of respiratory symptoms from the baseline

Time: Day 1 to Day 8

Secondary Outcomes

Description: Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database

Time: Day 1 to Day 8

Description: Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).

Measure: Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database

Time: Day 1 to Day 8

Description: Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.

Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4

Time: Day 4

Description: This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).

Measure: At least 50% change of the score of respiratory symptoms from the baseline on day 4

Time: Day 4

Description: Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following pO2/FiO2 less than 150 Need for mechanical or non-mechanical ventilation (CPAP)

Measure: Range of development of severe respiratory failure

Time: Day 1 to Day 14

Description: Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.

Measure: Range of hospital readmission until day 14

Time: Day 1 to Day 14

Description: Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8

Measure: Change of viral load in respiratory secretions from baseline on day 8

Time: Day 1 to Day 8

Description: Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of function of monocytes at days 1 and 8

Time: Day 1 to Day 8

Description: Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.

Measure: Change of function of Th1 cells at days 1 and 8

Time: Day 1 to Day 8

Description: Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.

Measure: Change of function of Th2 cells at days 1 and 8

Time: Day 1 to Day 8

Description: Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8

Time: Day 1 to day 8

Description: Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8

Time: Day 1 to day 8

Description: Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of serum human beta defensin-2 (hBD-2) between days 1 and 8

Time: Day 1 to day 8

Description: Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8

Time: Day 1 to day 8

Description: Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8

Time: Day 1 to day 8

Description: Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of the IL-10/TNFα ratio between days 1 and 8

Time: Day 1 to Day 8
259 Characteristics of COVID-19 Infection Among PREGnant Women

In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.

NCT04398264
Conditions
  1. Corona Virus Infection
  2. Pregnancy Related
Interventions
  1. Other: COVID-19 positive via testing
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission

Measure: Asymptomatic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Secondary Outcomes

Description: Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission

Measure: Asymptomatic Hispanic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Description: Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms

Measure: Follow up of asymptomatic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Description: Prevalence of COVID-19 positive newborns from infected mothers

Measure: COVID-19 positive newborns

Time: Through completion of the study, an average of 1 year

Description: Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19

Measure: Severe COVID-19 disease in pregnant women

Time: Through completion of the study, an average of 1 year
260 A proof-of Concept Study of the Use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the Treatment of COVID-19-related Pneumonia

The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.

NCT04399798
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Baricitinib
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: A patient is consider responder in the absence of either moderate to severe oxygenation impairment according to Berlin criteria - measured as Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)

Measure: Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria)

Time: 8 days

Description: Absence of death within 8 days from enrollment

Measure: Response to treatment: survival

Time: 8 days

Secondary Outcomes

Description: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)

Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days

Time: 8 days

Description: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)

Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days

Time: 15 days

Description: To quantify mortality within 8 and 15 days

Measure: Mortality

Time: 8 days and 15 days

Description: SpO2 will be assessed with the median and 25th-75th percentiles

Measure: Peripheral capillary oxygen saturation (SpO2)

Time: 8 days; 15 days

Description: PaO2/FiO2 will be assessed with the median and 25th-75th percentiles

Measure: Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)

Time: 8 days; 15 days

Description: Number of patients over the number of patients enrolled

Measure: To assess the rate of patients admitted to the intensive care unit

Time: 8 days; 15 days

Description: Median number of days and 25th-75th percentiles

Measure: To measure the length of hospital stay

Time: 8 days; 15 days

Description: To quantify 28-day mortality

Measure: 28-day mortality

Time: 28 days

Description: Number of patients readmitted over the number patients enrolled

Measure: To quantify the rate of re-admission within 28 days

Time: 28 days

Description: Number, type, and severity of adverse events

Measure: To quantify the cumulative incidence and severity of adverse events

Time: 28 days

Description: Serial serum assessments from baseline up to 15 days

Measure: Interleukin (IL)-1; IL-2; IL-10; IL-6; IL-8; IL-17; IL-2 receptor levels;

Time: 15 days

Description: Serial serum assessments from baseline up to 15 days

Measure: TNFalpha; vascular endothelial growth factor (VEGF); interferon gamma (IFNgamma) levels

Time: 15 days

Description: Serial assessments from baseline up to 15 days for viral load persistence

Measure: Viral load analyses

Time: 15 days
261 Pilot Study of Safety and Efficacy of Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in COVID-19 Related Acute Respiratory Distress Syndrome (ARDS)

This is a 30 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. IND 19968 to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The key secondary endpoints are 28 day survival, an increase in PaO2/FiO2 ratio by 50% at 96 hours, days to hospital discharge to home or rehab, and number of days requiring mechanical ventilation. Patients will be eligible for treatment with 3 daily consecutive doses of hCT-MSC at 1 million cells/kg (max dose 100 million cells), 18-30 hours apart, if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS. Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 20 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.

NCT04399889
Conditions
  1. COVID
  2. Corona Virus Infection
  3. COVID19
Interventions
  1. Biological: human cord tissue mesenchymal stromal cells
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence of infusion reactions measured by any one of the following: fever, anaphlyaxis, rash, hypertension, hypotension, tachycardia, nausea, vomiting, or any other new or worsening symptoms associated with the infusion.

Measure: Safety of the Investigational Product

Time: 24 hours

Description: Incidence of later reactions attributed to the investigational product as measured by any one of the following: rash, infection, allergic reaction, or any other symptoms associated with infusion of the investigational product.

Measure: Safety of the Investigational Product

Time: 28 days

Description: Formation of new anti-PRA antibodies as measured by an antibody screen test at 28 days post first infusion of the investigational product.

Measure: Safety of the Investigational Product

Time: 28 days

Secondary Outcomes

Description: Survival after 28 days after the first dose of MSCs

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 28 days

Description: Increase in PaO2/FiO2 ratio by 50%

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 3 days after MSCs

Description: The number of days from hospitalization to discharge to home

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 90 days

Description: The number of ventilator free days

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 90 days

Description: A 50% decrease in opacities by CT chest one week post initiation of MSC therapy

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 7 days

Description: The number of days requiring oxygen support

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 90 days

Description: Changes in viral load after MSCs measured by routine PCR testing from baseline to 4 days, 7 days and 28 days after MSCs

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: baseline, day 4, day 7, and day 28

Description: Number of patients able to be on the randomized portion of this study

Measure: Describe the potential for MSC therapy to favorably alter the course of COVID-ARDs

Time: 90 days
262 The Effectiveness of Ozone Therapy in the Prevention of COVID-19 Infection

Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection. In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.

NCT04400006
Conditions
  1. Corona Virus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection

Measure: The survey that was taken by telephone calls

Time: Day 0
263 Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. Controlled Clinical Trial, Randomized Triple Blind by Clusters (PREVICHARM Study)

Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.

NCT04400019
Conditions
  1. Sar
  2. Sars-CoV2
  3. Coronavirus Infection
  4. Prevention
  5. Prevention &
  6. Prevention & Control
  7. Nursing Home
  8. Hydroxychloroquine
Interventions
  1. Drug: Hydroxychloroquine Only Product in Oral Dose Form
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Secondary Outcomes

Description: Dichotomous qualitative variable (1: Death 0: Survival)

Measure: Mortality

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period

Measure: Compliance with treatment

Time: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at six days

Time: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection

Measure: Hospitalization

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine
264 A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19

The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation. It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs. Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9 plus standard of care. Part 2 of the study is double-blind, randomized; participants will receive either APL-9 or the vehicle-control plus standard of care.

NCT04402060
Conditions
  1. COVID
  2. Covid-19
  3. Coronavirus
  4. Coronavirus Infection
  5. Severe Acute Respiratory Syndrome
  6. Severe Acute Respiratory Syndrome Coronavirus 2
  7. Sars-CoV2
  8. Ards
  9. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: APL-9
  2. Other: Vehicle Control
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Measure: Cumulative incidence of treatment-emergent serious adverse events and treatment-emergent adverse events.

Time: Day 1 through Day 51

Secondary Outcomes

Measure: Hospital length of stay

Time: Day 1 through Day 21

Measure: Any cause of mortality

Time: Day 1 through day 58

Description: The minimum value is 0 and maximum value is 24. The higher a score the worse the outcome.

Measure: Sequential Organ Failure Assessment

Time: Day 1 through day 21

Measure: Total duration of mechanical ventilation and/or oxygen therapy

Time: Day 1 through day 21

Measure: Total duration of oxygen therapy

Time: Day 1 through day 21
265 A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic

The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

NCT04402879
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. COVID-19
  3. Acute Respiratory Distress Syndrome
  4. ARDS
  5. Hypoxemic Respiratory Failure
Interventions
  1. Procedure: Prone Positioning (PP)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Syndrome

Primary Outcomes

Description: In-hospital mortality or discharge to hospice at Day 60.

Measure: Hospital mortality or discharge to hospice

Time: 60 days

Secondary Outcomes

Description: An Adverse Event (AE) is any unfavourable or other finding (including clinically significant laboratory tests), symptom or disease occurring during the during of the study, whether or not it is considered to be related to the medicinal (investigational) product, not explicitly classified elsewhere in this protocol, and whether or not it is expected. A Serious Adverse Event (AE) is any unfavourable medical finding (including clinically significant laboratory tests) at any dose that: Results in death (primary outcome) Is life threatening Results in persistent of significant disability or incapacity Requires in in-patient hospitalisation or prolongation of Hospitalisation

Measure: Adverse Events and Serious Adverse Events

Time: 60 days

Description: Change in SpO2 during each PP session (SpO2 in prone position - SpO2 prior to prone positioning). Clinicians will be asked to record this change for the first proning session per shift (for 12 hour shifts this will result in 2 proning sessions being documented per 24 hour period, and for 8 hour shifts this will result in 3 proning sessions being documented per 24 hour period).

Measure: Change in SpO2

Time: 60 days

Description: Number of hospital free days in the 60 days after enrolment.

Measure: Hospital free days

Time: 60 days

Description: Admission to the Intensive Care Unit.

Measure: Admission to ICU

Time: 60 days

Description: Patient is intubated and requires mechanical ventilation.

Measure: Intubation and mechanical ventilation

Time: 60 days

Description: Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).

Measure: Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).

Time: 60 days

Description: The number of oxygen-free days at Day 60 (censored at discharge).

Measure: Oxygen-free days

Time: 60 days

Description: Time from admission to all-cause in-hospital death.

Measure: In-hospital death (time)

Time: 60 days

Description: Death at 90 days.

Measure: Death at 90 days

Time: 90 days
266 Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.

COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world. If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date). However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms. Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc. Given the novelty of this infection, several questions remain: - What are all the symptoms that can be contracted by a COVID-19 patient? - Are there clinical forms not described? - What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis? - What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?

NCT04402905
Conditions
  1. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: measure of the absence of symptoms to assess the rate of complete clinical recovery on day 30

Measure: COVID-PSL Cohort

Time: 3 months
267 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.

NCT04402957
Conditions
  1. COVID
  2. Severe Acute Respiratory Syndrome
  3. Sars-CoV2
  4. Acute Kidney Injury
Interventions
  1. Drug: LSALT peptide
  2. Drug: Placebo
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Acute Kidney Injury Syndrome Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.

Measure: Development of Acute Respiratory Distress Syndrome (ARDS) and Other Organ Injuries

Time: 28 days

Secondary Outcomes

Description: High-frequency oscillatory ventilation, with its rapid delivery of low tidal volumes and a respiratory rate in the range of 60 to 900 breaths/minute, has also been utilized in ARDS patients.

Measure: Ventilation-free days

Time: 28 days

Description: Oxygen therapy provided as non-invasive therapy for ARDS patients.

Measure: Time on nasal cannula or oxygen masks

Time: 28 days

Description: 28 day mortality - all cause and attributable

Measure: 28 day mortality - all cause and attributable

Time: 28 days

Description: ICU and hospitalization length of stay (days)

Measure: ICU and hospitalization length of stay (days)

Time: 28 days

Description: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rate

Measure: SARS-CoV2 testing

Time: 28 days

Description: Extracorporeal membrane oxygenation (ECMO) is often used for severe ARDS to allow lung healing/repair and reverse respiratory failure.

Measure: Need and duration for extracorporeal membrane oxygenation (ECMO)

Time: 28 days

Description: Vasopressor free days

Measure: Vasopressor free days

Time: 28 days

Description: Chest X-rays performed at Baseline, Day 3, at clinical improvement, and end-of-treatment (EOT) and study (EOS) to determine presence of bilateral opacities.

Measure: Radiographic pulmonary assessments

Time: 28 days

Description: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcome

Measure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores

Time: 28 days

Description: Incidence of other organ (non-lung) disorders

Measure: Incidence of non-lung disorders

Time: 28 days

Description: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline

Measure: Measures of liver dysfunction

Time: 28 days

Description: Change in SCr and eGFR from baseline

Measure: Measures of kidney dysfunction

Time: 28 days

Description: Change in highly-sensitive troponin (hs-troponin) from baseline

Measure: Measures of cardiac dysfunction

Time: 28 days

Description: Change from baseline ACT, aPTT, and/or PT/INR levels

Measure: Measures of coagulopathies

Time: 28 days

Description: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.

Measure: Changes in immunogenic responses

Time: 28 days

Description: Changes in total healthcare costs from admission to discharge between treatment groups.

Measure: Healthcare outcomes

Time: 28 days

Description: Change in serum cytokines including IL-1α, IL-1ß, IL-1ra, IL-5, IL-6, IL-8, IL-12, TNFα, CXCL10/IP10, MCP-3, and ferritin drawn at the same time as LSALT peptide levels

Measure: Molecular changes in pro-inflammatory pathways

Time: 28 days

Description: Pharmacokinetics of LSALT peptide over the study period.

Measure: Pharmacokinetics of LSALT peptide

Time: 28 days
268 Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.

NCT04403100
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Virus Disease
  4. Acute Respiratory Infection
  5. SARS-CoV Infection
Interventions
  1. Drug: Hydroxychloroquine Sulfate Tablets
  2. Drug: Lopinavir/ Ritonavir Oral Tablet
  3. Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets
  4. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)

Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease

Time: Measuring during 28-day period since randomization (Intention to treat analysis)

Measure: Proportion of participants who died due to COVID-19 progression and/ or complications

Time: Measuring during 28-day period since randomization (Intention to treat analysis)

Secondary Outcomes

Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)

Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization

Time: Measuring during 14-day period since randomization

Description: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.

Measure: Time to clinical improvement

Time: Measuring during 28-day period since randomization

Description: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;

Measure: Time to clinical failure

Time: Measuring during 28-day period since randomization

Description: Proportion of participants with hospitalization for any cause

Measure: Hospitalization for any cause

Time: Measuring during 28-day period since randomization

Measure: Proportion of participants who died due to pulmonary complications

Time: Measuring during 28-day period since randomization

Measure: Proportion of participants who died due to cardiovascular complications

Time: Measuring during 28-day period since randomization

Description: Evaluation of adverse events evaluated as associated to any of study arms

Measure: Proportion of participants who presented with adverse events

Time: Measuring during 28-day period since randomization

Description: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.

Measure: Time to improvement on respiratory scale symptoms

Time: Measuring during 28-day period since randomization

Measure: proportion of non-adherent participants to any of study drugs

Time: Measuring during 10-day period since randomization
269 Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial

There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.

NCT04403646
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Coronavirus Infection
Interventions
  1. Dietary Supplement: ARBOX
  2. Other: PLACEBO
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: defined as the time from first dose of polyphenol extract to hospital discharge

Measure: Time to hospital discharge

Time: Throughout the Study (Day 0 to Day 28)

Secondary Outcomes

Description: proportion

Measure: 28-day all-cause mortality

Time: Throughout the Study (Day 0 to Day 28)

Description: proportion

Measure: invasive ventilation on day 28

Time: Throughout the Study (Day 0 to Day 28)

Description: mean difference

Measure: Difference in Pro and antiinflammatory citoquine levels

Time: day 1-14

Measure: Difference in fecal intestinal microbiota composition

Time: day 1-14

Description: proportion

Measure: Negativization of COVID-PCR at day 14

Time: day 14
270 A Phase III Prospective, Interventional, Cohort, Superiority Study to Evaluate the Benefit of Rapid COVID-19 Genomic Sequencing (the COVID-19 GENOMICS UK Project) on Infection Control in Preventing the Spread of the Virus in United Kingdom NHS Hospitals

Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.

NCT04405934
Conditions
  1. Covid-19
  2. Nosocomial Infection
  3. Coronavirus
  4. Coronavirus Infection
  5. SARS-CoV 2
Interventions
  1. Other: Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures
MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence rate of IPC-defined HOCIs, measured as incidence rate of recorded cases per week per 100 inpatients, during each phase of the study based on case report forms.

Measure: Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs)

Time: 6 months

Description: Identification of nosocomial transmission using sequencing data in potential HOCIs in whom this was not identified by pre-sequencing IPC evaluation, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing

Time: 6 months

Secondary Outcomes

Description: Incidence rate of IPC-defined hospital outbreaks, defined as cases of hospital transmission linked by location and with intervals between diagnoses of no greater than 2 weeks (relevant data extracted from case report forms), measured as incidence rate of outbreak events per week per 100 inpatients during each phase of the study.

Measure: Incidence rates of IPC-defined hospital outbreaks

Time: 6 months

Description: Incidence rate of IPC+sequencing-defined hospital outbreaks, defined by retrospective review of all available sequencing and epidemiological data for identification of transmission clusters and measured as outbreak events per week per 100 inpatients during each phase of the study.

Measure: Incidence rates of IPC+sequencing-defined hospital outbreaks

Time: 6 months

Description: Changes to IPC actions implemented following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Changes to IPC actions following viral sequence reports

Time: 6 months

Description: Changes to IPC actions that would ideally have been implemented (given unlimited resources) following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Recommended changes to IPC actions following viral sequence report - not implemented

Time: 6 months

Description: Health economic benefit of standard and rapid sequencing reports to IPC measured using bespoke health economic case report data comparison between baseline, standard and rapid sequencing phases.

Measure: Health economic benefit to IPC of standard vs rapid sequencing reports

Time: 6 months

Description: Number of HCW days off work measured from sampling these data points on case report forms at all study phases.

Measure: Impact of both standard and rapid sequencing reports on number of HCW days off work

Time: 6 months
271 Prevention of Coronavirus Disease (COVID-19) Outbreaks by Prophylactic Treatment With Nitazoxanide

The new coronavirus outbreak has led to a public health emergency of international concern, putting all health organizations on high alert. As part of the hygienic measures, isolation and reinforcement cleaning strategies have been followed. It is known that special attention and efforts should be applied to protect or reduce transmission in susceptible populations, including the elderly or those with comorbidities.It has also been proposed a semaforization to classify patients with respiratory symptoms based on: Fever (38ºC or more), dry cough, headache, dyspnea, joint pain, muscle pain, sore throat, nose discharge, conjunctivitis, chest pain, diarrhea, anosmia, ageusia. Nitazoxanide has shown to be effective against several viruses, of both types RNA and DNA, including other coronavirus that produced the Severe Acute Respiratory Syndrome (SARS) and the Middle East Respiratory Syndrome (MERS). Facing the lack of options against COVID-19 outbreaks for example in health workers, nitazoxanide could contribute to decrease the contagious dissemination of SARS-CoV-2, thus reducing at the same time the Hospital saturation of patients positive to this virus.

NCT04406246
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Nitazoxanide 500Mg Oral Tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The percentage of health workers that require hospitalization after beginning an early treatment with nitazoxanide in case of referring symptoms of COVID-19.

Measure: Health workers that require hospitalization

Time: Two weeks since the begining of symptoms
272 Investigation of Systemic Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of Coronavirus Disease-19.

Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.

NCT04406545
Conditions
  1. Coronavirus Infection
  2. Endothelial Dysfunction
  3. Microvascular Rarefaction
Interventions
  1. Other: evaluation of skin microvascular flow and reactivity
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Microvascular Rarefaction

Primary Outcomes

Description: skin laser Doppler perfusion monitoring before and after local thermal hyperemia

Measure: To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19.

Time: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
273 Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection

Observational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

NCT04407143
Conditions
  1. Lung Cancer
  2. COVID
  3. Corona Virus Infection
Interventions
  1. Diagnostic Test: IgG test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Neoplasms
HPO:Neoplasm of the lung

Primary Outcomes

Description: Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.

Measure: Description of the characteristics of patients

Time: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks
274 Convalescent Plasma Therapy in Patients With COVID-19

Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.

NCT04407208
Conditions
  1. Convalescence
  2. Corona Virus Infection
  3. Plaque
Interventions
  1. Biological: Convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Convalescence

Primary Outcomes

Description: PNRT50

Measure: Plaque reduction neutralization test (PNRT)

Time: day 7 after first transfusion

Description: Change of D-dimer compared between pre and post transfusion

Measure: D-dimer

Time: day 1,4,7,14 after first transfusion

Description: Change of CRP compared between pre and post transfusion

Measure: C-Reactive Protein (CRP)

Time: day 1,4,7,14 after first transfusion

Description: Change of INR compared between pre and post transfusion

Measure: International Normalized Ratio (INR)

Time: day 1,4,7,14 after first transfusion

Description: Change of OI compared between pre and post transfusion

Measure: Oxygenation Index

Time: day 1,4,7,14 after first transfusion

Description: Change of CXR with CXR covid score compared between pre and post transfusion

Measure: Chest X-ray

Time: day 1,4,7,28 after first transfusion

Secondary Outcomes

Description: every adverse event that cause patient to die, prolonged hospitalization or worsening clinical stage of illness

Measure: severe adverse event

Time: from day 0 to 14 days after plasma transfusion
275 Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)

The United Kingdom and wider world is in the midst of the 2019 novel coronavirus (SARS-CoV-2) pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance to our response. Widespread population testing has proven difficult in western countries and has been limited by test availability, human resources and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients and early treatment for those most at risk. The life sciences industry has responded to the pandemic by developing multiple new in vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests we require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation in this global pandemic, we will conduct a platform adaptive diagnostic study on a national level, utilising a national network of expertise in the evaluation of diagnostic technology. This study will enable the evaluation of multiple assays in three priority areas: 1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2 2. Evaluation of assays monitoring the immune response to SARS-CoV-2 infection 3. Evaluation of the prognostic value of commercially available tests for predicting prognosis in patients with suspected or confirmed SARS-CoV-2 infection. (This arm will not be active immediately but may be activated after initiation).

NCT04408170
Conditions
  1. Coronavirus Infection
  2. COVID-19
Interventions
  1. Diagnostic Test: Point-of-care test for SARS-CoV-2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This will be determined using the point-of-care test and the laboratory test results

Measure: If the participant has an active SARS-CoV-2 infection during admission

Time: Baseline

Description: This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results

Measure: The participant has had a past SARS-CoV-2 infection

Time: Day 90
276 Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure

The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.

NCT04408222
Conditions
  1. Oxygen Deficiency
  2. Coronavirus Infection
Interventions
  1. Other: Awake proning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: SpO2 was measured by peripheral pulse oximetry.

Measure: Change in SpO2

Time: Before proning and 1 hour after initiation of the prone position

Secondary Outcomes

Description: The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. <95% 1 hour after initiation of the prone position was assessed.

Measure: Mean Risk Difference in Intubation Rates

Time: Duration of hospitalization or up to 1 month from admission
277 Retrospective Change in the Ratio of Mean Platelet Volume (MPV) to Platellet(PLT) in Covid-19 Pneumonia Patients

Morbidity, mortality and progress depends on systemic inflammation especially in ARDS patients. Previous studies claims that the proportion of mean platellet volume to platellet which can simply be determined with simple blood tests that are performed at admission, might predict the mortality in ARDS patients. Covid-19 pneumonia has a very similar clinical outlook with ARDS. Therefore we decided to research whether that proportion is legitimate for detecting the progress of Covid-19 pneumonia or not.

NCT04408378
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: observation of covid 19 pneumonia
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: İt has been studied that MPV/PLT ratio can show the cl inical couses of several diseases as well as ARDS. we thought that we can identify the coronavirus pneumonia patients earlier, at admission of hospital by using the hemogrames.

Measure: estimation of inflammatory changes in Covid 19 pneumonia by using MVP/PLT ratio

Time: March-May 2020
278 Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19)

In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 30 seconds, for 4 weeks.

NCT04409873
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Severe Acute Respiratory Syndrome Coronavirus 2
  4. Virus Disease
  5. Coronavirus Infections
  6. Pharyngeal Diseases
Interventions
  1. Drug: Oral-B Mouth Sore mouthwash
  2. Drug: Crest Pro-Health Multi-Protection mouthwash
  3. Drug: CloSYS mouthwash
  4. Drug: Distilled water
  5. Drug: Listerine Mouthwash Product
MeSH:Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome Pharyngeal Diseases

Primary Outcomes

Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load

Measure: Change in SARS-Cov-2 viral load

Time: Baseline to 4 weeks

Secondary Outcomes

Description: Change in self-reported (questionnaire) clinical symptom onset. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.

Measure: Change in self-reported clinical symptom onset

Time: Baseline to 4 weeks

Description: Change in healthcare utilization and hospitalization

Measure: Change in healthcare utilization and hospitalization

Time: Baseline to 4 weeks

Other Outcomes

Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers

Measure: Change in SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers

Time: Baseline to 4 weeks

Description: Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.

Measure: Change in self-reported clinical symptom onset in tobacco users, marijuana smokers, or vapers

Time: Baseline to 4 weeks

Description: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers

Measure: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers

Time: Baseline to 4 weeks
279 Microbiota in COVID-19 Patients for Future Therapeutic and Preventive Approaches

In light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global population and health care systems are facing unprecedented challenges through the combination of transmission and the potential for severe disease. Acute respiratory distress syndrome (ARDS) has been found with unusual clinical features dominated by substantial alveolar fluid load. It is unknown whether this is primarily caused by endothelial dysfunction leading to capillary leakage or direct virus induced damage. This knowledge gap is significant because the initial balance between fluid management and circulatory support appear to be decisive. On progression of the disease, bacterial superinfection facilitated by inflammation and virus related damage, has been identified as the main factor for patient outcome, but the role of the host versus the environment microbiome remains unclear. The overarching aim of the present research proposal is to improve therapeutic strategies in critically ill patients with ARDS due to SARS-CoV-2 infection by advancing the pathophysiological understanding of this novel disease. This research thus focuses on inflammation, microcirculatory dysfunction and superinfection, aiming to elucidate risk factors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients and contribute to the rationale for therapeutic strategies. The hypotheses are that (I) the primary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggerated pro-inflammatory response causing primary endothelial dysfunction, and subsequently acting two-fold on the degradation of the lung parenchyma - through the primary cytokine response, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophil axis. The pronounced inflammation and primary damage to the lung disrupts the pulmonary microbiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterial superinfections are a significant cause of morbidity and mortality in COVID-19 patients. Pathogen colonization main Risk Factor for lower respiratory tract infections. To establish colonization, pathogens have to interact with the local microbiota (a.k.a. microbiome) and certain microbiome profiles will be more resistant to pathogen invasion. Finally, (III) Handheld devices used in clinical routine are a potential reservoir and carrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.

NCT04410263
Conditions
  1. Corona Virus Infection
  2. ARDS
  3. Coinfection
Interventions
  1. Diagnostic Test: Sampling (EDTA blood, pharyngeal and nose swabs, bronchoalveolar lavage ,urine)
MeSH:Coinfection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Daily recorded Vitals and Inflammatory Response will be analyzed by means of multivariable mixed effect models analysis and generalized linear models, with corrections for time and randomness. To account for the different units of measure we will standardize all values to an absolute measure by means of the z-score. The following variables will be considered: Respiratory values, Vital signs, Haemodynamic monitoring, Microcirculation, Inflammatory values, Hematology: T-cells CD3, 4 and 6 Chemistry: Inflammatory Cytokines and Biomarkers:CRP, PCT, MR-ProADM, IFN-1, IFN-γ, TNF-α/β, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, MIG, RANTES, MCP-1, IP-10, PD1, PD-L1 Lipid-pannel3: LDL, HDL, Cholesterol, Triglyceride Other: HLA DR/DQ TBS, Swabs, sublingual nonnvasive microscopy

Measure: Change of pro-inflammatory response over the ICU stay as a causative for primary endothelial dysfunction

Time: Admission, on day 0, day 1, day 2 , day 3, day 5, every 5 days up to 1 year

Description: COX proportional hazards model and generalized mixed effect models assessing the effect of positive bacterial infection on mortality. Correction for time and randomness (multiple sampling). Super infection will be defined as a positive bacterial/ fungal sample (Bood cultures, BAL, TBS, Swabs, Urine)

Measure: Time-to-event "pulmonary bacterial superinfection or death"

Time: Through study completion, an average of 30 days

Description: Mobile devices will be swabed for bacterial and viral contamination, simultaneously adherence of the user to disinfection protocols will be assessed.

Measure: Positive bacteria and/ or SARS-CoV-2 cultures on handheld devices used in clinical routine and correlation to the adherence to disinfection protocols

Time: Through study completion, an average of 30 days

Secondary Outcomes

Description: SF 36 questionnaire

Measure: Life Quality after COVID-19 Infection

Time: follow up 30 + 90 days and 1 year after discharge
280 PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic

To find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease

NCT04410484
Conditions
  1. Inflammatory Bowel Diseases
  2. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Intestinal Diseases Inflammatory Bowel Diseases
HPO:Abnormal intestine morphology Inflammation of the large intestine

Primary Outcomes

Measure: Flare of IBD needing change in therapy or surgery

Time: 3 months
281 Study of the P2Et Extract Obtained From Caesalpinia Spinosa in the Symptomatic Treatment of Subjects With COVID-19 at the Hospital Universitario San Ignacio, Colombia.

Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct. The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data). These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.

NCT04410510
Conditions
  1. COVID
  2. Coronavirus Infection
  3. SARS-CoV 2
  4. COVID19
Interventions
  1. Drug: P2Et (Caesalpinia spinosa extract)
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients who reduce the time in the hospital

Measure: Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19

Time: 30 days

Secondary Outcomes

Description: Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19

Measure: Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19

Time: 30 days

Description: Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment

Measure: Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment

Time: 30 days

Description: Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment

Measure: Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment

Time: 30 days

Description: Assess the efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.

Measure: Efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.

Time: 30 days

Description: Evaluate the efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.

Measure: Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.

Time: 30 days

Description: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19

Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19

Time: 30 days
282 Psychological Impact and Effect of the Corona Virus (SARS-CoV-2) and COVID-19 Pandemic in Individuals With Psychiatric Disorders - an Online Survey

The aim of this study is to measure current affective symptoms and psychological distress in individuals with severe mental illness during the COVID-19 pandemic using an online questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep quality, attitudes concerning the virus, the adherence to the measures, believing processes, and coping strategies/resilience patterns referring to COVID-19 in different study centers.

NCT04410835
Conditions
  1. Corona Virus Infection
  2. Psychiatric Disorder
  3. Psychological Distress
Interventions
  1. Diagnostic Test: Online Survey
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Brief Symptom Inventory-18 with higher scores meaning a worse outcome (more depression, anxiety and somatization); Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 72)

Measure: Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index)

Time: 1 year

Description: Beck Depression Inventory-II with higher scores mean a worse Outcome (more depressive Symptoms; each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)

Measure: Depressive symptoms

Time: 1 year

Description: Pittsburgh Sleep Quality Index (PSQI) with higher scores mean a worse Outcome (more sleeping disturbances; Each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)

Measure: Sleep disorders and Sleep Quality

Time: 1 year

Secondary Outcomes

Description: Lifestyle Questions including physical activity, eating behavior, substance use, smoking

Measure: Life style changes

Time: 1 year

Description: Food Craving Inventory (FCI) with higher scores mean a worse Outcome (more Food craving; Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 112)

Measure: Food Craving

Time: 1 year

Description: COVID-19 questionnaire with higher scores meaning a worse Outcome (more fears and negative emotions; each item is weighted on a 0-10 interval scale)

Measure: COVID-19 associated fears and emotional responses to the pandemic

Time: 1 year
283 Convalescent Plasma to Treat Coronavirus - Associated Severe Pulmonary Complications: A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Patients With Severe Respiratory Distress Due to COVID-19

Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.

NCT04411602
Conditions
  1. Severe Acute Respiratory Syndrome
  2. COVID
Interventions
  1. Drug: SARS-CoV-2 plasma
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma

Measure: Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure.

Time: Track patient progress for 28 days post initial convalescent dose.

Secondary Outcomes

Description: Measure reduction in ventilator use and/or changes in mechanical ventilator parameters

Measure: Ventilatory free days

Time: Track patient progress for 28 days post initial convalescent dose.

Description: Measure length of stay from the time of admission to the hospital and subsequent admission to the ICU. Document resolution of COVID-19 infection or alternatively patient death.

Measure: Patient mortality (including death from any cause)

Time: Track patient progress for 28 days post initial convalescent dose.
284 Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days) vs late (after at least 10 days) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality will be evaluated and compared.

NCT04412356
Conditions
  1. Covid-19
  2. ARDS
  3. Tracheostomy Complication
  4. Respiratory Insufficiency
  5. Corona Virus Infection
Interventions
  1. Procedure: Tracheotomy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Pulmonary Valve Insufficiency
HPO:Pulmonary insufficiency

Primary Outcomes

Description: Number of days without mechanical ventilation

Measure: Mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Number of days at ICU

Measure: ICU stay

Time: 28 days

Description: Number of days with need of additional oxygen support

Measure: Oxygen support

Time: 28 days

Description: Number of days with the need of sedation

Measure: Sedation

Time: 28 days

Description: Various adverse events associated with the tracheotomy/tracheostomy

Measure: Adverse events

Time: 28 days

Description: Mortality

Measure: Mortality

Time: 90 days
285 Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

NCT04412395
Conditions
  1. Corona Virus Infection
  2. Middle East Respiratory Syndrome (MERS)
  3. Acute Respiratory Distress Syndrome
  4. Coronavirus Infection
  5. COVID-19
  6. SARS-CoV 2
Interventions
  1. Dietary Supplement: Lactoferrin (Apolactoferrin)
  2. Drug: Placebo of excipient(s) will be administered
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Comparing the influence of the intervention on the Survival rate.

Measure: Survival rate.

Time: up to 8 weeks.

Description: For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.

Measure: Rate of disease remission.

Time: up to 4 weeks.

Description: Comparing the influence of the intervention on the PCR negative results.

Measure: The number of patients with PCR negative results.

Time: up to 4 weeks.

Secondary Outcomes

Description: Recording the changes from severe to moderate or mild and the time taken.

Measure: Mean change in the disease severity (clinical assessment).

Time: up to 4 weeks.

Description: Recording the changes in blood pressure mmHg.

Measure: Mean change in blood pressure.

Time: up to 4 weeks.

Description: Recording the changes in heart rate in beat/second.

Measure: Mean change in heart beats.

Time: up to 4 weeks.

Description: Recording the changes in body temperature in Celsius.

Measure: Mean change in body temperature.

Time: up to 4 weeks.

Description: Recording the changes in the respiratory rate in breath/minute.

Measure: Mean change in body respiratory rate.

Time: up to 4 weeks.

Description: Recording the changes in arterial oxygen saturation in mmHg.

Measure: Mean change in oxygen saturation.

Time: up to 4 weeks.

Description: Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Measure: Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Time: up to 4 weeks.

Description: Recording the changes in complete blood picture (CBC) in cells per liter.

Measure: Mean change in complete blood picture (CBC).

Time: up to 4 weeks.

Description: Recording the changes in C reactive protein (CRP) in mg/L.

Measure: Mean change in C reactive protein (CRP).

Time: up to 4 weeks.

Description: Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.

Measure: Mean change in erythrocyte sedimentation rate (ESR).

Time: up to 4 weeks.

Description: Recording the changes in D-dimer in ng/mL.

Measure: Mean change in D-dimer.

Time: up to 4 weeks.

Description: Recording the changes in ferritin in ng/mL.

Measure: Mean change in ferritin.

Time: up to 4 weeks.

Description: Recording the changes in liver Albumin in g/L.

Measure: Mean change in liver Albumin.

Time: up to 4 weeks.

Description: Recording the changes in total and direct Bilirubin in mg/dL.

Measure: Mean change in total and direct Bilirubin.

Time: up to 4 weeks.

Description: Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).

Measure: Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).

Time: up to 4 weeks.

Description: Recording the changes in aspartate aminotransferase (AST) in IU/L.

Measure: Mean change in aspartate aminotransferase (AST).

Time: up to 4 weeks.

Description: Recording the changes in Alanine Aminotransferase (ALT) in IU/L.

Measure: Mean change in Alanine Aminotransferase (ALT).

Time: up to 4 weeks.

Description: Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.

Measure: Mean change in Blood Urea Nitrogen (BUN).

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in mg/dL.

Measure: Mean change in Serum Creatinine.

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in ml/min.

Measure: Mean change in Serum Creatinine clearance.

Time: up to 4 weeks.

Description: Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.

Measure: Mean change in Glomerular filtration rate (GFR ).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-1 (IL-1) in pg/ml.

Measure: The mean change in serum interleukin-1 (IL-1).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-6 (IL-6) in pg/ml.

Measure: The mean change in serum interleukin-6 (IL-6).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-10 (IL-10) in pg/ml.

Measure: The mean change in serum interleukin-10 (IL-10).

Time: up to 4 weeks.

Description: Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.

Measure: The mean change in serum tumor necrosis factor-alpha (TNF alpha).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin G (IgG) in ng/ml.

Measure: Mean changes in immunoglobulin G (IgG).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin M (IgM) in ng/ml.

Measure: Mean changes in immunoglobulin M (IgM).

Time: up to 4 weeks.

Description: Recording the changes in PCR viral load in copies/mL.

Measure: The mean change in PCR viral load.

Time: up to 4 weeks.

Description: Recording the changes in lung CT.

Measure: Mean change in lung CT manifestation.

Time: up to 4 weeks.

Description: Recording any unexpected Adverse Events of the intervention.

Measure: Nature and severity of Adverse Events.

Time: up to 4 weeks.

Description: Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.

Measure: Time for lung recovery.

Time: up to 8 weeks.

Description: Recording the changes the event of missed drug doses.

Measure: The number of missed drug doses among each treatment group.

Time: up to 4 weeks.
286 Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.

NCT04412551
Conditions
  1. Corona Virus Infection
  2. Virus Diseases
  3. Coronaviridae Infections
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Severe Acute Respiratory Syndrome Coronaviridae Infections

Primary Outcomes

Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU

Measure: Identification of requirement of mechanical ventilation

Time: 3 weeks

Secondary Outcomes

Description: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU

Measure: Prediction of requirement of mechanical ventilation

Time: 3 weeks

Description: Descriptive assessment of clinical parameters and LUS-score over time

Measure: Association of LUS to clinical parameters

Time: 3 weeks

Description: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19

Measure: Description of findings on LUS

Time: 3 weeks
287 Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms

By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China. It is known that some predisposing conditions lead to a worse outcome with coronavirus. In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36). The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms. In the future, this study will provide answers for two main questions 1. Why diabetics are more at risk of developing Covid-19 infection? 2. Why diabetics are at high risk of developing severe forms?

NCT04412746
Conditions
  1. Coronavirus Infections
  2. Diabetes Mellitus
  3. Prevalence
  4. Risk Factors
  5. Patient Outcome Assessment
  6. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: MANAGEMENT OF COVID-19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen

Measure: Prevalence of diabetes among all hospitalized COVID-19

Time: 3 months

Description: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

Measure: Diabetes-related factors risk

Time: 3 months
288 Clinical Characteristics of Critically Ill Patients With 2019 Novel Coronavirus (COVID-19): Do We Need a New Triage System?

Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Hence, it may be need a new scoring system for contagious critically ill patients.

NCT04413435
Conditions
  1. Coronavirus Infection
  2. Critical Illness
  3. Characteristics Disease
Interventions
  1. Other: File Scanning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Description: To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.

Measure: Polymerase Chain Reaction (PCR) test

Time: 5 days

Secondary Outcomes

Description: To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.

Measure: A scoring system for patients to be admitted to the intensive care unit

Time: 5 days
289 Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19

COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.

NCT04413747
Conditions
  1. Coronavirus Infection
  2. Cytokine Storm
  3. Mental Disorder
Interventions
  1. Behavioral: morning Yoga-based breathing support
  2. Behavioral: pre_lunch Yoga-based breathing support
  3. Behavioral: pre_dinner Yoga-based breathing support
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Mental Disorders Psychotic Disorders
HPO:Psychosis

Primary Outcomes

Description: COVID-19's Patients mortality all cause: incidence proportion.

Measure: Mortality

Time: 12 months.

Description: COVID-19's Patients suicide: incidence proportion.

Measure: Mortality-suicide

Time: 12 months.

Secondary Outcomes

Description: In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -

Measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients-

Time: 1 months.

Description: Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.

Measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder.

Time: 12 months.

Description: Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.

Measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).

Time: 12 months.

Description: Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.

Measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).

Time: 12 months.
290 Contamination and Transmission of the SARS-CoV-2 Virus in Exposed, Confined and Community-based Infants: A Cross-sectional, Multicentre, Interventional Seroprevalence Study

According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.

NCT04413968
Conditions
  1. Coronavirus
  2. Coronavirus Infection
  3. Covid19
  4. Sars-CoV2
Interventions
  1. Diagnostic Test: Rapid detection test
  2. Diagnostic Test: Nasopharyngeal swab
  3. Diagnostic Test: Stool collection
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of children with a positive rapid serological test (presence of anti-SARS-CoV2 antibodies (IgM or IgG)).

Measure: Assess the serological status/rate of past infections in the children of priority staff in the nursery during the containment period

Time: Day of intervention (1 day)
291 A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial

Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

NCT04414267
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Corona Virus Infection
  4. Coronary Heart Disease
  5. Chronic Obstructive Pulmonary Disease
Interventions
  1. Biological: BCG vaccine
  2. Biological: Placebo
MeSH:Infection Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Heart Diseases Coronary Disease
HPO:Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

Time: Visit 3 (90 +/- 5 days)

Secondary Outcomes

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

Time: Visit 4 (135 +/- 5 days)

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

Time: Visit 5 (180 +/- 5 days)

Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

Measure: Prevalence of IgG/IgM against SARS-CoV-2

Time: Screening Visit and Visit 3 (90 +/- 5 days)

Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

Measure: The impact of new cardiovascular events between the two study groups

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)
292 Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2a Study, in Adult Subjects Hospitalized With SARS-CoV-2 Positive Pneumonia

This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. 20 patients will receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive matching placebo in addition to standard of care unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.

NCT04414618
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Opaganib
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To compare the total oxygen requirement (area under the curve) for each arm using daily supplemental oxygen flow (L/min) over 14 days

Measure: Measurement of the oxygen requirement

Time: 14 days

Secondary Outcomes

Description: To comparing the time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min

Measure: Measurement of the reduction in oxygen requirement.

Time: 14 days

Description: To comparing the proportion of patients in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14

Measure: Eliminating supplemental oxygen

Time: 14 days

Description: To compare the proportion of afebrile patients in each arm at Day 14 via measurement of temperature.

Measure: Elimination of fever

Time: 14 days

Description: To compare the time in each arm to negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab for SARS-CoV-2

Measure: Time to negative swabs for SARS-CoV-2 by PCR post treatment

Time: 6 weeks

Description: To comparing the time in each arm to achieve negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab for SARS-CoV-2 during treatment

Measure: Time to negative swabs for SARS-CoV-2 by PCR at Day 14

Time: 14 days

Description: To compare the percentage of patients in each arm who require intubation and mechanical ventilation by Day 14

Measure: Intubation and mechanical ventilation requirements

Time: From screening phase and every day from day 1 to day 14 of treatment

Description: To compare the time in each arm for the patient to require mechanical ventilation.

Measure: Evaluation of the time to mechanical ventilation

Time: From screening phase and every day from day 1 to day 14 of treatment

Description: To compare the proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14

Measure: Evaluation the proportion of patients, with at least one measurement of fever at baseline who are afebrile at Day 14

Time: From screening phase and every day from day 1 to day 14 of treatment

Description: To compare the mortality in each arm 30 days post-baseline.

Measure: Evaluation of mortality 30 days post-baseline

Time: 30 days after day 1 of treatment

Other Outcomes

Description: To compare the number of all treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Measure: Safety

Time: 6 weeks
293 Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).

The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

NCT04414631
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Conestat alfa
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.

Measure: Disease severity

Time: on day 7

Secondary Outcomes

Description: Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)

Measure: Time to clinical improvement

Time: within 14 days after enrolment

Description: Proportion of participants alive and not having required invasive or non-invasive ventilation

Measure: Proportion of participants alive and not having required invasive or non-invasive ventilation

Time: at 14 days after enrolment

Description: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Measure: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Time: within 14 days after enrolment

Other Outcomes

Description: Changes in the ordinal WHO scale

Measure: Changes in the ordinal WHO scale

Time: from baseline over 14 days

Description: Length of hospital stay in survivors

Measure: Length of hospital stay in survivors

Time: until day 28

Description: Proportion of participants progressing to mechanical ventilation

Measure: Proportion of participants progressing to mechanical ventilation

Time: on day 7 and day 14

Description: Proportion of participants requiring ICU treatment

Measure: Proportion of participants requiring ICU treatment

Time: on day 7 and 14

Description: Length of ICU stay

Measure: Length of ICU stay

Time: until day 28

Description: 28 Ventilator-free days

Measure: 28 Ventilator-free days

Time: until day 28

Description: All-cause mortality

Measure: All-cause mortality

Time: time from randomisation to death within four weeks

Description: Changes in biomarker level CRP

Measure: Changes in biomarker level CRP (mg/l)

Time: until day 14

Description: Changes in biomarker level LDH

Measure: Changes in biomarker level LDH (U/l)

Time: until day 14

Description: Changes in biomarker level D-Dimer

Measure: Changes in biomarker level D- Dimer (yg/ml)

Time: until day 14

Description: Changes in biomarker level Ferritin

Measure: Changes in biomarker level Ferritin (ng/ml)

Time: until day 14

Description: Changes in biomarker level IL-6

Measure: Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml)

Time: until day 14

Description: Changes in lymphocyte count

Measure: Changes in lymphocyte count (cells per microliter of blood)

Time: until day 14

Description: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Measure: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Time: time from enrolment to first of 2 negative assays at least 12 hours apart

Description: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Measure: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Time: within 14 days

Description: Time to defervescence (temperature <38.0°C)

Measure: Time to defervescence (temperature <38.0°C)

Time: sustained for at least 48 hours

Description: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)

Measure: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28

Time: until day 28

Description: Duration of supplemental oxygen

Measure: Duration of supplemental oxygen

Time: until day 28

Description: Peak serum concentration of conestat alfa will be measured

Measure: Change in pharmacokinetics of conestat alfa

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date

Description: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

Measure: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date
294 the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course

According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.

NCT04416009
Conditions
  1. Extracellular Fluid Alteration
  2. Corona Virus Infection
Interventions
  1. Device: NİCaS
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Changes of three measurements of extracellular water in both lungs

Measure: ECW

Time: three measurements with half an hour intervals
295 COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

NCT04416373
Conditions
  1. Coronavirus Infection
  2. Pregnancy Complications
  3. Vertical Transmission of Infectious Disease
  4. Breastfeeding
  5. Neonatal Infection
Interventions
  1. Diagnostic Test: RT PCR SARS-CoV-2
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pregnancy Complications

Primary Outcomes

Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Measure: SARS-CoV-2 Neonatal Infection

Time: 7 days

Secondary Outcomes

Description: stillbirths and deaths in the first week of life

Measure: Perinatal mortality

Time: 35 weeks

Description: maternal ICU admission due to COVID-19

Measure: ICU maternal admission

Time: 35 weeks

Description: Newborn 5 minute Apgar Score < 7

Measure: 5 minute Apgar Score < 7

Time: 1 day

Description: Delivery between 24 and 36 weeks

Measure: Preterm labour

Time: 35 weeks

Description: Preterm premature rupture of the membranes between 24 and 36 weeks

Measure: PPROM

Time: 35 weeks

Description: spontaneous pregnancy loss before 24 weeks

Measure: Miscarriage

Time: 14 weeks
296 Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation

At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus. Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells. Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible. The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.

NCT04416399
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Budesonide dry powder inhaler
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19

Measure: Emergency department attendance of hospitalisation related to COVID-19

Time: Day 1 to day 28

Secondary Outcomes

Description: Evaluate the effect of intervention on body temperature

Measure: Body temperature

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on blood oxygen level

Measure: Blood oxygen saturation level

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.

Measure: Symptoms as assessed by common cold questionnaire

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.

Measure: Symptoms as assessed by FluPro questionnaire

Time: Day 1 to day 14

Description: Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load

Measure: Nasal/throat swab SARS-CoV-2 viral load

Time: Day 1, 7 and 14
297 Quality of Life and Long-term Outcomes in Patients With Pneumonia Associated With SARS-Cov2 Infection, Survivors of Intensive Care Units: a Prospective Multicenter Cohort Study

Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.

NCT04416464
Conditions
  1. Quality of Life
  2. Long-term Outcomes
  3. Coronavirus Infection
  4. Morality
  5. Rehospitalization
Interventions
  1. Other: COVID-19 Pneumonia
MeSH:Infection Coronavirus Infectio Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Measure: Health-related quality of life.

Time: One-year (12 months) after ICU discharge.

Secondary Outcomes

Description: Length of stay at the ICU.

Measure: Length of stay at the ICU.

Time: The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).

Description: Incidence of all-cause mortality.

Measure: Incidence of all-cause mortality

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Rehospitalization.

Measure: Rehospitalization.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.

Measure: Percentage of long-term ventilatory support need.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Percentage of patients requiring any kind of renal replacement therapy.

Measure: Percentage of renal replacement therapy need.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).

Measure: Symptoms of anxiety and depression.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence).

Measure: Score of functional independence.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms.

Measure: Score of cognitive function.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Percentage of major cardiac events.

Measure: Percentage of major cardiac events.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario.

Measure: Score of Chronic obstructive pulmonary disease (COPD)

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).

Measure: Symptoms of posttraumatic stress disorder

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

Measure: Utility score of health-related quality of life at 3, 6, and 9 months.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

Description: The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health).

Measure: Score of self-rated health.

Time: The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.
298 A Proposed Alternative to the N-95 Mask Shortage in the COVID-19 Pandemic. A Feasibility Study

The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System

NCT04416919
Conditions
  1. Coronavirus Infection
  2. Disease Prevention
Interventions
  1. Other: Assembled mask
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Conduct a quantitative fit test and calculate the percentage of participants who pass the test.

Measure: Success Percentage

Time: 15 minutes

Secondary Outcomes

Description: Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask

Measure: End-tidal CO2 Variation. Description: mmHg.

Time: at 0 and 15 minutes

Description: Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask

Measure: Oxygen Pulse Oximetry Variation. Description: mmHg.

Time: at 0 and 15 minutes.

Description: Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes

Measure: Mask Visibility. Description: Likert Scale.

Time: 15 minutes

Description: When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.

Measure: Willingness of usage. Description: Likert Scale.

Time: after 15 minutes
299 Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial

In-vitro studies revealed that nafamostat mesylate has antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and anti-inflammatory and anti-coagulation effect. However, there is no clinical studies on the efficacy of nafamostat in patients with COVID-19. This study is conducted to evaluate the clinical efficacy of nafamostate mesylate in adult patients hospitalized with COVID-19 pneumonia.

NCT04418128
Conditions
  1. Corona Virus Infection
  2. COVID-19
Interventions
  1. Drug: Nafamostat Mesylate
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status. * Seven-category ordinal scale of clinical status not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalization, not requiring supplemental oxygen; hospitalization, requiring supplemental oxygen; hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; death.

Measure: Proportion of patients with clinical improvement

Time: Day 14 & Day 28

Secondary Outcomes

Description: Time to clinical improvement (TTCI) was defined as time from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first.

Measure: Time to clinical improvement (TTCI)

Time: up to 28 days

Description: * Seven-category ordinal scale of clinical status not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalization, not requiring supplemental oxygen; hospitalization, requiring supplemental oxygen; hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; death. Higher scores of Seven-category ordinal scale mean serious clinical status.

Measure: Clinical status assessed by 7-category ordinal scale

Time: days 7, 14, and 28

Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The range of NEW score is from zero to 23. Higher scores of NEWS mean the higher risk of poor outcomes. The NEW Score is being used as an efficacy measure.

Measure: Change in National Early Warning Score (NEWS)

Time: Day 1 trough Day 28

Measure: Time to National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours

Time: Day 1 through Day 28

Measure: Duration of hospitalization

Time: Day 1 through Day 28

Measure: Duration of new non-invasive ventilation or high flow oxygen use

Time: Day 1 through Day 28

Measure: Incidence of new non-invasive ventilation or high flow oxygen use

Time: Day 1 through Day 28

Measure: Duration of new supplement oxygen use

Time: Day 1 through Day 28

Measure: Incidence of new supplement oxygen use

Time: Day 1 through Day 28

Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use

Time: Day 1 through Day 28

Measure: Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use

Time: Day 1 through Day 28

Measure: Mortality at day 28

Time: Day 1 through Day 28

Measure: Time (days) from treatment initiation to death

Time: Day 1 through Day 28

Measure: Proportions of patients with a negative nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR

Time: days 3, 7, 10, 14, and 21

Measure: Viral load change (log10 viral load) of nasopharyngeal swab and sputum sample for SARS-CoV-2 quantitative RT-PCR

Time: days 3, 7, 10, 14, and 21

Measure: Adverse events that occurred during treatment

Time: Day 1 through Day 28
300 A Pilot Study to Explore the Efficacy and Safety of Rescue Therapy With Antibodies From Convalescent Patients Obtained With Double-filtration Plasmapheresis (DFPP) and Infused in Patients With Coronavirus Disease 2019 (COVID-19) and Need of Oxygen Support Without Mechanical Ventilation

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 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 treatment with pulsed methylprednisolone. 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. Moreover, plasma-exchange is expensive and requires large volumes of substitution fluid 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 use of plasma as a substitution fluid further increases treatment costs and is associated with risk of infections, allergic reactions and citrate-induced hypocalcemia. Albumin is better tolerated and less expensive, but exchanges using albumin solutions increase the risk of bleeding because of progressive coagulation factor depletion. The aforementioned limitations of plasma therapy can be in part overcome by using selective apheresis methods, such as double-filtration plasmapheresis (DFPP)3. During DFPP, plasma is separated from cellular components by a plasma filter, and is then allowed to pass through a fractionator filter. Depending on the membrane cut-off, the fractionator filter retains larger molecules and returns fluid along with smaller molecules to the circulation. Thus, the selection of a membrane with an appropriate sieving coefficient for IgG allows to efficiently clear autoantibodies in patients with antibody-mediated diseases (e.g., macroglobulinemia, myasthenia gravis and rheumatoid arthritis) with negligible fluid losses and limited removal of albumin and coagulation factors1. In patients with severe membranous nephropathy and high titer of autoreactive, nephritogenic antibodies against the podocyte-expressed M type phospholipase A2 receptor (PLA2R), DFPP accelerated anti PLA2R depletion4. Measurement of the antibody titer in treated patient and recovered fluid showed that antibody removal was extremely effective and that large part of antibodies was removed during the first DFPP procedure. This therapeutic regimen was safe and well tolerated and easy to apply4. In an ongoing pilot study we found that the same methodological approach can be used to remove circulating antibodies from patients who recovered from COVID 19 and to infuse these antibodies in patients with active viral infection. Treatment was well tolerated and preliminary findings are encouraging. Thus, in this novel pilot study we aim 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 patients with earlier stages of coronavirus (COVID-19) pneumonia requiring oxygen supply without mechanical ventilation.

NCT04418531
Conditions
  1. Pneumonia, Viral
  2. Corona Virus Infection
Interventions
  1. Biological: Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Time to weaning of oxygen support

Time: Through study completion, an average of 3 months

Secondary Outcomes

Measure: Chest XR or CT scan evaluation

Time: Changes during the study up completion, an average of 3 months

Measure: Survival,

Time: Through study completion, an average of 3 months

Measure: Viral titer

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Measure: Anti COVID 19 IgG antibodies

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Measure: Anti COVID 19 IgM antibodies

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: C5a concentration

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: C3a concentration

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum C5b-9 concentration Marker of complement activation

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-6 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-1b levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IFNγ levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum MCP-1 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum TNFα levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-10 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-2 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.

Description: Marker of complement activation in plasma.

Measure: Serum IL-7 levels

Time: Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.
301 Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease

The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease

NCT04419025
Conditions
  1. COVID
  2. Sars-CoV2
  3. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  4. Oxidative Stress
Interventions
  1. Drug: N-acetylcysteine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Decrease in dyspnea measured by respiratory rate (RR)

Measure: Decrease in Respiratory Rate

Time: First hour after first dose of NAC

Description: Hospital LOS for admitted patients

Measure: Hospital length of stay (LOS)

Time: Through study completion, average 9 months

Description: Whether a patient needed mechanical ventilation (intubation)

Measure: Need for mechanical ventilation

Time: Through study completion, average 9 months

Description: If intubated, how long needing mechanical ventilation

Measure: Length of time intubated

Time: Through study completion, average 9 months

Description: Outpatients on NAC needing admission to the hospital

Measure: Need for hospitalization

Time: Through study completion, average 9 months

Description: Whether outpatients continued to recover as outpatients; whether admitted patients were managed on medical floors or level of care increased to ICU level of care; whether patients expired

Measure: Recovery disposition

Time: Through study completion, average 9 months
302 Multicentric Pragmatic Randomized Controled Trial to Evaluate the Efficacy Chloroquine or Hydroxychloroquine for Five Days in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.

NCT04420247
Conditions
  1. COVID
  2. COVID-19
  3. SARS-CoV 2
  4. Coronavirus
  5. Corona Virus Infection
Interventions
  1. Drug: Chloroquine
  2. Drug: Hydroxychloroquine
  3. Other: standard care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Evaluation of the clinical status of patients on the 14th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.

Measure: World Health Organization (WHO) 9-levels ordinal scale (from 0-8)

Time: 14 days after randomization

Secondary Outcomes

Description: Evaluation of the clinical status of patients on the 5th, 7th, 10th and 28th day after randomization defined by the 9-levels ordinal scale, with lower scores meaning better outcomes.

Measure: World Health Organization (WHO) 9-levels ordinal scale (from 0-8)

Time: 5, 7, 10 and 28 days after randomization

Description: All-cause mortality at 28 days after randomization

Measure: Mortality

Time: 28 days after randomization

Description: Number of days without need of Mechanical Ventilation at 28 days after randomization

Measure: Ventilation free days

Time: 28 days after randomization

Description: ICU Lenght of Stay on survivors at 28 days after randomization

Measure: ICU Lenght of Stay

Time: 28 days after randomization

Description: Hospital Lenght of Stay on survivors at 28 days after randomization

Measure: Hospital Lenght of Stay

Time: 28 days after randomization

Description: Acute Kidney Disease incidence measured by Kidney Disease Improving Global Outcomes (KDIGO) stage 3 sometime until the 28th day after randomization.

Measure: Acute Kidney Disease incidence

Time: 28 days after randomization

Description: Percentage of patients needing dialysis sometime until the 28th day.

Measure: Percentage of patients needing dialysis

Time: 28 days after randomization

Description: Presence of coagulopathy sometime until the 28th day (platelets < 150000 and/or INR >1.5 and/or KPTT > 35 seconds).

Measure: Coagulopathy incidence

Time: 28 days after randomization

Description: Mean of C Reactive Protein Levels on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization

Measure: Mean of C Reactive Protein Levels

Time: 5, 7, 10, 14 and 28 days after randomization

Description: Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.

Measure: Sequential Organ Failure Assessment (SOFA) scores

Time: 5, 7, 10, 14 and 28 days after randomization

Description: Neutrophils/lymphocytes ratio on the 5th, 7th, 10th, 14th and 28th day after randomization, during period of hospitalization.

Measure: Neutrophils/lymphocytes ratio

Time: 5, 7, 10, 14 and 28 days after randomization

Other Outcomes

Description: Safety outcome: Any kind of arrhythmia identified by the attending physician at the time of the intercurrence, confirmed by an electrocardiogram (ECG), sometime until the 28th day

Measure: Arrhythmia

Time: 28 days after randomization
303 Study of the Increase in ICU Beds Capacity and Caregivers During COVID-19 Pandemic in France : the FRENCH ICU Study

For preventing the overwhelming of ICU beds capacity during COVID-19 pandemic in France, national and regional Health-Care institutions decided to optimize the Intensive Care Unit beds availability by opening new ICU beds in institutions with and without prior ICU. The Present study was design to retrospectively describe the origin of the ICU beds and human resources created during the COVID-19 outbreak in France.

NCT04420286
Conditions
  1. Coronavirus Infections
  2. COVID19 Outbreak in France
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the origin of the ICU beds created during the COVID-19 outbreak in France.

Measure: origin of the ICU beds created during the COVID-19 outbreak in France.

Time: DAY 0

Secondary Outcomes

Description: Describe the human resources (medical and non-medical) mobilized to ensure that all acute patients could be managed (physicians according to their initial specialty, nurses and nursing auxiliaries).

Measure: Human Resources

Time: DAY 0
304 Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.

NCT04420988
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. SARS-CoV Infection
Interventions
  1. Biological: COVID-19 Convalescent Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

305 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Subjects With Mild or Moderate Coronavirus (COVID-19)

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

NCT04421508
Conditions
  1. COVID-19
  2. Coronavirus
  3. Coronavirus Infection
Interventions
  1. Combination Product: INOpulse
  2. Combination Product: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: The proportion of subjects who died or had respiratory failure

Time: Through Day 28

Secondary Outcomes

Description: The assessment of clinical status at the first assessment of a study day. The scale is: 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: Clinical status using National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale

Time: Day 7, 14, 28 and day of discharge

Measure: Proportion of subject to recover, defined as return to room air or baseline O2, or discharged alive

Time: Through Day 28

Measure: Proportion of subjects discharged alive from hospital

Time: Through Day 28

Measure: Duration of Hospitalization

Time: Through Day 28

Measure: Mortality - all cause and cardiopulmonary

Time: Through Day 28

Measure: Proportion of subjects with a negative conversion of reverse transcription polymerase chain reaction (RT-PCR) from a nasopharyngeal swab

Time: Through Day 28

Other Outcomes

Measure: Proportion of subjects with adverse events leading to study drug discontinuation

Time: Through Day 28
306 Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)

Study Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

NCT04421664
Conditions
  1. Corona Virus Infection
  2. SARS-CoV Infection
  3. Coronavirus
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

Measure: Ordinal Scale of COVID19 Disease Severity at 14 days

Time: 14 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 COVID-19 related Death

Time: 90 days

Description: Outcome reported as the number of participants in each arm who expire due to all causes.

Measure: Incidence of all-cause Death

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: 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
307 Observational Prospective Cohort Study - Registry of Patients With Hematologic Disease and COVID-19 in Russia (CHRONOS19)

This is an observational prospective cohort study to evaluate the clinical course and outcomes of COVID-19 and the underlying disease in patients with hematologic disease (malignant or non-malignant).

NCT04422470
Conditions
  1. Coronavirus Infection and Hematologic Diseases
Interventions
  1. Other: Non-interventional study
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hematologic Diseases
HPO:Abnormality of blood and blood-forming tissues

Primary Outcomes

Description: Rate of death from any cause

Measure: 30-day all-cause mortality

Time: 30 day

Secondary Outcomes

Description: Rate of COVID-19 complications

Measure: COVID-19 complications

Time: 30 day

Description: Rate of ICU admission

Measure: ICU admission

Time: 30 day

Description: Rate of mechanical ventilation / O2 requirement

Measure: Mechanical ventilation / O2 requirement

Time: 30 day

Description: Rate of relapse or progression of hematologic disease

Measure: Relapse or progression of hematologic disease

Time: 30 day, 90 day and 180 day

Description: Number of patients alive

Measure: Overall survival

Time: 30 day, 90 day and 180 day

Description: Putative risk factors for the severity and lethality of COVID-19

Measure: Risk factors

Time: 30 day, 90 day and 180 day
308 Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

NCT04422535
Conditions
  1. Coronavirus Infection
  2. Intensive Care Patients
MeSH:Inf Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.

Measure: Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection

Time: through study completion, an average of 1 year

Secondary Outcomes

Description: To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.

Measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval

Time: through study completion, an average of 1 year
309 A Nested Interventional Cohort Study to Assess the Efficacy and Safety of Adjunctive Humanized Monoclonal Interleukin-6 Receptor Blocker Tocilizumab (TCZ) Therapy to Standard of Care for the Reduction of Hyperinflammation Related Mortality in SARS-Cov2 Positive Patients

This is a cohort study of COVID-19 patients with hyperinflammation. It aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death when untreated is estimated to be 50-80%.

NCT04423042
Conditions
  1. Covid19
  2. COVID-19
  3. Severe Acute Respiratory Syndrome Coronavirus 2
  4. Coronavirus
  5. Inflammation
Interventions
  1. Biological: Tocilizumab
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Inflammation

Primary Outcomes

Description: Mortality status of participants

Measure: All-cause mortality

Time: Assessed at 30 days post treatment

Secondary Outcomes

Description: Uninfected, ambulatory, hospitalized: mild disease, hospitalized: severe disease, death

Measure: Ordinal Scale for evaluating subject clinical status at days 3, 8, 15, 30, 60 post treatment.

Time: Assessed at days 3, 8, 15, 30, 60 post treatment
310 Thrombosis Risk Assessment May Predict Clinical Presentation and Length of Hospital Stay in Covid-19 Pneumonia

Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due to infection-associated inflammation and the resulting cytokine storm, are strongly associated with high mortality rates. In this study, the association between thrombosis risk and clinical presentation of Covid-19 is investigated.

NCT04423315
Conditions
  1. Corona Virus Infection
  2. Thromboembolic Disease
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Thrombosis Thromboembolism
HPO:Pneumonia Thromboembolism

Primary Outcomes

Description: from admission to discharge expressed in days

Measure: length of hospital stay

Time: 2 months
311 COVID-19 Related Health and Infection Control Practices Among Dentists

As dentists begin reopening their practices during a global pandemic, the risk of COVID-19 infection that dentists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. The goal of the proposed study is to understand U.S.-based dentists' health and dental-practice reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These findings could be used to describe the prevalence and incidence of COVID-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.

NCT04423770
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Other: No intervention
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimen

Measure: COVID-19 probable or confirmed case

Time: 18 months

Secondary Outcomes

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.

Measure: Anxiety

Time: 12 months

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.

Measure: Depression

Time: 12 months

Description: Self-reports of infection control efforts in the respondents' primary dental practices

Measure: Dental practice infection control efforts

Time: 12 months

Description: Self-reports of personal protective equipment use

Measure: Dentists' use of personal protective equipment

Time: 12 months
312 Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers

The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.

NCT04424017
Conditions
  1. COVID
  2. Corona Virus Infection
Interventions
  1. Biological: Specific anti-SARS-CoV-2 antibodies
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies

Time: 3 Months
313 Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronаVirUs Infection Requiring HospiTalization

Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.

NCT04424134
Conditions
  1. COVID 19
Interventions
  1. Drug: Bromhexine and Spironolactone
  2. Drug: Base therapy
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: change in CAS COVID 19 between baseline and 12th +/- 2 days CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4). Minimal number of points - 0; max - 20.Lower the score-better health

Measure: Change from baseline in clinical assessment score COVID 19 (CAS COVID 19)

Time: baseline, day 12

Secondary Outcomes

Description: time to death or mechanical ventilation

Measure: - Combine endpoint -

Time: 12 days, 45 days

Description: - Change from baseline in C-reactive protein

Measure: C-reactive protein

Time: 12 days, 45 days

Description: - Change from baseline in D-dimer

Measure: D-dimer

Time: 12 days, 45 days

Description: Change from baseline in EQ-5D. The EQ-5D descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Measure: EuroQol Group. EQ-5D™

Time: 12 days, 45 days

Description: Change from baseline in EQ VAS EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.

Measure: EuroQol Group. EQ VAS

Time: 12 days, 45 days

Description: - Change from baseline Hospital Anxiety and Depression Scale/The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case

Measure: HADS

Time: 14 days, 45 days

Description: Time from admission to the hospital to discharge form the hospital

Measure: Hospital length of stay

Time: up to 45 days
314 Possibilities of Chest Magnetic Resonance Imaging (MRI) in Diagnostics of COVID-19. The Use of MRI to Assess Lung Damage in Patients With Coronavirus Infection

Since the onset of the COVID-19 pandemic, the importance of chest computed tomography (CT) in detecting signs of viral pneumonia has become clear from the literature. However, the increased patient flow creates an additional pressure on CT centers. We believe, the use of chest magnetic resonance imaging (MRI) can help to test patients for CОVID-19 when CT scan is not available. Lung MRI may be useful in routing a patient in a difficult epidemiological situation.

NCT04424355
Conditions
  1. Coronavirus Infections
  2. Pneumonia
Interventions
  1. Diagnostic Test: Chest MRI
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Expected number - more than two zones

Measure: Number of zones of pulmonary parenchyma corresponding to viral pneumonia detected by chest MRI in comparison with CT scan

Time: Upon completion, up to 1 year
315 the Effect of HFNC Treatment on Mortality and Length of ICU Stay in Patient With COVID-19 Pneumonia

coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.

NCT04424836
Conditions
  1. Coronavirus Infection
  2. Pneumonia, Viral
  3. Acute Respiratory Failure
Interventions
  1. Device: high flow nasal cannula device
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: the mortality rate of patients

Measure: short term mortality

Time: in 28 days.

Description: means the stay day of patients in intensive care unit

Measure: icu stay

Time: up to 28 days

Secondary Outcomes

Description: partial oxygen pressure, partial carbon dioxide pressure . both measured in mmhg

Measure: blood gases

Time: at the admission time and 24th hour
316 Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France

Disproportionate impact of COVID-19 in patients with obesity is now well established. Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19. The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

NCT04425213
Conditions
  1. COVID
  2. Severe Acute Respiratory Syndrome
  3. Obesity
  4. Comorbidities and Coexisting Conditions
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Obesity Critical Illness
HPO:Obesity

Primary Outcomes

Description: number of fatal cases

Measure: ICU mortality

Time: through study completion, an average of 14 days

Secondary Outcomes

Description: number of patients with invasive mechanical ventilation

Measure: Invasive mechanical ventilation

Time: through study completion, an average of 14 days

Description: number of fatal cases

Measure: In-hospital mortality

Time: through study completion, an average of 21 days
317 Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses and Assymptomatic Carriers Among a Cohort of 2,300 Healthcare Workers at the Consorci Sanitari Del Maresme (CSdM)

Observational and prospective study with one year of follow-up of the cohort of workers of the CSdM, including workers of subcontracted companies working in the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months. All CSdM workers will be invited to participate by e-mail and by announcements in the corporate website. A space will be set up on the corporate intranet where workers will be informed about the study, will be able to give their informed consent and will be able to answer an electronic questionnaire regarding socio-demographic, clinical and labour personal characteristics. Once the questionnaire answered, participants will be authorized to schedule a blood extraction. Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG). PCR will be also performed for IgM and IgA positive subjects.

NCT04425759
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SARS-CoV 2
  4. COVID
Interventions
  1. Diagnostic Test: Blood sample
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Screening for the entire population with total IgA, IgM, IgG to screen the negatives ELISA for positives with differentiated IgM+IgA vs IgG specific for SARS-Cov-2 seroprevalence of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk of infection in CSdM professionals; c) contribute to the improvement of knowledge about the infection and the social and occupational factors that affect its spread; and d) allow in the future to identify the duration of immunity against SARS-CoV-2.

Measure: Antibodies to SARS-CoV2: IgA, IgM, IgG

Time: 1 year

Description: To detect symptomatic or asymptomatic carriers New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears

Measure: PCR of nasopharyngeal smears on all IgM +

Time: 1 year
318 Evaluation of Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of covid19

The associated use of Ivermectin, aspirin, dexamethasone, and enoxaparin (in different combinations and doses) will reduce the impact of COVID infection 19, the need of admission to the intensive care unit, and mortality.

NCT04425863
Conditions
  1. Severe Acute Respiratory Syndrome
  2. Ventilation Pneumonitis
Interventions
  1. Drug: Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets
  2. Other: Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets
  3. Other: Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU.
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Number of patients who did not go to a more severe stage of disease or die (i.e. they neither go from mild to moderate or severe, nor go from moderate to severe or die, if they had been already enrolled in a severe condition)

Measure: Patients Who Improved Their Condition or Did Not Worsen it

Time: 7 days

Description: Number of patients needing ICU-treatment including mechanical ventilation after 2-week treatment

Measure: ICU-treated Patients After 2-week Treatment

Time: 14 days

Description: Patients who died within 30 days after enrollment

Measure: Mortality

Time: 30 days

Description: Patients who needed dose adjustment of any of the drugs involved in the treatment protocol

Measure: Patients Needing Drug Dose Adjustment

Time: 14 days

Description: Patient presenting serious adverse events

Measure: Adverse Events

Time: 14 days
319 Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19

The study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study. At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing. Following the interim analysis, based on the results, another 800 people are planned to involve.

NCT04426253
Conditions
  1. COVID-19
  2. Sars-CoV2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Disease Progression

Primary Outcomes

Description: Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants

Measure: Identification of genetic factors determining the course of the disease in case of COVID-19

Time: 2020. December
320 Cancer: Rapid Diagnostics and Immune Assessment for SARS-CoV-2 (COVID-19)

People with cancer may be at higher risk of poor outcomes with COVID-19 infection. This observational study aims to describe the clinical course of COVID-19 infection in people with cancer and evaluate the utility of antibody and antigen tests for COVID-19. The results of this study will inform clinical practice in the management of cancer patients with COVID-19.

NCT04427280
Conditions
  1. Infectious Disease
  2. Cancer
  3. Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Proportion of patients, at each sample timepoint, with a positive detection of IgM and IgG specific antibodies to SARS-CoV-2.

Time: 56 days

Secondary Outcomes

Description: Duration of clinical symptoms

Measure: Clinical course of SARS-CoV-2 infection in cancer patients.

Time: 56 days

Description: Severity of clinical symptoms

Measure: Clinical course of SARS-CoV-2 infection in cancer patients.

Time: 56 days

Description: Number of patients whose cancer treatment has been impacted by SARS-CoV-2

Measure: Clinical course of SARS-CoV-2 infection in cancer patients.

Time: 56 days

Measure: Proportion of patients, at each sample timepoint, with SARS-CoV-2 viral clearance by throat/nose swab by RT-PCR.

Time: 56 days

Measure: Time from start of symptoms to Day 0 testing in the study.

Time: 56 days

Description: Proportion of samples successfully processed and result obtained, with 95% confidence interval Proportion of samples processed with a positive result by lateral flow, by the gold standard (throat/nose RT-PCR)

Measure: Feasibility of SARS-CoV-2 testing with a lateral flow assay.

Time: 56 days
321 Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement

This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

NCT04429594
Conditions
  1. Coronavirus Infections
Interventions
  1. Other: blood sampling
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: number of positive serologies

Measure: positive serologies

Time: 12 months
322 Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)

In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.

NCT04431466
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Ivermectin
  2. Other: Standard treatment for COVID-19
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab after Intervention Initiation.

Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

Time: 7 days following intervention

Secondary Outcomes

Description: Viral load variation in the nasopharyngeal swab during treatment.

Measure: Viral load variation in the nasopharyngeal swab.

Time: 7 days following intervention.

Description: Variation of serum lymphocyte counts during treatment.

Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

Time: 7 days following intervention.

Description: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab at the end of follow-up.

Measure: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.

Time: 7 after intervention.

Description: Proportion of patients with clinical improvement, defined as the time to normalize fever, respiratory rate and oxygen saturation and cough relief at the end of follow-up.

Measure: Proportion of patients with clinical improvement.

Time: 7 after intervention.
323 ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)

The goal of this study is to evaluate the safety and effectiveness of COVID-19 convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. - Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator - Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against SARS-CoV-2 and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.

NCT04432272
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome (SARS)
  3. Coronavirus Infections
Interventions
  1. Biological: COVID-19 convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated

Measure: Avoidance of intubation at 28 days (group A)

Time: 28 days

Description: Count of group B participants (participants who are intubated at study entry) who die

Measure: Mortality (group B)

Time: 28 days

Secondary Outcomes

Description: Count of participants who experienced cardio-circulatory arrest

Measure: Cardio-circulatory arrest

Time: 28 days

Description: Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome

Measure: Patient Outcome at 28 days

Time: 28 days

Description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.

Measure: Renal failure

Time: 28 days

Description: Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%

Measure: Liver failure

Time: 28 days

Description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)

Measure: Cytokine Storm

Time: 28 days

Description: Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation .

Measure: Respiratory support

Time: 28 days

Description: Count of participants who received pressor drugs, as ordered by treating physicians

Measure: Vasopressor medication support

Time: 28 days

Description: Length of ICU stay in days, for participants who entered ICU

Measure: Length of ICU length of stay

Time: 28 days

Description: Count of patients admitted to the ICU who die in ICU

Measure: Intensive Care Unit (ICU) mortality

Time: 28 days

Description: Length of hospital stay in days

Measure: Hospital length of stay

Time: 28 days

Description: Number of ventilator-free hospitalized days

Measure: Ventilator free days

Time: 28 days

Description: Length of intubation, measured in days

Measure: Intubation duration

Time: 28 days

Description: Count of participants readmitted to hospital following index procedure hospital discharge

Measure: Readmission

Time: 90 days

Description: Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.

Measure: Serum anti-SARS-CoV-2 IgG

Time: During hospitalization, a maximum of 28 days

Description: Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.

Measure: SARS-CoV-2 RNA

Time: During hospitalization, a maximum of 28 days

Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die

Measure: Mortality (group A)

Time: 28 days

Description: Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)

Measure: Time from Transfusion to end of ventilator support (group B)

Time: During hospitalization, a maximum of 28 days
324 Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III of Best Supportive Care +/- Whole Lung Low-Dose Radiation Therapy in Hospitalized Patients

This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.

NCT04433949
Conditions
  1. Pneumonia
  2. Severe Acute Respiratory Syndrome
  3. Symptomatic COVID-19 Infection Laboratory-Confirmed
Interventions
  1. Other: Best Practice
  2. Radiation: Low Dose Radiation Therapy
MeSH:Laboratory Infection Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.

Measure: Time to clinical recovery

Time: Up to follow-up day 14 after study start

Secondary Outcomes

Description: The rates from both cohort will be reported.

Measure: Freedom from ICU admission

Time: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.

Description: Temperature in degrees (F)

Measure: Temperature

Time: Up to follow-up day 14 after study start

Description: Heart rate in beats per minutes

Measure: Heart rate

Time: Up to follow-up day 14 after study start

Description: Systolic blood pressure in mm Hg

Measure: Systolic Blood pressure

Time: Up to follow-up day 14 after study start

Description: Oxygen saturation in percentage

Measure: Oxygen saturation

Time: Up to follow-up day 14 after study start

Description: Oxygen saturation in percentage

Measure: Supplemental oxygenation need

Time: Up to follow-up day 14 after study start

Description: Respiratory rate in breaths per minute.

Measure: Respiratory rate

Time: Up to follow-up day 14 after study start

Description: Pre and post intervention; Minimum of 3 (poor) to best (15)

Measure: Glasgow Comma Scale from minimum of 3 to maximum of 15.

Time: Up to follow-up day 14 after study start

Description: Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;

Measure: Performance status

Time: Up to follow-up day 14 after study start

Description: Survival in percentage

Measure: Survival

Time: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.

Description: Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.

Measure: Serial chest x-rays severe acute respiratory syndrome (SARS) scoring

Time: Up to follow-up day 14 after study start;

Description: CT scans with volume of consolidation measured in cubic centimeters.

Measure: Changes on computed tomography (CT) scans pre and post RT

Time: Baseline up to follow-up day 14 after study start

Description: C-Reactive Protein in mg/L

Measure: CRP

Time: Up to follow-up day 14 after study start

Description: Will be summarized descriptively.

Measure: Serum chemistry + complete blood cell (CBC) with differential

Time: Up to follow-up day 14 after study start

Description: pH (no unit)

Measure: Blood gases pH(when available)

Time: Up to follow-up day 14 after study start

Description: Albumin in gm/dL

Measure: Albumin

Time: Up to follow-up day 14 after study start

Description: Procalcitonin in ng/mL

Measure: Procalcitonin

Time: Up to follow-up day 14 after study start

Description: Asparatate Aminotransferase in units/L

Measure: Aspartate aminotransferase (AST)

Time: Up to follow-up day 14 after study start

Description: Creatinine in mg/dL

Measure: Creatine kinase

Time: Up to follow-up day 14 after study start

Description: Coagulation pathway time in seconds

Measure: Prothrombin time (PT)/partial thromboplastin time (PTT)

Time: Up to follow-up day 14 after study start

Description: Troponin-I in ng/mL

Measure: Troponin

Time: Up to follow-up day 14 after study start

Description: Lactic Acid in mmol/L

Measure: Lactate

Time: Up to follow-up day 14 after study start

Description: B-Natriuretic Peptid in pg/mL

Measure: NT-pBNP (cardiac injury)

Time: Up to follow-up day 14 after study start

Description: Gamma-glutamyl transferase in units/L

Measure: Gamma-glutamyl transferase (GGT)

Time: Up to follow-up day 14 after study start

Description: Trygliciericdes in mg/dL

Measure: Triglycerides

Time: Up to follow-up day 14 after study start

Description: Fibrinogen in mg/dL

Measure: Fibrinogen

Time: Up to follow-up day 14 after study start

Description: Will be summarized descriptively.

Measure: Changes in CD8 T cells

Time: Up to follow-up day 14 after study start

Description: Will be summarized descriptively.

Measure: Changes in CD4 T cells

Time: Up to follow-up day 14 after study start

Description: Will be summarized descriptively.

Measure: Changes in serum antibodies against COVID-19 epitope

Time: Up to follow-up day 14 after study start

Description: Lactate Dehydrogenase in units/L

Measure: LDH

Time: Up to follow-up day 14 after study start

Description: D-Dimer in ng/mL

Measure: D-Dimer

Time: Up to follow-up day 14 after study start

Description: Interleukin-6 in pg/mL

Measure: IL-6

Time: Up to follow-up day 14 after study start

Description: Myoglobin in ng/mL

Measure: Myoglobin

Time: Up to follow-up day 14 after study start

Description: Potassium in mmol/L

Measure: Potassium

Time: Up to follow-up day 14 after study start

Description: Ferritin in ng/mL

Measure: Ferritin

Time: Up to follow-up day 14 after study start

Description: Alanine Aminotransferase in units/L

Measure: ALT

Time: Up to follow-up day 14 after study start
325 Compassionate Use of Opaganib in Patients With Severe COVID-19

Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

NCT04435106
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Opaganib
  2. Drug: Standard of Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Measure the time to weaning from high-flow nasal cannula

Time: Every day from day 1 to day 14

Measure: Measure the time to breathing ambient (room) air

Time: Every day from day 1 to day 14

Secondary Outcomes

Measure: Measure change in lymphocyte count

Time: On day of admission or day 1 of treatment and every 2-4 days, till day 14

Measure: Measure change in C-reactive protein

Time: On day of admission or day 1 of treatment and every 2-4 days, till day 14
326 Uncovering the Cardiac Phenotype of Individuals With SARS-COV-2 and Cardiac Injury

At the end of December of 2019, a series of patients in Wuhan, China were struck with a mysterious respiratory infection. These isolated events have rapidly grown into a deadly, global pandemic. This pandemic is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which results in the Coronavirus Disease 2019 (COVID-19). For individuals infected with COVID-19, approximately 30% of the hospitalized cases are associated with cardiovascular complications. Data are emerging that individuals with pre-exiting conditions (like hypertension, diabetes, cancer, or medical issues related to the immune system) are most susceptible to complications related to COVID-19. Furthermore, individuals of certain racial and ethnic backgrounds (e.g. African American and Hispanic) are at a higher risk of death from COVID-19. Despite these emerging observations, it remains unclear who will develop the cardiovascular complications (acute myocardial injury with evidence of a myocarditis-like picture and cardiogenic shock) and what the long term sequelae of this disease will be for survivors of this infection after hospitalization. Thus, the goals of this project are to better understand the epidemiology of cardiac injury in acutely ill COVID-19 patients through deep cardiac phenotyping and identify the molecular profile of individuals most susceptible to cardiac injury from COVID-19.

NCT04435457
Conditions
  1. SARS-CoV 2
  2. SARS Pneumonia
  3. COVID-19
  4. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  5. Cardiac Complication
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Patterns of late gadolinium enhancement and T1 and T2 mapping consistent with myocarditis on a post-hospitalization cardiac magnetic resonance imaging examination

Measure: Prevalence of Myocarditis

Time: Up to 4 weeks

Secondary Outcomes

Description: This includes categorically abnormal structural, mechanical functional, vascular, and metabolic using cardiac magnetic resonance imaging

Measure: Prevalence of cardiac abnormalities by cardiac magnetic resonance imaging

Time: Up to 4 weeks

Description: Presence of cardiac autoantibodies and defects within the immune system as detected by Whole Exome Sequencing making an individual susceptible to subacute cardiac injury during COVID-19 infection

Measure: Prevalence of molecular and genetic immune system abnormalities

Time: Up to 4 weeks
327 Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients

Stem cell therapy has emerged as a revolutionary treatment for diseases that were considered untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have been shown to repair damaged liver, kidney, heart, pancreas, skin, cartilage, and cornea in animal models and several human trials. In addition to cellular replacement through regeneration, UCMSCs mediate through paracrine signaling pathways resulting in immune modulation. Clinical manifestations of coronavirus disease 2019 (COVID-19), are believed to arise from septic shock and cytokine storm that cause acute respiratory dysfunction and acute cardiac injury. There is presently no cure for the COVID-19 viral disease; however, multi-treatment strategies are being examined. During the past two months, four reports were published that suggest, mesenchymal stem cells (MSCs), owing to their powerful immunomodulatory ability, may prevent the cytokine storm and thus reduce the COVID-19 related morbidity. All studies reported that COVID-19 patients responded favorably to MSCs therapy. These reports, taken together with the previous successes of stem cell therapy in animal models, the investigators, a seven-institution consortium, propose to explore the efficacy of UCMSC treatment in COVID-19 patients at Jinnah hospital, Lahore. The investigators propose to administer UCMSCs in patients with acute pulmonary inflammation due to COVID-19 infection with moderate to severe symptoms. In the first cohort of 15 patients, UCMSCs will be administered with three intravenous infusions of 500,000 UCMSCs per Kg body weight each on days 1, 3, and 5. The second group of five patients serving as control will only receive standard treatment. During the 30-day post-infusion period, a battery of tests will be performed to evaluate the safety and efficacy of the UCMSCs treatment. In parallel, the investigators propose a comparative study to determine COVID-19 viral count by quantitative real-time PCR and through viral coat protein ELISA, developed in the investigator advisor lab (Dr. Tauseef Butt, Progenra Inc. Philadelphia, USA) with the ultimate objective to locally developing a rapid diagnostic assay.

NCT04437823
Conditions
  1. Corona Virus Infection
Interventions
  1. Biological: Intravenous Infusions of Stem Cells
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants with significant side effects in stem cell treated group

Measure: Safety and efficacy assessment of infusion associated adverse events

Time: Day 01 to Day 30

Description: Assessment of Pneumonia improvement as a result of stem cell infusions

Measure: Chest Radiograph or Chest CT Scan

Time: Day 01 to Day 30

Secondary Outcomes

Description: Quantitative real-time PCR analysis for the evaluation of negative corona virus test results following stem cell treatment

Measure: COVID-19 Quantitative Real Time PCR

Time: Day 01 to Day 30

Description: Evaluation of organ function (Each organ system is assigned a value for 0 (normal) to 4 (highest degree of dysfunction))

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: Day 01 to Day 30

Description: Number of all mortalities within 30 days post first infusion

Measure: Rate of mortality

Time: Day 01 to Day 30

Description: Examination of improvement in the physiology of lungs after treatment

Measure: Clinical Respiratory Changes

Time: Day 01 to Day 30
328 Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.

NCT04442230
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: NasoVAX
  2. Other: Placebo
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Decrease from baseline in mean resting SpO2

Measure: Proportion of patients with clinical worsening

Time: Day 1 to Day 14

Secondary Outcomes

Description: Proportion of patients requiring hospitalization

Measure: Maximal severity of COVID-19 after treatment

Time: Day 1 to Day 42

Measure: All-cause mortality

Time: Day 1 to Day 42
329 Controlled and Randomized Clinical Trial for Evaluating the Effect of a Supplement of Glycine as Adjuvant in the Treatment of COVID-19 Pneumonia in Patients Initiating Mechanical Ventilation

This study will explore whether a daily supplement of glycine, a substance that has antiinflammatory, cytoprotective, and endothelium-protecting effects, can improve mortality, as well as clinical and biochemical parameters, in patients with severe COVID-19 who initiate mechanical ventilatory support.

NCT04443673
Conditions
  1. COVID-19
  2. SARS-CoV Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. SARS Pneumonia
  5. ARDS, Human
  6. Pneumonia, Viral
Interventions
  1. Dietary Supplement: Glycine
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Adult
HPO:Pneumonia

Primary Outcomes

Description: Number of participants who die divided by number of subjects enrolled in the that study group.

Measure: Mortality

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Secondary Outcomes

Description: Number of days spent under mechanical ventilation.

Measure: Days under mechanical ventilation

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Arterial pressure of oxygen divided by inspired fraction of oxygen.

Measure: PaO2/FiO2 ratio

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Plasma concentration of lactate in arterial blood.

Measure: Arterial plasma lactate

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 1β.

Measure: Serum IL-1β

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 2.

Measure: Serum IL-2

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 4.

Measure: Serum IL-4

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 5.

Measure: Serum IL-5

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 6.

Measure: Serum IL-6

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 7.

Measure: Serum IL-7

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 8.

Measure: Serum IL-8

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 10.

Measure: Serum IL-10

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 12 (p70).

Measure: Serum IL-12

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 13.

Measure: Serum IL-13

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interleukin 17A.

Measure: Serum IL-17

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of granulocyte colony stimulating factor.

Measure: Serum G-CSF

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of granulocyte monocyte colony stimulating factor.

Measure: Serum GM-CSF

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of interferon gamma.

Measure: Serum IFN-γ

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of monocyte chemoattractant protein 1 (MCAF).

Measure: Serum MCP-1

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of macrophage inflammatory protein 1β

Measure: Serum MIP-1β

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of tumor necrosis factor alpha.

Measure: Serum TNF-α

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of creatinine.

Measure: Serum creatinine

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of alanine aminotransferase. .

Measure: Serum alanine aminotransferase

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of aspartate aminotransferase. .

Measure: Serum aspartate aminotransferase

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of alkaline phosphatase.

Measure: Serum alkaline phosphatase

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of total bilirubin.

Measure: Serum total bilirubin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of unconjugated bilirubin.

Measure: Serum unconjugated bilirubin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of conjugated bilirubin

Measure: Serum conjugated bilirubin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of C reactive protein.

Measure: Serum C reactive protein

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Blood concentration of hemoglobin.

Measure: Hemoglobin

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of white blood cells per µl blood.

Measure: Total leukocytes

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of neutrophils per µl blood.

Measure: Neutrophils

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of lymphocytes per µl blood.

Measure: Lymphocytes

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of monocytes per µl blood.

Measure: Monocytes

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of eosinophils per µl blood.

Measure: Eosinophils

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of basophils per µl blood.

Measure: Basophils

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Number of platelets per µl blood.

Measure: Platelets

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Time that blood takes to clot.

Measure: Prothrombin time

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Serum concentration of plasminogen activator inhibitor 1 (PAI-1).

Measure: Serum PAI-1

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Sequence Organ Failure Assessment (SOFA) score, composed by assessment of PaO2/FiO2 ratio, Glasgow coma scale, mean arterial pressure, bilirubin, and platelets.

Measure: SOFA score

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.

Description: Acute Physiology And Chronic Health Evaluation II (APACHE II) score, composed by assessment of AaDO2 or PaO2, temperature, mean arterial pressure, pH arterial, heart rate, respiratory rate, sodium, potassium, creatinine, hematocrit, white blood cell count, Glasgow coma scale.

Measure: APACHE II score

Time: From date of enrollment and until the date of weaning from ventilator or death, whichever came first, assessed up to 12 months.
330 Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19

This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.

NCT04443868
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Nitric Oxide-Releasing Drug
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the SARS-CoV-2 viral load (Cycle threshold) at baseline through Day 6 between NONI and control arms.

Measure: To Measure the efficacy of NONI compared to saline placebo control to shorten the duration of COVID-19 viral infectivity

Time: 6 Days

Secondary Outcomes

Description: Measure the proportion of subjects reaching Ct threshold (ie: unmeasurable viral load) between NONI and control

Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection

Time: 2, 4 and 6 days

Description: Measure the difference in time-to Ct threshold (ie: unmeasurable viral load) between NONI and control.

Measure: To Measure the virucidal effect of NONI compared to placebo in the nasal cavity in subjects with mild COVID-19 infection

Time: 2, 4 and 6 days

Description: Measure the proportion of subjects requiring hospitalization or ER/ED visits for COVID-19/flu-like symptoms

Measure: To Measure the efficacy of NONI in prevention of progression of COVID-19

Time: 28 days

Description: Measure the difference in 12-point COVID Symptom PROs score 0-3 (min 0 & max 36) and a QoL score from 0-100 (lower is worse) from baseline between NONI and control arms.

Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life (QoL) in subjects with COVID-19

Time: 6 days

Description: Measure the difference in proportion of subjects experiencing a reduction of ≥ 5 from baseline between NONI and control arms.

Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19

Time: 2, 4, 6, 14 and 28 days

Description: Measure the difference in proportion of subjects with reduction to a score of zero from baseline between NONI and control arms.

Measure: To measure reduction of patient reported outcome (PRO) of clinical cold score symptoms and quality of life in subjects with COVID-19

Time: 2, 4, 6, 14 and 28 days

Description: Number of participants lost-to-follow-up,discontinuing study treatment or number of treatments due to intolerance

Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection

Time: 14 days

Description: Severity and frequency of adverse events, pain, discomfort or discontinuations of treatment.

Measure: To measure the tolerance of NONI compared to saline placebo in participants with mild COVID-19 infection

Time: 14 days
331 Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19

Published papers evaluating coagulopathy on COVID-19 patients indicate a higher incidence of thromboembolic events, sometimes, as high as 20%. Such events increase ICU admissions and are associated with death. Considering the importance of thromboembolic events concurring to deteriorate clinical state, we propose to conduct a parallel pragmatic open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and with low oxygen saturation.

NCT04444700
Conditions
  1. COVID
  2. Coronavirus Infection
  3. Severe Acute Respiratory S
  4. Severe Acute Respiratory Syndrome
  5. Thromboembolism, Venous
  6. Anticoagulants and Bleeding Disorders
Interventions
  1. Drug: Therapeutic anticoagulation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Thromboembolism Hemostatic Disorders Venous Thromboembolism Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Thromboembolism

Primary Outcomes

Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.

Measure: Composite main outcome

Time: up to 28 days

Secondary Outcomes

Description: All-cause death

Measure: All-cause death

Time: 28 days

Description: Composite outcome of ICU admission or all-cause death

Measure: Composite outcome of ICU admission or all-cause death

Time: 28 days

Description: Major bleeding

Measure: Major bleeding

Time: 28 days

Description: Red Blood Cell transfusion (greater than or equal to 1 unit)

Measure: Number of participants who received red blood cell transfusion

Time: 28 days

Description: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate

Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate.

Time: 28 days

Description: Hospital-free days alive up to day 28

Measure: Number of hospital-free days alive up to day 28

Time: 28 days

Description: ICU-free days alive up to day 28

Measure: Number of ICU-free days alive up to day 28

Time: 28 days

Description: Ventilator-free days alive up to day 28

Measure: Number of ventilator-free days alive up to day 28

Time: 28 days

Description: Venous thromboembolism

Measure: Number of participants with venous thromboembolism

Time: 28 days

Description: Arterial thromboembolism

Measure: Number of participants with arterial thromboembolism

Time: 28 days

Description: Heparin induced thrombocytopenia

Measure: Number of participants with heparin induced thrombocytopenia

Time: 28 days
332 Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.

NCT04445207
Conditions
  1. COVID
  2. Sars-CoV2
  3. Corona Virus Infection
Interventions
  1. Biological: Convalescent Plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

333 An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso

This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

NCT04445441
Conditions
  1. Coronavirus Infection
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The impact of the treatment on virological clearance (viral load) post-treatment

Measure: Clearance of viral load

Time: 14 days

Secondary Outcomes

Description: This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters

Measure: Safety of the treatment

Time: 14 days
334 Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

NCT04445454
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: Mesenchymal stromal cells
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess the infusional toxicity

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Secondary Outcomes

Description: To assess the clinical status (on a 7-point WHO ordinal scale)

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the duration of oxygen therapy and/or mechanical ventilation

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the length of stay at the intensive care unit and of hospitalization

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of organ failures

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the intensity of the inflammatory response

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the evolution of coagulation parameter

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the presence of Biomarker of lung lesion, repair and scarring

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the pulmonary function

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Other Outcomes

Description: To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations

Measure: To investigate immune modulation

Time: Day 28

Description: To assess the cytotoxic activity by MLR

Measure: To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro

Time: Day 28
335 Anti-Androgen Treatment for COVID-19

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

NCT04446429
Conditions
  1. COVID-19
  2. SARS-CoV2
  3. Androgenetic Alopecia
  4. Prostate Cancer
  5. Benign Prostatic Hyperplasia
  6. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Drug: Proxalutamide
  2. Other: Standard of Care
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Prostatic Hyperplasia Alopecia Hyperplasia
HPO:Alopecia Alopecia of scalp Benign prostatic hyperplasia Frontal balding

Primary Outcomes

Description: Percentage of subjects hospitalized due to COVID-19

Measure: COVID-19 hospitalization

Time: 30 days
336 Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

NCT04447235
Conditions
  1. Cancer
  2. COVID
  3. Coronavirus Infection
Interventions
  1. Drug: Placebo
  2. Drug: Ivermectin
  3. Drug: Losartan
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death

Measure: Incidence of severe complications due COVID-19 infection

Time: 28 days

Secondary Outcomes

Description: Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%

Measure: Incidence of Severe Acute Respiratory Syndrome

Time: 28 days

Description: Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute

Measure: Incidence of Severe Acute Respiratory Syndrome

Time: 28 days

Description: Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)

Measure: Adverse events

Time: 28 days

Description: Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)

Measure: Adverse events

Time: 28 days

Description: Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)

Measure: Adverse events

Time: 28 days

Description: Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of > 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.

Measure: Adverse events

Time: 28 days

Description: Death of any cause since protocol enrollment

Measure: Overall survival

Time: 28 days
337 A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.

NCT04447781
Conditions
  1. Coronavirus Infection
  2. SARS-CoV 2
Interventions
  1. Biological: INO-4800
  2. Device: CELLECTRA® 2000
  3. Other: Saline-sodium citrate (SSC) buffer
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity] Incidence of adverse events among participants during the study period [Safety and Tolerability] Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability] Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]

Measure: Primary Outcome Measures

Time: Baseline up to Week 52
338 Characterizing SARS-CoV-2 Persistence in Host Reservoirs, Post-viral Sequelae, and Associations With Host and Viral Determinants in a Cohort of Convalescent COVID-19 Cases

The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 250 people who had COVID-19 based on lab testing to participate. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 8 times over 6 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in the convalescent phase of COVID-19 infection.

NCT04448145
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS-CoV 2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR naso/oropharyngeal test, as determined by the established cycle threshold cut-off on a validated real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

Measure: Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples

Time: Up to 24 weeks

Description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR stool or rectal swab samples, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.

Measure: Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples

Time: Up to 24 weeks

Description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR semen sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.

Measure: Duration of SARS-CoV-2 viral persistence in semen samples

Time: Up to 24 weeks

Description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR breast milk sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.

Measure: Duration of SARS-CoV-2 viral persistence in breast milk samples

Time: Up to 24 weeks

Description: Prevalence defined as the number of participants with B cell, cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer (NK), and natural killer T (NKT) cell immune responses. Plasma will be used for evaluation of neutralizing and binding antibody titers to SARS-CoV-2.

Measure: Prevalence of cell immune responses

Time: Up to 24 Weeks

Description: The duration, in weeks, of COVID-19 symptoms as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.

Measure: Duration of COVID-19 Symptoms

Time: Up to 24 weeks

Description: Prevalence defined as the number of participants that develop post-viral sequelae as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.

Measure: Prevalence of post-viral sequelae

Time: Up to 24 weeks

Description: Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.

Measure: Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures

Time: Up to 24 weeks
339 Observational Evaluation of the Impact of COVID-19 Outbreak on Transgender Subject's Health and on the Organization of Trans-population Health Care Services

During the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all categories of subjects in order to minimize unnecessary movements of people while maintaining an adequate level of assistance. This is also true for transgender people, who are periodically requested to come into the clinic for hormonal therapy monitoring and continuation. In our center telemedicine programs dedicated to users have been activated for the remote management of hormone therapy. We use a web-based survey to assess the impact of COVID-19 outbreak on trans-population health and to assess the specific needs of this population in this particular moment.

NCT04448418
Conditions
  1. Transgender Persons
  2. Coronavirus
  3. Coronavirus
  4. Coronavirus Infection
  5. COVID
  6. COVID-19
Interventions
  1. Other: web based survey
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Evaluation of the specific health care needs of this population

Measure: Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy

Time: through study completion, an average of 6 months

Description: Evaluation of socioeconomical and working condition of this population

Measure: Assessment of risk factors for COVID-19 infection in the traspopulation

Time: through study completion, an average of 6 months

Secondary Outcomes

Description: Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)

Measure: Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring

Time: through study completion, an average of 6 months

Description: Use of web based validated questionnaire: Impact of Event Scale-Revised (in Italian) to investigate perception of the COVID-19 event and subjects' mood. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. Minimum score=0, maximum score=60, higher scores correspond to a worse outcome.

Measure: Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy

Time: through study completion, an average of 6 months

Description: Use of web based validated questionnaire: Beck Depression Inventory to investigate mood. The 21 symptoms and attitudes contained in the questionnaire reflect the severity of the depression; the final score ranges from 0 to 63, with worse outcome with higher values.

Measure: Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy

Time: through study completion, an average of 6 months

Description: Use of web based validated questionnaire: Short Form 2, to assess the impact of health on an individual's everyday life. The SF-12 is made of an eight-scale profile of scores as well as physical and mental health summary measures. Total scores range from 16 to 47 with worse outcomes for lower scores.

Measure: Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy

Time: through study completion, an average of 6 months
340 Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area

In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area. A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted. The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study

NCT04448769
Conditions
  1. Coronavirus Infection
  2. Prevalence
Interventions
  1. Biological: Anti-SARS-CoV-2 IgT seropositivity
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area

Measure: Anti-SARS-CoV-2 IgT (IgM/IgA/IgG) seropositivity

Time: through study completion, an average of 4 hours

Secondary Outcomes

Description: To estimate the proportion of occurrence of an episode of clinical symptoms since the beginning of the epidemic among seropositive people using self report questionnaires.

Measure: Proportion of asymptomatic, symptomatic cases among seropositive people

Time: through study completion, an average of 4 hours

Description: To estimate the proportion of asymptomatic cases (asymptomatic fraction) by the proportion of seropositive individuals who did not show any sign or symptom of COVID-19 since the beginning of the epidemic in France (mid-February).

Measure: Proportion of asymptomatic cases among seropositive people

Time: through study completion, an average of 4 hours

Description: To understand susceptibility factors to infection by comparing infected and uninfected persons on the basis of age, sex, weight status, smoking status, occupation and education.

Measure: Identification of risk groups - Anti-SARS-CoV-2 IgT seropositivity by age, sex and as a function of weight status, smoking status, work activity and social status.

Time: through study completion, an average of 4 hours

Description: Determining the prevalence of seropositive people according to the level of social disadvantage

Measure: Proportion of seropositive subjects according to the level of social disadvantage measured by the EPICES score

Time: through study completion, an average of 4 hours

Description: To estimate the prevalence of infected households

Measure: Proportion of infected households

Time: through study completion, an average of 4 hours

Description: To provide knowledge on intra-household dissemination

Measure: Anti-SARS-CoV-2 IgT seropositivity in the household

Time: through study completion, an average of 4 hours

Description: To develop symptom association profiles in seropositive subjects

Measure: Clinical expression patterns of infection by symptom/antibody association

Time: through study completion, an average of 4 hours

Description: To study the serum distribution of seropositive people, particularly in each symptom typology group.

Measure: Serological Response to Infection

Time: through study completion, an average of 4 hours

Description: To use the results of the SARS-CoV-2 seroprevalence testing campaign and questionnaires to refine our knowledge of the current and future situation and make better projections with better calibrated mathematical models of SIR infectious diseases.

Measure: Anti-SARS-CoV-2 IgT seropositivity

Time: through study completion, an average of 4 hours

Description: 10. To evaluate the in vitro neutralisation capacity of the viral infectivity of the antibodies detected.

Measure: • Evaluation of serum neutralisation of persons positive for anti-SARS-CoV-2 antibodies, of the infectivity of viral strains in cell culture: percentage neutralisation compared to a viral strain not exposed to seropositive serum.

Time: through study completion, an average of 4 hours
341 Knowledge, Attitude and Practice About COVID-19 and Awareness of Infection Control to Prevent COVID-19 Transmission in Clinics and Perception About Online Learning During Lock Down Period: A Cross-sectional Study

Coronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The disease is highly infectious, and its main clinical symptoms include fever, dry cough, fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to the severe stage, which is characterized by acute respiratory distress syndrome, septic shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction. After China, COVID-19 spread across the world and many governments implemented unprecedented measures like suspension of public transportation, the closing of public spaces, close management of communities, and isolation and care for infected people and suspected cases. The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May 2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle against COVID-19 is still continuing in Malaysia and all over the world. Due to the CMO and CMCO in the country, public and private universities have activated the e-learning mode for classes and as the government ordered, universities are closed and no face-to-face activities allowed. This has forced students of all disciplines including dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning mode. To guarantee the final success for fight against COVID-19, regardless of their education status, students' adherence to these control measures are essential, which is largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP theory. Once the restrictions are eased students have to come back and resume their clinical work in the campus. Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19 and the students preference for online learning.

NCT04449081
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Corona Virus Infection
  3. Acute Lung Injury
  4. Fever
  5. Myalgia
  6. Cough
  7. Dyspnea
  8. Septic Shock
  9. Bleeding
Interventions
  1. Behavioral: Knowledge, Attitude, Practice, Awareness, Preference
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Myalgia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Dyspnea Lung Injury
HPO:Dyspnea Myalgia Respiratory distress

Primary Outcomes

Description: KAP towards COVID-19 was assessed using validated questionnnaire

Measure: Knowledge, Attitude, Practice of dental students towards COVID-19

Time: 4 months

Secondary Outcomes

Description: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire

Measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics

Time: 4 months

Description: Preference towards online learning. was assessed using a standard questionnaire

Measure: Preference towards online learning.

Time: 4 months
342 COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults

This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

NCT04449276
Conditions
  1. Severe Acute Respiratory Syndrome
  2. Coronavirus
  3. SARS-CoV-2
  4. COVID-19
Interventions
  1. Biological: CVnCoV Vaccine
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This data will be collected for decisions on subsequent vaccination of an additional open-label sentinel group with the same dose level.

Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination

Time: Up to 24 hours after vaccination on Day 1

Description: This data will be collected for decisions on dose escalation as well as continuation of enrollment at the same dose level in the observer-blind placebo-controlled part of the trial.

Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination

Time: Up to 60 hours after vaccination on Day 1

Measure: Number of Participants with Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

Time: 7 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events

Time: 28 days after vaccination

Measure: Intensity of Unsolicited Adverse Events Assessed by the Investigator

Time: 28 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

Time: 28 days after vaccination

Measure: Number of Participants with One or More Serious Adverse events (SAEs)

Time: Baseline to Day 393

Measure: Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine

Time: Baseline to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

Time: Baseline to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

Time: Baseline to Day 393

Secondary Outcomes

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using an activity assay.

Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using an activity assay.

Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

Description: Measured using an activity assay.

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393
343 A Multicenter, Randomized, Double-blind, Adaptive, Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe SARS-CoV-2 Infection (COVID-19)

The primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64 mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 29.

NCT04452474
Conditions
  1. COVID-19
Interventions
  1. Drug: Olokizumab 64 mg
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Difference between OKZ and placebo groups in the percentage of subjects with an improvement of at least 2 categories of the 5-points clinical status scale relative to baseline or in the "Not hospitalized" category. The points of the scale are: 1. Not hospitalized; 2.Hospitalized, not requiring supplemental oxygen; 3.Hospitalized, supplemental oxygen, spontaneous breathing;4. Hospitalized, mechanical ventilation (invasive/non-invasive) or extracorporeal membrane oxygenation (ECMO); 5. Death

Measure: Percentage of subjects achieving a change in their clinical status defined as improvement for at least 2 categories of the 5-points clinical status scale relative to baseline or in the "Not hospitalized" category

Time: at Day 29

Secondary Outcomes

Description: Subjects' clinical status distribution based on 5-point clinical status scale during the study

Measure: Subjects' clinical status distribution based on 5-point clinical status scale during the study

Time: from Day 2 tо Day 15, Day 29, Day 60

Description: 28-day case fatality rates

Measure: 28-day case fatality rates

Time: from Day 1 to Day 29

Other Outcomes

Description: Case fatality rates during the intensive care unit (ICU) stay at Days 7, 15, and 60

Measure: Case fatality rates during the intensive care unit (ICU) stay, at Days 7, 15, and 60

Time: from Day 1 to Day 60

Description: Duration of oxygen support (if applicable)

Measure: Duration of oxygen support

Time: From Day 1 to Day 60

Description: The time period until SpO2 ≥ 94% at ambient air during 2 consequence days is reached

Measure: The time period until SpO2 ≥ 94% at ambient air during 2 consequence days is reached

Time: from Day 2 to Day 60

Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable)

Measure: Changes of oxygenation index PaO2/FiO2 from baseline

Time: from Day 2 to Day 60

Description: Duration of oxygen support (if applicable), in days

Measure: Duration of oxygen support (if applicable)

Time: from Day 1 to Day 60

Description: Duration of mechanical ventilation and/or ECMO (if applicable), in days

Measure: Duration of mechanical ventilation and/or ECMO (if applicable)

Time: from Day 1 to Day 60

Description: Duration of ICU stay (if applicable)

Measure: Duration of ICU stay (if applicable)

Time: from Day 1 to Day 60

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte counts

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte count

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP)

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP)

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: The time period until National Early Warning Score 2 (NEWS2) ≤ 2 during 2 consequent days is reached

Measure: The time period until National Early Warning Score 2 (NEWS2) ≤ 2 during 2 consequent days is reached

Time: from Day 1 and until the end of hospitalization, Day 29 as a maximum

Description: The time period until National Early Warning Score 2 (NEWS2) ≤ 4 during 2 consequent days is reached

Measure: The time period until National Early Warning Score 2 (NEWS2) ≤ 4 during 2 consequent days is reached

Time: from Day 1 and until the end of hospitalization, Day 29 as a maximum
344 Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection

This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir with or without Dexamethasone.

NCT04452565
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Infection
  3. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Drug: NA-831
  2. Combination Product: NA-831 and Atazanavir
  3. Combination Product: NA-831and Dexamethasone
  4. Combination Product: Atazanavir and Dexamethasone
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

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: 1. Time (Hours) to recovery

Time: [ Time Frame: 36 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: [ Time Frame: 36 days ]
345 Randomized Double-blind Controlled Parallel Study of (Hesperidin and Diosmin Mixture) for Treatment of COVID-19 Newly Diagnosed Patients in Egypt

SARS-CoV-2 or COVID-19 is representing the major global burden that implicated more than 10 million infected cases and 500 thousand deaths worldwide. The prevalence of this pandemic disease is expected to rise every day. The challenge is to control its rapid spread meanwhile looking for a specific treatment to improve patient outcomes. Hesperidin is a classical herbal medicine used worldwide for a long time with an excellent safety profile. Hesperidin is a well-known herbal medication used as an antioxidant and anti-inflammatory agent. Available shreds of evidence support the promising use of hesperidin in prophylaxis and treatment of COVID 19. Herein, we discuss the possible prophylactic and treatment mechanisms of hesperidin based on previous and recent findings. Hesperidin can block coronavirus from entering host cells through ACE2 receptors which can prevent the infection. Anti-viral activity of hesperidin might constitute a treatment option for COVID-19 through improving host cellular immunity against infection and its good anti-inflammatory activity may help in controlling cytokine storm. Hesperidin mixture with diosmin co-administrated with heparin protect against venous thromboembolism which may prevent disease progression. Based on that, hesperidin might be used as a meaningful prophylactic agent and a promising adjuvant treatment option against SARS-CoV-2 infection.

NCT04452799
Conditions
  1. Coronavirus Infection
Interventions
  1. Drug: Hesperidin and Diosmin mixture
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: PCR negative

Measure: PCR test

Time: 14 days

Secondary Outcomes

Description: Changes in respiratory rate

Measure: respiratory rate

Time: 14 days

Description: Change in patients PaO2

Measure: patients PaO2

Time: 14 days

Description: change in serum IL1β

Measure: serum IL1β

Time: 14 days

Description: changes in serum TNF-α

Measure: serum TNF-α

Time: 14 days

Description: decrease in Mortality rate

Measure: Mortality rate

Time: 14 days
346 The Assessment of the Prevalence, Clinical Course and Treatment of COVID-19 Complications

SAR-Cov-2 infection and its clinical manifestation known as COVID-19 beside the respiratory and lung involvement may include the cardiovascular system, the nervous system and the liver. In the acute phase of the disease, all of these conditions may be life-threatened. As a result, after the acute phase of COVID-19, early complications may be observed, including heart, lungs, brain, muscles and liver. A few papers to date have been reported of myocarditis, ventricular arrhythmias, post-inflammatory changes in the lung and liver, as well as ischemic changes in the brain, diseases of skeletal muscle, which may have adverse prognostic effects. Due to the extent of the pandemic, the severity of the complications and the expected high complications' prevalence in the early post-recovery period, a study was designed to determine the extent of the problem of early complications after COVID-19. Complex cardiological, pulmonary, neurological and hepatological diagnostics are planned, including laboratory, imaging and functional tests. The results obtained, in addition to determining the scale of the problem, will allow the selection of studies that optimally identify patients with early complications. The purpose of this procedure is to enable rapid treatment of diseases that are complications of SARS-COV-2 infection. An additional aspect raised in the project will be the issue of psychiatric disorders (anxiety, depression, post traumatic disorders). The main three purposes of the study include: 1. the assessment of prevalence of particular complications after COVID-19. 2. identification of the demographic and clinical risk factors of COVID-19 complications 3. determining the diagnostic tests which are sufficient to detect early complications of COVID-19

NCT04453748
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Sars-CoV2
  4. Complications
Interventions
  1. Other: Complex diagnostic panel
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Complications include pulmonary, cardio-vascular, neurological, hepatologic and psychiatric disordes that might be linked to the COVID-19. The diagnostic tests: blood tests, transthoracic echocardiography, spirometry, high-resolution computed tomography, neurological examination, liver ultrasonography and elastography, vasular ultrasonography (veins and arteries), psychiatric questionnairies

Measure: Prevalence of COVID-19 complications

Time: 2 months

Secondary Outcomes

Description: Analysis which demographic and clinical parametrs were associated with particular COVID-19 complication. Statistical analysis of relation between clinical parameters before and during COVID19 and the occurence of COVID19 complications

Measure: Assessment of risk factors of COVID-19 complications

Time: 2 months
347 A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects

This is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.

NCT04453852
Conditions
  1. Coronavirus Infection
  2. COVID
Interventions
  1. Biological: COVID19 vaccine
  2. Biological: Saline
MeSH:Coronavirus Infections Se Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence of Adverse Events 1 week post immunisation

Measure: Incidence of Adverse Events

Time: 1 weeks post immunisation

Description: COVID19 neutralizing antibody titers post immunisation

Measure: COVID19 neutralizing antibody titers

Time: 2 weeks post second immunisation

Description: Frequency of COVID19 spike specific T cells 3 weeks post second immunisation

Measure: COVID19 T cell immunogenicity

Time: 3 weeks post second immunisation

Secondary Outcomes

Description: COVID19 spike specific antibody titers 6 months post second immunisation

Measure: Durability of antibody response

Time: 6 months post immunisation
348 Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2

The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

NCT04456088
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Corona Virus Infection
Interventions
  1. Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System
  2. Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Time to deterioration as measured by any one of the following: need for non-invasive ventilation need for high flow nasal cannula (HFNC) or need for intubation Death from any cause

Measure: Time to deterioration

Time: up to 14 days

Secondary Outcomes

Description: Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air

Measure: Time to stable oxygen saturation

Time: up to 14 days

Other Outcomes

Description: Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment

Measure: Treatment Emergent Adverse Events and SAEs

Time: 30 days after last inhalation treatment
349 Evaluation of the Characteristics of Patients and Healthcare Workers With Suspected or Confirmed of COVID-19 in Villavicencio and Meta State, Colombia

This observational study aims to collect detailed clinical information on confirmed or suspected patients of COVID-19 treated in hospitals from Meta State, Colombia. The objectives are: 1. To establish the characteristics of patients and healthcare workers treated with COVID-19. 2. To assess previous predisposing morbidity. 3. To detail clinical factors associated with complications. 4. To profile clinical indicators for severity and outcomes.

NCT04456426
Conditions
  1. COVID
  2. SARS-CoV 2
  3. SARS Pneumonia
  4. SARS (Disease)
  5. SARS (Severe Acute Respiratory Syndrome)
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Death within 30 days of hospital admission

Measure: Mortality

Time: 30 days

Description: Need for intensive care unit admission

Measure: ICU admission

Time: 30 days

Description: Need for intubation and invasive mechanical ventilation

Measure: Mechanical ventilation

Time: 30 days

Secondary Outcomes

Description: Duration of stay in the intensive care unit

Measure: ICU length of stay

Time: 30 days

Description: Duration of stay in hospitalization

Measure: Hospital length of stay

Time: 30 days

Description: Duration of mechanical ventilation included with intubation or tracheostomy

Measure: Days of mechanical ventilation

Time: 30 days
350 PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.

NCT04459351
Conditions
  1. Coronavirus
  2. Corona Virus Infection
  3. COVID-19
  4. 2019nCoV
  5. 2019 Novel Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary purpose is to characterise the different presentations and features of COVID-19 and outcomes.

Measure: Identification of baseline characteristics which correlate with disease severity

Time: Based on clinical need - Up to 1 year follow up.

Description: Relationship between changes in markers of inflammation (CRP, D dimer, ferritin, fibrinogen, pro-calcitonin) and pulmonary, renal and cardiac complications post hospitalisation for Covid-19 infection.

Measure: Identification of blood biomarkers which correlate with disease severity

Time: Based on clinical need - Up to 1 year follow up.

Description: Genomic, proteomic and transcriptomic analysis of blood samples to look for genetic susceptibility to severe disease presentations and to identify new biomarkers that predict disease severity or disease trajectory

Measure: Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations

Time: Based on clinical need - Up to 1 year follow up.

Secondary Outcomes

Description: Incidence of: Interstitial lung disease Pulmonary embolism Pulmonary hypertension as determined by pulmonary artery systolic pressure on echocardiogram or mean pulmonary artery pressure on right heart catheterisation if performed Renal dysfunction (as defined by new persistent impairment of egfr or new sustained protenuria measured using urinary protein-creatinine ratio) Cardiac dysfunction (new LV or RV systolic dysfunction on echocardiogram) Psychological distress as measured using Hospital anxiety and depression scale

Measure: Incidence

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed through Leicester Cough Questionnaire: Domain scores 1-7; Total scores 3-21

Measure: Change in respiratory symptom scores

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed through the modified Medical Research Council Dyspnoea Scale: Scores range from 0-4.

Measure: Change in respiratory symptom scores

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed thought the Short Form Survey (36): 8 scales, each scored between 0-100.

Measure: Change in frailty and quality of life scores

Time: Based on clinical need - Up to 1 year follow up.

Description: Assessed through the Clinical Frailty Scale: Scores range from 1-9.

Measure: Change in frailty and quality of life scores

Time: Based on clinical need - Up to 1 year follow up.

Description: D dimer/ fibrinogen and new pulmonary embolism

Measure: Relationship between serum markers and clinical outcomes

Time: Based on clinical need - Up to 1 year follow up.

Description: Troponin/ BNP and cardiac disease

Measure: Relationship between serum markers and clinical outcomes

Time: Based on clinical need - Up to 1 year follow up.

Description: Markers of inflammation (CRP, procalcitonin, ferritin, fibrinogen, D dimer, ESR) and persistent radiological abnormalities

Measure: Relationship between serum markers and clinical outcomes

Time: Based on clinical need - Up to 1 year follow up.

Other Outcomes

Description: Changes in health behaviours such as alcohol consumption and tobacco use Mental health and psychological wellbeing Factors affecting compliance with Public Health England guidelines The impact of cultural and religious beliefs on behaviours during the pandemic

Measure: Thematic analysis of semi-structured interviews exploring the following areas:

Time: Up to 1 year follow up.
351 Psychiatric Disturbances in Patients Infected With COVID-19: A Cross Sectional Study

This observational study aims at Assessment of the prevalence and types Psychiatric disturbances that affects patients with COVID-19 infection with and without previous psychiatric diseases. in addition to, Assessment of the types of Psychiatric disturbances in patients with COVID-19 infection in correlation to age, disease severity, co-morbid conditions and treatments applied

NCT04459403
Conditions
  1. Corona Virus Infection
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: The General Health Questionnaire: To measure psychiatric well-being. Taylor Manifest Anxiety Scale: To determine the level of anxiety. Beck Depression Inventory: To assess symptoms of depression. The Brief-COPE scale: To assess coping responses. These questionnaires are combined in one questionnaire filled by the patients. it needs from 15-20 minutes.

Measure: Psychiatric well-being, level of anxiety, symptoms of depression and coping strategies questionnaire

Time: 3 months

Description: prevalence of each type and correlation with age, disease severity, co-morbid conditions and treatments applied

Measure: Prevalence and types of Psychiatric disturbances in patients with COVID-19 infection

Time: 3 months
352 A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

NCT04459702
Conditions
  1. COVID
  2. COVID-19
  3. Corona Virus Infection
  4. Coronavirus Infection
  5. Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
  6. Coronavirus-19
  7. SARS-CoV 2
  8. SARS Pneumonia
Interventions
  1. Drug: hydroxychloroquine
  2. Drug: Azithromycin
  3. Drug: Ritonavir
  4. Drug: Lopinavir
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores

Time: 6 months

Description: Time to non-infectivity as measured by PCR testing

Measure: Efficacy of Treatment by Time to Non-Infectivity

Time: 10 days

Secondary Outcomes

Description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores

Time: 6 months

Description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.

Time: 6 months

Description: Changes in blood parameters measured in a Complete Blood Count (CBC).

Measure: Safety of Dual Therapy as Measured by Complete Blood Count

Time: 6 months

Description: Changes in blood parameters measured in a Complete Metabolic Panel.

Measure: Safety of Quadruple Therapy as Measured by Complete Blood Count

Time: 6 months

Description: Changes in serum albumin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin

Time: 6 months

Description: Changes in serum albumin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin

Time: 6 months

Description: Changes in serum albumin/globulin ratio

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio

Time: 6 months

Description: Changes in serum albumin/globulin ratio

Measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio

Time: 6 months

Description: Changes in serum alkaline phosphatase levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase

Time: 6 months

Description: Changes in serum alkaline phosphatase levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase

Time: 6 months

Description: Changes in serum AST levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST

Time: 6 months

Description: Changes in serum AST levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST

Time: 6 months

Description: Changes in serum ALT levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT

Time: 6 months

Description: Changes in serum ALT levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT

Time: 6 months

Description: Changes in serum BUN/Creatinine Ratio

Measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Time: 6 months

Description: Changes in serum BUN/Creatinine Ratio

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio

Time: 6 months

Description: Changes in serum Blood Urea Nitrogen levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN

Time: 6 months

Description: Changes in serum Blood Urea Nitrogen levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN

Time: 6 months

Description: Changes in serum calcium levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium

Time: 6 months

Description: Changes in serum calcium levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium

Time: 6 months

Description: Changes in serum carbon dioxide levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide

Time: 6 months

Description: Changes in serum carbon dioxide levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide

Time: 6 months

Description: Changes in serum chloride levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride

Time: 6 months

Description: Changes in serum chloride levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride

Time: 6 months

Description: Changes in serum creatinine levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine

Time: 6 months

Description: Changes in serum creatinine levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine

Time: 6 months

Description: Changes in serum globulin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin

Time: 6 months

Description: Changes in serum globulin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin

Time: 6 months

Description: Changes in blood glucose levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose

Time: 6 months

Description: Changes in blood glucose levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose

Time: 6 months

Description: Changes in blood potassium levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium

Time: 6 months

Description: Changes in blood potassium levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium

Time: 6 months

Description: Changes in serum total bilirubin levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin

Time: 6 months

Description: Changes in serum total bilirubin levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin

Time: 6 months

Description: Changes in serum total protein levels

Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein

Time: 6 months

Description: Changes in serum total protein levels

Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein

Time: 6 months

Description: Presence or absence of treatment related serious adverse events Grade III or higher

Measure: Safety of Dual Therapy as Measured by Treatment Related SAE

Time: 6 months

Description: Presence or absence of treatment related serious adverse events Grade III or higher

Measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE

Time: 6 months
353 A Phase 1 Randomized Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers

This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows: - To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered. - To determine the recommended Phase 2a dose (RP2D). Secondary objectives: • To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.

NCT04461353
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Aerolized Hydroxychloroquine Sulfate
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: TEAEs (defined as AEs with onset after study drug administration or existing AEs that worsen in severity after study drug administration)

Measure: Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0

Time: after treatment (Day 1) through to Day 30

Description: Blood sample collected for CBC with differential will be assessed from baseline (at screening)

Measure: Change from baseline in clinical laboratory test results for CBC with differential

Time: Screening and Day 8

Description: Screening blood sample collected for CBC with differential, counting the number of abnormal clinical tests

Measure: Incidence of abnormal laboratory test results for CBC with differential at Screening

Time: Screening

Description: Day 8 blood sample collected for CBC with differential

Measure: Incidence of abnormal laboratory test results for CBC with differential - Day 8

Time: Day 8

Description: Blood sample collected for blood glucose and measured with a glucometer

Measure: Changes from baseline for blood glucose

Time: Screening and Day 1

Description: Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)

Measure: Incidence of abnormal laboratory test results for chemistry -Screening

Time: Screening

Description: Blood sample collected for chemistry panel (albumin, total protein, ALP, ALT, AST, direct and indirect bilirubin, GGT, BUN, creatinine, glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and LDH)

Measure: Incidence of abnormal laboratory tests results for chemistry - Day 8

Time: Day 8

Description: Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood

Measure: Incidence of abnormal laboratory tests results for urinalysis - Screening

Time: Screening

Description: Collection of urine sample to test pH, specific gravity, protein, glucose, ketones, urobilinogen, bilirubin, leukocyte esterase, squamous cells, epithelial cells, clarity, bacteria, blood

Measure: Incidence of abnormal laboratory tests results for urinalysis- Day 8

Time: Day 8

Description: The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (September 2007) (TGSHAAV) will be used as the primary criteria for assessment of clinical abnormalities. Mild (17-20 breaths per minute) to Potentially Life Threatening (intubation)

Measure: Changes in vital signs from baseline (pre-dose) - respiratory rate

Time: Screening, Day 1, Day 2 and Day 8

Description: Oral temperature

Measure: Changes in vital signs from baseline (pre-dose)- temperature

Time: Screening, Day 1, Day 2 and Day 8

Description: Systolic and diastolic blood pressure

Measure: Changes in vital signs from baseline (pre-dose) - seated blood pressure

Time: Screening, Day 1, Day 2 and Day 8

Description: Heart rate measure by radial pulse rate (beats/min)

Measure: Changes in vital signs from baseline (pre-dose) - pulse

Time: Screening, Day 1, Day 2 and Day 8

Description: O2 saturation (%), measured by pulse oximeter. Graded as per TGSHAAV (September 2007) from Moderate (pulse oximeter <92%) to Potentially Life Threatening (Life-threatening airway compromise; urgent intervention indicated)

Measure: Changes in vital signs from baseline (pre-dose) - O2 saturation

Time: Screening, Day 1, Day 2 and Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening- general appearance

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1 - general appearance

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2- general appearance

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8- general appearance

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening- neurological

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1- neurological

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2- neurological

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8- neurological

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular

Time: Day 1 (pre-dose, within 3 hours of dose)

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening - lungs

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1 - lungs

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2 - lungs

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8 - lungs

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening- abdomen

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1 - abdomen

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2- abdomen

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8- abdomen

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during screening- endocrine

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1 - endocrine

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2- endocrine

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8- endocrine

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening- extremities

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1- extremities

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2- extremities

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8- extremities

Time: Day 8

Description: Physical exam by clinician. A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during Screening- lymphatic

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1- lymphatic

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2 - lymphatic

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8- lymphatic

Time: Day 8

Description: A directed physical examination will be conducted

Measure: Incidence of abnormal and physical examinations findings during screening - skin

Time: Screening

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 1 - skin

Time: Day 1

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 2 - skin

Time: Day 2

Description: Physical exam by clinician. A directed physical examination assessing and documenting changes from the previous visit, including any new abnormalities, will be conducted

Measure: Incidence of abnormal and physical examinations findings on Day 8 - skin

Time: Day 8

Description: Pulmonary function testing and recording of FEV1, both actual and percent predicted

Measure: Changes from baseline for pulmonary function tests (PFTs) - FEV1

Time: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.

Description: Pulmonary function testing and recording of FVC, , both actual and percent predicted

Measure: Changes from baseline for pulmonary function tests (PFTs) - FVC

Time: Screening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.

Description: Pulmonary function testing and recording of FEV1/FVC

Measure: Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC

Time: creening, Day 1 at pre-dose (within 25 minutes of dose) and at +15 minutes, +1, +3 and +6 hours after study treatment, and on Day 2 and Day 8.

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval (msec) will be the assessment parameter.

Measure: Changes from baseline for ECG readings - QT interval

Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QTcB interval (msec) will be the assessment parameter.

Measure: Changes from baseline for ECG readings - QTcB Interval

Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QRS duration (msec) will be the assessment parameter.

Measure: Changes from baseline for ECG readings - QRS duration

Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG PR interval (msec) will be the assessment parameter.

Measure: Changes from baseline for ECG readings - PR interval

Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG heart rate (beats/min) will be the assessment parameter.

Measure: Changes from baseline for ECG readings - heart rate

Time: Screening and on Day 1 pre-dose (within 3 hours of dose) and approximately +2 and +6 hours, and on Days 2 and 8.

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Measure: Incidence of abnormal ECG - Screening

Time: Screening

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Measure: Incidence of abnormal ECG- Day 1

Time: Day 1 pre-dose (within 3 hours of dose) and +2 and +6 hours

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Measure: Incidence of abnormal ECG - Day 2

Time: Days 2

Description: The ECG will be performed after the participant is allowed to rest seated for at least 5 minutes, before transferring to the examination bed/table for the ECG. ECG will be performed before PFTs or blood drawing. ECG QT Interval will be the assessment parameter.

Measure: Incidence of abnormal ECG - Day 8

Time: Days 8.

Secondary Outcomes

Description: Blood samples for PK analysis will be collected via indwelling catheter or via direct venipuncture.

Measure: HCQ concentration in whole blood versus time profiles

Time: Day 1 pre-dose (time 0) and +2, +3, +5, and +15 minutes after dose, and also +1, +2, +4 and +6 hours post-dose completion. Day 2 (+24±4 hours post dose) and Day 8.
354 Prevention, Efficacy and Safety of BCG Vaccine in COVID-19- Randomized Clinical Trial

In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability to contain the disease. There is currently no vaccine to prevent the disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant mortality has been reported, not related only to tuberculosis. BCG vaccine has been hypothesized to have a non-specific role towards other unrelated pathogens such as viruses that cause airway disease, with reduced morbidity and mortality. In murine as well as in human models it has been shown to decrease the incidence of acute respiratory influenza infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it increases the epigenetic response, causing an increase in the transcription of genes important in the antimicrobial response, as well as an improvement in cellular function. This is the first national clinical trial to evaluate prospectively the effect that the BCG vaccine offers towards the prevention and reduction of severity in cases of COVID-19.

NCT04461379
Conditions
  1. BCG
  2. COVID-19
  3. SARS-CoV2
  4. Corona Virus Infection
Interventions
  1. Biological: BCG vaccine
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Cumulative incidence of infection in 6 months: disease defined as positive SARS-Cov-2 test (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: Demonstrate COVID- 19 disease incidence among Health care workers:

Time: During the 6 months study period

Description: Cumulative incidence of hospitalization for COVID-19

Measure: Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers:

Time: During the 6 months study period

Description: Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months

Measure: Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers

Time: During the 6 months study period

Description: Number of participants who needed hospitalization

Measure: Hospitalization of severe disease COVID-19

Time: During the 6 months study period

Description: Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients

Measure: Oxygen supplementation in severe disease COVID-19

Time: During the 6 months study period

Description: Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients

Measure: Need for intubation or non-invasive ventilation for the patient.

Time: During the 6 months study period

Description: Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients

Measure: Critical care admission with SARS-CoV2

Time: During the 6 months study period

Description: Mortality associated to progressive pulmonary disease in hospitalized patients

Measure: Mortality associated to progressive pulmonary disease

Time: During the 6 months study period

Secondary Outcomes

Measure: Evaluate the safety of the vaccine by measuring the incidence rates of local and systemic adverse effects that occur after one month its application.

Time: 1 month after vaccine/placebo application

Measure: Calculate the incidence of COVID-19 complications

Time: During the 6 months study period

Measure: Determine the mean days of hospitalization and days in intensive care unit by COIVD-19

Time: During the 6 months study period

Measure: Calculate the cost associated with in-hospital medical care

Time: During the 6 months study period

Description: SOFA score: PaO2/FIO2 (mm Hg), SaO2/FIO2, Platelets (×10³/µL), Bilirubin (mg/dL), Hypotension, Glasgow Coma Score and Creatinine (mg/dL) or urine output (mL/d).

Measure: Determine the scores of the Clinical Prediction Rules associated with mortality using Sequential Organ Failure Assessment (SOFA score) at the patient's hospital admission:

Time: During the 6 months study period

Description: APACHE: History of severe organ failure or immunocompromise Heart Failure Class IV, cirrhosis, chronic lung disease, or dialysis-dependent, Age, Temperature (C°), Mean arterial pressure (mmHg), pH, Sodium (mEq/L), Potassium (mEq/L), Creatinine (mg/dL), Hematocrit (%), WBC (x 109/L)

Measure: Determine the scores of the Clinical Prediction Rules associated with mortality using Acute Physiology and Chronic Health disease Classification System (APACHE) at the patient's hospital admission:

Time: During the 6 months study period

Description: CPR, ESR, Ferritin, D-dimer, LDH,Troponins, Procalcitonin, Interleukin-6, Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, MCV, HCM, MCHC, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Glucose, Urea, Creatinine, BUN, Sodium, Potassium, Chlorine, Calcium, Serum albumin, Direct bilirubin, Indirect bilirubin, Alkaline phosphatase, AST, ALT, bleeding time, Prothrombin Time, Activated partial thromboplastin time, Arterial / Venous Blood Gasometry, pH, pCO2, HCO3, pO2, SaO2%, Lactate.

Measure: Evaluate and determine the alteration profile in laboratory studies at the patient's hospital admission

Time: During the 6 months study period

Measure: Registration of chronic medications

Time: During the 6 months study period

Measure: Need for vasopressors

Time: During the 6 months study period
355 Clinical and Laboratory Predictors of COVID-19 Progression and Maternal and Perinatal Outcomes in Infected Pregnant and Postpartum Women in Six Reference Centers in the Northeast of Brazil

A prospective and retrospective cohort study. The objective will to determine the frequency of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate clinical and laboratory predictors of COVID-19 progression and to determine the factors associated with adverse maternal and perinatal outcomes in healthcare centers in two states of Northeast Brazil.The study will be conducted including pregnant and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be included. The data will be collected in specific forms. The exams will be carried out by trained professionals within each institution.

NCT04462367
Conditions
  1. COVID19
  2. Coronavirus Infection
  3. Pregnancy Disease
  4. Severe Acute Respiratory Syndrome
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.

Measure: Near miss maternal:

Time: 42 days

Description: It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.

Measure: Maternal death

Time: 42 days

Description: It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar <7 in the 5th minute, birth weight <1,750 grams or gestational age <33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.

Measure: Near miss neonate

Time: 7 days

Description: Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.

Measure: Neonatal death

Time: 27 days

Description: Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable

Measure: Early neonatal death

Time: 7 days

Description: Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.

Measure: Fetal death

Time: 1 hour

Description: Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.

Measure: Perinatal death

Time: 7 days

Secondary Outcomes

Description: Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.

Measure: Maternal age

Time: 1 hour

Description: maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.

Measure: Maternal pre-pregnancy weight

Time: 1 hour

Description: expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.

Measure: Maternal height

Time: 1 hour

Description: classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to <16.99), low weight grade I (≥ 17 , 00 to <18.49), ideal weight (≥ 18.50 to <24.99), overweight (≥ 25.00 to <29.99), grade I obesity (≥ 30.00 to <34.99) , grade II obesity (≥35.00 to <39.99) and grade III obesity (≥ 40.00).

Measure: Pre-gestational nutritional classification

Time: 1 hour

Description: expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.

Measure: Pre-gestational body mass index (BMI)

Time: 1 hour

Description: according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.

Measure: Maternal color

Time: 1 hour

Description: defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.

Measure: Number of people living in the household

Time: 1 hour

Description: collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.

Measure: Family income per capita

Time: 1 hour

Description: as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (> 12 years) ). Numerical and discrete variable.

Measure: Maternal education

Time: 1 hour

Description: as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.

Measure: Maternal occupation

Time: 1 hour

Description: as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.

Measure: Maternal occupation with financial income

Time: 1 hour

Description: declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.

Measure: Maternal marital status

Time: 1 hour

Description: as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.

Measure: Maternal origin

Time: 1 hour

Description: according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.

Measure: Maternal religion

Time: 1 hour

Description: smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

Measure: Maternal smoking

Time: 1 hour

Description: habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

Measure: Maternal alcoholism

Time: 1 hour

Description: use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

Measure: Maternal use of illicit drugs

Time: 1 hour

Description: number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

Measure: Number of pregnancies

Time: 1 hour

Description: number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

Measure: Parity

Time: 1 hour

Description: number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

Measure: Number of previous cesarean sections

Time: 1 hour

Description: number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

Measure: Number of previous vaginal births

Time: 1 hour

Description: number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

Measure: Number of previous abortions

Time: 1 hour

Description: number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.

Measure: Number of children alive

Time: 1 hour

Description: as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.

Measure: Number of prenatal consultations

Time: 1 hour

Description: gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.

Measure: Gestational age of the onset of flu-like signs and symptoms

Time: 1 hour

Description: number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.

Measure: Number of puerperium days of onset of flu-like signs and symptoms

Time: 14 days

Description: number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.

Measure: Duration of maternal symptoms

Time: 1 hour

Description: when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.

Measure: Social isolation during the signs and symptoms of flu-like syndrome

Time: 14 days

Description: it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.

Measure: Social distance before the signs and symptoms of flu-like syndrome

Time: 1 hour

Description: when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.

Measure: Quarantine

Time: 14 days

Description: when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.

Measure: Need for hospitalization due to flu-like syndrome and/or complications

Time: 1 hour

Description: day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.

Measure: Day of hospitalization due to flu syndrome and/or complications

Time: 1 hour

Description: length of stay, in days, as described in the medical record. Numerical and discrete variable.

Measure: Length of hospital stay due to flu-like syndrome and/or complications

Time: 14 days

Description: As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).

Measure: Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months

Time: 24 months

Description: result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.

Measure: Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months

Time: 24 months

Description: result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.

Measure: Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel)

Time: 10 days

Description: result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.

Measure: Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months

Time: 24 months

Description: result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.

Measure: Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months

Time: 24 months

Description: result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.

Measure: Serial maternal IgM COVID-19

Time: 6 months, 12 months and 24 months

Description: result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.

Measure: Serial maternal IgA COVID-19

Time: 6 months, 12 months and 24 months

Description: result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.

Measure: Serial maternal IgG COVID-19

Time: 6 months, 12 months and 24 months

Description: rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.

Measure: Serial maternal serology day

Time: 6 months, 12 months and 24 months

Description: after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.

Measure: Maternal reinfection

Time: 14 days

Description: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

Measure: Cytokines in maternal diagnosis

Time: 14 days

Description: day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first blood count from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.

Measure: Hemoglobin of maternal diagnosis

Time: 14 days

Description: value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.

Measure: Leukocytes from maternal diagnosis

Time: 14 days

Description: when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.

Measure: Deviation to the left of the maternal diagnosis

Time: 14 days

Description: value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.

Measure: Platelets of maternal diagnosis

Time: 14 days

Description: value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.

Measure: Typical lymphocytes of maternal diagnosis

Time: 14 days

Description: value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.

Measure: Atypical lymphocytes of maternal diagnosis

Time: 14 days

Description: day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first coagulogram from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.

Measure: Maternal diagnosis bleeding time (TB)

Time: 14 days

Description: value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

Measure: Maternal diagnosis clotting time (CT)

Time: 14 days

Description: value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.

Measure: Maternal prothrombin time of diagnosis (TD)

Time: 14 days

Description: value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.

Measure: Maternal active partial thromboplastin time of diagnosis (APTT)

Time: 14 days

Description: value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.

Measure: International normalized ratio (INR)

Time: 14 days

Description: day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first urea from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.

Measure: Urea from maternal diagnosis

Time: 14 days

Description: day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first creatinine from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.

Measure: Creatinine of maternal diagnosis

Time: 14 days

Description: defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.

Measure: Transaminases in maternal diagnosis

Time: 14 days

Description: day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19:

Time: 14 days

Description: value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.

Measure: VSH of maternal diagnosis

Time: 14 days

Description: day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.

Measure: CRP of maternal diagnosis

Time: 14 days

Description: day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first D-dimer from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

Measure: D-dimer of maternal diagnosis

Time: 14 days

Description: day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.

Measure: DHL of maternal diagnosis

Time: 14 days

Description: day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.

Measure: Alkaline phosphatase in maternal diagnosis

Time: 14 days

Description: day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first troponin from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.

Measure: Troponin in maternal diagnosis

Time: 14 days

Description: day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first ferritin from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

Measure: Ferritin in maternal diagnosis

Time: 14 days

Description: defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.

Measure: Bilirubins in maternal diagnosis

Time: 14 days

Description: day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first blood culture from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Blood culture of maternal diagnosis

Time: 14 days

Description: name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

Measure: Blood culture microorganism in maternal diagnosis

Time: 14 days

Description: day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the first uroculture from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Uroculture of maternal diagnosis

Time: 14 days

Description: name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

Measure: Uroculture microorganism in maternal diagnosis

Time: 14 days

Description: worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.

Measure: IgM COVID-19 worst maternal result

Time: 5 days

Description: Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.

Measure: IgA COVID-19 worst maternal result

Time: 5 days

Description: worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.

Measure: Maternal IgG COVID-19 - worst serial result

Time: 14 days

Description: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

Measure: Cytokines worst maternal outcome

Time: 14 days

Description: day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the worst urea result from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.

Measure: Urea worst maternal result

Time: 14 days

Description: day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.

Measure: Creatinine worst maternal result

Time: 14 days

Description: defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.

Measure: Transaminases worst maternal outcome

Time: 14 days

Description: day of the worst VSH result from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

Measure: Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the worst result of VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.

Measure: VSH worst maternal result

Time: 14 days

Description: day of the worst CRP result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19

Time: 14 days

Description: value of the worst CRP result measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.

Measure: CRP worst maternal result

Time: 14 days

Description: day of the worst D-dimer result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19

Time: 14 days

Description: value of the worst D-dimer result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

Measure: D-dimer worst maternal result

Time: 14 days

Description: day of the worst DHL result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

Measure: Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19

Time: 14 days

Description: value of the worst DHL result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.

Measure: DHL worst maternal result

Time: 14 days

Description: value of the worst result of alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.

Measure: Alkaline phosphatase worst maternal result

Time: 14 days

Description: value of the worst result of troponin dosed in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.

Measure: Troponin worst maternal result

Time: 14 days

Description: value of the worst result of ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

Measure: Ferritin worst maternal result

Time: 14 days

Description: defined as the worst result of total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.

Measure: Bilirubins worst maternal result

Time: 14 days

Description: result of the worst blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Blood culture worst maternal result

Time: 14 days

Description: name of the microorganism, which grew on the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

Measure: Blood culture microorganism worst maternal result

Time: 14 days

Description: result of the worst uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Uroculture worse maternal result

Time: 14 days

Description: name of the microorganism, which grew in the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

Measure: Uroculture microorganism worst maternal result

Time: 14 days

Description: presence of any radiological changes, described in a medical report. Yes / No categorical and dichotomous variable.

Measure: Presence of changes in maternal chest radiography

Time: 14 days

Description: description of any radiological alterations, described in a medical report.

Measure: Result of maternal chest radiography

Time: 14 days

Description: presence of any changes in the tomography described in a medical report. Yes / No categorical and dichotomous variable.

Measure: Presence of changes in the mother's chest tomography

Time: 14 days

Description: day of the normalization of any alteration of the tomography, described in a medical report, as of the appearance. Numerical and discrete variable.

Measure: Day of normalization of the alteration of the tomography of the maternal chest

Time: 14 days

Description: description of any alteration of the tomography described in a medical report.

Measure: Result of maternal chest tomography

Time: 14 days

Description: need for maternal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

Measure: Use of maternal nasal catheter

Time: 1 month

Description: need for Venturi mask to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

Measure: Use of maternal Venturi Mask

Time: 1 month

Description: when the patient was placed in prone position on spontaneous ventilation, face down, which was used to improve oxygenation. Yes / No categorical and dichotomous variable.

Measure: Prone maternal position on spontaneous ventilation

Time: 1 month

Description: need for antibiotic therapy to treat associated bacterial infection. Yes / No categorical and dichotomous variable.

Measure: Use of therapeutic antibiotics

Time: 14 days

Description: need for azithromycin as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of azithromycin

Time: 14 days

Description: need for hydroxychloroquine / chloroquine as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of maternal hydroxychloroquine/chloroquine

Time: 14 days

Description: need for antiparasitic drugs as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of antiparasitic drugs

Time: 14 days

Description: need for anticoagulant as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of anticoagulant

Time: 14 days

Description: need for antiretroviral as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of antiretroviral

Time: 14 days

Description: need for corticosteroid pulse therapy as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of pulse therapy

Time: 14 days

Description: need for patient-cured plasma from COVID-19 (convalescent) as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.

Measure: Use of convalescent plasma

Time: 14 days

Description: need for AMV as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.

Measure: Assisted Mechanical Ventilation (AMV)

Time: 1 month

Description: need for medication for neuromuscular block, such as pancuronium, as assessed by the attending physician and described in the medical record. Yes / No categorical and dichotomous variable.

Measure: Use of neuromuscular blocker

Time: 14 days

Description: need to use ECMO to better oxygenate the lungs and heart. Yes / No categorical and dichotomous variable.

Measure: Use of Extracorporeal Circulation (ECMO)

Time: 1 month

Description: need for dialysis (peritoneal or hemodialysis) as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.

Measure: Renal replacement therapy (dialysis)

Time: 1 month

Description: need for blood products as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.

Measure: Blood products

Time: 1 month

Description: need for other complementary treatments of COVID-19. Yes / No categorical and dichotomous variable.

Measure: Other therapeutic modalities

Time: 1 month

Description: defined by the amniotic fluid index (ILA) or the largest pocket, according to the experience of the ultrasonographer. The ILA will be measured in cm, being defined as the sum of the largest pockets of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 8.0 and 18.0cm), decreased (between 7.9 and 5.0cm), moderate oligohydramnios (between 4.9 and 3.0cm), severe oligohydramnios (<3 , 0cm), increased (between 18.1 and 24cm) and polyhydramnios (ILA> 24cm) (81.82). The largest pocket will also be measured in cm, being defined as the measure of the largest pocket of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 3.0 and 8.0cm), decreased (between 2.9 and 2.0cm), moderate oligoamine (between 1.9 and 1.0cm), severe oligoamine (<1.0cm), increased (ILA between 8.1 and 12.0cm) and polyhydramnios (ILA> 12.0cm).

Measure: Amniotic fluid in the last ultrasound examination

Time: 14 days

Description: defined by the Delphi procedure 2016 . Yes / No categorical and dichotomous variable.

Measure: Fetal growth restriction

Time: 14 days

Description: defined when the estimated fetal weight is <10pct for gestational age and does not meet the criteria for IUGR. Yes / No categorical and dichotomous variable.

Measure: Small fetus for gestational age (SGA)

Time: 14 days

Description: presence of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound. Yes / No categorical and dichotomous variable.

Measure: Presence of fetal morphological changes

Time: 1 month

Description: description of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound.

Measure: Fetal morphological changes

Time: 1 month

Description: increased FFT diagnosed by ultrasound or Doppler sonar, with sinus rhythm, when greater than 160bpm. Yes / No categorical and dichotomous variable.

Measure: Frequency of fetal tachycardia (FFT)

Time: 1 month

Description: from the pulsatility index (PI), which is automatically calculated by the ultrasound device, using the formula: systolic peak minus the diastolic peak divided by the average speed.

Measure: Doppler velocimetry parameters in the last ultrasound examination

Time: 1 month

Description: gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound of amniocentesis. Numerical and discrete variable.

Measure: Gestational age of amniocentesis

Time: 1 month

Description: indication for amniocentesis, due to COVID-19 or another cause.

Measure: Amniocentesis indications

Time: 1 month

Description: result of RT-PCR for COVID-19, in amniotic fluid, according to the usual technique, being categorized as positive, negative and indeterminate.

Measure: Result of amniocentesis for COVID19

Time: 1 month

Description: substances capable of modulating the cellular response of several cells, such as interleukins IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in amniotic fluid, in pg / ml, from the beginning of the flu syndrome or COVID-19 , and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

Measure: Amniocentesis cytokines

Time: 1 month

Description: need for hospitalization due to some comorbidity or obstetric complications. Yes / No categorical and dichotomous variable.

Measure: Need for hospitalization due to obstetric causes

Time: 1 month

Description: total hospital stay for any comorbidity or obstetric complications. Numerical and discrete variable.

Measure: Maternal hospital stay

Time: 1 month

Description: calculated based on the last BMI (weight [kg] / height [m] 2), by gestational age, using the curve by Atalah et al. Yes / No categorical and dichotomous variable.

Measure: Obesity

Time: 1 month

Description: defined as blood pressure (BP) greater than or equal to 140 / 90mmHg, diagnosed before pregnancy, or before the 20th week of pregnancy . Yes / No categorical and dichotomous variable.

Measure: Chronic arterial hypertension (CAH)

Time: 1 month

Description: defined as CAH associated with signs of severity . Yes / No categorical and dichotomous variable.

Measure: Superimposed preeclampsia

Time: 1 month

Description: defined as BP greater than or equal to 140 / 90mmHg, diagnosed above the 20th week of pregnancy, with no signs of severity or proteinuria . Yes / No categorical and dichotomous variable.

Measure: Gestational hypertension

Time: 1 month

Description: defined as BP greater than or equal to 140 / 90mmHg, above the 20th week of pregnancy, associated with proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3 ), or target organ dysfunction, which can be categorized as severe and non-severe . Yes / No categorical and dichotomous variable.

Measure: Pre-eclampsia

Time: 1 month

Description: defined as BP greater than or equal to 140 / 90mmHg above the 20th week of gestation, in the presence of proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3), associated with seizures. Yes / No categorical and dichotomous variable.

Measure: Eclampsia

Time: 1 month

Description: defined by the presence of hemolysis, elevated liver enzymes, decreased platelets (below 100,000 / L), elevated TGO / TGP (above 70UI / L) . Yes / No categorical and dichotomous variable.

Measure: HELLP syndrome

Time: 1 month

Description: defined by the presence of one of the criteria: HbA1C ≥ 6.5% or fasting blood glucose ≥ 126mg / dl - the test should be repeated - or random blood glucose> 200mg / dl, associated with symptoms of diabetes , depending on diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.

Measure: Clinical diabetes

Time: 1 month

Description: defined by the presence of at least one of the criteria after an oral glucose tolerance test (TOTG) performed between the 24th and 28th weeks of gestation: fasting glucose ≥ 92mg / dl, or ≥ 180mg / dl (after one hour), or ≥ 153mg / dl (after two hours) , according to the diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.

Measure: Gestational diabetes

Time: 1 month

Description: spontaneous rupture of the membranes, diagnosed by anamnesis and clinical examination of the pregnant woman, before the start of labor. Yes / No categorical and dichotomous variable.

Measure: Premature rupture of membranes

Time: 1 month

Description: defined as the spontaneous triggering of labor before term (<37 weeks), when there were above three contractions in 30 minutes and cervical alteration, according to clinical and obstetric evaluation. Yes / No categorical and dichotomous variable.

Measure: Premature labor

Time: 1 month

Description: define when the placental insertion is low, close to the cervix, regardless of its classification (total, partial and marginal), according to ultrasound report. Yes / No categorical and dichotomous variable.

Measure: Placenta previa

Time: 1 month

Description: termination of pregnancy before the 22nd week and / or below 500 g, gestational age preferable, provided it is reliable, regardless of whether it is spontaneous or provoked. Yes / No categorical and dichotomous variable.

Measure: Abortion

Time: 1 month

Description: defined as vaginal bleeding and / or uterine hypertonia, leading to emergency delivery, with evidence of retroplacental hematoma in the postpartum period. Yes / No categorical and dichotomous variable.

Measure: Normally inserted placental abruption

Time: 1 month

Description: defined when urine culture is positive for any microorganism, and treatment has been started, regardless of symptoms. Yes / No categorical and dichotomous variable.

Measure: Maternal urinary tract infection

Time: 1 month

Description: presence of any congenital or acquired maternal heart disease, according to the patient's information, or diagnosed during hospitalization. Yes / No categorical and dichotomous variable.

Measure: Maternal heart disease

Time: 1 month

Description: as reported by the patient and / or described in the medical record presenting the diagnosis of asthma. Yes / No categorical and dichotomous variable.

Measure: Bronchial asthma

Time: 1 month

Description: as reported by the patient and / or described in the medical record presenting the diagnosis of COPD. Yes / No categorical and dichotomous variable.

Measure: Chronic obstructive pulmonary disease (COPD)

Time: 1 month

Description: as reported by the patient and / or described in the chart that presents the diagnosis of cerebrovascular disease. Yes / No categorical and dichotomous variable.

Measure: Cerebrovascular disease

Time: 1 month

Description: as reported by the patient and / or described in the chart that presents the diagnosis of CRL. Yes / No categorical and dichotomous variable.

Measure: Chronic kidney injury

Time: 1 month

Description: as reported by the patient and / or described in the chart that presents the diagnosis of immunosuppressive disease or use immunosuppressive medication. Categorical and dichotomous Yes / No type.

Measure: Immunosuppression

Time: 1 month

Description: presence of the flu syndrome associated with laboratory changes, such as leukocytosis or leukopenia, and radiological, such as localized or diffuse interstitial infiltrate, or presence of a condensation area, as diagnosed by the attending physician. Yes / No categorical and dichotomous variable.

Measure: Maternal pneumonia

Time: 1 month

Description: life-threatening organ dysfunction resulting from an unregulated response by the body to an infection. Yes / No categorical and dichotomous variable.

Measure: Maternal sepsis

Time: 1 month

Description: defined as a situation of sepsis, associated with signs of hypoperfusion, with fluid-refractory hypotension and requiring vasopressor therapy (Lactate> 2 mmol / L). Yes / No categorical and dichotomous variable.

Measure: Septic shock

Time: 1 month

Description: flu-like syndrome (fever, cough, dyspnoea and other nonspecific), accompanied by oxygen saturation <95% (SatO2), respiratory distress or tachypnea, hypotension and worsening of the clinical conditions of the underlying disease. Yes / No categorical and dichotomous variable.

Measure: Severe acute respiratory syndrome (SARS)

Time: 1 month

Description: increased postpartum bleeding, according to the assessment of the attending physician, requiring some maneuver or therapy for control. Yes / No categorical and dichotomous variable.

Measure: Postpartum hemorrhage

Time: 14 days

Description: exit of purulent secretion by the surgical scar, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.

Measure: Infection of the operative site

Time: 14 days

Description: characterized by the discharge of purulent secretion from the uterine cervix, remaining dilated, with an unpleasant odor and fever for a minimum of two consecutive days, excluding the first 24 hours, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.

Measure: Endometritis

Time: 14 days

Description: characterized by abdominal pain, with compatible image examination, according to the assessment of the attending physician. Categorical and dichotomous Yes / No type.

Measure: Peritonitis

Time: 14 days

Description: removal of the uterus, for any indication, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.

Measure: Need for postpartum hysterectomy

Time: 1 month

Description: defined as the type of delivery performed, categorized as normal, instrumental (vacuum or forceps) or cesarean delivery.

Measure: Type of delivery

Time: 1 hour

Description: if a cesarean section was performed, insert the indication that the attending physicians described, which can be later modified, according to the medical record evaluation by the researchers. The main indications are: dystocias, including cephalopelvic disproportion, macrosomia, impaired fetal vitality, placenta previa, cord prolapse, placental abruption, among others.

Measure: Indication of cesarean section

Time: 1 hour

Description: gestational age at birth, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the amniocentesis. Numerical and discrete variable.

Measure: Gestational age at birth

Time: 1 hour

Description: use of pharmacological labor analgesia, as indicated by the attending physician and declared in medical records. Yes / No categorical and dichotomous variable.

Measure: Use of labor analgesia

Time: 4 hours

Description: method of anesthesia for performing cesarean section, categorized into spinal anesthesia, epidural and general anesthesia.

Measure: Type of anesthesia for cesarean section

Time: 1 hour

Description: as noted in the medical records, referring to the complete course of betamethasone (12mg two doses in a 24h interval) or dexamethasone (6mg 12 / 12h, for two days), incomplete course, not taking corticosteroids or without indication for accelerating fetal lung maturity.

Measure: Antenatal corticosteroid therapy (pulmonary maturity)

Time: 14 days

Description: as noted in the medical record, magnesium sulphate for neuroprotection, before delivery and until the 32nd week of pregnancy, being categorized as complete course (performance of attack and first stage of magnesium sulfate before delivery), incomplete, not performed or without indication.

Measure: Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia)

Time: 32 weeks

Description: as noted in the medical records, referring to the use of the prophylactic regimen of crystalline penicillin to prevent neonatal infection with group B Streptococcus, being categorized as complete (completion of at least two phases) crystalline penicillin before delivery), incomplete, not performed or without indication.

Measure: Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis)

Time: 14 days

Description: when the pregnant patient was admitted and discharged while pregnant. Yes / No categorical and dichotomous variable.

Measure: Hospital discharge when pregnant

Time: 1 month

Description: when the pregnant or puerperal patient has been admitted and discharged in the puerperal state. Yes / No categorical and dichotomous variable.

Measure: Hospital discharge when puerperal

Time: 1 month

Description: when maternal death occurs with the pregnant patient. Categorical and dichotomous Yes / No type.

Measure: Maternal death when pregnant

Time: 1 month

Description: when maternal death occurs with the patient in the puerperal state. Categorical and dichotomous Yes / No type.

Measure: Maternal death when puerperal

Time: 45 days

Description: birth of a fetus without vitality. Yes / No categorical and dichotomous variable.

Measure: Fetal death

Time: 10 hours

Description: fetal or neonatal death (up to and including the 27th day of life). Yes / No categorical and dichotomous variable.

Measure: Perinatal death

Time: 27 days

Description: as measured on a standard scale, in the delivery room, in grams, and recorded in medical records. Numerical and discrete variable.

Measure: Birth weight

Time: 1 hour

Description: classification of birth weight, according to gestational age, being categorized as: small for gestational age (SGA), when <10th pct; suitable for gestational age (AGA), when between 10º pct and 90º pct; and great for gestational age (GIG), when> 90º pct.

Measure: Adequacy of birth weight

Time: 1 hour

Description: as calculated by the classic Apgar score , in the first minute of birth, recorded in medical records, which can be later categorized. Numerical and discrete.

Measure: Apgar scores in the first minute

Time: 1 minute

Description: as calculated by the classic Apgar score, in the fifth minute of birth, recorded in medical records, which can be further categorized. Numerical and discrete variable.

Measure: Apgar scores in the fifth minute

Time: 5 minutes

Description: defined as the newborn's stay in the neonatal intensive care unit after delivery, to perform any procedure. Yes / No categorical and dichotomous variable.

Measure: Neonatal ICU admission

Time: 1 hour

Description: defined as the need for resuscitation maneuvers, performed on the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.

Measure: Need for neonatal resuscitation

Time: 27 days

Description: defined as the need for assisted mechanical ventilation, provided to the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.

Measure: Need for neonatal mechanical ventilation

Time: 27 days

Description: need for a neonatal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

Measure: Neonatal nasal catheter

Time: 27 days

Description: need for neonatal CPAP to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.

Measure: Neonatal Continuous Positive Airway Pressure (CPAP) mask

Time: 27 days

Description: defined when the axillary temperature is less than or equal to 35ºC, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.

Measure: Neonatal hypothermia

Time: 27 days

Description: defined as peripheral blood glucose below 40mg / dl, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.

Measure: Neonatal hypoglycemia

Time: 27 days

Description: defined as any neonatal infection diagnosed as noted in the medical record by neonatal care. Yes / No categorical and dichotomous variable.

Measure: Neonatal infection

Time: 27 days

Description: defined as the infection of the amniotic cavity, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.

Measure: Chorioamnionitis

Time: 27 days

Description: defined as newborn's respiratory distress (RDS), transient tachypnea of the newborn (NRT) or absent respiratory distress, as noted in the medical record for neonatal care.

Measure: Neonatal respiratory distress modality

Time: 1 month

Description: defined as any congenital infection confirmed at birth, based on fetal PCR, neonatal examination or maternal serology, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.

Measure: Neonatal congenital infection (TORCHS)

Time: 1 month

Description: defined as any fetal congenital malformation present, as noted in medical records by neonatal care. Yes / No categorical and dichotomous variable.

Measure: Congenital malformation

Time: 1 month

Description: exclusive breastfeeding, during hospitalization, by natural method or pasteurized breast milk. Yes / No categorical and dichotomous variable.

Measure: Breastfeeding

Time: 1 month

Description: can be divided into early, when performed in less than three minutes, and timely, when between three to five minutes. Categorical and dichotomous variable.

Measure: Cord ligation

Time: 10 minutes

Description: as early contact was made between the mother and the baby, early, still in the delivery room. Yes / No categorical and dichotomous variable.

Measure: Skin-to-skin contact

Time: 1 hour

Description: according to breastfeeding, early, still in the delivery room. Yes / No categorical and dichotomous variable.

Measure: Breastfeeding in the delivery room

Time: 1 hour

Description: days of life of the newborn until the newborn's diagnostic suspicion. Numerical and discrete variable.

Measure: Days of life of the newborn's diagnostic suspicion

Time: 1 month

Description: result of RT-PCR in the diagnosis of COVID-19, through the blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.

Measure: Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months

Time: 6 months, 12 months and 24 months

Description: result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.

Measure: Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel)

Time: 6 months, 12 months and 24 months

Description: result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.

Measure: Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months

Time: 6 months, 12 months and 24 months

Description: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine)

Measure: Neonatal cytokines

Time: 6 months, 12 months and 24 months

Description: result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according with the reference values of each serological kit, performed after the 5th day of signs and symptoms.

Measure: Neonatal IgM COVID-19

Time: 5 days

Description: result of IgA COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.

Measure: IgA COVID-19 neonatal serial

Time: 5 days

Description: result of IgG COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 14th day of signs and symptoms. Numeric and continuous variable.

Measure: Serial neonatal IgG COVID-19

Time: 14 days

Description: after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.

Measure: Neonatal reinfection

Time: 14 days

Description: value of the first hemoglobin measured in neonatal blood, in g / dL, from the suspicion of the diagnosis by COVID-19. Numeric and continuous variable.

Measure: Hemoglobin from neonatal diagnosis

Time: 14 days

Description: value of the first BT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Diagnostic neonatal bleeding time (BT)

Time: 1 month

Description: value of the first CT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Diagnostic neonatal clotting time (CT)

Time: 1 month

Description: value of the first urea measured in neonatal blood, in mg / dL, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Urea from neonatal diagnosis

Time: 1 month

Description: value of the first creatinine measured in neonatal blood, in mg / dL, based on the suspected diagnosis by COVID-19. Numerical and discrete variable.

Measure: Creatinine from neonatal diagnosis

Time: 1 month

Description: defined as aspartate aminotransferase or glutamic-oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase, based on the suspicion of the diagnosis by COVID-19.

Measure: Transaminases of the neonatal diagnosis

Time: 1 month

Description: result of the first blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Blood culture of the neonatal diagnosis

Time: 1 month

Description: result of the first urine culture, based on the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Uroculture of neonatal diagnosis

Time: 1 month

Description: worst result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate , according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.

Measure: IgM COVID-19 - worst neonatal result

Time: 5 days

Description: worst result of IgG COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 14th day of signs and symptoms. Numeric and continuous variable.

Measure: Neonatal IgG COVID-19 - worst serial result

Time: 14 days

Description: worst result of cytokines, substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12 , IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from suspected diagnosis. Numeric and continuous variable (for each cytokine).

Measure: Cytokines - worst neonatal result

Time: 14 days

Description: day of the worst blood count result, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19

Time: 1 month

Description: day of the realization of the worst value of the coagulogram, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19

Time: 1 month

Description: value of the worst BT result measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Bleeding time - worst neonatal result (BT)

Time: 1 month

Description: value of the worst result of urea measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Urea - worst neonatal result

Time: 1 month

Description: value of the worst result of creatinine measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.

Measure: Creatinine - worst neonatal result

Time: 1 month

Description: defined as the worst result of aspartate aminotransferase (AST) or glutamic oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase measurements, from the beginning of suspected COVID-19 diagnosis.

Measure: Transaminases - worst neonatal result

Time: 1 month

Description: result of the worst blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Blood culture - worst neonatal result

Time: 1 month

Description: result of the worst urine culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

Measure: Uroculture - worst neonatal result

Time: 1 month

Description: defined as the worst result of measuring hydrogen potential, excess of bases, bicarbonate, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2) and oxygenation index, in neonatal arterial blood, from the beginning of suspected COVID-19 diagnosis.

Measure: Gasometry - worst neonatal result

Time: 1 hour

Description: result of RT-PCR in the diagnosis of COVID-19, through the placenta, according to the usual technique, being categorized as positive, negative and indeterminate.

Measure: Result of RT-PCR of the placenta

Time: 1 month

Description: result of the RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through the placenta, according to the technique and kit used, categorized according to the virus found.

Measure: Placental viral panel

Time: 1 month

Description: result of the histopathological of the placenta, according to the usual technique.

Measure: Histopathological of the placenta

Time: 1 month

Description: result of RT-PCR in the diagnosis of COVID-19, using breast milk, according to the usual technique, being categorized as positive, negative and indeterminate.

Measure: Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge

Time: 1 month

Description: result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through breast milk, according to the technique and kit used, categorized according to the virus found.

Measure: Viral panel in breast milk

Time: 1 month

Description: presence of any radiological alteration, described in a medical report. Yes / No categorical and dichotomous variable.

Measure: Presence of alteration of the neonatal chest radiography

Time: 1 day

Description: description of any radiological changes, according to a medical report.

Measure: Result of neonatal chest radiography

Time: 1 day

Description: presence of any alteration of the tomography, described in a medical report. Yes / No categorical and dichotomous variable.

Measure: Presence of alteration of the neonatal chest tomography

Time: 1 day

Description: description of any alteration of the tomography, according to a medical report.

Measure: Result of neonatal chest tomography

Time: 1 day

Description: measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.

Measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference

Time: 6, 12 and 24 months

Description: measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.

Measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight

Time: 6, 12 and 24 months

Description: measured by the assistant pediatrician as noted on the prenatal card, in cm. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.

Measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height

Time: 6, 12 and 24 months

Description: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as adequate, when all are present, and inappropriate, if any of the situations is absent: the baby is firmer and already sits with support; he turns around and rolls from side to side; grabs toys like rings and rattles, holding tight and resisting if someone tries to take them out of your hand; and when he hears some noise, he turns his head to find where it comes from.

Measure: Development of the newborn up to 6 months

Time: 6 months

Description: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inappropriate, if any of the situations is absent: the baby can stand up, leaning on furniture or with the help of a person; clap your hands, you can point with your finger what you want to catch and have fun saying goodbye; and you may be speaking a word or two like mom, pope, give.

Measure: Development of the newborn up to 12 months

Time: 12 months

Description: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inadequate, if any of the situations is absent: start to put two words together and speak simple phrases like "where's the cat?" or "milk not"; he demonstrates his own will, tests limits and speaks the word "no" a lot; climbs on chairs and sofas. Run, go up and down stairs, standing, with the help of an adult; can help to dress; and you can start to learn how to control pee and poop.

Measure: Development of the newborn up to 24 months

Time: 24 months
356 Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2

This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

NCT04462848
Conditions
  1. Corona Virus Infection
Interventions
  1. Biological: anti-SARS-CoV-2 human convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated. A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.

Measure: Cumulative incidence of Grade 3 and Grade 4 adverse events

Time: up to Day 28 post-administration of study plasma

Description: A serious adverse event is any untoward or unfavorable medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect, or is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

Measure: Cumulative incidence of serious adverse events

Time: up to Day 28 post-administration of study plasma

Secondary Outcomes

Description: Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.

Measure: Proportion of participants with disease worsening event.

Time: up to Day 28 post-administration of study plasma

Description: Anti-SARS-CoV-2 antibody titer changes over time

Measure: Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies

Time: Days 0, 7, 14, and 28

Description: This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers to be collected once between 60 and 120 days post study plasma administration

Measure: Percentage of participants with a natural antibody response to SARS-CoV-2 infection

Time: once between Day 60 and Day 120
357 Arrhythmic Manifestations and Management Strategies in Hospitalized COVID-19 Patients: Proposal for a Multicenter Registry

Although arrhythmias appear to be common in COVID-19 patients, arrhythmia mechanisms and characteristics, predisposing factors, incidence of sudden cardiac death and predictors, therapeutic strategies employed as well as long term outcomes are not well understood. Hence, we seek to develop a multicenter registry aimed to characterize arrhythmic manifestations, employed treatment strategies and long-term outcomes among hospitalized COVID-19 patients in the US.

NCT04465552
Conditions
  1. Coronavirus Infections
Interventions
  1. Other: Patients received standard of care treatment during hospitalization
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.

Measure: To better characterize arrhythmic manifestations, employed treatment strategies and long- term outcomes in hospitalized COVID-19 patients in the US through a multicenter retrospective chart review.

Time: January 1, 2020 - June 30, 2020
358 A Longitudinal, Non-randomized Study to Evaluate the Utility of the INanoBio's Protein Arrays in Detecting Unique Antibodies in COVID-19 Patients

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment. The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable. Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.

NCT04465981
Conditions
  1. COVID-19
  2. Corona Virus Infection
Interventions
  1. Diagnostic Test: Sampling
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Detection versus No Detection of the virus and indicate which viral protein antigens are most useful for serological testing.

Measure: Detection Test of COVID-19

Time: through study completion, an average of 1 year
359 Combination Therapies to Reduce the Nasopharyngeal Carriage of SARS-CoV-2 and Improve the Outcome of COVID-19 Infection in Ivory Coast (INTENSE-COV): a Phase IIb Randomized Clinical Trial

In January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO has described the global situation of COVID-19 as a pandemic. In Côte d'Ivoire, as in other African countries, the number of cases is increasing exponentially. Coronaviruses are a family of viruses that cause illnesses ranging from the common cold to more severe pathologies. COVID-19 can result in fever or a feeling of fever (chills, hot-cold), cough, headache, aches and pains, unusual tiredness, sudden loss of smell, total disappearance of taste, or diarrhea. In severe forms, respiratory difficulties can lead to hospitalization in intensive care or even death. Numerous studies are currently being conducted around the world to seek effective treatment, but few of them have started specifically in Africa. Moreover, most of these studies are using a single drug to control the infection, whether these are repositioned drugs, i.e. already being used for other diseases, or other newer drugs. Currently in Côte d'Ivoire, the preferred treatment for COVID-19 is an antiviral: lopinavir/ritonavir (LPV/r), usually directed against the Human Immunodeficiency Virus (HIV). Since the number of viruses (viral load) is high in the respiratory tract during COVID-19 infection, we propose in INTENSE-COV (ICOV) clinical trial to study whether the combination of two drugs is more effective than taking a single drug on reducing the viral load in the respiratory tract but also on reducing inflammation. These drugs include the LPV/r already in use in Côte d'Ivoire as well as an antihypertensive drug - telmisartan, and a drug that lowers blood cholesterol - atorvastatin. All three have been known for a long time and have been shown to be effective against other viruses. In addition, they are generic, inexpensive and readily available in all countries. The objectives of the ICOV study are therefore to improve viral eradication from the patient's body and respiratory tract, to reduce inflammation, to improve more rapidly the patient's state of health and to reduce the risk of transmission of the virus to others. To participate in ICOV, patients must be over 18 years of age, have a COVID-19 infection confirmed by a specific test, have clinical manifestations of the infection, and have signed an informed consent. They will then be randomized into 3 treatment groups to ensure the robustness of the study results. The reference group will be treated with LPV/r, according to current recommendations in Côte d'Ivoire. The other 2 groups will be treated with LPV/r + telmisartan and LPV/r + atorvastatin respectively. The treatment will last 10 days and patients will be followed for a total of 28 days.

NCT04466241
Conditions
  1. COVID-19
  2. COVID-19 Drug Treatment
  3. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet
  2. Drug: Telmisartan 40Mg Oral Tablet
  3. Drug: Atorvastatin 20 Mg Oral Tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11

Time: Day 11

Secondary Outcomes

Measure: Proportion of patients with clinical improvement on the 7-point ordinal scale at Day 11 and Day 28

Time: Day 11 and Day 28

Measure: Kinetics of SARS-CoV-2 viral load

Time: Up to Day 28

Measure: Death rate at Day 11 and Day 28

Time: Day 11 and Day 28

Measure: All causes of death and Acute respiratory distress syndrome (ARDS) at Day 28

Time: Day 28

Measure: Time to hospital discharge

Time: Up to Day 28

Measure: Duration of oxygen supplementation

Time: Up to Day 28

Measure: Prevalence of grade III or IV adverse events

Time: Up to Day 28

Measure: Residual concentration of lopinavir, telmisartan and atorvastatin

Time: Up to Day 28

Measure: Evolution of inflammatory and immunological markers (CRP, fibrinogen, ferritin, d-dimer, dosing of IgG, IgA, IgM; TCD4, CD8, B lymphocytes, NK lymphocytes; naïve/memory T lymphocytes)

Time: Up to Day 28

Measure: Evolution of endothelial activation markers (VEGF and soluble VEGF receptor,VE-cadherin, PECAM/CD31, CD42 and angiopoietin-2)

Time: Up to Day 28

Measure: Proportion of patients with good results according to HIV status

Time: Up to Day 28

Measure: Number of contact cases infected by COVID-19 at Day 28

Time: Day 28
360 Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.

NCT04468009
Conditions
  1. SARS-Associated Coronavirus
  2. Covid19
  3. SARS-CoV Infection
Interventions
  1. Biological: Convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Mortality at 30 days of Intensive Care Unit (ICU) admission

Measure: Mortality at ICU at 30 days

Time: Mortality at 30 days

Description: Mortality at 90 days of ICU admission

Measure: Mortality at ICU at 90 days

Time: Mortality at 90 days

Secondary Outcomes

Description: Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28

Measure: SOFA score of study days 1, 3, 5, 7, 14 and 28

Time: Study days 1, 3, 5, 7, 14 and 28

Description: Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment

Measure: Need for supportive therapy after enrollment

Time: Duration of supportive therapy through study completion, an average of 3 months

Description: Duration (number of days) of stay in ICU between ICU admission and ICU final discharge

Measure: Lenght of stay in ICU

Time: Duration of stay in ICU through study completion, an average of 3 months

Description: Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation

Measure: Lenght of mechanical ventilation

Time: Duration of mechanical ventilation through study completion, an average of 3 months

Description: Duration (number of days) of hospitalization between hospital admission and final hospital discharge

Measure: Lenght of hospitalization

Time: Duration of hospitalization through study completion, an average of 3 months

Other Outcomes

Description: Duration (number of days) of hospitalization after ICU discharge

Measure: Lenght of hospitalization after ICU discharge

Time: Duration (number of days) of hospitalization through study completion, an average of 3 months

Description: Number of days without ventilation after enrollment

Measure: Days without ventilation after enrollment

Time: Days without ventilation through study completion, an average of 3 months

Description: Number of days without vasopressors after enrollment

Measure: Days without vasopressors after enrollment

Time: Days without vasopressors through study completion, an average of 3 months

Description: Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment

Measure: Changes in Chest X-ray

Time: Changes in Chest X-ray through study completion, an average of 3 months
361 Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR

The current coronavirus disease pandemic has posed a problem and a challenge for health systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and monitoring disease outbreaks. In this pandemic, the qPCR technique has become vitally important in virus detection, due to its wide detection and quantification range, and the high levels of sensitivity and specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the prior extraction of viral genetic material, which is carried out using commercial kits created for this purpose. Currently, the high demand for supplies to carry out this technique has generated reagent shortage problems, including commercial kits for the extraction of viral genetic material. This research aims to evaluate a solution called AAA-Safe and its method, developed to optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We hope that this alternative can be implemented in any molecular diagnostic laboratory, in order to speed up the delivery of a fast and safe diagnosis.

NCT04468217
Conditions
  1. COVID
  2. SARS-CoV2
  3. Corona Virus Infection
Interventions
  1. Diagnostic Test: Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Two workflows for the detection of SARS-CoV-2 will be compared: Gold Standard: Obtaining nasopharyngeal sample in validated transport medium, RNA extraction by columns and qPCR. Alternative method: Obtaining nasopharyngeal sample in AAA-Safe proprietary transport medium, alternative method of extraction and qPCR.

Measure: Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples.

Time: 3 months

Secondary Outcomes

Measure: Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in oropharyngeal, nasal, buccal and saliva samples

Time: 3 months

Measure: Establish a sample bank of nasopharyngeal, oropharyngeal, nasal, buccal and saliva mucosa for future analytical validations of new solutions associated with the detection of the SARS-CoV-2 virus.

Time: 3 month
362 A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Immunomodulatory Effect of the RIPK1 Inhibitor SAR443122 in Hospitalized Patients With Severe COVID-19

Primary Objective: To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with severe coronavirus disease 2019 (COVID-19) Secondary Objectives: - To evaluate the time to onset of effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by CRP levels - To evaluate the time to onset of effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on total duration of supplemental oxygen requirement - To evaluate the effect of SAR443122 relative to the control arm on length of ventilator support needed - To evaluate the effect of SAR443122 relative to the control arm on laboratory markers of severe COVID-19 - To evaluate the effect of SAR443122 relative to the control arm on mortality - To evaluate the effect of SAR443122 relative to the control arm on need for thrombolytic therapy - To evaluate the effect of SAR443122 relative to the control arm on need for vasopressor treatment - To evaluate the safety of SAR443122 as compared to the control arm up to End of Study - To evaluate the effect of SAR443122 relative to the control arm on total duration without high flow supplemental oxygen requirements

NCT04469621
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: SAR443122
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Relative change from baseline in CRP level on Day 7

Measure: Relative change from baseline in CRP level

Time: Day 7

Secondary Outcomes

Description: The time to 50% decrease from baseline in CRP level

Measure: Time to 50% decrease from baseline in CRP level

Time: Baseline to Day 28

Description: The time to improvement of oxygenation as measured by oxygen saturation >/=92% breathing room air over 48 hrs or until discharge

Measure: Time to improvement of oxygenation

Time: Baseline to Day 28

Description: Change from baseline in SPO2/FiO2 ratio at Day 7

Measure: Change from baseline in SPO2/FiO2 ratio

Time: Day 7

Description: Number of Days without need for oxygen support and alive (oxygen saturation >=92% breathing room air) up to Day 28

Measure: Number of Days without need for oxygen support and alive

Time: Baseline to Day 28

Description: Numbers of Ventilator-free days and alive up to Day 28

Measure: Numbers of Ventilator-free days and alive

Time: Baseline to Day 28

Description: Change from baseline in white blood cell count and differential blood lymphocytes at Day 7 and End of treatment (EOT)

Measure: Change from baseline in markers of inflammation: white blood cell count and differential blood lymphocytes

Time: Day 7 and Day 15

Description: Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT

Measure: Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio

Time: Day 7 and Day 15

Description: Change from baseline in IL-6 at Day 7 and EOT

Measure: Change from baseline in marker of inflammation: interleukin 6 (IL-6)

Time: Day 7 and Day 15

Description: Change from baseline in D-Dimer at Day 7 and EOT

Measure: Change from baseline in D-Dimer

Time: Day 7 and Day 15

Description: Incidence of Deaths up to Day 28

Measure: Incidence of Deaths

Time: Baseline to Day 28

Description: Percentage of participants receiving thrombolytic treatment up to Day 28

Measure: Percentage of participants receiving thrombolytic treatment

Time: Baseline to Day 28

Description: Percentage of participants receiving vasopressor treatment up to Day 28

Measure: Percentage of participants receiving vasopressor treatment

Time: Baseline to Day 28

Measure: Incidence of serious adverse events (SAEs), adverse events of special interest (AESI) and treatment-emergent adverse events (TEAEs) leading to treatment discontinuation

Time: Baseline to Day 28

Measure: Incidence of TEAEs leading to study discontinuation (primary reason)

Time: Baseline to Day 28

Description: Numbers of Respiratory Failure-Free Days (RFFD) and alive up to Day 28

Measure: Numbers of Respiratory Failure-Free Days (RFFD) and alive

Time: Baseline to Day 28
363 RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor

To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.

NCT04470544
Conditions
  1. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Camostat Mesilate
  2. Other: Standard of Care
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.

Measure: Change in the proportion of patients alive and free from respiratory failure

Time: 28 Days

Secondary Outcomes

Description: To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.

Measure: Change in the proportion of patients alive and free of ventilator use or ECMO

Time: 28 Days

Description: To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 and 56 days as compared to SOC treatment combined with placebo.

Measure: Mortality Rate

Time: 28 and 56 Days

Description: Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.

Measure: Clinical Change

Time: 14 and 28 Days

Description: Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.

Measure: Adverse Events

Time: up to 56 days
364 Evaluation of Clinical Parameters Following COVID-19 Infection in Pregnancy (COpregVID)

Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.

NCT04470583
Conditions
  1. COVID-19
  2. 2019 Novel Coronavirus Infection
  3. COVID-19 Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.

Measure: Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.

Time: From the start of the study up until one month prior to study end.

Description: Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.

Measure: Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.

Time: From the start of the study up until one month prior to study end.

Secondary Outcomes

Description: Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.

Measure: Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.

Time: From the start of the study up until one month prior to study end.
365 Italian Web-based EPICOVID19 Cross-sectional Survey

The outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that started in late December 2019 in the Hubei province of China caused millions of cases worldwide in just a few months, and evolved into a real pandemic. However, only approximately 20% of SARS-CoV-2 infected patients required intensive on sub-intensice medical care and the remained experience mild or subclinical form of the disease that did not require hospital admission and a relatively high percentage (40 to 45%) remained asymptomatic. Understanding the occurrence of SARS-CoV-2-like infectious in a large non-hospitalized population, when the epidemic peak was occurring in Italy, is of paramount importance but data are scarce. The goal of this research project is to estimate the number of suspected cases of COVID-19 and to investigate the role of the potential factors associated with SARS-CoV-2 infection in a large Italian sample of respondents living in Italy during the lockdown (started in Italy on 9 March 2020). EPICOVID19 is an Italian countrywide self-administered cross-sectional web-based survey on adult volunteers launched on April 13, 2020. The on-line questionnaire has been developed starting from the available literature and implemented using an open source platform focusing on beahvioural and clinical features of participants.

NCT04471701
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Survey, Family Life
  4. Epidemic Disease
  5. Self-Assessment
Interventions
  1. Behavioral: Environmental exposure and clinical features
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measured by using answers on the Clinical evaluation section of the questionnaire: Fever > 37.5 °C for at least 3 consecutive days; cough; sore throat/rhinorrea; headache; myalgia; olfactory/taste disorders; shortness of breath; chest pain; tachycardia; gastrointestinal disorders; conjunctivitis. Variables on symptomatology will be created by considering each symtom singularly and by combining them using a priori definition (e.g. WHO) and a posteriori approach (based on EPICOVID19 data). Logistic regression models will be applied to assess the measurements of association between exposures of interest and COVID-19-like symptoms by estimating the aOR and 95%CI.

Measure: Number of participants (%) with COVID-19-like symptoms

Time: 3 months (July 2020) after initial data collection (April 2020)

Description: Measured by using answers collected thorugh the on-line questionnaire about molecular NPS tests results. Logistic regression models will be applied to assess the measurements of association between exposures of interest and SARS-CoV-2 NPS positivity versus negativity by estimating the odds ratios (aOR) and 95% Confidence Intervals (CI).

Measure: Number of participants (%) with SARS-CoV-2 nasopharyngeal swab (NPS) test positivity

Time: 3 months (July 2020) after initial data collection (April 2020)
366 Physiotherapy as a Complimentary Treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors With CoViD-19: A Clinical-Controlled Study

Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv with multiple comorbidities. Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic acid content in the test sample (NA) will be recorded from the virology test results. Their exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes' walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements will be taken at every three days intervals from admission to discharge from hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video platforms will be used for the interactions between the physiotherapists and the participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and Nervous System Disorders research group of the University of Lagos, Nigeria will be used for the E-exercises. The exercise package will be loaded into the phones of the participants at hospital admission. The Physiotherapists will lead in the exercises through video interaction will the participants watches the video programme. Their risks for respiratory complications (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval). Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence for inclusion of Physiotherapy in the acute management of individuals tested positive for CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage to reduce the odds of developing complications expedite discharge and reduce odd of death.

NCT04471831
Conditions
  1. Corona Virus Infection
  2. Stroke
Interventions
  1. Other: Rehabilitation exercise protocol
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Stroke
HPO:Stroke

Primary Outcomes

Description: The CT value of a reaction is defined as the cycle number when the fluorescence of a PCR product can be detected above the background signal. The CT value is associated with the amount of PCR product in the reaction. The lower the CT value, the more PCR product that is present. It does not have unit of measurement

Measure: Cycle Threshold (CT) values as recorded from the series of the qRT-PCR

Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

Description: This is the inverse of the Cycle Threshold. It does not have unit of measurement.

Measure: Nucleic acid values as calculated from the Cycle Threshold recorded from the series of the qRT-PCR

Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

Description: Perceived life experience by the participants in relation to the present situation. It does not have unit of measurement.

Measure: Quality of Life perception

Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

Description: The maximum amount of physical exertion that a patient can sustain. It will be tested using the 3-metre walk test. This is the time taken to complete a 3-metre distance. The unit of measurement is in seconds

Measure: Exercise capacity

Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

Description: The maximum length a patient can sustain an exercise procedure, It will be tested using the 3-minutes' walk test This is the distance covered within a 3-minute walk. The unit of measurement is in metres

Measure: Exercise endurance

Time: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented
367 Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc and Nigella Sativa: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients

To measure the effect of Ivermectin (sub-cutaneous) with or without zinc and Nigella sativa in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

NCT04472585
Conditions
  1. Coronavirus Infection
  2. COVID
  3. Sars-CoV2
Interventions
  1. Drug: Nigella Sativa / Black Cumin
  2. Drug: Ivermectin Injectable Solution
  3. Other: Placebo
  4. Drug: Zinc
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: time needed to turn positive COVID-19 PCR to negative

Measure: qRT-PCR

Time: 14 days

Secondary Outcomes

Description: time needed to make patients clinically better

Measure: Severity of symptoms

Time: 14 days
368 Epidemiologic Assessment of SARS-CoV-2 Prevalence in Minnesota

The purpose of this epidemiologic study is to estimate the prevalence and incidence of anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also estimate the risk of SARS-CoV-2 exposure in target population.

NCT04473183
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. SARS-CoV-2
  4. Corona Virus Infection
Interventions
  1. Diagnostic Test: Specimen Collection
  2. Diagnostic Test: Surveys
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.

Measure: Prevalence of Symptomatic Infection

Time: 1 year

Description: Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.

Measure: Prevalence of Subclinical Infection

Time: 1 year
369 Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients

The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

NCT04473261
Conditions
  1. Covid19
  2. SARS-CoV-2
  3. Corona Virus Infection
Interventions
  1. Drug: Iodine Complex
  2. Drug: Iodine Complex
  3. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time taken for viral load clearance

Measure: qRT-PCR

Time: 14 days

Secondary Outcomes

Description: Time taken for symptomatic response in patients

Measure: Severity of Symptoms

Time: 14 days
370 GlitazOne Treatment for Coronavirus HypoxiA, a Safety and Tolerability Open Label With Matching Cohort Pilot Study

Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.

NCT04473274
Conditions
  1. Coronavirus Infection
  2. Diabetes
Interventions
  1. Drug: Pioglitazone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hypoxia
HPO:Hypoxemia

Primary Outcomes

Description: Number and type of adverse events

Measure: Adverse events outcomes without attribution

Time: Baseline, until 30 days after last dose

Description: Number and type of adverse events

Measure: Adverse events attributable

Time: Baseline, until 30 days after last dose

Secondary Outcomes

Description: Disease severity as measured by 7 point ordinal scale

Measure: Clinical improvement

Time: Baseline, until 30 days after last dose

Description: Type of oxygen support treatment

Measure: Levels of treatment

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of d-Dimer

Measure: d-Dimer

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of CRP

Measure: C Reactive Protein

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of Ferritin

Measure: Ferritin

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of Lactate dehydrogenase

Measure: Lactate dehydrogenase

Time: Baseline, until 30 days after last dose

Description: Change from Baseline of A1c

Measure: A1c

Time: Baseline, until 30 days after last dose
371 Can the Electronic Nose Smell COVID-19? A Proof-of-principle Study

Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis. Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.

NCT04475562
Conditions
  1. SARS-CoV Infection
  2. Covid19
Interventions
  1. Device: Aeonose
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns.

Measure: COVID 19 positive vs negative

Time: 3 months
372 Can the Electronic Nose Smell COVID-19 Antibodies? A Proof-of-principle Study

Corona Virus Disease (COVID-19), spread worldwide and has become an emergency of major international concern. In March 2020, the WHO declared the COVID-19 outbreak a global pandemic. Accurate and fast diagnosis is crucial in managing the pandemic. Current diagnostic approaches raise several difficulties: they are time-consuming, expensive, invasive, and most important lacking high sensitivity. The gold standard diagnostic test for COVID-19, reverse transcription polymerase chain reaction (RT-PCR), is highly dependent on adequate deep sampling of the swab in the naso- and oropharynx. A new diagnostic test that can correctly and rapidly identify infected patients and asymptomatic carriers is urgently required to prevent further virus transmission and thus reduce mortality rates. Aim: This proof-of-principle study aims to investigate if an electronic nose (Aeonose) can distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs). Methods: between April and July 2020, persons undergoing RT-PCR and a serology test for COVID-19 were recruited at Maastricht UMC+ for breath analysis. All participants had to breathe through the Aeonose for five consecutive minutes. The VOC pattern in their exhaled breath was then linked to the matching RT-PCR and serological test results.

NCT04475575
Conditions
  1. SARS-CoV Infection
  2. Covid19
Interventions
  1. Device: Aeonose
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Ability of the electronic nose (Aeonose) to distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs).

Measure: COVID-19 antibodies vs COVID-19 negative

Time: 3 months
373 A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)

COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.

NCT04475601
Conditions
  1. COVID-19
  2. Corona Virus Infection
Interventions
  1. Drug: Enzalutamide Pill
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale

Measure: Time to worsening of disease

Time: Up to 30 days after inclusion

Description: Time to discharge from hospital assessed by the 7-point ordinal scale

Measure: Time to improvement of disease

Time: Up to 30 days after inclusion

Secondary Outcomes

Description: Safety evaluation, as measured by AEs

Measure: Adverse events

Time: Up to 6 months

Description: Total days of extra oxygen

Measure: Duration of supplemental oxygen (days)

Time: Up to 30 days

Description: Frequence of admission to ICU

Measure: Admission to ICU

Time: Up to 30 days and up to 6 months

Description: Changes of laboratory parameters: Hb

Measure: Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6

Time: Up to 30 days

Description: PCR based SARS-CoV-2 measurement from upper respiratory tract

Measure: Virus load assessment day 0, 2, 4 and 6

Time: UP to 7 days

Description: Total number of days evaluated at 30 days and 6 months

Measure: Hospital stay (days)

Time: Up to30 days and 6 months

Description: If admitted to hospital due to COVID-19 disease after discharge from hospital

Measure: Re-admission to hospital due to rebound COVID-19

Time: Evaluated for 30 days and after 6 months

Description: Death due to any cause

Measure: Mortality at 6 months

Time: up to 30 days and up to 6 months respectively

Description: Testosterone and estrogen levels

Measure: Hormonal status at 6 months

Time: from baseline to 6 months

Description: Identification of serologic immunity based after 6 months from inclusion

Measure: Serological immunity for COVID-19

Time: At 6 months

Description: Changes of laboratory parameters: CRP

Measure: Laboratory assessment of CRP concentration day 0, 2, 4 and 6

Time: Up to 30 days

Description: Changes of laboratory parameters: ALAT, ASTA and/or ALP

Measure: Laboratory assessment of liver function day 0, 2, 4 and 6

Time: Up to 30 days

Description: Changes of laboratory parameters: Createnin

Measure: Laboratory assessment of creatinine concentration day 0, 2, 4 and 6

Time: Up to 30 days

Description: Changes of laboratory parameters: D-dimer

Measure: Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6

Time: Up to 30 days

Description: Changes of laboratory parameters: TPK

Measure: Laboratory assessment of platelets concentration day 0, 2, 4 and 6

Time: Up to 30 days

Description: Changes of laboratory parameters: IL-6

Measure: Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6

Time: Up to 30 days

Description: Changes of laboratory parameters: Differentiate count of leucocytes

Measure: Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6

Time: Up to 30 days
374 Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease

This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

NCT04476680
Conditions
  1. SARS-CoV Infection
  2. Vitamin D Deficiency
  3. Covid19
  4. Acute Respiratory Tract Infection
Interventions
  1. Dietary Supplement: Vitamin D 1000 IU
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency Asymptomatic Infections
HPO:Low levels of vitamin D Respiratory tract infection

Primary Outcomes

Description: asymptomatic seroconversion for SARS-CoV-2

Measure: Seroconversion

Time: 24 weeks

Description: asymptomatic seroconversion for SARS-CoV-2

Measure: Interim analysis - seropositivity at 12 weeks

Time: 12 weeks

Secondary Outcomes

Description: Sensitivity and specificity of dried blood spot assay compared with venous blood serology

Measure: Dried Blood Spot performance

Time: 24 weeks

Description: Sensitivity and specificity of salivary IgA compared with venous blood serology

Measure: Salivary IgA performance

Time: 24 weeks

Description: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.

Measure: Prevalence of SARS-CoV-2

Time: 24 weeks

Description: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time

Measure: Change in seropositivity

Time: 24 weeks

Description: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity

Measure: Change in seroconversion rate

Time: 24 weeks
375 Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units

Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.

NCT04476914
Conditions
  1. Respiratory Failure
  2. SARS-CoV 2
  3. Corona Virus Infection
  4. Post Intensive Care Unit Syndrome
  5. Family Members
  6. Post Traumatic Stress Disorder
  7. Anxiety
  8. Depression
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD

Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)

Time: 90-120 days after admission of patient to the ICU

Secondary Outcomes

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety

Measure: Symptoms of Anxiety

Time: 90-120 days after admission of patient to the ICU

Description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression

Measure: Symptoms of Depression

Time: 90-120 days after admission of patient to the ICU

Description: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication

Measure: Family Satisfaction with Communication and Decision Making

Time: 90-120 days after admission of patient to the ICU
376 Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients

NCT04476979
Conditions
  1. Coronavirus Infection
  2. SARS (Severe Acute Respiratory Syndrome)
  3. Virus Diseases
  4. Coronaviridae Infections
  5. Nidovirales Infections
  6. RNA Virus Infe
  7. RNA Virus Infections
  8. Respiratory Tract Infections
  9. Respiratory Tract Disease
Interventions
  1. Drug: Tocilizumab
  2. Drug: Dexamethasone
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Nidovirales Infections Respiratory Tract Diseases
HPO:Respiratory tract infection

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.

Measure: Survival without needs of ventilator utilization at day 14

Time: day 14

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 at day 7 and 14

Time: day 7 and day 14

Description: Overall survival

Measure: Overall survival at 14, 28, 60 and 90 days

Time: 14, 28, 60 and 90 days

Description: Cumulative incidence of discharge alive

Measure: Cumulative incidence of discharge alive at 14 and 28 days

Time: 14 and 28 days

Description: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of mechanical ventilation at day 1

Time: day 1

Description: Cumulative incidence of oxygen supply independency

Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days

Time: 14 and 28 days
377 A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients

Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).

NCT04476992
Conditions
  1. Hypoxemia
  2. Pneumonia, Viral
  3. Coronavirus Infection
Interventions
  1. Drug: Nitric Oxide-Sessions
  2. Drug: Nitric Oxide-Continuous and Sessions
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Hypoxia
HPO:Hypoxemia Pneumonia

Primary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobin levels between the groups at 48 hours after randomization.

Measure: Change in Methemoglobin level at 48 hours

Time: 48 hours

Secondary Outcomes

Description: The primary outcome will be evaluated with the difference in Methemoglobineamia between the groups at 96 hours after randomization.

Measure: Change in Methemoglobin level at 96 hours

Time: 96 hours

Description: The secondary outcome, "Improve the oxygenation at 48 hours," will be evaluated with the measure of the difference in oxygenation among the groups at 48 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 48 hours or at discharge if before 48 hours

Time: 48 hours

Description: The secondary outcome, "Improve the oxygenation at 96 hours," will be evaluated with the measure of the difference in oxygenation between the groups at 96 hours. Oxygenation will be measured in terms of the SpO2/FiO2 ratio.

Measure: Improvement in oxygenation between the groups at 96 hours or at discharge if before 96 hours

Time: 96 hours

Description: The secondary outcome "difference in the rate of negative RT-PCR for SARS CoV-2" will be evaluated as the rate of negativization of the RT-PCR for SARS-CoV-2 at 5 days after randomization, at discharge and at 28 days after randomization.

Measure: Rate of positive RT-PCR for SARS-CoV-2 between groups in 5 days, discharge, and 28 days

Time: 28 days

Description: The secondary outcome "different time to clinical recovery" will be evaluated as the time between the randomization and the clinical indication to interrupt the administration of oxygen for 24 hours.

Measure: Time to clinical recovery among groups, defined as time to interruption of oxygen administration for 24 hours or discharge

Time: 28 days

Description: The secondary outcome "Different reduction in inflammatory markers" will be evaluated as improvement in the inflammatory markers (IL-6; Ferritin; White Blood Cells; Leucocyte count; CRP; D-Dimer) observed in blood samples collected at day 1, 2, 3, 4, and 7 compared to the Baseline value.

Measure: Reduction in the inflammatory markers among groups

Time: 7 days

Description: The secondary outcome "rate of AKI between groups" will be evaluated as the presence of a comparable rate of AKI during the hospital stay. The AKI will be defined according to the KDIGO classification.

Measure: Rate of Acute Kidney Disease (AKI) between groups during hospitalization

Time: 28 days

Description: The secondary outcome "Difference in Katz score between groups" will be evaluated as the difference in Katz Activities of Daily Living between Baseline and day 28. This questionnaire will coincide with the 28-day phone call to assess health status and survival.

Measure: Difference in Katz score between groups

Time: 28 days

Other Outcomes

Description: 1. The exploratory outcome "Effect of nitric oxide on heart function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in heart ultrasound at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in heart ultrasound during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on cardiovascular hemodynamics assessed using cardiac ultrasound in COVID-19 hypoxemic patients

Time: 96 hours

Description: 2. The secondary outcome "Effect of NO gas on lung function in COVID-19 hypoxemic patients" will be evaluated as: the changes observed in spirometry at 48 and 96 hours (or at discharge) compared to the Baseline in all groups. the changes observed in spirometry during the administration of NO comparing pre-treatment, during treatment, and post-treatment.

Measure: Effect of NO gas treatment on lung function evaluated with serial spirometry in COVID-19 hypoxemic patients

Time: 96 hours
378 A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects

The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.

NCT04477902
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Quality of Life
  4. Risk Reduction
Interventions
  1. Other: none - observational
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.

Measure: Longitudinal survey

Time: 2 years
379 Randomized, Double-Blind Clinical Trial of Ruxolitinib in Patients With Acute Respiratory Disorder Syndrome Due to SARS-CoV-2 Infection

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

NCT04477993
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. SARS-CoV2
Interventions
  1. Drug: Janus Kinase Inhibitor (ruxolitinib)
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases Syndrome

Primary Outcomes

Measure: A composite outcome of death or ICU admission or mechanical ventilation at day 14.

Time: 14 days

Secondary Outcomes

Measure: A composite outcome of death or ICU admission or mechanical ventilation at day 28

Time: 28 days

Description: ICU admission, mechanical ventilation, death or consent withdrawal

Measure: Time to treatment failure

Time: 28 days

Measure: Overall survival at days 14 and 28

Time: 14 and 28 days

Measure: Cumulative incidence of ICU admission rate at days 14 and 28

Time: 14 and 28 days

Measure: Cumulative incidence of mechanical ventilation at days 14 and 28

Time: 14 and 28 days

Measure: Duration of hospital stay

Time: 28 days

Measure: Duration of ICU stay

Time: 28 days

Measure: Duration of mechanical ventilation

Time: 28 days

Measure: Duration of non-invasive ventilation

Time: 28 days

Measure: Secondary hemophagocytic syndrome rate

Time: 28 days

Measure: Cumulative incidence nosocomial infection rate at days 14 and 28

Time: 14 and 28 days

Measure: Incidence of discontinuation of oxygen supplementation at days 14 and 28

Time: 14 and 28 days

Measure: Rate of grade 1-2 and 3-5 emerging adverse events at day 28

Time: 28 days

Measure: Cumulative dose of methylprednisolone at days 14 and 28

Time: 14 and 28 days

Measure: Change in PaO2/FiO2 ratio from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in d-dimer levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in ferritin levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in C reactive protein levels [mg/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in alanine aminotransferase [U/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in creatinine levels [mg/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in glucose levels [mg/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in hemoglobin levels [g/dL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in prothrombin time ratio from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in partial thromboplastin time ratio from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in bilirubin [mg/dl] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in CPK-MB [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in troponin [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in ADAMTS-13 [%] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in von Willebrand multimeters from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in E-selectin levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in P-selectin levels [ng/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in endothelin [fmol/mL] from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in circulating microparticles from baseline to days 14 and 28

Time: 14 and 28 days

Measure: Change in thromboelastography from baseline to days 14 and 28

Time: 14 and 28 days
380 Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

The purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with Coronavirus Disease 2019 (COVID-19).

NCT04478071
Conditions
  1. Acute Respiratory Distress Syndrome
  2. Coronavirus Infection
Interventions
  1. Drug: vadadustat
  2. Drug: placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities

Measure: Number of participants who are classified 8 (dead), 7 (hospitalized, on invasive mechanical ventilation or ECMO), or 6 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the NIAID ordinal scale

Time: day 14

Secondary Outcomes

Description: Modified Sequential Organ Failure Assessment (MSOFA) scale: Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (≤ 400); 2 (≤ 315); 3 (≤ 235); 4 (≤ 150) Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine ≤ 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine ≤ 0.1, Norepinephrine ≤ 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1) Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6) Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0)

Measure: Number of participants with a total score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) scale

Time: day 14
381 The Change of Critical Patient Managements and Subsequent Influences Under Epidemic of Coronavirus Disease 19 (COVID-19)

In the ER of National Taiwan University Hospital, the critical patients are treated (including tracheal intubation and cardiopulmonary resuscitation) in either resuscitation area or negative pressure isolation rooms based on the past history and present illness. During COVID-19 epidemic, whether sequential changes in environmental and personal protective equipment would change the difference of treatment efficacy and patient safety remains unclear. Whether treating patients in resuscitation area or negative pressure isolation room would cause different physical and psychological stress of medical staff and environmental contamination is also unknown. This study aims to conduct a prospective sequential allocation clinical trial to investigate the success rate, patient safety, physical and psychological stress of medical staff, and the risk of environmental contamination of tracheal intubation and cardiopulmonary resuscitation between the resuscitation area and negative pressure isolation room. The results of the study may be used to improve the protocol and protective policy in treating critical patients during an epidemic.

NCT04479332
Conditions
  1. Corona Virus Infection
  2. Critical Illness
Interventions
  1. Procedure: Tracheal intubation and cardiopulmonary resuscitation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Description: Comparison between the duration and number of tries needed to intubate a patient, or achieve ROSC in patients requiring cardiopulmonary resuscitation, in resuscitation area and negative pressure isolation rooms.

Measure: The success rate of tracheal intubation between resuscitation area and negative pressure isolation rooms

Time: 6 months

Description: Comparison between the survival rate of patients who were intubated in the resuscitation area and negative pressure isolation rooms, taking into account the duration of hospital stay, respiratory status (successful extubation, post tracheostomy, etc), and neurological state (using the Glasgow coma score, cerebral performance categories, and overall performance categories) upon discharge from the hospital.

Measure: The patient prognosis between resuscitation area and negative pressure isolation rooms

Time: 6 months

Description: The medical staff involved in the intubation and/or cardiopulmonary resuscitation procedures will be asked to voluntarily fill up a survey form to determine their level of psychological stress. They will also be followed up within 14 days post exposure for covid-19 symptoms and undergo testing and quarantine if needed.

Measure: The physical and psychological stress of medical staff

Time: 14 days

Description: The facilities in both resuscitation area and negative pressure isolation rooms will be sampled and compared for the presence of the coronavirus after each intubation or cardiopulmonary resuscitation procedure.

Measure: The amount of environmental contamination between resuscitation area and negative pressure isolation rooms

Time: 14 days
382 Brazilian COVID-19 Registry for Clinical Presentation of Individuals With COVID-19: a National, Multicentre, Prospective Observational Study (SARS-Brazil)

This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection. The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients. A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.

NCT04479488
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Other: Hospital admission
  2. Other: Non-hospitalization procedures
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: All-cause mortality rates at 60 days

Measure: All-cause mortality

Time: 60 Days

Secondary Outcomes

Description: To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days

Measure: Incidence and course of symptoms of COVID-19 infection

Time: 60 Days

Description: Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)

Measure: Hospitalizations

Time: 60 Days

Description: Rate of patients requiring oxygen therapy

Measure: Oxygen supplementation

Time: 60 Days

Description: Rate of patients requiring invasive mechanical ventilation

Measure: Use of invasive mechanical ventilation

Time: 60 Days

Description: ICU length of stay

Measure: Intensive care unit length of stay

Time: 60 Days

Other Outcomes

Description: Percentual changes in serum proteome of patients with mild or moderate to severe disease

Measure: Serum proteomic

Time: 60 Days

Description: Percentual changes in serum metabolome of patients with mild or moderate to severe disease

Measure: Serum metabolomic

Time: 60 Days

Description: Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease

Measure: Genomic description

Time: 60 Days
383 A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers

The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.

NCT04480333
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Severe Acute Respiratory Syndrome
  4. Severe Acute Respiratory Infection
  5. Severe Acute Respiratory Syndrome (SARS) Pneumonia
  6. Severe Acute Respiratory Syndrome of Upper Respiratory Tract
  7. Neurodegeneration
  8. Neuroinflammatory Response
Interventions
  1. Drug: Drug: NA-831 - 0.10 mg/kg
  2. Drug: Placebo- 0.10 mg/kg
  3. Drug: Drug: NA-831 - 0.20 mg/kg
  4. Drug: Placebo- 0.20 mg/kg
  5. Drug: Drug: GS-5734 - 1.00 mg/kg
  6. Drug: Placebo- 1.00 mg/kg
  7. Drug: Drug: GS-5734 - 2.00 mg/kg
  8. Drug: Placebo- 2.00 mg/kg
  9. Combination Product: Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)
  10. Combination Product: Placebo 0.10 mg + 1.00 mg/kg
  11. Combination Product: Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)
  12. Combination Product: Placebo 0.20 mg + 2.00 mg/kg
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Nerve Degeneration
HPO:Neurodegeneration Pneumonia Respiratory tract infection

Primary Outcomes

Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events

Time: First dose date up to Day 30 Follow-up Assessment

Description: This will be assessed at various time points by clinical laboratory tests and vital signs.

Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities

Time: First dose date up to Day 30 Follow-up Assessment

Secondary Outcomes

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.

Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum

Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734

Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734

Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞)

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.

Measure: Half-Life (t1/2) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.

Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.

Measure: Clearance [CL] - Pharmacokinetic Assessment

Time: 7 days
384 Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery

We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this context.

NCT04480580
Conditions
  1. Covid19
  2. Surgery
  3. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Diagnostic Test: SARS-CoV-2 Ab
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Positivity of specific IgM or IgG

Measure: Seroprevalence of SARS-CoV-2

Time: 3 months
385 A Phase II Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection

In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.

NCT04482686
Conditions
  1. COVID
  2. Covid-19
  3. Corona Virus Infection
  4. Coronavirus Infection
  5. Coronavirus-19
  6. SARS-CoV2
  7. SARS-CoV Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Doxycycline Hcl
  3. Dietary Supplement: Zinc
  4. Dietary Supplement: Vitamin D3
  5. Dietary Supplement: Vitamin C
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to negative RT-PRC result indicating that patient is no longer infective

Measure: Time to Non-Infectivity by RT-PCR

Time: 6 months

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)

Time: 6 months

Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

Measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)

Time: 6 months

Description: Patients will have serum stored for titer testing to compare antibody levels over time

Measure: Efficacy of Treatment as measured by Titer

Time: 6 months

Description: Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment

Measure: Efficacy of Treatment as measured by RT-PCR

Time: 10 days

Secondary Outcomes

Description: Blood D-Dimer levels

Measure: Safety of Treatment as Measured by D-Dimer

Time: 6 Months

Description: Blood Pro-Calcitonin levels

Measure: Safety of Treatment as Measured by Pro-Calcitonin

Time: 6 Months

Description: Blood CRP levels

Measure: Safety of Treatment as Measured by C-Reactive Protein

Time: 6 Months

Description: Blood ferritin levels

Measure: Safety of Treatment as Measured by Ferritin

Time: 6 Months

Description: Blood enzyme levels

Measure: Safety of Treatment as Measured by Liver Enzymes

Time: 6 Months

Description: CBC

Measure: Safety of Treatment as Measured by Complete Blood Count

Time: 6 Months

Description: Blood electrolytes

Measure: Safety of Treatment as Measured by Electrolyte Levels

Time: 6 Months

Description: Presence or absence of Grade 3 or high treatment related adverse events

Measure: Safety of Treatment as Measured by Treatment Related Adverse Events

Time: 6 months
386 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

NCT04483973
Conditions
  1. Covid19
  2. Coronavirus
  3. Coronavirus Infection
  4. Corona Virus Infection
Interventions
  1. Drug: Ebselen
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: 30 days

Secondary Outcomes

Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.

Measure: WHO Ordinal Scale

Time: 30 days

Description: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

Measure: Degree of supplemental oxygen

Time: 30 days

Description: Peripheral oxygen saturation measured by pulse oximetry

Measure: Peripheral Oxygen Saturation (SpO2)

Time: 30 days
387 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.

NCT04484025
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Coronavirus
  4. Coronavirus Infection
Interventions
  1. Drug: Ebselen
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: 30 days

Secondary Outcomes

Description: Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.

Measure: WHO Ordinal Scale

Time: 30 days

Description: Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

Measure: Degree of supplemental oxygen

Time: 30 days

Description: Peripheral oxygen saturation measured by pulse oximetry

Measure: Peripheral Oxygen Saturation (SpO2)

Time: 30 days
388 Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study

The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes. The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care. This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.

NCT04485351
Conditions
  1. Diabetes Mellitus
  2. Coronavirus Infection
  3. Metabolic Disease
  4. Glucose Metabolism Disorders
Interventions
  1. Other: no intervention
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders
HPO:Diabetes mellitus

Primary Outcomes

Description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.

Measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.

Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown

Secondary Outcomes

Description: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records

Measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy

Time: 6 weeks period following the end of the lockdown

Description: Use BMI, lipid profile, renal and hepatic function from medical records

Measure: Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.

Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown

Description: Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization

Measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation

Measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco

Measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)

Measure: Describe healthcare consumption of patients with diabetes during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.

Measure: Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.

Time: 6 weeks period following the end of the lockdown
389 Clinical Outcome of Anti-IL6 vs Anti-IL6 Corticosteroid Combination in Patients With SARS-CoV-2 Cytokine Release Syndrome

The cytokine storms mediated by over production of proinflammatory cytokines have been observed in a large population of critically ill patients infected with COVID-19. Patients diagnosed with cytokine storms progress to cardiovascular collapse, multiple organ dysfunction and death rapidly. Therefore, early identification, treatment and prevention of the cytokine storms are of crucial importance for the patients. Immuomedulator such as interleukin-6 (IL-6) antagonist, emerged as an alternative treatment for COVID-19 patients with a risk of cytokine storms recently. In this study, we aimed to evaluate the safety and efficacy of anti-IL6 alone vs anti-IL6 corticosteroid combination in patients with COVID-19 pneumonia

NCT04486521
Conditions
  1. Critical Illness
  2. Corona Virus Infection
  3. Cytokine Release Syndrome
Interventions
  1. Drug: Interleukin 6 (IL6) Antagonist
  2. Drug: Interleukin 6 (IL6) Antagonist and corticosteroids
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome Critical Illness

Primary Outcomes

Description: The median ventilator-free days will be calculated as calendar days with no ventilator support to day 28 . Participants who die before day 28 are assigned zero free days.

Measure: Ventilator-Free Days

Time: Up to Day 28

Secondary Outcomes

Description: From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 28 days whichever occurs first.

Measure: Median duration of ventilation

Time: Up to Day 28

Description: Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2)

Measure: Median change in the PaO2/FiO2

Time: Up to Day 28

Description: The median vasopressor-free days will be calculated as calendar days with no vasopressor support to day 28. Participants who die before day 28 are assigned zero free days.

Measure: Vasopressor-Free days

Time: Up to Day 28

Description: To compare ICU LOS

Measure: Duration of ICU Stay

Time: Up to 28 days

Description: To compare hospital LOS

Measure: Duration of Hospital Stay

Time: Up to 28 days

Description: Death that occurs during 28 days

Measure: Mortality Rate

Time: Up to Day 28

Description: adverse events that occurs during 28 days

Measure: Percentage of participants with adverse events [transaminitis, hyperglycemia]

Time: Up to 28 days

Description: Concentration of inflammatory markers

Measure: Concentration of Ferritin, IL6, D dimer, fibrinogen, C-reactive protein (CRP), Lactate dehydrogenase (LDH) and absolute lymphocyte count and their correlation with the effectiveness of the treatment

Time: Up to 28 days

Measure: Rate of superinfection (bacterial, viral, invasive fungal infections)

Time: Up to 28 days

Measure: Time to the first COVID 19 test negative

Time: Up to 28 days
390 Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection

In this study, a total of 80 patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive Duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and at the University of Pennsylvania and will be identified and recruited by their treating physician and research team.

NCT04487886
Conditions
  1. COVID-19
Interventions
  1. Drug: Duvelisib
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.

Measure: Number of Participants Requiring Mechanical Ventilation or Dying

Time: Up to Day 29

Secondary Outcomes

Description: Time to recovery (in days) is defined as a score of greater than 5 from the following eight categories from the NIAID ordinal scale. 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: Days to Recovery

Time: Up to Day 29

Description: The number of days spent hospitalized will be compared between study arms.

Measure: Duration of Hospitalization

Time: Up to Day 29

Description: The incidence of death within 29 days of randomization will be compared between study arms.

Measure: Incidence of Death

Time: Up to Day 29

Description: Comparing the proportion of subjects in each group requiring ICU transfer within 29 days of randomization

Measure: Proportion of Participants Transferred to ICU

Time: Up to Day 29

Description: The ECOG Performance Status instrument includes a single item assessing overall physical status. Health status is rated on a scale of 0 to 5 where 0 = fully active and 5 = dead. Median ECOG performance will be compared between study arms.

Measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score

Time: Day 15, Day 29

Description: The incidence of grade III-V adverse events or Serious Adverse Events (SAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5, will be compared between study arms.

Measure: Incidence of Grade III-V Adverse Events

Time: Up to Day 29

Description: The incidence of documented secondary bacterial or viral infections among participants will be compared between study arms.

Measure: Incidence of Secondary Bacterial or Viral Infections

Time: Up to Day 29

Description: The mean frequency of Th1 T cells in blood mononuclear cells will be compared between study arms.

Measure: Change in Th1 T Cell Frequency

Time: Weeks 1, 2, and 4

Description: The mean frequency of Th17 T cells in blood mononuclear cells will be compared between study arms.

Measure: Change in Th17 T Cell Frequency

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-2 will be compared between study arms.

Measure: Change in Interleukin-2 (IL-2)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-2R will be compared between study arms.

Measure: Change in Interleukin-2 receptor (IL-2R)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-6 will be compared between study arms.

Measure: Change in Interleukin-6 (IL-6)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-7 will be compared between study arms.

Measure: Change in Interleukin-7 (IL-7)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-8 will be compared between study arms.

Measure: Change in Interleukin-8 (IL-8)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IL-10 will be compared between study arms.

Measure: Change in Interleukin-10 (IL-10)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker IP-10 will be compared between study arms.

Measure: Change in Interferon gamma-induced Protein 10 (IP-10)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker MIP-1a will be compared between study arms.

Measure: Change in Macrophage Inflammatory Protein 1alpha (MIP-1a)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker MCP-1 will be compared between study arms.

Measure: Change in Monocyte Chemoattractant Protein-1 (MCP-1)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker G-CSF will be compared between study arms.

Measure: Change in Granulocyte Colony-stimulating Factor (G-CSF)

Time: Weeks 1, 2, and 4

Description: Mean levels of the inflammatory serum biomarker TNF-alpha will be compared between study arms.

Measure: Change in Tumor Necrosis Factor (TNF)-alpha

Time: Weeks 1, 2, and 4

Description: VIP is a peptide hormone with immunosuppressive properties. Mean levels VIP will be compared between study arms.

Measure: Change in Vasoactive Intestinal Peptide (VIP)

Time: Weeks 1, 2, and 4

Description: Mean levels of the Tregs will be compared between study arms.

Measure: Change in Gene Expression Profile of Regulatory T Cells (Tregs)

Time: Weeks 1, 2, and 4

Description: Mean levels of CD8+IFNg+GM-CSF+ will be compared between study arms.

Measure: Change in Gene Expression Profile of cluster of differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage colony-stimulating factor (GM-CSF)+

Time: Weeks 1, 2, and 4

Description: Mean levels of CD8+Tim3+PD-1+ will be compared between study arms.

Measure: Change in Gene Expression Profile of CD8+ T cell immunoglobulin and mucin domain-containing protein 3 (Tim3)+ Programmed cell death protein 1 (PD-1)+

Time: Weeks 1, 2, and 4

Description: Mean levels of CD14+CD16+ monocytes will be compared between study arms.

Measure: Change in Gene Expression Profile of cluster of differentiation 14 (CD14)+ cluster of differentiation (CD16)+ monocytes

Time: Weeks 1, 2, and 4

Description: Mean levels of SARS-CoV-2 viremia in respiratory specimens will be compared between study arms.

Measure: Change in SARS-CoV-2 Viremia

Time: Weeks 1, 2, and 4

Description: Median titers of IgG antibodies to SARS-CoV-2 will be compared between study arms.

Measure: Change in Immunoglobulin G (IgG) Antibodies

Time: Weeks 1, 2, and 4

Description: Median titers of IgM antibodies to SARS-CoV-2 will be compared between study arms.

Measure: Change in Immunoglobulin M (IgM) Antibodies

Time: Weeks 1, 2, and 4

Description: Overall survival is defined as days from randomization to death and censored at last follow up.

Measure: Overall Survival

Time: Up to Day 29
391 Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients

To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.

NCT04489628
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Vitamin D3 or Placebo
  2. Device: Doctella telehealth monitoring
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients requiring admission to the hospital or experiencing death by Day 15

Measure: Patients requiring admission to the hospital or experiencing death

Time: Days 1 to 15
392 Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)

The use of nanomaterials in facial respirators could decrease the permeability of particles and promote a biocidal effect compared to conventional respirators (N95) and, therefore, enhance the filtering power, aiming to mitigate harmful effects of bacteria and viruses. Chitosan is a natural cationic polymer derived from chitin, with important characteristics such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity. This polymer shows virucidal activity in several types of viruses, including other coronavirus serotypes, given the attractive factor of its cationic charge for negative charges. The effectiveness of a novel individual protection semi facial respirator (called VESTA) will be investigated, compared to a conventional N95 respirator. The respirators will be tested in healthcare professionals working in hospital environments and the effectiveness will be attributed to the lower incidence rate of infection by the SARS-CoV-2. The effectiveness of respirators will also be attributed to the ability to filter these viruses after use by healthcare professionals exposed to potentially contaminated environments. The study will be carried out in two stages: i) Pilot Randomized Clinical Trial with reduced sample and ii) Controlled Randomized Clinical Trial (RCT). This RCT will be conducted with healthcare professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital sectors with greater vulnerability to infection (urgency, emergency and intensive care units). The pilot trial will be conducted initially with a group of fifty participants (n = 25 in each group) for initial investigation of the potential for efficacy with the use of the respirators (VESTA and conventional N95) in two sectors (emergency and ICU) of a Hospital. The RCT will consist of two parallel groups: (1) Experimental Group (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use the standard respirator (N95). Participants will be recruited from participating centers and will be accompanied by eight consecutive shifts (each shift lasting 6 to 12 hours, followed by approximately 36 hours of rest). Participants will be accompanied during 21 days, and will be assessed at baseline (T0), at the end of the 10th day (T1) and at the end of the 21st day (T2). The respirators will be assessed after the end of the 1st hospital shift for morphological characterization (virus quantity and inactivation).

NCT04490200
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Worker-Patient Transmission, Healthcare
Interventions
  1. Device: VESTA respirator
  2. Device: Conventional N95 respirator
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of professionals infected, confirmed by reverse-transcription polymerase chain reaction (RT-PCR)

Measure: Incidence of laboratory-confirmed COVID-19

Time: 21 days

Description: Electron microscopy technique will be used, to identify if there is viruses present (through its direct visualization and morphological recognition) and they are inactive. This assessment will occur after the end of the first hospital shift.

Measure: Ability of the filtering element to inactivate the SARS-Cov-2

Time: 24 hours

Secondary Outcomes

Description: 11-point Likert scale ranging from -5 ("extremely unsatisfied"), 0 ("neutral"), to 5 ("completely satisfied")

Measure: Usability and comfort of the respirator

Time: Assessments at T1 (day 10) and T2 (day 21)

Description: quantified based on the activities and procedures performed by the participants. Adherence will be measured by a self-report recorded in a diary, estimating the percentage of use referring to the total workhours.

Measure: Adherence to the use of the Respirator

Time: Assessments at the end of the first and second weeks of intervention

Description: Measured by the Job Stress Scale Questionnaire (17 questions composed by 4-point Likert scales)

Measure: Stress

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Maslach Burnout Inventory

Measure: Burnout

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Six-dimensional short form quality of life questionnaire (SF-6D), with scores ranging from 0 to 1 (in which 0 is equal to the worst health state and 1 is equal to the best health state).

Measure: Self-reported quality of life

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by the Nordic Musculoskeletal Questionnaire, which assess the self-report of musculoskeletal symptoms in the last 12 months and last 7 days. Identification of areas of the body causing musculoskeletal problems in a body map (possible sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet).

Measure: Musculoskeletal discomfort

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)

Description: Measured by a VAS-scale ranging from 0 to 10, being 0 the worst work ability and 10 the best work ability, considering the present time.

Measure: Work ability

Time: Change from Pre-Intervention (T0), compared to Post-Intervention (T2 - day 21)
393 Turkish Validity And Reliability of the SARS-CoV-2 Anxiety Scale

The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.

NCT04490473
Conditions
  1. Anxiety
  2. SARS-CoV Infection
Interventions
  1. Other: survey work
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Anxiety Disorders

Primary Outcomes

Description: anxiety increase in SARS-CoV-2 in humans.

Measure: Anxiety in SARS-CoV-2

Time: 4 weeks

Description: The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.

Measure: Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale

Time: 4 weeks
394 Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms

NCT04490486
Conditions
  1. COVID-19
  2. Acute Respiratory Distress Syndrome
  3. Corona Virus Infection
Interventions
  1. Biological: UCMSCs
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.

Measure: Percent of participants with treatment related Serious Adverse Events (SAE)

Time: 12 months

Secondary Outcomes

Description: Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.

Measure: Change in inflammatory marker levels

Time: Baseline, Day 30

Description: Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.

Measure: Change in systemic inflammatory marker levels

Time: Baseline, Day 30

Description: Assessed using blood samples or nose/throat swabs.

Measure: COVID-19 Viral Load

Time: Up to 30 Days

Description: Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.

Measure: Change in SOFA score

Time: Baseline, Up to 30 Days

Description: Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.

Measure: Change in electrolytes levels

Time: Baseline, Up to 30 Days

Description: Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.

Measure: Change in LDH levels

Time: Baseline, Up to 30 Days

Description: ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.

Measure: Number of subjects discharged from the ICU

Time: Up to 7 Days

Description: Percentage of participants requiring less use of vasoactive agents will be reported.

Measure: Percentage of participants with less requirement for vasoactive agents

Time: Up to 30 Days

Description: Percentage of participant deaths throughout the study period.

Measure: Rate of Mortality

Time: Up to 30 Days

Description: The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.

Measure: Percentage of participants with changes in immune marker expression

Time: Up to 30 Days

Description: Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).

Measure: Percentage of participants with changes in radiologic findings

Time: Up to 30 Days

Description: Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.

Measure: Percentage of participants with less pneumonia symptoms

Time: Up to 30 Days
395 COVID-19 Seroprevalence Study in French Guiana

Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

NCT04490850
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Syndrome
  3. SARS-CoV Infection
  4. Covid19
Interventions
  1. Procedure: Blood sample
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies

Measure: Measure of the COVID-19 immunity of the population

Time: 1 year

Secondary Outcomes

Description: The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population

Measure: Evaluation of the level of asymptomatic and pauci-symptomatic infections

Time: 1 year
396 COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

NCT04492371
Conditions
  1. Multiple Myeloma
  2. Covid19
  3. Corona Virus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma

Primary Outcomes

Description: The duration of infection.

Measure: Nature of COVID19

Time: 1 years

Description: Costs related to Covid in terms of health resource needs.

Measure: Costs related to COVID-19

Time: 1 years

Description: Number of infection recovery for each systemic anti-cancer subgroup.

Measure: Systemic anti-cancer therapy subgroup

Time: 1 years

Description: Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.

Measure: Laboratory values collected at hospitalization

Time: 1 years

Description: Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.

Measure: COVID-19 infection in myeloma patient subgroups

Time: 1 years

Description: Number of frail patients with COVID-19 infection and resolution of it.

Measure: Incidence of COVID-19 infection in frail patients

Time: 1 years

Description: Number of infection and outcome per country.

Measure: Infection outcome in different countries

Time: 1 years
397 Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to Coronavirus SARS-CoV-2

This research aims to investigate the incidence, clinical condition, mode of transmission and laboratory data of women and their babies, who were exposed to COVID-19 infection during pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess periodontal condition and quality of life before and after delivery of women with excess weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence of congenital syndrome in babies associated with the presumed maternal infection with SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical examination, being a group with congenital malformations and their respective controls and an interview with the mother was carried out.

NCT04492449
Conditions
  1. Exposure During Pregnancy
  2. Corona Virus Infection
Interventions
  1. Other: congenital malformation
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.

Measure: Periodontal status

Time: Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.

Secondary Outcomes

Description: Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.

Measure: Quality of life of pregnants

Time: Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).

Other Outcomes

Description: IgM and IgG serology test for COVID19

Measure: Maternal infection

Time: Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.
398 HYPONATREMIA AND INFLAMMATION AND CLINICAL OUTCOMES IN HOSPITALIZED COVID-19 PATIENTS

SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES.

NCT04493268
Conditions
  1. Hyponatremia
  2. Covid19
  3. Corona Virus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Hyponatremia
HPO:Hyponatremia

Primary Outcomes

Description: HYPONATREMIA AND MORTALITY

Measure: MORTALITY

Time: 30 DAYS

Secondary Outcomes

Description: HYPONATREMIA AND ICU HOSPITALIZATION

Measure: ICU HOSPITALIZATION

Time: 30 DAYS
399 Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19

ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

NCT04494386
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SARS-CoV Infection
  4. ARDS
  5. Coronavirus
Interventions
  1. Biological: Umbilical Cord Lining Stem Cells (ULSC)
  2. Other: Placebo (carrier control)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of subjects with a DLT event during or within 24 hours after ULSC infusion [Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.]

Measure: Incidence of Dose Limiting Toxicity (DLT)

Time: 24 hours

Description: Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion

Measure: Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)

Time: 1 week

Description: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up

Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE)

Time: 1 month

Description: Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up

Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE)

Time: 12 months

Secondary Outcomes

Description: Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS

Measure: Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS

Time: 1 month

Description: Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator

Measure: Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio

Time: 1 month

Description: Number of ventilator-free days (VFD) in period of 1 month from study treatment

Measure: Number of ventilator-free days (VFD)

Time: 1 month

Description: Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in Complete Blood Count (CBC) with differential from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of blood glucose (mg/dL) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of sodium (mEq/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of potassium (mEq/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of alanine transaminase (ALT; U/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of alanine transaminase (ALT; U/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria

Measure: Change in Urinalysis (UA) from baseline

Time: 1 month
400 Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) - COVEN Study

This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.

NCT04497454
Conditions
  1. Respiratory Distress Syndrome
  2. Severe Acute Respiratory Syndrome Due to Coronavirus (SARS-CoV2)
  3. Mechanical Ventilation
Interventions
  1. Other: EIT-Group
  2. Other: ARDSNet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Syndrome

Primary Outcomes

Description: This score originally ranges from 0 to 4 points based on the average of 4 parameters (PaO2/FiO2, chest X-Ray, PEEP level, and Respiratory compliance). In the modified version, if the patient dies, he or she automatically receives a score of 5 irrespective of the other four parameters. If the patient is extubated, the score is automatically zero. We also substituted FiO2 for PEEP guaranteeing equivalence of the score when either the low or high PEEP-FiO2 table is applied.

Measure: Average daily Modified Lung injury score until day 28

Time: daily

Secondary Outcomes

Description: Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28

Measure: High oxygen dependence free days until day 28

Time: 28 days

Description: Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28

Measure: Mechanical ventilation free days until day 28

Time: 28 days

Description: Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma

Measure: Incidence of shock or barotrauma

Time: 28 days

Description: Occurrence of acute renal failure that justifies renal replacement therapy

Measure: Incidence of acute renal failure requiring renal replacement therapy

Time: 28 days

Description: Percentage of patients who died in each arm up to 28 days

Measure: 28-day mortality

Time: 28 days
401 Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group

Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited. Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.

NCT04506515
Conditions
  1. Covid19
  2. Stress, Psychological
  3. Work Related Stress
  4. Epidemic Disease
  5. SARS-CoV Infe
  6. SARS-CoV Infection
Interventions
  1. Diagnostic Test: Psychological stress and adaptation at work score (PSAS)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Occupational Stress Stress, Psychological

Primary Outcomes

Description: evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers

Measure: PSAS (Psychological Stress and Adaptation at work Score) during the crisis

Time: during the pandemic (April 9, 2020 to April 19, 2020)

Secondary Outcomes

Description: evaluate the psychological stress in Spain in healthcare workers

Measure: PSAS (Psychological Stress and Adaptation at work Score) in basal conditions

Time: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
402 A Rapid Research Platform to Inform Prevention & Improve the Clinical Management of COVID-19 Illness for Priority Older Adult Groups: The McMaster Multi-regional Hospital Coronavirus Registry

The McMaster Multi-Regional Hospital Coronavirus Registry (COREG) is a platform that is collecting detailed case data on laboratory confirmed COVID-19 hospital inpatients and outpatients. The COREG platform will provide rapid high-quality evidence to improve the prevention and clinical management of COVID-19 for older adults in Canada, and internationally. The COREG platform will also provide researchers and partners with complete regional level clinical data on COVID-19 cases to inform rapid decision-making and projections, sub-studies, extensions, and linkage for all affected populations.

NCT04508959
Conditions
  1. Coronavirus Infection
  2. Coronavirus
  3. SARS-CoV-2 Infection
  4. Covid19
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.

Measure: Serious COVID-19 infection

Time: through study completion, an average of 1 year

Description: Defined as persons admitted with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform. We will also conduct sub analyses of hospital acquired COVID-19 also captured in the COREG platform.

Measure: Severe infection (requiring admission)

Time: through study completion, an average of 1 year

Description: Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.

Measure: COVID-19 related death

Time: through study completion, an average of 1 year

Secondary Outcomes

Description: Days from admission to discharge.

Measure: Length of stay

Time: through study completion, an average of 1 year

Description: New or increased severity of conditions and syndromes from pre-morbid state.

Measure: Complications

Time: through study completion, an average of 1 year

Description: Rate of intensive interventions during hospital stay.

Measure: Intensive interventions

Time: through study completion, an average of 1 year
403 Characterizing the Immune Response and Neuronal Damage in SARS-CoV-2 Infected Individuals

The Investigators plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in SARS-Cov-2 infected individuals. Patients with mild, moderate and severe COVID-19 disease will be enrolled.

NCT04510012
Conditions
  1. SARS-CoV Infecti
  2. SARS-CoV Infection
  3. Covid-19
Interventions
  1. Other: Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)

Measure: Cytokine response to SARS-Cov-2

Time: At enrollment

Description: Measurement of cytokine concentration (pg/ml) in serum (IL-6, IL-8, IL-1b,TNF-alpha)

Measure: Cytokine response to SARS-Cov-2

Time: 28 days (+/-7) after enrollment

Description: Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

Measure: Innate immune response to SARS-Cov-2

Time: At enrollment

Description: Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

Measure: Innate immune response to SARS-Cov-2

Time: 3 days after enrollment

Description: Measurement of HLA-DR expression on CD14+ cells (flowcytometry)

Measure: Innate immune response to SARS-Cov-2

Time: 5 days after enrollment

Description: Measurement of neutralizing SARS-Cov-2 antibody concentrations (plaque reduction assay)

Measure: Humoral immune response

Time: At enrollment

Description: Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)

Measure: Cell mediated immune response

Time: At enrollment

Description: Measurement of frequencies of SARS-Cov-2 specific T-cells (ELISPOT assay)

Measure: Cell mediated immune response

Time: 28 days (+/-7) after enrollment

Description: Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)

Measure: Neurological damage

Time: At enrollment

Description: Measurement of neurofilament light chains in serum (on ELLA platform; Protein Simple, Bio-techne)

Measure: Neurological damage

Time: 28 days (+/-7) after enrollment

Secondary Outcomes

Description: Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9

Measure: Complement activation

Time: At enrollment

Description: Measurement of factor B, factor H, factor I, C3a, C4a, C5a, SC5b9

Measure: Complement activation

Time: 28 days (+/-7) after enrollment
404 Assessing the Effects of Coronavirus Disease (COVID-19) on Multiple Organ Systems and Impact on Quality of Life, Functional Capacity and Mental Health

The C-MORE study is prospective observational holistic longitudinal study which will characterise the prevalence of multi-organ injury among COVID-19 survivors post hospital discharge and assess its effects on quality of life, exercise tolerance and mental health.

NCT04510025
Conditions
  1. Coronavirus Infection
  2. Multi-Organ Disorder
Interventions
  1. Diagnostic Test: Magnetic Resonance Imaging
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Characterise and compare the prevalence and extent of lung, heart, liver, kidney, brain injury on magnetic resonance imaging (MRI) in patients with moderate to severe COVID-19 disease with matched uninfected controls.

Measure: Prevalence of damage (quantitative measures of injury) on lung, heart, liver, kidneys and brain MRI.

Time: 6 months

Secondary Outcomes

Description: Characterise and compare the prevalence and extent of lung, heart, liver and kidney, brain injury on magnetic resonance imaging (MRI) in patients with moderate to severe COVID-19 disease with matched uninfected controls.

Measure: Prevalence of damage (quantitative measures of injury) on lungs, heart, liver, kidneys and brain on MRI.

Time: 3 and 12 months

Description: Characterise and compare the prevalence of cardiac, renal and liver injury on blood test in COVID-19 survivors and controls.

Measure: Prevalence of acute/chronic cardiac, renal and liver injury on blood tests.

Time: 3, 6,12 months

Description: Characterise and compare VO2 max on cardiopulmonary exercise testing in COVID-19 survivors and controls.

Measure: VO2 max on cardiopulmonary exercise testing

Time: 3, 6,12 months

Description: Characterise and compare the prevalence of lung function test abnormalities among survivors and controls.

Measure: Prevalence of abnormal lung function test (any of the following: Forced expiratory volume in 1 second (FEV1)< 80% of predicted FEV1, or forced vital capacity (FVC)<80% predicted, ratio of FEV1/FVC >0.7 or diffusion lung capacity (<80% predicted))

Time: 3, 6,12 months

Description: For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).

Measure: Quality of life - Short form-36 SF-36 score

Time: 3, 6,12 months

Description: Described and compare the prevalence of impaired cognition (MoCA) between COVID-19 survivors and controls. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.

Measure: Prevalence of impaired cognitive function on Montreal Cognitive assessment (MoCA<26)

Time: 3, 6,12 months

Description: Compare 6-minute walk distance between COVID-19 survivors and controls.

Measure: 6-minute walk distance

Time: 3, 6,12 months

Description: Compare prevalence and severity of anxiety between COVID-19 survivors and controls.

Measure: Severity of anxiety on GAD-7 (Score)

Time: 3, 6,12 months

Description: Compare prevalence and severity of depression among COVID-19 survivors and controls. PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent outpoints for mild, moderate, moderately severe and severe depression, respectively.

Measure: Severity of depression on PHQ-9 (Score)

Time: 3, 6,12 months

Description: To assess the association of multi organ damage on MRI and inflammatory response.

Measure: Association between the extent of multi-organ injury (continuous variable) and markers of inflammation (white cell count).

Time: 3,6,12 months

Description: To assess the association of ongoing symptomatology and multi-organ injury/inflammation.

Measure: Correlation between the extent of symptoms (dyspnoea-12 score and fatigue score) and multi-organ injury.

Time: 3,6,12months.
405 MET-Covid Trial - Metformin for Outpatient Treatment and Post-exposure Prophylaxis (PEP) of COVID-19

The purpose of this trial is to conduct a Stage 1 Substudy powered to detect a difference in continuous laboratory outcomes: 1. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 can improve laboratory outcomes associated with Covid-19 severity 2. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 infection can prevent emergency department utilization for Covid-19. 3. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 disease can prevent Covid-19 disease progression.

NCT04510194
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: Metformin
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is one of the primary outcomes for the stage 1 trial. Outcome is reported as the change in serum concentrations of c-reactive protein (mg/L) from baseline to 5 days and baseline to 10 days.

Measure: Change in C-Reactive Protein

Time: 10 days

Description: This is one of the primary outcomes for the stage 1 trial. Outcome is reported as the change in serum concentrations of albumin (g/dL) from baseline to 5 days and baseline to 10 days.

Measure: Change in Albumin

Time: 10 days

Description: This is one of the primary outcomes for the stage 1 trial. Outcome is reported as the change in serum viral load (copies per ml of blood) from baseline to 5 days and baseline to 10 days.

Measure: Change in Viral load

Time: 10 days

Secondary Outcomes

Description: For Covid-19 Symptoms (as defined by current CDC definition of Covid-19 symptoms).

Measure: Emergency Department Utilization

Time: 14 days, 28 days

Description: Assessed with Symptom Scale Recommended by FDA for Industry 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: Incidence of Possible COVID-19 Symptoms

Time: 14 days, 28 days

Description: Incidence of hospitalization for Covid-19 Incidence of oxygen therapy needed Incidence of mechanical ventilation Incidence of death

Measure: WHO Disease Progression Scale

Time: 14 days, 28 days.
406 Canakinumab in Patients With COVID-19 and Type 2 Diabetes - CanCovDia Trial

The purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).

NCT04510493
Conditions
  1. Coronavirus Infection
  2. Diabetes Mellitus, Type 2
Interventions
  1. Drug: Canakinumab
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Treatment and placebo will be compared on the basis of the unmatched win-ratio approach of Pocock. When comparing two patients, the winner will be determined by the first component in which the two patients differ (4 weeks after randomization): longer survival time longer ventilation-free time longer ICU-free time shorter hospitalization time If there is no difference between treatment and Placebo: the win ratio is 1. If there is a difference between treatment and Placebo: the win ratio is not 1.

Measure: unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint)

Time: within 4 weeks after treatment with canakinumab or placebo

Secondary Outcomes

Description: Time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever comes first. "The seven-category ordinal scale consists of the following categories: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and death"

Measure: Time to clinical improvement

Time: From randomization up to 4 weeks

Description: Death rate during the 4-week period after study treatment

Measure: Death rate

Time: 4 weeks

Description: Admission to the intensive care unit from the medical ward during the 4-week period after study treatment

Measure: Admission to intensive care unit (ICU)

Time: 4 weeks

Description: Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)

Measure: Secondary worsening of disease

Time: 4 weeks

Description: Prolonged hospital stay > 3 weeks

Measure: Prolonged hospital stay

Time: >3 weeks

Description: Ratio to baseline in the glycated hemoglobin

Measure: Change in ratio to baseline in the glycated hemoglobin

Time: Baseline, Day 29 and Day 90

Description: Ratio to baseline in the fasting glucose

Measure: Change in ratio to baseline in the fasting glucose

Time: Baseline, Day 29

Description: Ratio to baseline in the fasting insulin

Measure: Change in ratio to baseline in the fasting insulin

Time: Baseline, Day 29

Description: Ratio to baseline in the fasting c-peptide

Measure: Change in ratio to baseline in the fasting c-peptide

Time: Baseline, Day 29

Description: Ratio to baseline in the C-reactive protein (CRP)

Measure: Ratio to baseline in the C-reactive protein (CRP)

Time: Baseline, Day 29 and Day 90

Description: Ratio to baseline in the D-dimer

Measure: Change in ratio to baseline in the D-dimer

Time: Baseline, Day 29

Description: Ratio to baseline in the Natriuretic peptide (NTproBNP)

Measure: Change in ratio to baseline in the Natriuretic peptide (NTproBNP)

Time: Baseline, Day 29 and Day 90

Description: Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

Measure: Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

Time: Baseline, Day 29 and Day 90

Description: Type of antidiabetic treatment at Day 29

Measure: Type of antidiabetic treatment at Day 29

Time: Day 29

Description: Number of antidiabetic treatment at Day 29

Measure: Number of antidiabetic treatment at Day 29

Time: Day 29

Description: Type of antidiabetic treatment at three months

Measure: Type of antidiabetic treatment at three months

Time: Month 3

Description: Number of antidiabetic treatment at three months

Measure: Number of antidiabetic treatment at three months

Time: Month 3
407 Epidemiological Study of the Spread of SARS-CoV-2 in the Household of a Person Who Has Had a COVID-19 Disease

Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus. Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach. As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people. All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved. If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus. The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.

NCT04511949
Conditions
  1. Coronavirus Infection
Interventions
  1. Diagnostic Test: COVID-19 IgG / IgM rapid test (whole blood, serum, plasma)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure of anti-SARS-CoV-2 antibodies using COVID-PRESTO (AAZ company)

Measure: Measure of the proportion of contact persons who have developed anti-SARS-CoV-2 antibodies (secondary transmission rate) within the same household of a subject who had a COVID-19 disease assessed by a rapid diagnostic-oriented test

Time: 4 hours
408 Cross Sectional Survey Of Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV-2) Infection And Seroprevalence In A Cohort Of HIV-Infected Children, Youth, And Adolescents Receiving Care At A Single Tertiary Care Medical Center In Miami-Dade County, Florida

The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine. We will be using a Real Time Polymerase Chain Reaction (RT-PCR) assay collected by a nasopharyngeal (nose) swab. RT-PCR is a real time test that can detect the amount of genetic material of a specific virus.The study is funded by The Miami Center for AIDS Research (CFAR)

NCT04514016
Conditions
  1. SARS-CoV Infection
  2. Covid19
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay

Measure: Number of participants who tested positive with SARS COV-2 Infection

Time: month 3

Description: SARS COV-2 antibody will be analyzed from blood samples via serological assay

Measure: Number of participants who tested positive with SARS COV-2 antibody

Time: month 3
409 Clinical Respiratory Investigation in Post Covid-19 Patients

To evaluate pulmonary changes and the results of a cardiopulmonary rehabilitation protocol (CPRP) in patients after SARS-VOC-2 infection. Clinical trial type study to be conducted between 2020 and 2024 involving clinical-functional cardiopulmonary imaging and blood transcriptome profile: before CPRP (T1), 2 months after CPRP (T2) and 1 year later (T3). Expected results: a) clinical, image and transcriptome changes; b) clinical-functional improvement after CPRP.

NCT04514705
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: Exercise
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: In the supine position, the patient will perform deep inspiration followed by momentary apnea inside the high resolution scanner to capture cross-sectional images of the chest with smaller cuts than 1mm of collimation which helped in the detection of even small lesions.

Measure: Characteristics of lung

Time: post treatment in 3 days

Description: Respiratory muscle strength will be assessed using the digital manovacuometer. The measurement will be performed as follows the patient will be asked to empty the lungs to the residual volume and then perform an inhalation until the total lung capacity.

Measure: Respiratory muscle strength

Time: post treatment in 3 days
410 Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020

The aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.

NCT04514874
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Other: Questionnaire
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Prevalence of COVID-19 infection will be estimated on the basis of the replies to the questionnaire

Measure: Prevalence of COVID-19 infection among French military professional aircrew

Time: At enrollment

Secondary Outcomes

Description: Predictive factors of COVID-19 infection will be assessed using a top-down logistic regression model taking into account socio-demographic and occupational variables.

Measure: Predictive factors of COVID-19 infection

Time: At enrollment

Description: Techniques used for COVID-19 screening will be estimated on the basis of the replies to the questionnaire (among participants who reported being tested for COVID-19)

Measure: Techniques used for COVID-19 screening

Time: At enrollment

Description: Reasons for COVID-19 screening will be estimated on the basis of the replies to the questionnaire (among participants who reported being tested for COVID-19)

Measure: Reasons for COVID-19 screening

Time: At enrollment

Description: Experienced symptoms of COVID-19 will be estimated on the basis of the replies to the questionnaire (among participants who reported being infected)

Measure: Experienced symptoms of COVID-19

Time: At enrollment

Description: Medical care of COVID-19 will be estimated on the basis of the replies to the questionnaire (among participants who reported being infected)

Measure: Medical care of COVID-19

Time: At enrollment

Description: Social consequences of the COVID-19 pandemic will be estimated on the basis of the replies to the questionnaire

Measure: Social consequences of the COVID-19 pandemic

Time: At enrollment

Description: Factors associated with pejorative consequences of the COVID-19 pandemic will be assessed using a top-down logistic regression model taking into account socio-demographic and occupational variables.

Measure: Factors associated with pejorative consequences of the COVID-19 pandemic

Time: At enrollment
411 COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age

This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.

NCT04515147
Conditions
  1. Coronavirus
  2. Covid19
  3. SARS-CoV-2
  4. Severe Acute Respiratory Syndrome
Interventions
  1. Biological: CVnCoV 6 μg
  2. Biological: CVnCoV 12 μg
  3. Biological: Hepatitis A vaccine
  4. Biological: Pneumococcal vaccine
  5. Biological: CVnCoV 12μg
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of Participants with Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

Time: 7 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events

Time: 28 days after vaccination

Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale

Time: 28 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

Time: 28 days after vaccination

Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

Time: Baseline to Day 393

Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

Time: Baseline to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

Time: Baseline to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

Time: Baseline to Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

Time: Day 29

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

Time: Day 43

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

Time: Day 29

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

Time: Day 43

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

Time: Day 29

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

Time: Day 43

Description: Measured using an activity assay.

Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

Time: Day 29

Description: Measured using an activity assay.

Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

Time: Day 43

Description: Measured using an activity assay.

Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

Time: Day 29

Description: Measured using an activity assay.

Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

Time: Day 43

Description: Measured using an activity assay.

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

Time: Day 29

Description: Measured using an activity assay.

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

Time: Day 43

Secondary Outcomes

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Number of Participants with Solicited Local Adverse Events Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Duration of Solicited Local Adverse Events Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Number of Participants with Solicited Systemic Adverse Events Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Duration of Solicited Systemic Adverse Events Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine

Time: 7 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Number of Participants with Unsolicited Adverse Events Following the Booster Vaccine

Time: 28 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

Time: 28 days after booster vaccination

Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine

Time: 28 days after booster vaccination

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

Time: Day 57, Day 85, Day 180, Day 208 and Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

Time: Day 57, Day 85, Day 180, Day 208 and Day 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

Time: Day 57, Day 85, Day 180, Day 208 and Day 393

Description: Measured using an activity assay.

Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

Time: Day 57, Day 85, Day 180, Day 208 and Day 393

Description: Measured using an activity assay.

Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

Time: Day 57, Day 85, Day 180, Day 208 and Day 393

Description: Measured using an activity assay.

Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

Time: Day 57, Day 85, Day 180, Day 208 and Day 393
412 A Prospective, Randomized, Placebo-controlled, Double-blinded, Phase III Clinical Trial of the Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19

A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19

NCT04516811
Conditions
  1. COVID-19
  2. SARS-CoV-2 Infection
  3. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Biological: COVID-19 convalescent plasma (CCP) plus standard of care (SOC)
  2. Biological: Standard of care (SOC) plus placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R&D BOSCI 1) by Day 28 post-randomisation.

Measure: Clinical Improvement

Time: Day 28

Secondary Outcomes

Description: 1. Proportion of participants with adverse events of special interest (Transfusion-Associated Circulatory Overload (TACO); Transfusion-Related Acute Lung Injury (TRALI); allergic transfusion reaction).

Measure: Adverse Events of special interest

Time: Day 28

Description: 2. Proportion of participants with serious adverse events.

Measure: Serious Adverse Events

Time: Day 28

Description: 3. Proportion of participants surviving at Day 28 post-randomisation.

Measure: Survival

Time: Day 28

Description: 4. Proportion of participants requiring invasive mechanical ventilation.

Measure: Invasive mechanical ventilation

Time: Day 28

Description: 5. Proportion of participants with moderate and severe ARDS.

Measure: Disease severity

Time: Day 28

Description: 6. Time from randomization to death, clinical improvement, ICU admission, and invasive mechanical ventilation.

Measure: Time to outcomes of interest

Time: Day28

Description: 7. Duration of hospitalisation, ICU stay, and mechanical ventilation in survivors.

Measure: Length of stay meausures

Time: Day28

Description: 8. Proportion negative SARS-CoV-2 PCR at Day 28; time to viral clearance (PCR-negativity); change in SARS-CoV-2 PCR Ct value.

Measure: SARS-CoV PCR

Time: Day28

Description: 9. Proportion with and time to normalisation of inflammatory markers, including CRP, lymphocyte count, D-dimer, ferritin.

Measure: Inflammatory markers

Time: Day28

Description: 10. Worsening of radiographic abnormalities.

Measure: Radiography

Time: Day28

Description: 11. Proportion with and time to resolution of fever and hypoxia.

Measure: Fever & Hypoxia

Time: Day28

Description: 12. Proportion of patients with HIV infection and other comorbidities (obesity, diabetes, hypertension) with primary efficacy outcome.

Measure: patients with HIV infection and other comorbidities

Time: Day 28

Description: 13. Relationship between timing of transfusion from symptom onset and primary efficacy outcome.

Measure: Timing of IP & Efficacy Outcome

Time: Day 28

Description: 14. Relationship between convalescent plasma neutralizing antibody titers and primary efficacy outcome

Measure: Neutralising Ab

Time: Day28

Description: 15. Comparison of anti-SARS-CoV-2 titer dynamics between treatment arms

Measure: SARS CoV Antibody titre

Time: Day28
413 Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel

Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission is by droplet route, with an R0 of approximately 3. Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions. Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced. During the period of containment, the majority of students from the Lyon-Bron Military Medical Schools were sent as reinforcement in Army Training Hospitals and in the Military Reanimation Unit (Mulhouse). Some students developed symptomatic forms of SARS-Cov-2 infection, documented by positive PCR, during Operation Resilience or on their return from the mission. The Lyon-Bron Military Medical Schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.

NCT04516928
Conditions
  1. SARS-CoV Infection
  2. Covid19
Interventions
  1. Diagnostic Test: Anti-SARS-CoV2 Serology
  2. Other: Questionnaire
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The proportion of anti-SARS-CoV2 seropositive participants will be determined. ELISA serology test will be used to detect anti-SARS-CoV2 antibodies (IgG and IgM) at Day 0.

Measure: Proportion of anti-SARS-CoV2 seropositive participants

Time: Day 0

Secondary Outcomes

Description: The proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants) will be determined. COVID-19 symptoms will be measured using a questionnaire.

Measure: Proportion of asymptomatic participants (among anti-SARS-CoV2 seropositive participants)

Time: Day 0

Description: Correlation coefficient between medical risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.

Measure: Correlation coefficient between medical risk factors and a positive serology

Time: Day 0

Description: Correlation coefficient between epidemiological risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.

Measure: Correlation coefficient between epidemiological risk factors and a positive serology

Time: Day 0

Description: Correlation coefficient between social risk factors and a positive serology will be assessed using a step-by-step top-down regression analysis.

Measure: Correlation coefficient between social risk factors and a positive serology

Time: Day 0
414 Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting

There is emerging evidence that patients with SARS-CoV-2 are affected by increased coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to the lung but also involving the kidneys, heart and gut. Thrombin plays a central role in mediating clot forming as well as in mediating inflammation. A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the risk of venous and arterial thrombotic complications. Colchicine is an inexpensive (generic drug), orally administered, and a potent anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance. The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR.

NCT04516941
Conditions
  1. SARS-CoV Infection
  2. COVID-19
Interventions
  1. Drug: Edoxaban Tablets
  2. Drug: Colchicine Tablets
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess the effect of edoxaban versus no active treatment on the composite endpoint of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-CNS systemic embolism or death at day 25 (+/-3) after randomization.

Measure: Edoxaban vs. no active treatment

Time: Baseline to day 25

Description: To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.

Measure: Colchicine vs no active treatment

Time: Baseline to day 14

Secondary Outcomes

Description: An intraluminal filling defect on CT scan or MR venography in the IVC or iliac veins.

Measure: Number of patients with asymptomatic proximal deep-vein thrombosis

Time: Baseline to day 25

Description: Typical symptoms of DVT associated with non-compressible vein segment on ultrasonography or an intra-luminal filling defect on venography, CT venography or MRI venography,located in the inferior vena cava (IVC), the iliac vein, the common femoral vein, the femoral or the popliteal vein.

Measure: Number of patients with symptomatic proximal or distal deep-vein thrombosis

Time: Baseline to day 25

Description: Typical symptoms of PE associated with an intra-luminal filling defect in (sub) segmental or more proximal branches on spiral computed tomography scan (CT) or computerized tomographic pulmonary angiography (CTPA). a considerable perfusion defect (~ 75% of a segment) with a local normal ventilation result (high probability) during perfusion-ventilation lung scan (PLS, VLS or V/Q scan). an intraluminal filling defect or a sudden cut-off of vessels (~more than 2.5 mm in diameter) on a catheter guided pulmonary angiogram. In case of an inconclusive CTPA, inconclusive V/Q scan or inconclusive angiography demonstration of DVT in the lower extremities e.g. by compression ultrasound or venography will be required

Measure: Number of patient with symptomatic pulmonary embolism or thrombosis

Time: Baseline to day 25

Description: For the primary analysis, MI endpoint will be defined based on the third universal definition of myocardial infarction with the exception of periprocedural MI after PCI, which will be defined according to the SCAI definition.

Measure: Number of patients with myocardial infarction

Time: Baseline to day 25

Measure: Number of patients with ischemic stroke

Time: Baseline to day 25

Description: Ischemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by CNS infarction

Measure: Number of patients with non-CNS systemic embolism

Time: Baseline to day 25

Description: Death will be classified in 5 categories with respect to cause. Thromboembolism, cardiovascular, bleeding, Pulmonary other known cause. In general, all deaths will be assumed to be due to thromboembolism or pulmonary in nature unless another cause is obvious

Measure: Number of deaths

Time: Baseline to day 25

Description: Need for non-invasive or invasive ventilation

Measure: Ventilation need

Time: Baseline to day 25
415 Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions

Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.

NCT04517136
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Burnout, Caregiver
  4. Burnout, Professional
Interventions
  1. Behavioral: Assessment of work-related stress
  2. Biological: Saliva sample collection
  3. Device: Cardiac and electrodermal recordings
  4. Behavioral: Assessment of behavioral response to emotional stimulation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Burnout, Professional Burnout, Psychological

Primary Outcomes

Description: Professional burnout is measured at D21 by the Burnout Measure Short Version (BMS) questionnaire It is a 10-item questionnaire used to assess burnout regardless of the occupational category. Each item is rated from 0 to 6 ("never" to "always"). An average score (sum/10) below 2.4 indicates a very low degree of burnout exposure; a score between 2.5 and 3.4 indicates a low degree of burnout exposure; a score between 3.5 and 4.4 indicates the presence of burnout; a score between 4.5 and 5.4 indicates a high degree of burnout exposure; a score above 5.5 indicates a very high degree of burnout exposure.

Measure: Professional burnout

Time: 21 days after enrollment (Day 21)

Description: Mindfulness level is assessed at D0 thanks to the Freiburg Mindfulness Inventory. It is a 14 item scale. Each item is rated from 1 to 4 ("almost never" to "almost always"). The total score is between 14 and 56. The mean value in a population of young adults under 36 years of age is 38.5 (+/- 5.1 standard deviation).

Measure: Mindfulness level

Time: Day 1

Secondary Outcomes

Description: Perceived stress level is assessed with the Perceived Stress Scale (PSS). It is a 14 item scale. Each item is rated from 0 to 5 ("never" to "very often"). The total score ranges from 0 to 56 with higher scores indicating greater perceived stress.

Measure: Perceived stress level following the emotional stimulation

Time: Day 1

Description: Parasympathetic flexibility is assessed through dynamic electro-physiological analysis of cardiac and electrodermal conductance recordings. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall.

Measure: Parasympathetic flexibility evolution during emotional recall

Time: Day 1

Description: The activity of the sympathetic tone is assessed by the measurement of the resting state salivary Chromogranin A. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall. The activity of the sympathetic tone is assessed by the measurement of the resting salivary Chromogranin A

Measure: Sympathetic tone at rest

Time: Day 1

Description: Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio

Measure: Corticotropic activation at rest

Time: Day 1

Description: The Hospital Anxiety and Depression Scale (HAD-s32) is used to assess mood disorders in the general non-psychiatric population. It is used to discriminate between anxiety and depression. Scores greater than 11 are indicative of characterized anxiety/depression.

Measure: Mood disorders (anxiety / depression)

Time: Day 1

Description: Post-traumatic disorder is assessed with the PTSD Checklist (PCL-5). It is a 20-item self-administered questionnaire representing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Post-traumatic stress disorder (PTSD) diagnosis symptoms rated by the subject on a scale from 0 ("not at all") to 4 ("extremely") during the past month. Scores range from 0 to 80. A score greater than of 33 evokes the presence of post-traumatic stress disorder.

Measure: Post-traumatic stress disorder

Time: Day 1

Description: Sleep quality is assesses thanks to the Leeds Sleep Evaluation questionnaire (LEEDS). It consists of ten visual analogue scales assessing four aspects of sleep: (i) quality of falling asleep and degree of drowsiness, (ii) quality of sleep, (iii) quality of wakefulness, and (iv) quality of post-wakefulness and performance.

Measure: Sleep quality

Time: Day 1
416 Efficacy and Safety of Lactobacillus Plantarum and Pediococcus Acidilactici as Co-adjuvant Therapy for Reducing the Risk of Severe Disease in Adults With SARS-CoV-2 and Its Modulation of the Fecal Microbiota: A Randomized Clinical Trial

Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to progress to moderate or severe COVID and associated advantages such as reduce the risk of death. Adittionnally this RCT is launching to explore the benefits of this combination of strains to modulate fecal microbiome and explore how this correlate with clinical improvement.

NCT04517422
Conditions
  1. SARS-CoV Infection
Interventions
  1. Dietary Supplement: Probiotics
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Frequency of randomized subjects who progress from mild to moderate or severe COVID-19, as evaluated by WHO Clinical Progression Scale

Measure: Severity progression of COVID-19

Time: 30 days

Description: Length of stay at Intensive care unit

Measure: Stay at ICU

Time: 30 days

Description: Mortality ratio for all the causes related to COVID-19

Measure: Mortality ratio

Time: 30 days

Secondary Outcomes

Description: Frequency of lung abnormalities clasified by severity and measured by x-ray and artificial intelligence

Measure: Lung abnormalities

Time: 30 days

Description: Description of SARS-Cov-2 viral load evaluated by RT-PCR at screening and on days 15 and 30

Measure: Viral load

Time: 30 days

Description: Levels of Immunoglobulin G and Immunoglobulin M evaluated on day 15 and 30

Measure: Levels of immunoglobulins

Time: 30 days

Description: Frequency and severity of gastrointestinal manifestation evaluated by Gastrointestinal Symptom Rating Scale (GSRS)

Measure: Gastrointestinal manifestations, where 0 means good health status and 5 worse status

Time: 30 days

Description: Changes on fecal microbiome evaluated by 16S analysis on day 1st and 30th

Measure: Fecal microbiome

Time: 30 days

Description: Frequency of adverse events reported on dairy report form after randomization and until day 30

Measure: Adverse events

Time: 30 days

Description: Change on C-reactive high sensitivity protein (hsCRP) and D-Dimer

Measure: Change on Serum Biomarkers

Time: Days 1st, 15th and 30th after randomization
417 Acute Kidney Injury In Subjects With Severe Acute Respiratory Syndrome Due to SARS-CoV2 Infection

Severe pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial infections and high costs. We need many studies for determinated the risk factors for AKI in subjects with COVID-19. This study pretends identify the incidence of AKI in subjects with severe pneumoniae by COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and determine the evolution of urinary biomarkers during hospitalization, like neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2 (CoV2) in subjects with or without AKI.

NCT04517630
Conditions
  1. Coronavirus Infection
  2. Covid19
  3. SARS (Severe Acute Respiratory Syndrome)
  4. AKI
Interventions
  1. Diagnostic Test: urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: To estimate the strength of association between the elevation of urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 and the development of AKI associated with SARS-CoV-2 pneumonia

Measure: Urinary levels of renal biomarkers

Time: Seven days

Secondary Outcomes

Description: Describe the incidence of AKI in critically ill patients with severe COVID-19 pneumonia

Measure: Incidence of AKI

Time: One month

Description: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with mortality

Measure: Urinary levels of renal biomarkers and mortality

Time: 30 days

Description: Estimate the strength of association of elevated urinary levels of NGAL, TIMP-2, IGFBP7 and IL-6 with teh severity of the disease.

Measure: Urinary levels of renal biomarkers and severity of the disease.

Time: 30 days

Description: Identify possible risk factors (epidemiological, clinical, paraclinical, use of nephrotoxic agents) for the development of AKI in critically ill patients with COVID-19 pneumonia.

Measure: Risk factors for AKI in severe COVID-19

Time: 30 days

Description: Compare the evolution over time of renal function markers (NGAL, TIMP-2 and IGFBP7) in patients with and without kidney injury.

Measure: Evolution renal biomarkers

Time: 7 days

Description: Compare the evolution over time of the SARS-CoV-2 viral load in patients with and without acute kidney injury.

Measure: Evolution of viral load

Time: 7 days

Description: Analyze the complement pathway in urine and compare its evolution over time in patients with and without acute kidney injury and SARS-CoV-2 infection.

Measure: Evolution of complement pathway

Time: seven days

Description: Analyze the metabolomic profile in urine in patients with and without acute kidney injury with SARS-CoV-2 infection.

Measure: Metabolomic profile

Time: 7 days

Description: Describe partial arterial oxygen concentration/inspired oxygen faction (PaO2/FiO2) ratio and radiologic evolution in patients with severe SARS COV2 pneumonia.

Measure: Respiratory changes

Time: 30 days

Other Outcomes

Description: Stablish the nosocomial infections in subjects with or without AKI

Measure: Nosocomial Infections

Time: 30 days
418 Effectiveness of the Use of Personal Protective Equipment in Addition to Tenofovir/Emtricitabine for the Prevention of the Transmission of SARS-COV-2 to Health Care Personnel. Randomized Clinical Trial

Effectiveness of the use of Tenofovir/Emtricitabine in addition to personal protective equipment for the prevention of the transmission of SARS-COV-2 to health care personnel. A Randomized Clinical Trial. This is an experimental study whose aim is to evaluate the effectiveness of a drug to prevent infection with the virus that causes COVID-19 (SARS-CoV-2), in health care workers. The drug under study is Tenofovir /Emtricitabine, a well-known antiretroviral, which is safe and is used as prophylaxis and treatment for HIV and other viral infections such as Hepatitis. Several laboratory-based studies indicate that this drug has the potential to inhibit SARS-CoV-2 replication. In addition, one study in HIV infected persons found that those taking Tenofovir /Emtricitabine tended to have a lower occurrence of COVID-19. In this study, we will compare the occurrence of infection with SARS-CoV-2/ COVID19 in health care workers between those assigned to an intervention group and those assigned to a control group. The intervention group will receive Tenofovir /Emtricitabine during 60 days in addition to the use of personal protective equipment (PPE), and the control group will receive a placebo during 60 days in addition to the use of personal protective equipment (PPE). The study will recruit 950 health professionals above 18 and less than 70 years, working in the emergency room, COVID wards and intensive care units of seven hospitals in Colombia. To make the comparison groups very similar, the participants will be assigned through a random mechanism to either the intervention (475), or the control (475) groups. In order to prevent biases in the evaluation of the results, neither the participants nor the clinical investigators, data managers, analysts and support personnel will know which intervention the participants are receiving. To determine the occurrence of infection with the virus the study will use both molecular tests that detect the presence of viral genes in respiratory secretions, and serological tests that detect the response of the immune system to the virus. The study will evaluate also the safety of this drug determining the occurrence of adverse events.

NCT04519125
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. COVID-19
Interventions
  1. Drug: Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)
  2. Other: Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Positivity of RT-PCR in nasopharyngeal samples in any of the measurements during follow up, or in symptomatic participants at any time. Positive IgG antibodies against SARS- CoV-2 in any of the measurements during follow up

Measure: SARS-CoV-2 infection

Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

Secondary Outcomes

Description: Reported Serios and non serious adverse events during follow up

Measure: Serious and non-serious adverse events

Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

Description: To discontinue the intervention during follow up

Measure: Discontinuation of using TDF/FTC for any reason

Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)

Description: number of tablets taken/total number of dispensed tablets

Measure: Adherence to TDF/FTC

Time: At any time during the 60 days of intervention

Description: Severity of SARS-CoV-2 infections according to the following categories: Asymptomatic infection Mild symptomatic SARS-CoV-2 infection with no need for hospitalization Moderate symptomatic SARS-CoV-2 infection that requires hospitalization, but no ICU Severe SARS-CoV-2 infection: dyspnea with other SARS-CoV-2 symptoms requiring ICU hospitalization

Measure: Severity of SARS-CoV-2 infection

Time: At any time during follow up 75 days ( 60 days of intervention + final follow-up 15 days post-intervention)
419 Investigating the Involvement of ACE and Angiotensinogen Genes' Polymorphism Along With Other Thrombophilic Genotypes in Severe Forms of COVID-19 With/Without Thrombotic Events

An estimated 22% of the global population is at an increased risk of a severe form of COVID-19, while one in four coronavirus patients admitted to intensive care unit will develop a pulmonary embolism. A major public health question remains to be investigated: why COVID-19 is mild for some, critically severe for others and why only a percentage of COVID-19 patients develop thrombosis, despite the disease's proven hypercoagulable state? Patients' intrinsic characteristics might be responsible for the deep variety of disease forms. Our study aims to assess the validity of the hypothesis according to which underlining genetic variations might be responsible for different degrees of severity and thrombotic events risks in the novel coronavirus disease. Moreover, we suspect that prothrombotic genotypes occuring in the genes that encode angiotensin-converting enzyme (ACE-DEL/INS) and angiotensinogen (AGT M235T) are involved in the unpredictable evolution of COVID-19, both in terms of severity and thrombotic events, due to the strong interactions of SARS-CoV-2 with the renin-angiotensin-aldosterone system (RAAS). Therefore, we also aim to assess the validity of the theory according to which there is a pre-existing atypical modulation of RAAS in COVID-19 patients that develop severe forms and/or thrombosis. Our hypothesis is based on various observations. Firstly, there is a substantial similarity with a reasonably related condition such as sepsis, for which there is a validated theory stating that thrombophilic mutations affect patients' clinical response. Secondly, racial and ethnic genetic differences are responsible for significant dissimilar thrombotic risks among various nations. Thirdly, an increase in stroke incidence has been reported in young patients with COVID-19, without essential thrombosis risk factors, favoring the idea that a genetic predisposition could contribute to increase the thrombotic and thromboembolic risk. Fourthly, the plasminogen activator inhibitor (PAI)-1 4G/5G inherited mutation was found to be responsible for a thrombotic state causing post-SARS osteonecrosis.

NCT04519398
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Thrombosis
  4. ARDS
  5. Thrombophilia
  6. Thromboses, Intracranial
  7. Thromboses, Deep Vein
  8. RAAS
Interventions
  1. Genetic: Complete thrombophilic profile testing by multiplex PCR
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Intracranial Thrombosis Thrombosis Venous Thrombosis Thrombophilia
HPO:Deep venous thrombosis Hypercoagulability Venous thrombosis

Primary Outcomes

Description: The difference of prothrombotic genotypes frequency between the three groups

Measure: Number of patients with thrombophilic profile alterations

Time: One year

Secondary Outcomes

Description: The differences of RAAS components levels between the three groups

Measure: Number of patients with RAAS components alterations

Time: One year
420 Antibodies Responses to SARS-CoV 2 Infection (COVID-19) in Hospitalized Patients. A Prospective Observational Study

1.5. Why this clinical study? The prevalence of seropositivity following SARS-CoV 2 infection might have its own potential benefits in terms of predicting the end of pandemic and the validity of herd immunity. It is not clear if SARS-CoV 2 infection would have a long-lasting antibody-mediated immunity, and if the antibodies' persistence is dependent on disease severity.depends on the severity of illness. If evidence is provided about the persistence of antibodies that is reflective of the protective immune response, serodiagnosis will be an important tool to identify individuals with various risk for infection, and those who are in need of receiving the forthcoming vaccines. The here proposed prospective clinical study will test the prevalence of seropositivity following SARS-CoV 2 infection in critically ill patients compared to those who do not require intensive care unit (ICU) admission or invasive ventilation with respect to the IgM and IgG levels.

NCT04520880
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV 2 Infection)
  2. Hospitalized Patients
  3. Laboratory-confirmed SARS-CoV 2 Infection
Interventions
  1. Diagnostic Test: Testing procedure for Binding antibodies
  2. Diagnostic Test: Neutralizing antibodies
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The measurements are dependent on epitope recognitions for synthetic, adsorbed S proteins

Measure: Changes in the levels of S specific antibodies in severely ill patients compared to mild cases.

Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: The measurements are dependent on epitope recognitions for synthetic, adsorbed N proteins

Measure: Changes in the levels of N specific antibodies in severely ill patients compared to mild cases.

Time: Changes from baseline (4 to 6 weeks) at 16 weeks after the onset of symptoms of SARS-Cov2 infection

Secondary Outcomes

Description: Titers of the S specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions

Measure: S specific binding antibodies of SARS-CoV-2

Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Titers of the N specific binding antibodies of SARS-CoV-2 would be assayed as described in the interventions

Measure: N specific binding antibodies of SARS-CoV-2

Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Titers of the neutralizing antibodies directed against S protein of SARS-CoV-2 would be assayed as described in the interventions

Measure: Neutralizing antibodies directed against S protein of SARS-CoV-2

Time: 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: The severity category of critically ill patients would be estimated using an APACHI II score. Minimum score = 0; maximum score = 71.

Measure: The severity category of critically ill

Time: Day 0, 4 to 6 weeks and 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Length of ICU stay from the admission day to the ICU

Measure: Length of ICU

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: Length of hospital stay from the hospital admission day

Measure: Length of hospital stays

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: If the patients alive or dead through a telephone interview.

Measure: Alive status at 28-days

Time: For 28 days after the onset of symptoms of SARS-Cov2 infection

Description: If the patients alive or dead through a telephone interview.

Measure: Alive status at 90-day

Time: For 90 days after the onset of symptoms of SARS-Cov2 infection

Description: To correlate the levels of S neutralizing antibodies in severely ill patients compared to mild cases.

Measure: Correlation between the levels of S neutralizing antibodies and disease severity

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection

Description: To correlate the levels of N neutralizing antibodies in severely ill patients compared to mild cases.

Measure: Correlation between the levels of N neutralizing antibodies and disease severity

Time: For 16 weeks after the onset of symptoms of SARS-Cov2 infection
421 Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients

Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.

NCT04521309
Conditions
  1. COVID-19
Interventions
  1. Biological: SARS-CoV-2 antibody based IVIG therapy
MeSH:Severe Acute Respiratory Syndrome

Primary Outcomes

Description: All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.

Measure: 28 Days mortality

Time: 28 days

Description: Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient

Measure: Requirement of supplemental oxygen support

Time: 28 days

Description: Number of days a participant will be requiring assisted ventilation both invasive and noninvasive

Measure: Number of days on assisted ventilation

Time: 28 days

Description: Shifting from ICU to ward

Measure: Days to step down

Time: 28 days

Description: Duration from day of enrollment in study to Day of hospital discharge

Measure: Days to Hospital Discharge

Time: 28 days

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

Measure: Adverse events during hospital stay

Time: 28 days

Description: Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation

Measure: Change in C-Reactive Protein (CRP) levels

Time: 28 days

Description: change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation

Measure: Change in neutrophil lymphocyte ratio

Time: 28 days

Secondary Outcomes

Description: change in Ferritin level from baseline will be used to monitor inflammation and immune dysregulation

Measure: Change in Ferritin levels

Time: 28 days

Description: change in LDH from baseline will be used to monitor infections and tissue health

Measure: Change in lactate dehydrogenase (LDH) levels

Time: 28 days

Description: Any change seen in radiological chest X-ray findings

Measure: Change in radiological (X-ray) findings

Time: 28 days

Description: Time taken for participant to receive negative COVID-19 PCR test

Measure: Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test

Time: 28 days

Description: Anti-SARS-CoV-2 antibody titre from blood measured by semi-qualitative method

Measure: Anti-SARS-CoV-2 Antibody

Time: 28 days

Description: Change in body temperature from baseline will be used to monitor safety and efficacy

Measure: Change in fever

Time: 28 days

Description: Change in electrolytes (Sodium) seen in participants

Measure: Change in Sodium levels

Time: 28 days

Description: Change in electrolytes (Potassium) seen in participants

Measure: Change in Potassium levels

Time: 28 days

Description: Change in electrolytes (Chloride) seen in participants

Measure: Change in Chloride levels

Time: 28 days

Description: Change in electrolytes (Bicarbonate) seen in participants

Measure: Change in Bicarbonate levels

Time: 28 days
422 Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia

Coronavirus-2019 disease (COVID-19) and community-acquired pneumonia are significant problems of modern medicine. Pneumonia is the most common severe complication of COVID-19. But at the same time, COVID-19 is not the only cause of community-acquired pneumonia. Moreover, pneumonia is only one of the numerous possible severe complications of COVID-19. Medical centers specialized for the hospital treatment of patients with severe COVID-19 and community-acquired pneumonia were organized in different regions of Russia during coronavirus pandemic-2020. The indications for hospitalization to one of these centers based in the National Medical and Surgical Center (NMSC) are: confirmed or suspected severe COVID-19 or community-acquired pneumonia. A prospective medical registry of such patients hospitalized to NMSC, is intended to analyze and compare their clinical and instrumental data, co-morbidity, treatment, short-term and long-term outcomes in real clinical practice. Stage 1. Hospital treatment in NMSC Duration of this stage: from the date of admission to the hospital up to the date of discharge from the hospital / or up to the date of death during the reference hospitalization. The date of admission to the hospital will be the date of enrollment to the study. Evaluation of electronic health record data using the Medical Information System (MIS). Assessment of the outcomes of the hospital phase (discharge from the hospital, death) and significant events (acute respiratory and pulmonary failure, requiring mechanical ventilation; cardiovascular events - myocardial infarction, cerebral stroke, acute heart failure, paroxysmal heart rhythm disturbances, bleedings, thrombosis of large vessels and thromboembolic complications). A survey of patients to clarify data on risk factors, somatic diseases, and drug therapy before hospitalization. COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was confirmed by Polymerase chain reaction (PCR). Pneumonia was confirmed according to computerized tomography (CT) data. Stage 2. Prospective outpatient follow-up for 24 months Duration of this stage: 24 months after discharge from the hospital This work will be delivered by investigators from the National Medical Research Center for Therapy and Preventive Medicine. Evaluation of long-term outcomes and events among residents of Moscow and the Moscow Region according to a patient survey (contact by phone for 30-60 days, 6 months, 12 and 24 months after discharge from the hospital) and medical records.

NCT04522076
Conditions
  1. COVID 19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Overall survival

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Time to all-cause mortality or Artificial Pulmonary Ventilation (APV)

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Time to all-cause mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization

Time: from discharge up to two years after reference hospitalization

Secondary Outcomes

Description: Damage area >50% according to the computer tomography data at any time point during hospitalization

Measure: Proportion of patients with severe pneumonia

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Description: SpO2 <90% - at any point during hospitalization

Measure: Proportion of patients with low oxygen saturation value

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Proportion of patients with Hb <90 g/l (9.0 g/dl) at any point during hospitalization

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Proportion of patients hospitalized or transferred to Intensive Care Unit (ICU)

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Overall survival

Time: from discharge up to two years after reference hospitalization

Measure: Time to nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization

Time: from discharge up to two years after reference hospitalization

Description: In patients with pneumonia during reference hospitalization time to recurrent pneumonia. In patients without pneumonia during reference hospitalization - time to first pneumonia

Measure: Time to pneumonia/recurrent pneumonia

Time: from discharge up to two years after reference hospitalization

Description: In patients without COVID-19 - time to primary diagnosis and in patients with COVID-19 - time to recurrent event

Measure: Time to primary or recurrent coronavirus infection disease (COVID-19)

Time: from discharge up to two years after reference hospitalization

Other Outcomes

Measure: proportion of patients with nonfatal myocardial infarction

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: proportion of patients with nonfatal cerebral stroke

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: proportion of patients with bleedings

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Description: proportion of patients with thromboembolic events

Measure: thromboembolic events

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Description: the sum of the days when the patients required artificial pulmonary ventilation

Measure: Duration of Artificial Pulmonary Ventilation

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Minimal value of oxygen blood saturation (SpO2) during the hospital stage.

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Measure: Minimal value of hemoglobin (Hb) during the hospital stage

Time: from admission to discharge or death during reference hospitalization, assessed up to 90 days

Description: proportion of patients with rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV)

Measure: Rehospitalization due to pneumonia, COVID-19, flu and other acute respiratory infections (ARV)

Time: from discharge up to two years after reference hospitalization

Description: proportion of patients with hospitalization due to cardiovascular disease

Measure: Hospitalization due to cardiovascular disease (CVD)

Time: from discharge up to two years after reference hospitalization

Measure: time to Flu and other ARV (except COVID-19)

Time: from discharge up to two years after reference hospitalization
423 An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

NCT04522986
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Biological: Mesenchymal stem cell
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Adverse events which appear in subjects with ADR-001 treatment are evaluated.

Measure: Safety: Adverse Event

Time: 12 weeks
424 Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents: A Randomized, Doubled-Blinded, Comparative Group Observational Study

The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.

NCT04523246
Conditions
  1. Herpes Zoster
  2. Allergy and Immunology
  3. Corona Virus Infection
Interventions
  1. Biological: SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)
  2. Drug: Normal Saline
MeSH:Virus Diseases Herpes Zoster Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.

Measure: Evidenced of active and trained innate immunity

Time: Day 61 and 90 (post vaccination)

Secondary Outcomes

Description: cases ( nasal swab for viral antigen and antibody testing), symptoms (symptom checklist), hospitalizations (MDS 3.0 report/chart reviews) and deaths (MDS 3.0 report/chart reviews) associated with flu, pneumonia, and COVID-19.

Measure: Respiratory Disease Severity (6 month)

Time: Days 90 through 180
425 Prediction Models for Diagnosis and Prognosis of Severe COVID-19

Clinical observation has found that COVID-19 patients often present inconsistency of clinical features, nucleic acid of the SARS-CoV-2 and imaging findings, which brings challenges to the management of patients.The quantitative assessment of patients' pulmonary lesions of chest CT, combined with the basic information, epidemiological history, clinical symptoms, basic diseases and other information of patients, will quickly establish a reliable prediction model for the severe COVID-19. This model will greatly contribute to the effective diagnosis and treatment of COVID-19.

NCT04525287
Conditions
  1. Coronavirus Infection
  2. COVID19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: chest CT imaging data of the patient, basic patient information, epidemiological history, clinical symptoms, and underlying diseases

Measure: Chest CT and clinical features

Time: 2020-1-1 to 2020-6-1
426 MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients

While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.

NCT04525404
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV Infection
Interventions
  1. Diagnostic Test: MRI (heart, brain, lungs, liver)
  2. Diagnostic Test: Bloodwork
  3. Other: Cognitive testing
  4. Other: Olfaction testing
  5. Diagnostic Test: Spirometry
  6. Other: Walk Test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls

Measure: Native myocardial T1 relaxation time

Time: 12 weeks post COVID-19 diagnosis

Secondary Outcomes

Description: Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging

Measure: FLAIR imaging

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline

Measure: Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline

Time: 12 weeks post COVID-19 diagnosis

Description: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

Measure: Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

Time: 12 weeks post COVID-19 diagnosis

Description: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic

Measure: Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic

Time: 12-24 weeks post COVID-19 diagnosis
427 High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.

NCT04525820
Conditions
  1. Covid19
  2. Vitamin D Deficiency
  3. Corona Virus Infection
  4. ARDS
  5. Coronavirus
  6. SARS-CoV Infection
Interventions
  1. Drug: Single high dose vitamin D
  2. Drug: Placebo
  3. Drug: Treatment as usual vitamin D
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency
HPO:Low levels of vitamin D

Primary Outcomes

Description: Overall duration of the hospitalization from day of admission until the day of discharge or fatality

Measure: Length of hospitalization

Time: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)

Secondary Outcomes

Description: Did the patient need a intensive care treatment during the hospitalization (yes/no)

Measure: Need of intensive care

Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: Day of admission to ICU until discharge or fatality

Measure: Lenght of the Intensive Care Treatment

Time: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: Percentage of patient died during hospitalization

Measure: Overall mortality

Time: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: percentage of patients with 25-hydroxyvitamin D > 50nmol/L (>20ng/mL) at day 7 - The values of calcium, phosphorus, 24-hydroxyvitamin D, 1.25-dihydroxyvitamin D, parathyroid hormone.

Measure: Development of vitamin D levels

Time: Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)

Description: percentage of patients developing a sepsis

Measure: Development of sepsis

Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)

Other Outcomes

Description: We assess every other complications which occurs due to COVID-19

Measure: Complications due to COVID-19

Time: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: The BP will be assessed daily in mmHg

Measure: Blood pressure (BP)

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: The heart rate will be assessed daily in bpm

Measure: Heart rate

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Description: The SpO2 will be assessed daily in %

Measure: Peripheral oxygen saturation (SpO2)

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Requirement for oxygen will be assessed daily (yes/no) if yes how many liters per minute

Measure: Percentage of patients who require oxygen

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Breathing frequence will be assessed daily in breaths per minute

Measure: Breathing frequency

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: GCS will be assessed daily 3 to 15 points. It describes the extent of impaired consciousness. 15 points means no impairment, 3 points means severe impairment of consciousness.

Measure: Glasgow Coma Scale (GCS)

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Assessing the history of smoking in pack years (PY). the assessment will be made with the following options for answering Current smoker: Smoking for how many years? Cigarettes per day? Former smoker, how many years smoked? How many cigarettes per day Life-long non-smoker

Measure: Percentage of patients are smokers, former smokers or lifelong non-smokers

Time: Assessing of the smoking Status at Basleine

Description: Assessed in No/ Mild/ Moderate /Severe

Measure: Current Symptoms

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)

Description: Temperature will be assessed daily in degrees celsius

Measure: Temperature

Time: Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID 19)
428 Detecting SARS-CoV-2 Virus in Tears From Patients With COVID-19

Purpose: - To determine the presence of SARS-CoV-2 in tears - To determine SARS-CoV-2 receptors in tear production system

NCT04526769
Conditions
  1. COVID
  2. COVID-19
  3. Corona Virus Infection
  4. SARS-CoV-2
Interventions
  1. Diagnostic Test: Tear Collection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Outcome is reported as the percent of tear samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.

Measure: COVID-19 Virus Detection in Tears

Time: single time point

Description: Outcome is reported as the percent of nasopharyngeal swab samples that test either "positive", "negative", or "indeterminant" for SARS-CoV-2 Virus presence.

Measure: COVID-19 Virus Detection in Nasopharyngeal Swabs

Time: single time point

Secondary Outcomes

Description: Pathology slides of lacrimal gland samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of lacrimal gland samples scored in each category (no expression, mild expression, or heavy expression).

Measure: Expression of ACE2 in Lacrimal Gland Samples

Time: single time point

Description: Pathology slides of ocular surface samples will be assessed for ACE2 expression and rated as having no expression (score=1), mild expression (score=2), or heavy expression (score=3). Outcome reported as the percent of ocular surface samples scored in each category (no expression, mild expression, or heavy expression).

Measure: Expression of ACE2 in Ocular Surface Samples

Time: single time point
429 A Pilot Assessment of the COVID-19 Antibody Status and Associated Factors, in Individuals Employed by a Large Acute NHS Trust During the Coronavirus Pandemic

The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans. Currently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk. Currently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection. Therefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period. The study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds. Participants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.

NCT04527432
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Other: Survey
  2. Diagnostic Test: SARS-CoV-2 antibody test
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: evidence of SARS-CoV-2 antibodies

Measure: The number of employees tested who have evidence of SARS-CoV-2 antibodies

Time: 12 months

Description: Survey to establish Type of healthcare role Ethnicity Age Index of multiple deprivation Previous RT-PCR test status Previous clinical COVID infection Previous period of self isolation Level of COVID-19 related anxiety Presence of one or more high risk factors for COVID 19 Presence or absence of self-reported COVID 19 symptoms

Measure: Factors associated with a positive test

Time: 12 months

Description: Infection compared to antibody presence

Measure: Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests

Time: 12 months
430 A Single-center, Pilot, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ensifentrine in the Recovery of Hospitalized Patients With COVID-19

This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection.

NCT04527471
Conditions
  1. Coronavirus Infection
  2. Covid-19
  3. SARS-CoV-2
Interventions
  1. Drug: Ensifentrine Dose 1
  2. Drug: Placebo pMDI
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.

Measure: Proportion of patients with recovery

Time: Day 29

Secondary Outcomes

Description: Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.

Measure: Time to recovery

Time: Day 1 to Day 29

Measure: Proportion of patients with recovery

Time: Day 60

Measure: Proportion of patients with improvement (from Day 1) of one category using the 7-point ordinal scale

Time: Days 7, 14 and 29

Measure: Proportion of patients with improvement (from Day 1) of two categories using the 7-point ordinal scale

Time: Days 7, 14 and 29

Description: All-cause mortality

Measure: Mortality rate

Time: Days 29 and 60

Description: respiratory failure = requiring invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]

Measure: Proportion of patients alive and not in respiratory failure

Time: Day 29

Measure: Proportion of patients needing re-hospitalization

Time: Day 60

Measure: Duration of hospitalization from Day 1

Time: Day 1 to Day 29

Measure: Mean change from baseline in 7-point ordinal scale

Time: Days 7, 14 and 29

Measure: Total time on supplemental oxygen

Time: Day 1 to Day 29

Measure: Incidence of new non-invasive ventilation or high flow oxygen use

Time: Day 1 to Day 29

Measure: Duration of new non-invasive ventilation or high flow oxygen use

Time: Day 1 to Day 29

Measure: Incidence of new oxygen use

Time: Day 1 to Day 29

Measure: Duration of new oxygen use

Time: Day 1 to Day 29

Measure: Incidence of new mechanical ventilator use

Time: Day 1 to Day 29

Measure: Duration of new mechanical ventilator use

Time: Day 1 to Day 29

Measure: Proportion of patients receiving invasive mechanical ventilation or ECMO

Time: Days 7, 14 and 29

Other Outcomes

Measure: Incidence of Adverse Events (AEs)

Time: Day 60

Description: breaths/minute

Measure: Respiration Rate

Time: Day 1 to Day 29

Description: beats/minute

Measure: Heart Rate

Time: Day 1 to Day 29

Measure: Body Temperature

Time: Day 1 to Day 29

Description: mmHg

Measure: Blood Pressure

Time: Day 1 to Day 29

Description: AVPU scale

Measure: Level of Consciousness

Time: Day 1 to Day 29

Description: SpO2 %

Measure: Oxygen saturation

Time: Day 1 to Day 29
431 Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection. A Multicenter, Interventional, Randomized, Three Arms Study Design

SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.

NCT04528888
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Pneumonia, Viral
  4. Coagulopathy
Interventions
  1. Drug: Enoxaparin
  2. Drug: Methylprednisolone
  3. Drug: unfractionated heparin
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: All-cause mortality at day 28, defined as the comparison of proportions of patients death for any cause at day 28 from randomization.

Measure: All-cause mortality at day 28

Time: Day 28 from randomization

Secondary Outcomes

Description: All-cause mortality at ICU discharge, defined as the comparison of proportions of patients death for any cause at ICU discharge.

Measure: All-cause mortality at ICU discharge

Time: from randomization to ICU discharge, censored at day 30

Description: All-cause mortality at Hospital discharge, defined as the comparison of proportions of patients death for any cause at hospital discharge

Measure: All-cause mortality at hospital discharge

Time: from randomization to ICU discharge, censored at day 90

Description: Occurrence of rescue administration of high-dose steroids or immune-modulatory drugs

Measure: Need of rescue administration of high-dose steroids or immune-modulatory drugs

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of new organ dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score ≥3 for the corresponding organ occurring after randomization.

Measure: New organ dysfunction during ICU stay

Time: From randomization to ICU discharge, censored at day 28

Description: Grade of organ dysfunction during ICU stay, grade of dysfunction is measured with Sequential Organ Failure Assessment (SOFA) score daily from randomization to day 28 or ICU discharge.

Measure: Grade of organ dysfunction during ICU stay

Time: From randomization to ICU discharge, censored at day 28

Description: Total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered.

Measure: ICU free days at day 28

Time: From randomization to day 28

Description: Occurrence of new infections including bacterial infections, fungal infections by Candida, Aspergillus, and viral reactivations including Adenovirus, Herpes Virus e Cytomegalovirus

Measure: Occurrence of new infections

Time: from randomization to day 28

Description: Total number of days that patient is alive and free of ventilation between randomisation and day 28. Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.

Measure: Ventilation free days at day 28

Time: From randomization to day 28, censored at hospital discharge

Description: Total number of days that patient is alive and free of vasopressors between randomisation and day 28.

Measure: Vasopressors free-days at day 28

Time: From randomization to day 28, censored at hospital discharge

Description: Occurrence of switch from non-invasive to invasive mechanical ventilation

Measure: Switch from non-invasive to invasive mechanical ventilation

Time: from randomization to ICU discharge, censored at day 28

Description: Total number of hours from start of non-invasive to invasive ventilation to switch to invasive ventilation

Measure: Delay from start of non-invasive ventilation to switch to invasive ventilation

Time: from randomization to ICU discharge, censored at day 28

Description: Adverse events occurred from randomization to day 28. Events that are part of the natural history of the primary disease process or expected complications of critical illness will not be reported as adverse events.

Measure: Occurrence of protocol related adverse events

Time: From randomization to day 28

Description: Occurrence of objectively confirmed venous thromboembolism, stroke or myocardial infarction

Measure: Occurrence of venous thromboembolism, stroke or myocardial infarction

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of major bleeding defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death)

Measure: Occurrence of major bleeding (safety end point)

Time: from randomization to ICU discharge, censored at day 28

Description: Occurrence of clinically relevant non-major bleeding defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm2, or 100 cm2, intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.

Measure: Occurrence of clinically relevant non-major bleeding (safety end point)

Time: from randomization to ICU discharge, censored at day 28

Other Outcomes

Description: Mean arterial pressure will be measured in millimeters of mercury

Measure: Mean arterial pressure

Time: Daily from inclusion until ICU discharge, censored day 28

Description: hearth rate will be measured in beats per minute

Measure: hearth rate

Time: Daily from inclusion until ICU discharge, censored day 28

Description: respiratory rate will be measured in breaths per minute

Measure: respiratory rate

Time: Daily from inclusion until ICU discharge, censored day 28

Description: diuresis will be measured daily in milliliters of urine output in the previous 24 hours

Measure: diuresis

Time: Daily from inclusion until ICU discharge, censored day 28

Description: systemic body temperature will be measured in celsius degrees

Measure: systemic body temperature

Time: Daily from inclusion until ICU discharge, censored day 28

Description: fluid balance will be measured in milliliters of fluids input and output in the previous 24 hours

Measure: fluid balance

Time: Daily from inclusion until ICU discharge, censored day 28

Description: Haemoglobin will be measured in mg/dl

Measure: Haemoglobin concentration

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: platelets count will be measured in U 10^3/mm^3

Measure: platelets count

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: white blood cells count will be measured in U per 10^9/L

Measure: white blood cells count

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: troponin will be measured in µg/L

Measure: troponin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: coagulative function will be measured with parameters INR, PT, aPTT

Measure: coagulative function

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: D-dimer will be measured in µg/ml

Measure: D-dimer

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: anti-thrombin will be measured as a percentage

Measure: anti-thrombin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: liver function will be assessed through measurement of AST, ALT in U/L

Measure: Liver function

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Bilirubin will be measured in mg/dL

Measure: Bilirubin

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Creatinine will be measured in mg/dL

Measure: Creatinine

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Blood cells count will be measured in Units per x 10^9/L of blood

Measure: Blood cells count

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: C-reactive protein (CRP) will be measured in mg/dl

Measure: C-reactive protein (CRP)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: procalcitonin(PCT) wiull be measured in ng/ml

Measure: procalcitonin(PCT)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: interleukin 6 (IL-6) will be measured in pg/ml

Measure: interleukin 6 (IL-6)

Time: daily from inclusion to ICU discharge (censored at day 28)

Description: Ventilation mode will be cathegorized in spontaneous breathing, invasive or non invasive ventilation

Measure: Ventilation mode

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: inspired oxygen fraction will be measured in percentage of oxygen in inspired air

Measure: inspired oxygen fraction

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: Gas exchanges will be assessed by measurement of PaO2, PaCO2 in mmHg by arterial blood gas analysis

Measure: Gas exchanges

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: lactates will be measured in mMol/L

Measure: lactates

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: pH will be measured in pH scale

Measure: pH

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: oxygen saturation in blood will be measured in arterial and venous samples in percentage values

Measure: oxygen saturation in blood

Time: Daily from inclusion to ICU discharge (censored at day 28)

Description: New blood, respiratory and urinary-tract infections will be recorded

Measure: New infections

Time: From randomization to day 28

Description: Viral reactivation measured by CMV DNA titres will be recorded.

Measure: Viral reactivation

Time: From randomization to day 28

Description: Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) will be recorded.

Measure: Need of new renal replacement therapy

Time: from randomization to day 28

Description: Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded

Measure: Adjunctive treatments

Time: from randomization to ICU discharge (censored at day 28);
432 Randomized, Blind, Placebo-controlled Phase- i Study and Randomized, Open Phase Phase-ii Study of QAZCOVID-IN®- COVID-19 Inactivated Vaccine in Healthy Adult Volunteers From 18 Years Old and Elder

Randomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder

NCT04530357
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Vaccine Adverse Reaction
Interventions
  1. Biological: QazCovid-in® - COVID-19 inactivated vaccine
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Frequency of adverse reaction in the seven days following each immunization per age group

Measure: Frequency of adverse events up to seven days after immunization

Time: Seven days after each immunization

Description: Frequency of adverse reaction in the 21 days following each immunization per age group

Measure: Frequency of adverse events up to 21 days after immunization

Time: 21 days after each immunization

Description: The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination compared with a placebo.

Measure: The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo

Time: at days 0, 21, 27, 42

Secondary Outcomes

Description: Incidence of serious adverse events during the study.

Measure: Incidence of serious adverse events during the study

Time: throughout the study, an average of 42 days

Description: Cell-mediated immune profile

Measure: Cell-mediated immune profile

Time: at days 0, 7, 21, 27, 42
433 Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization

Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.

NCT04530448
Conditions
  1. COVID
  2. Coronavirus
  3. Coronavirus Infection
  4. AKI
  5. Acute Kidney Injury
Interventions
  1. Drug: Sodium bicarbonate
  2. Other: Standard of Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.

Measure: pH

Time: 10 days

Description: Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.

Measure: Number of Days Alive Free of Stage 2-3 AKI

Time: 28 days post-treatment

Secondary Outcomes

Description: proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).

Measure: Stage 2-3 AKI

Time: 28 days

Description: Ventilator-free days to 28 days

Measure: Vent-Free

Time: 28 days

Description: Hospital-free days to 60 days

Measure: Hospital-Free

Time: 60 days post-index hospitalization
434 Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases

An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis

NCT04530461
Conditions
  1. SARS-CoV Infection
  2. Systemic Disease
  3. Systemic Lupus Erythematosus
  4. Sjogren's Syndrome
  5. Sarcoidosis
  6. Inflammatory Myopathy
  7. Behçet Disease
  8. Rheumatoid Arthritis
  9. Spondyloarthritis
Interventions
  1. Diagnostic Test: Serological test
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Sjogren's Syndrome Myositis Behcet Syndrome Sarcoidosis Lupus Erythematosus, Systemic
HPO:Inflammatory myopathy Myositis Systemic lupus erythematosus

Primary Outcomes

Description: Number of patients with positive serological test of SARS Cov2

Measure: Serological Profile

Time: Inclusion
435 The Effect of Melatonin and Vitamin C on COVID-19

This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.

NCT04530539
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Dietary Supplement: Vitamin C
  2. Dietary Supplement: melatonin
  3. Dietary Supplement: Placebo
  4. Other: Symptom Survey
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Symptom severity will be tracked electronically

Measure: Symptom Severity

Time: 14 days

Secondary Outcomes

Description: Determine symptom course of those with moderate or severe symptoms

Measure: Symptom progression

Time: 14 days
436 Efficacy and Safety Study to Evaluate the Use of Nebulized Heparin in Patients With Severe Acute Respiratory Syndrome Covid-19 (SARS-CoV-2)

To evaluate the safety and efficacy of the use of inhalational heparin in patients with pulmonary compromise / pneumonia / SARS associated with COVID-19, laboratory with marked inflammation parameters, and prothrombotic state secondary to it (Fibrinogen, Ferritin and / or elevated D-Dimer) , from admission to hospitalization. The combination of inhalation heparin combined with prophylactic doses of LMWH could reduce the progression to severe forms of the disease, and consequently the need for intensive care units and mechanical ventilation.

NCT04530578
Conditions
  1. Covid19
  2. Pneumonia
Interventions
  1. Drug: Heparin sodium
  2. Drug: Enoxaparin
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Blood Gas criteria :PaO2 / FiO2 <200 (or the inability to maintain an SpO2 of at least 92% with a reservoir mask). Acute ventilatory failure (pH less than 7.35 with PaCO2 greater than 45 mmHg)

Measure: Percentage of patients requirement mechanical ventilation

Time: 15 days

Secondary Outcomes

Description: Mean every 48 hours PaO2 to FiO2 ratio

Measure: Percentage of patients with PaO2 to Fi02 ratio > 300

Time: 7 days

Description: To compare the lengths of hospital-stay

Measure: Lengths of hospital-stay

Time: Days 60

Description: All cause mortality

Measure: Mortality rate

Time: 30 days
437 Clinical Characterization Protocol for Severe Emerging Infections: Coronavirus

This is a Brazilian version of the Clinical Characterization Protocol for Serious Emerging Infections (ISARIC/WHO ). This is a standardized protocol for the rapid, coordinated clinical investigation of Coronavirus disease (COVID-19). Patients with acute illness suspected to be caused by emerging will be enrolled. This protocol has been designed to enable data to be prospectively collected.

NCT04531202
Conditions
  1. Coronavirus Infection (COVID-1
  2. Coronavirus Infection (COVID-19)
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the clinical features of the illness or syndrome and complications, and determinants of severity. Assessment daily for 14 days, then hospital discharge.

Measure: Clinical characterization of coronavirus disease-2019 (COVID-19)

Time: 1 year
438 Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth

This QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.

NCT04532411
Conditions
  1. SARS-CoV Infection
  2. Respiratory Viral Infection
  3. Personal Protective Equipment
  4. Covid19
Interventions
  1. Other: Personal Protective Testing Booth
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Testing Throughput After Hexapod Implementation

Time: Up to 22 weeks

Description: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Isolation Gowns Utilized After Hexapod Utilization

Time: Up to 22 weeks

Description: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.

Measure: Change in Cost per Test After Hexapod Implementation

Time: Up to 22 weeks

Description: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.

Measure: Return on Investment

Time: Up to 22 weeks

Secondary Outcomes

Description: The difference in median shift salaries before and after Hexapod implementation will be calculated.

Measure: Change in Testing Personnel Cost Per Test

Time: Up to 22 weeks

Description: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.

Measure: Change in Cost of Isolation Gowns Utilized

Time: Up to 22 weeks

Other Outcomes

Description: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.

Measure: Cost of Additional Consumable Supplies Utilized

Time: Up to 22 weeks
439 Taste and Smell Impairment in Critically Ill COVID-19 Patients

Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study

NCT04532632
Conditions
  1. Smell Disorder
  2. Taste Disorders
  3. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Taste Disorders Olfaction Disorders Disease
HPO:Anosmia

Primary Outcomes

Description: incidence of taste and smell impairment in critically ill subjects

Measure: taste and smell impairment

Time: up to 3 months
440 Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled

This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1 x 10^8cells for the high-dose group after registration. Subjects assigned to the control group were administered with placebo in the same manner as the test drug (DW-MSC). At this time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to standard therapy. This clinical trial is a double-blind trial, in which a randomized method will be used. To maintain the double-blindness of the study, statistician who do not participate in this study independently generate randomization code. Subjects will be randomized to the test groups (low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio. After the completion of the trial, the randomization code will be disclosed after unlocking the database and unblinding procedures. Follow Up period: observed for 28 days after a single administration

NCT04535856
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SAR
Interventions
  1. Drug: allogeneic mesenchymal stem cell
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence of TEAE* in Treatment group * TEAE: Treatment-Emergent Adverse Event All adverse reactions will be organized according to System Organ Class (SOC) and Preferred Term (PT) using MedDRA (Medical Dictionary for Regulatory Activities), and the incidence of treatment-emergent adverse events will be summarized for the coded adverse reactions.

Measure: Incidence of TEAE* in Treatment group

Time: 28 days

Secondary Outcomes

Description: Survival rate is defined as the rate of subjects surviving until Day 14 and Day 28, and the number and rate of surviving subjects for each administration group is given.

Measure: Survival rate

Time: until Day 14 and Day 28

Description: Duration of hospitalization is defined as the number of days in the hospital until Day 28, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.

Measure: Duration of hospitalization

Time: 28 days

Description: Clinical improvement measured by Ordinal scale change for clinical improvement from baseline to Day 14 and 28

Measure: Clinical improvement Ordinal scale

Time: from baseline to Day 14 and Day 28

Description: Clinical improvement measured by National EWS (National Early Warning Score) change from baseline to Day 7, 14, 28. EWS Points, Risk and Interpretation as follows: 0~4: Low clinical risk; interpretation= Ward-based response 3~4 : Low~medium clinical risk; interpretation= Urgent ward-based response 5~6: Medium clinical risk; interpretation= Key threshold for urgent response

Measure: Clinical improvement National EWS

Time: from baseline to Day 7, 14 and Day 28

Description: Clinical improvement measured by Oxygenation index (PaO2/FiO2) change from baseline (Day 1, 3, 7, 10, 14, 28)

Measure: Clinical improvement Oxygenation index

Time: Day 1, 3, 7, 10, 14, 28

Description: Clinical improvement measured by Lung involvement change by Imaging from baseline (Day 7, 14, 28)

Measure: Clinical improvement Lung involvement change

Time: Day 7, 14, 28

Description: Inflammation markers change from baseline for WBC

Measure: Clinical improvement Inflammation markers change

Time: Day 7, 14, 28

Description: Inflammation markers change from baseline for Lymphocytes

Measure: Clinical improvement Inflammation markers change

Time: Day 7, 14, 28

Description: Inflammation markers change from baseline for ESR

Measure: Clinical improvement Inflammation markers change

Time: Day 7, 14, 28

Description: Inflammation markers change from baseline for CRP

Measure: Clinical improvement Inflammation markers change

Time: Day 7, 14, 28

Description: Inflammation markers change from baseline for Fibrinogen

Measure: Clinical improvement Inflammation markers change

Time: Day 7, 14, 28

Description: Inflammation markers change from baseline for IL-6, TNF-α, IL-1β, IF-γ (Day 7, 14, 28)

Measure: Clinical improvement Inflammation markers change

Time: Day 7, 14, 28
441 Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS: a Randomized, Placebo Controlled, Multicenter Trial

The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.

NCT04536350
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. ARDS
  4. Aviptadil
Interventions
  1. Drug: Aviptadil 67μg
  2. Drug: Placebo 0.9% NaCl solution
MeSH:Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to clinical improvement of a decrease of at least two points on a seven-point ordinal scale of clinical status or discharged alive from hospital. The seven-point scale consists of the following categories: not hospitalized; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; hospitalized, intubation and mechanical ventilation; ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); death

Measure: time to clinical improvement

Time: Randomization until discharge from hospital but up to maximum 28 days

Secondary Outcomes

Description: Frequency of Patient who need mechanical ventilation during hospital stay

Measure: Frequency of mechanical ventilation

Time: Randomization until discharge from hospital up to maximum 28 days

Measure: Time requiring oxygen supplementation

Time: Randomization until discharge from hospital up to maximum 28 days

Measure: Slope in SaO2

Time: Randomization until discharge from hospital up to maximum 28 days

Measure: Slope in FiO2

Time: Randomization until discharge from hospital but up to maximum 28 days

Measure: Slope in C-reactive Protein

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: Neutrophile ratio

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: lymphocyte ratio

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: Interleukine 6 level

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: Procalcitonin level

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Description: Frequency of Patient who showed a multi organ dysfunction Syndrome during Hospital stay

Measure: Frequency of Multi organ dysfunction Syndrome (MODS)

Time: Randomization until discharge from hospital up to maximum 28 days

Other Outcomes

Measure: duration of hospitalization in survivors

Time: randomization till discharge of hospital up to 28 days

Measure: Time from treatment initiation to death

Time: Treatment initiation to death up to maximum 28 days

Description: Blood pressure will be assessed daily in mmHg

Measure: Blood pressure

Time: Daily until discharge up to maximum 28 days

Description: Heart rate will be assessed daily in bpm

Measure: Heart rate

Time: Daily until discharge up to maximum 28 days

Description: Respiratory rate will be assessed daily in Counts per minute

Measure: Respiratory rate

Time: Daily until discharge up to maximum 28 days

Description: Body temperature (auricular) will be assessed daily in °C

Measure: Body temperature (auricular) in °C

Time: Daily until discharge up to maximum 28 days

Description: Pulse oximetry will be assessed daily in %

Measure: Pulse oximetry

Time: Daily until discharge up to maximum 28 days

Description: Glasgow Coma Scale will be assessed daily The lowes possible score is 3 = deep coma or death The highest possible score is 15 = Fully awake

Measure: Glasgow Coma Scale

Time: Daily until discharge up to maximum 28 days

Description: Visual analogue scale for dyspnea and cough as patient-related outcome parameter

Measure: Dispnea and caugh

Time: Randomization until discharge from hospital up to maximum 28 days
442 COVID-FIS: A Phase 2 Placebo-Controlled Pilot Study in COVID-19 of Fisetin to Alleviate Dysfunction and Excessive Inflammatory Response in Older Adults in Nursing Homes

The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.

NCT04537299
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: Fisetin
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Ordinal Scale for Clinical Improvement (minimum=0 and maximum=8; higher score = worse outcome)

Measure: Change in COVID-19 Severity

Time: baseline, Day 2, 7, 10, 14, 17, 30, 90 and 180
443 Avaliação do Covid-19 na Cavidade Oral, Orofaringe e Saliva após desinfecção Com soluções Antimicrobianas Orais: Estudo Piloto.

The aim of this study is to analyze oral disinfection with 1.5% hydrogen peroxide, 0.12% chlorhexidine gluconate or 0.075% cetylpyridinium chloride to 0.28% zinc lactate to reduce the SARS-CoV viral load -2 in the oral and oropharyngeal mucosa and saliva. Patients of both sexes, aged between 18 and 90 years, positive for SARS-CoV-2 by the RT-PCR method and who require oral hygiene care and other preventive and therapeutic dental procedures that are used in the randomized clinical study. The study comprises two arms: Arm 1 - patients hospitalized in the ICU bed with orotracheal intubation - undergo disinfection of the oral mucosa with 1.5% hydrogen peroxide solution, after the 0.12% non-alcoholic chlorhexidine solution ( Peroxide and Chlorhexidine Group) or only disinfection of the oral mucosa with 0.12% non-alcoholic chlorhexidine solution (Chlorhexidine Group - control); Arm 2 - patients hospitalized in the common bed without mechanical ventilation - will undergo oral disinfection or with 1.5% hydrogen peroxide solution (Peroxide Group), or with 0.12% chlorhexidine gluconate (Chlorhexidine Group) or with chloride 0.075% cetylpyridinium with 0.28% zinc lactate (Cetylpyridinium Group) or distilled water (Placebo Group). For the monitoring of viral load, the following procedures are performed: Arm 1 - a scrape with swab on the tongue, deep groove, oral soil, performed before the first oral disinfection (T0), after disinfection with hydrogen peroxide (T1) , after disinfection with chlorhexidine (T2) and 30 minutes after the last disinfection (T3); swab of the fluid adhered to the tube, before disinfecting the tube with hydrogen peroxide and chlorhexidine and immediately after this disinfection. Arm 2 - swab in oropharynx and saliva before application of solutions (T0), 30 min (T1) and 2 hours after application of solutions (T2). The quantification of SARS-CoV-2 will be done through the polymerase chain reaction with reverse-quantitative transcription (RT-qPCR). If some of these solutions are effective in reducing viral load in the oral cavity, this result may contribute to reduce the contamination of the environment caused by aerosols that require dental procedures, contributing to the improvement of biosafety protocols against SARS-CoV-2.

NCT04537962
Conditions
  1. Corona Virus Infection
Interventions
  1. Other: Colgate periogard mouthwash
  2. Other: Colgate Peroxyl mouthwash
  3. Other: Colgate Total mouthwash
  4. Other: Placebo mouthwash (water)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Viral load of SARS-CoV-2 in the oral mucosa, oropharynx and saliva of hospitalized patients already considered positive for the virus

Time: 6 months
444 Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days

NCT04539873
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Colchicine 0.5 MG
  2. Combination Product: CONTROL GROUP
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection

Measure: Number of participants who die or require transfer to Intesive care unit

Time: In the first 15 days after ramdomization

Secondary Outcomes

Description: The secondary end point is the ocurrence of death in the 15 days after ramdomization

Measure: Number of participants who die

Time: 15 days after ramdomization
445 A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Polio Vaccine and NA-831 for Prophylaxis and Treatment of Early Onset of Covid-19

In this randomized double blind Phase 3 clinical trial we will study the efficacy and safety of oral polio vaccine with and without NA-831 versus placebo.

NCT04540185
Conditions
  1. Covid19
  2. SARS (Severe Acute Respiratory Syndrome)
  3. SARS-CoV Infection
  4. SARS-CoV-
  5. SARS-CoV-2
Interventions
  1. Biological: Biological: oral polio vaccine
  2. Biological: Comparable Placebo
  3. Drug: NA-831
  4. Drug: Comparable Placebo of drug
  5. Combination Product: Combination of oral polio vaccine and NA-831
  6. Combination Product: Comparable Placebo of Oral Polio Vaccine and Placebo of drug
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Number of participants infected with Covid-19 after second dose

Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831

Time: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)

Description: Number of participants with adverse events

Measure: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

Time: Time Frame: Up to Day 365 (1 years after second dose)

Secondary Outcomes

Description: Clinical signs indicative of severe COVID-19 as predefined for the study.

Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831

Time: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)

Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of OPV with or without NA-831 or Placebo regardless of evidence of prior SARS-CoV-2 Infection

Time: Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)
446 The Prevalence of SARS-CoV-2 IgG Antibody Formation in Physicians at Advocate Lutheran General Hospital and Their Household Members

This study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China. These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). This will be a prospective, single-center observational study involving human subjects. IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH). IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection. To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing. Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time. Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study. Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing. For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test. Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive. All testing will be performed in a two-week window. All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment. We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care. The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum. One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020. The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.

NCT04540484
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Communicable Disease
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Identifying positive COVID-19 IgG formation

Time: up to 1 year

Secondary Outcomes

Description: The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.

Measure: Physician Prevalence of COVID-19 serum IgG

Time: up to 1 year

Description: The prevalence of COVID-19 serum IgG in household members (as defined above) of physician participants that are positive at the time the associated physician tested positive.

Measure: Household Member Prevalence of COVID-19 serum IgG

Time: up to 1 year

Description: The differences in prevalence of COVID-19 IgG in physician participants that are deemed to be at minimum, moderate or high risk of COVID-19 exposure.

Measure: Physician Risk of Exposure

Time: up to 1 year

Description: The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.

Measure: Physician and Household Member Transmission

Time: up to 1 year

Description: The correlation between IgG prevalence and previous COVID-19 symptoms - a means of quantifying the presence of asymptomatic carriers amongst the medical staff, an important and heretofore poorly described vector of transmission.

Measure: Asymptomatic Infection

Time: 1 year

Description: The correlation between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.

Measure: PPE Use and Positivity

Time: up to 1 year

Description: The development of COVID19 infections in physicians at our hospital over the test period of 12 months, and its correlation to Covid19_IgG positivity. This will allow us to understand the persistence of the antibody and its potential neutralizing power, over time.

Measure: Antibody Persistence

Time: up to 1 year
447 COVID-19-Related Health and Practices Among Dental Hygienists

As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.

NCT04542915
Conditions
  1. SARS-CoV Infection
  2. Anxiety
  3. Depression
  4. Occupational Problems
  5. Severe Acute Respiratory Syndrome
  6. Coronavirus Infection
Interventions
  1. Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: 2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody

Measure: COVID-19 probable or confirmed case

Time: 18 months

Secondary Outcomes

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.

Measure: Anxiety

Time: 12 months

Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.

Measure: Depression

Time: 12 months

Description: Self-reports of infection control efforts in the respondents' primary dental practices.

Measure: Dental practice infection control efforts

Time: 12 months

Description: Availability, frequency of use, and frequency of reuse of personal protective equipment

Measure: Personal protective equipment

Time: 12 months

Description: Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment.

Measure: Employment status

Time: 12 months
448 Can SARS-CoV-2 Viral Shedding in COVID-19 Disease be Reduced by Resveratrol-assisted Zinc Ingestion, a Direct Inhibitor of SARS-CoV-2-RNA Polymerase? A Single Blinded Phase II Protocol (Reszinate Trial)

Administration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting

NCT04542993
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Dietary Supplement: Zinc Picolinate
  2. Dietary Supplement: Resveratrol
  3. Dietary Supplement: Zinc Picolinate Placebo
  4. Dietary Supplement: Resveratrol Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Viral AUCs normalized to peak viral load and housekeeper genes will be calculated, the AUCs on subjects with complete data will be used as dependent measures in t-tests, regressions and repeated measures mixed ANOVAs to compare viral load reduction between groups

Measure: Reduction in SARS-CoV-2 Viral load

Time: 1 year

Description: Review of healthcare resource utilization during study period

Measure: Reduction in Severity of COVID-19 Disease

Time: 1 year
449 A Prospective Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards of a Tertiary University Hospital During the COVID-19 Pandemic

In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.

NCT04544072
Conditions
  1. SARS-CoV Infection
  2. Antimicrobial Stewardship
  3. Respiratory Tract Infections
  4. Antibiotic Resistance
MeSH:Infection Communicable Diseases Respiratory Tract Infections Superinfection Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'.

Time: 7 months

Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'.

Time: 7 months

Description: The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'.

Time: 7 months

Description: The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'.

Time: 7 months

Secondary Outcomes

Description: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/1000 patient days, DDD or DDA of unnecessary AB/1000 patient days, DDD or DDA of inappropriate AB/1000 patient days and DDD or DDA of suboptimal AB/1000 patient days. Used units: g/1000 hospitalized patients days

Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection

Time: 7 months

Description: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/hospitalization, DDD or DDA of unnecessary AB/hospitalization, DDD or DDA of inappropriate AB/hospitalization and DDD or DDA of suboptimal AB/hospitalization. Used units: g/hospitalization

Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2

Time: 7 months

Description: The number of C. Difficile infections in the inpatient setting

Measure: Rate of Clostridioides Difficile infections

Time: 7 months

Description: median or mean age (number) , comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: median or mean weight (kg), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of comorbidities expressed as mean Charlson Comorbidity Index score, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of chronical pulmonary disease, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in rate of chronical pulmonary disease as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of haematological or solid neoplasia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in rate of haematological or solid neoplasia as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of diabetes mellitus, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in rate of diabetes mellitus as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients with fever (t°>38°c), dyspnea, cough, runny nose, throat pain, thoracic pain, myalgia, fatigue, anosmia, confusion at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: significant difference in rate of patients with presence or not of at least one suggestive symptom of COVID-19 symptomatology, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients rate of patients having received an antibiotic prescription for a suspicion of respiratory tract infection during the 3 weeks before hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics?

Measure: significant difference in rate of patients with recent AB prescription, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients with significant positive respiratory cultures, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the rate of patients having had at least one positive significant respiratory germ culture, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of patients with oxygen suppletion need, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the rate of patients needing oxygen supletion at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean duration of hospitalization on a COVID-ward, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: significant difference in the mean duration of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: significant difference in the rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean SatO2/FiO2 ratio (number ranging from 50-500), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the mean value of oxygen saturation percentage over fractional oxygen percentage, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean/median qSOFA score at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in qSOFA score level at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: Rate of lymphopenia (<1250/mcl), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Measure: Is there a significant difference in the rate of lymphopenia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean CRP values (mg/dl) at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of C-reactive protein measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean WBC count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of white blood cell count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean neutrophil count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of neutrophil count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean lymphocyte count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics

Measure: significant difference in the mean value of lymphocyte count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean creatinine (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of creatinine measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean LDH (U/L) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of LDH measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean bilirubin (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of bilirubin measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean ferritin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of ferritin (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean troponin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of troponins (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months

Description: mean D-dimer (ng/ml) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

Measure: significant difference in the mean value of D-dimers (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

Time: 7 months
450 Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit

In this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric "adult COVID-19" intensive care unit.

NCT04544878
Conditions
  1. Covid19
  2. Pediatric ALL
  3. Infection
  4. Critical Illness
  5. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Description: Secondary infection will include healthcare associated infections as well as sepsis, and septic shock

Measure: Number of patient with secondary infection

Time: 2 weeks

Secondary Outcomes

Description: mortality

Measure: Number of patients dying

Time: 7-day, 28-day and 60-day

Description: Description of the variable clinical phenotypes of COVID-19 in adults and children. This include COVID-19 respiratory failure, acute myocarditis and multi system inflammatory syndrome in children (MIS-C)

Measure: Description of clinical phenotypes

Time: through study completion, an average of 4 weeks

Description: Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex

Measure: Description of immunological phenotypes

Time: through study completion, an average of 4 weeks
451 An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19

This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.

NCT04546581
Conditions
  1. COVID
  2. COVID-19
  3. SARS-CoV-2
  4. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Drug: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
  2. Other: Placebo
  3. Drug: Remdesivir
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary objective is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories: 7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19 Outcome is reported as the percent of participants in each of 7 categories.

Measure: Ordinal Outcome Scale - Day 7

Time: 7 days

Secondary Outcomes

Description: Outcome reported as the percent of participants who expire for any reason by day 28 post treatment.

Measure: All-cause mortality through Day 28

Time: 28 days

Description: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 14, and 28 of follow-up using the primary ordinal outcome. Outcome is reported as the percent of participants in each of 7 categories.

Measure: Ordinal Outcome Scale

Time: 3 days, 5 days, 14 days, and 28 days

Description: The National Early Warning Score (NEWS) is used to determine the degree of illness of a patient and prompt critical care intervention. The score takes into account respiratory rate, oxygen saturation, use of respiratory support, body temperature, blood pressure, and heart rate. These data are entered into a program to calculate a NEW score. Scores range from -3 to +3 with scores closer to zero representing a lower degree of illness. Scores will be collected at baseline and day 7 and the change in score at these 2 time points will be reported.

Measure: Change in National Early Warning Score (NEWS)

Time: 7 days

Description: Time to worsening is defined as the 3 least favorable categories on the primary ordinal scale. Outcome is reported as the percent of participants in each arm who are characterized as categories 5, 6, and 7 on the primary ordinal scale at 7, 14, and 28 days post treatment.

Measure: Time to Worsening

Time: 7 days, 14 days, and 28 days

Description: Outcome is reported as the percent of participants in each arm who are alive and discharged from the hospital to home or rehabilitation at days 7, 14, and 28 post treatment.

Measure: Discharge Status

Time: 7 days, 14 days, and 28 days

Description: Outcome is reported as the mean number of days alive and outside the hospital from study entry to Day 28 for participants in each arm.

Measure: Days Alive Outside the Hospital

Time: 28 days

Description: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 7, 14, and 28 post treatment limited to using the pulmonary elements of the primary ordinal outcome (e.g., requirement for invasive ventilation). Outcome is reported as the percent of participants in each arm who fall into each of the 7 categories of the primary ordinal outcome with regard to their pulmonary dysfunction only.

Measure: Pulmonary-only Components of the Primary Ordinal Outcome

Time: 3 days, 5 days, 7 days, 14 days, and 28 days

Description: A secondary outcome is to compare the clinical status of patients in each group on day 3, 5, 7, 14, and 28 post treatment limited to using the thrombotic conditions (e.g., arterial thrombosis) in the primary ordinal outcome. Outcome is reported as the percent of participants in each arm who fall in each of the 7 categories of the primary ordinal outcome with regard to thrombotic conditions only.

Measure: Thrombotic Components of the Primary Ordinal Outcome

Time: 3 days, 5 days, 7 days, 14 days, and 28 days

Description: Time to recovery is defined as the 2 most favorable categories on the primary ordinal scale. Outcome is reported as the percent of participants in each arm who are characterized as categories 1 or 2 at 7, 14, and 28 days post treatment.

Measure: Time to recovery

Time: 7 days, 14 days, and 28 days

Description: Clinical organ dysfunction is defined by new onset of any one or more of the following. Outcome is reported as the percent of participants in each arm who meet any 1 of the following criteria by day 28 post treatment. A) Respiratory dysfunction B) Cardiac and vascular dysfunction C) Renal dysfunction D) Hepatic dysfunction E) Neurological dysfunction F) Haematological dysfunction G) Serious infection

Measure: Clinical Organ Dysfunction

Time: 28 days

Description: Outcome is reported as the percent of participants in each arm who experience a new grade 3 or 4 event, a serious adverse event (SAE), or death through day 7 (primary safety endpoint) post treatment.

Measure: Safety and Tolerability - Adverse Events

Time: 7 days

Description: Outcome is reported as the percent of participants in each arm for who had any grade of reaction during the infusion or within 2 hours afterwards, for whom the infusion is interrupted prior to completion, or for whom the infusion is stopped prior to completion.

Measure: Safety and Tolerability - Infusion Reactions, Interruptions, or Cessation

Time: approximately 2 hours

Description: Outcome is reported as the percent of participants in each arm who experience a serious adverse event (SAE) or death through day 28 post treatment.

Measure: Safety and Tolerability - Serious Adverse Events

Time: 28 days

Description: Outcome is reported as the percent of participants in each arm who experience an adverse event (AE) of any grade present (new or continuing) on days 1, 3, 7, and 28 post treatment.

Measure: Safety and Tolerability - Prevalence of Adverse Events

Time: 1 day, 3 days, 7 days, and 28 days

Description: Outcome reported as the change in anti-SARS-CoV-2 IgG antibody level in blood from baseline to 1, 3, 7, and 28 days post treatment. Outcome is reported in units of antibody titer.

Measure: Change in Neutralizing Antibody Level

Time: 1 day, 3 days, 7 days, and 28 days
452 Prevalence and Persistence of SARS-CoV-2 in Stool of COVID-19 Positive Subjects

This is a longitudinal study in which participants that have been confirmed by a National Health Service (NHS) swab test as COVID-19 positive will be asked to provide faecal and saliva samples, and complete short health/lifestyle questionnaires at the time of sampling (referred to as a sample set). The number of sample sets collected from any participant will be dependent on how long the SARS-CoV-2 virus persists within the stool. The investigators aim to collect a minimum of 4 and a maximum of 8 sample sets, and will target all COVID-19-positive subjects, with the exception of those severally ill (e.g. in the intensive care unit (ICU)). The investigators aim to recruit a minimum of 100 and up to 200 participants. To obtain the desired numbers, it may be necessary to continue recruitment during any further United Kingdom (UK) COVID-19 infection peaks.

NCT04546776
Conditions
  1. SARS-CoV Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To verify the prevalence and persistence (starting from symptom onset/diagnosis, and up to seven weeks after recovery) of the SARS-CoV-2 virus in the faeces of people diagnosed with COVID-19 infection.

Measure: Prevalence and persistence of the SARS-CoV-2 virus in the faeces, and change in associated health status

Time: Weekly for a maximum of 8 weeks

Secondary Outcomes

Description: To use whole-genome sequencing (WGS) to type COVID-19 at the strain level to verify whether different viral strains have a different persistence in stool across participants

Measure: Viral strain-specific prevalence, associated with change in health status

Time: Weekly for a maximum of 8 weeks

Description: To use whole-genome sequencing (WGS) to type COVID-19 at the strain level to verify whether the viral strain(s) found in the gastrointestinal tract are identical to those found in the respiratory tract of participants

Measure: Biogeographical viral strain identification, associated with change in health status

Time: Weekly for a maximum of 8 weeks

Description: To create a repository of material (faeces and saliva) and associated data that will be used to understand the association between gastrointestinal health and SARS-CoV-2 infection in future research.

Measure: Create a SARS-CoV-2 biological sample repository

Time: Through study completion, up to two years
453 Recovery of Exertion Ability Following COVID-19 Infection in Military Staff

The Paris Fire Brigade staff have been particularly exposed to COVID-19 due to rescue and care activities for victims at risk in Paris area (where the virus was actively circulating). In addition, when the pandemic began in France, they had to take care of patients before procedures to protect caregivers were implemented. The contamination of young military personnel, whose physical capacity was put into strain at work, raises the question of the consequences of COVID-19 on their physical fitness. At the time, the medium- and long-term evolution of this disease and its possible repercussions on physical fitness are unknown. Moreover, like any soldiers who have been confined, they may present at least a cardio-respiratory deconditioning (sometimes independent of the disease making it difficult to distinguish between a sequelae of the infection or rehabilitation). Based on previous coronavirus epidemics (Sars-Cov 1 and Mers-Cov), it appears that long-term sequelae are possible even in mild forms and can result in an alteration of exertion ability. In the current context and in the absence of national or international recommendations on the return to physical activity, the French Armed Forces Health Service has proposed a simple management plan aiming at: i) allowing mass screening for possible exercise intolerance and targeting at-risk personnel, ii) allowing individualized re-training and iii) guaranteeing that military personnel can carry out their mission without jeopardizing their health.

NCT04548505
Conditions
  1. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Aerobic performance will be assessed through a test called VAMEVAL. VAMEVAL consists of running around a track marked out every 50 meters to the rhythm of a soundtrack that accelerates at a rate of 0.5 km/h in 2-minute increments until exhaustion or inability to maintain the pace of the race. The result of the test made on return to work will be compared to the last result on the same test performed before COVID-19 infection.

Measure: Magnitude of the decrease in aerobic performance on return to work

Time: Up to 18 months
454 Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19.

Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.). Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media. In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal. An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.

NCT04550390
Conditions
  1. SARS-CoV Infection
Interventions
  1. Diagnostic Test: Saliva collection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.

Measure: Qualitative result of molecular tests for the SARS-CoV-2 virus.

Time: At enrollment (day 1)
455 A Cluster Randomised Trial of Interferon Versus Standard of Care in the Reduction of Transmission of SARS-Cov-2. The Containing Coronavirus Disease 19 Trial (ConCorD-19)

In recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Mandatory quarantines have also been applied on index cases and their contacts, as well as an active search for asymptomatic patients. Current strategies to reduce the spread of SARS-CoV-2 do not include measures that could prevent transmission prior to the onset of symptoms. Subjects infected with SARS-CoV-2 have been known to shed virus and be contagious for up to 5 days prior to developing symptoms ('pre-symptomatic transmission'). In fact, nearly 60% of all infected subjects can shed virus pre-symptomatically. Pre- or even asymptomatic shedding occurs across all age groups, contributing to the rapidly expanding pandemic. Post-exposure prophylaxis (PEP) using type 1 interferon (IFN) can potentially eliminate the spread of SARS-CoV-2. IFN could reduce the period of viral shedding by ~1 week. Since pre-symptomatic shedding of virus can start up to 5 days prior to symptom onset, our approach of a PEP intervention to all contacts recently exposed to a case could possibly entirely interrupt the spread of the virus, and with that, the pandemic. The current study focuses on prevention of the disease in addition to its treatment. Thus, the key distinction between these other trials and this study is that this study focuses on containing coronavirus (i.e. cause) in the community, rather than simply its treatment (i.e. consequence) in the individual. Viral spread could be eliminated through interventions effective at abolishing viral transmission. However, such post-exposure prophylaxis interventions, that is initiation of antiviral therapy in pre-infectious contacts to reduce or even eliminate such spread, must be safe since they are given to asymptomatic and possibly uninfected subjects. In none of the previous clinical trials of IFN therapy for SARS-CoV-2 have serious adverse events been recorded. Furthermore, the IFN chosen for this study (pegylated IFN 1b) has been extensively studied in clinical trials, and has been in clinical use for years for multiple sclerosis. Pegylated IFN formulations allow for weekly injections while maintaining serum levels and limiting dose-dependent side effects. Together these data support a sound safety profile for the planned intervention. The aim of this study is to ascertain whether IFN administered to index cases and household contacts of an index case, starting immediately following confirmed exposure (index case confirmed positive for SARS-CoV-2), will reduce duration of SARS-CoV-2 detectable by PCR in the index cases, and incidence of SARS-CoV-2 detectable by PCR in household contacts.

NCT04552379
Conditions
  1. SARS-CoV Infection
  2. Interferon
  3. Covid19
Interventions
  1. Biological: Peginterferon beta-1a
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: The proportion of index cases shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.

Time: Day 11

Measure: The proportion of household contacts shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.

Time: Day 11

Secondary Outcomes

Measure: Duration (in days) of SARS-CoV-2 by PCR of samples taken on study days 1, 6, 11, 16, 21, and 29.

Time: Days 1,6,11, 21 and 29

Measure: Number of household contacts of participants in the IFN arm with positive upper airway PCR compared to that in the standard of care arm at day 1 & 11, and seroconversion (Ig) over the study period, up to day 29.

Time: Days 1,11 and 29

Measure: The proportion of infected cases in the active arm that are hospitalised or die due to COVID-19, as compared to the proportion in the standard of care arm.

Time: Days 1 to 29

Measure: Incidence and severity of reported adverse events in the interferon arm compared to the standard of care arm.

Time: Days 1 to 29
456 Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020

Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up. Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research) Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients. Material and methods: Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022 Expected results: Better knowledge of the cares of patients with CoViD-19

NCT04553575
Conditions
  1. Coronavirus Infections
Interventions
  1. Biological: serology
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: status : dead or alive persistante respiratory distress (yes / no)

Measure: Health status in the 2 years after CoViD-19 diagnosis

Time: 2 years follow up
457 SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

NCT04556149
Conditions
  1. Corona Virus Infection
  2. Coronavirus
Interventions
  1. Device: imPulse™ Una e-stethoscope
  2. Device: Philips Lumify Ultrasound System
MeSH:Cor Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.

Measure: Diagnostic performance characteristics

Time: through study completion, an average of 2 weeks
458 COVID-19 and Lactating Mothers

The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.

NCT04558320
Conditions
  1. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: RNA will be extracted from all sample types and SARS-CoV-2 primers used to amplify any present viral RNA using real-time qPCR. Repeated measures analysis will be used to compare the changes in sample viral load over time between women with mild to severe symptoms.

Measure: mean change in SARS-Cov-2 viral load in breast milk

Time: baseline, days 3, 10, 19, 28 and 90
459 A Multicenter Randomized Trial to Assess the Efficacy of CONvalescent Plasma Therapy in Patients With Invasive COVID-19 and Acute Respiratory Failure Treated With Mechanical Ventilation: the CONFIDENT Trial

The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.

NCT04558476
Conditions
  1. Covid19
  2. Mechanical Ventilation Complication
  3. Corona Virus Infection
  4. Respiratory Failure
  5. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Biological: Convalescent Plasma
  2. Other: Standard of Care
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Insufficiency

Primary Outcomes

Description: dead or alive

Measure: Vital status

Time: at day 28

Secondary Outcomes

Description: dead or alive

Measure: day 90 mortality

Time: at day 90

Description: to assess the ventilator free days

Measure: number of ventilator-free days at day 28

Time: at day 28

Description: to assess the number of renal replacement therapy free days

Measure: number of renal replacement therapy free days at day 28

Time: at day 28

Description: to assess the number of vasopressors free-days

Measure: number of vasopressors free-days at day 28

Time: at day 28

Description: to assess if ECMO was required

Measure: use of ECMO before day 28

Time: till day 28

Description: to assess the value of SOFA score

Measure: value of the SOFA score at days 7, 14 and 28

Time: Day 1, 7, 14, 28

Description: to assess the changes in SOFA scores (delta SOFA)

Measure: changes in SOFA scores (delta SOFA) over 7, 14 and 28 days

Time: Day 7, 14 and 28 days

Description: assessment of the SARS-CoV-2 viral load, expressed as cycle threshold, [2] in the tracheal aspirates (for intubated patients) or nasopharyngeal swabs (for extubated patients) at days 7, 14 and 28

Measure: assessment of the SARS-CoV-2 viral load

Time: Days 7, 14 and 28

Description: to assess the concentrations of C reactive protein (CRP)

Measure: blood C reactive protein (CRP) concentration

Time: Days 7, 14 and 28

Description: to assess the concentration of ferritin

Measure: ferritin concentration

Time: Days 7, 14 and 28

Description: to assess the count of lymphocyte

Measure: lymphocyte count

Time: Days 7, 14 and 28

Description: to assess the lenght of stay in the acute care

Measure: length of stay in the acute care hospital

Time: through study completion, 1 year

Description: to assess the location of the patient : acute care hospital, post acute care hospital, long-term residency, home

Measure: location of the patient

Time: Day 90

Description: to assess the Activity Day Living functional Min value: 0 = Low (patient very dependent) Max value: 6 = High (patient independent)

Measure: Katz Index of independence in Activity Day Living functional score

Time: Day 90 and 365

Description: to evaluate the anxiety-depression For each item 0-7 : Normal 8-10 : Bordeline abnormal (borderline case) 11-21 : Abnormal case

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: Day 90 and 365

Description: The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.

Measure: Quality of life scale EQ-5D-5L

Time: Day 90 and 365

Description: to assess the transfusion related adverse events

Measure: Transfusion related adverse events

Time: till 28 days
460 Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial

In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS. Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials

NCT04559113
Conditions
  1. SARS-CoV Infection
  2. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Drug: Methylprednisolone Injectable Product
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Clinical improvement of COVID-19 patients by methylprednisolone.

Measure: Clinical response after administration

Time: 10 days

Secondary Outcomes

Description: Overall survival of COVID-19 patients after drug administration.

Measure: Clinical response to treatment

Time: 28 days

Description: Number of days of hospital admission either in ICU or HDUs till date of discharge

Measure: Duration of hospitalization

Time: 28 days
461 Tocilizumab: A Therapeutic Cache Against the Treatment of Severe Cases of COVID-19

The most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.

NCT04560205
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Tocilizumab
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.

Measure: Clinical response after administration

Time: 10 days

Secondary Outcomes

Description: Overall survival of COVID-19 patients after drug administration.

Measure: Clinical response to treatment

Time: 15 days

Description: Number of days of hospital admission either in ICU or HDUs till date of discharge

Measure: Duration of hospitalization

Time: 15 days

Description: Mortality rate

Measure: Clinical outcome of the treatment

Time: 15 days

Description: Duration of increased supplemental oxygen requirement from baseline

Measure: Supplemental Oxygen Requirement from Baseline

Time: 15 days
462 Is Remdesivir a Possible Therapeutic Option for SARS-CoV-2 : An Interventional Study

Remdesivir is a monophosphoramidate prodrug of an adenosine analogue and it has a broad-spectrum antiviral activity against paramyxoviruses, falviviruses and coronaviruses. It showed in vitro activity on human airway epithelial cells against SARS-CoV-2. It is an investigational drug and granted an Emergency Use Authorization by Food and Drug Administration FDA, so it is under clinical trial. The potent mechanism of action of this drug is still unclear but it effects through several processes. It can interfere with nsp12 polymerase even when exoribonuclease proofreading is intact. It can also produce nucleoside triphosphate NTP that acts pharmacologically active alternate substrate of RNA-chain terminator, as a result NTP can constrain active triphosphates into viral RNA of coronaviruses. There is evidence of high genetic barrier to develop resistance against Remdesivir in coronavirus as a result of which is maintains its effectiveness in antiviral therapies against these viruses. Effectiveness of Remdesivir has been reported against different groups of coronaviruses including Alphacoronavirus NL63 and several SARS/MERS-CoV coronaviruses.

NCT04560231
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: Remdesivir
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement of COVID-19 patients by Remdesivir.

Measure: Clinical response after administration

Time: 10 days

Secondary Outcomes

Description: Overall survival of COVID-19 patients after drug administration.

Measure: Clinical response to treatment

Time: 15 days

Description: Number of days of hospital admission either in ICU or HDUs till date of discharge

Measure: Duration of hospitalization

Time: 15 days

Description: Duration of increased supplemental oxygen requirement from baseline

Measure: Supplemental Oxygen Requirement from Baseline

Time: 15 days
463 Prone Positioning and High Flow Nasal Canula (HFNC) Therapy: A Game Changer in COVID-19 Outcome

Many non-invasive ventilatory choices are available for COVID-19 patient who are having mild to moderate respiratory distress and their use will decrease the chance of ICU admission, intubation and mechanical ventilation in severe cases of COVID-19. However, all these respiratory supports and oxygen supply devices are aerosol generating and their selection should be precised enough to control nosocomial spread. High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen. In acute respiratory failure HFNC is proven to be very effective and it also reduced the need of mechanical ventilation in severe patients. Apart from the supply of oxygen, HFNC generating positive airway pressure and decreasing the rebreathing from anatomical dead space. Prone position is also a save therapy and has been proven to be effective for refractory hypoxia by increasing tidal volume, oxygenation and diaphragmatic functions in ARDS patients. Recent studies showed that prone positioning and HFNC might avoid the prerequisite of intubation in moderate to severe patients of ARDS and as a result it decreases the nosocomial infection in physicians who are doing these aerosol generating procedures.

NCT04560257
Conditions
  1. SARS-CoV Infection
  2. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Device: High flow nasal cannula HFNC
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The number of patients treated with non-invasive ventilation devices. HFNC related events (hot air feeling, nasal lesions)

Measure: Clinical response of HFNC

Time: 10 days

Secondary Outcomes

Description: Length of HFNC therapy to COVID-19 patients

Measure: Duration of intervention

Time: 15 days

Description: Number of days of hospital admission either in ICU or HDUs till date of discharge

Measure: Duration of hospitalization

Time: 15 days

Description: Duration of increased supplemental oxygen requirement from baseline

Measure: Supplemental Oxygen Requirement from Baseline

Time: 15 days

Description: Follow up radiological response HR-CT.

Measure: Radiological outcome

Time: 15 days
464 A Multi-center, Randomised, Open Label Study of Nitazoxanide (NTZ), or Sofosbuvir and Daclatasvir (SOF/DCV), Compared to no Pharmacological Intervention for the Prevention of COVID-19 Disease in Healthcare Workers at High Risk of Exposure to SARS-CoV-2

This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.

NCT04561063
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Sofosbuvir/Daclatasvir
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology.

Measure: Number of SARS-CoV-2 infections

Time: 6 months

Secondary Outcomes

Description: Duration of symptoms for each symptomatic infection

Measure: Duration of symptoms

Time: 6 months

Description: Maximum score on WHO Ordinal Scale for Clinical Improvement for each symptomatic infection. Score of 0 being uninfected and a score of 8 being dead.

Measure: Maximum score on WHO Ordinal Scale

Time: 6 months

Description: Time to onset of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology

Measure: Time to onset of SARS-CoV-2 infection

Time: 6 months

Description: Number of symptomatic SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology

Measure: Number of symptomatic SARS-CoV-2 infections

Time: 6 months

Description: Number of asymptomatic • Asymptomatic SARS-CoV-2 infection suggested by serological outcome

Measure: Number of asymptomatic SARS-CoV-2 infections

Time: 6 months

Description: Peak score on modified Flu-PRO during each symptomatic infection. 37-item questionairre assessing the severity of flu like symptoms one a scale of 0 - not at all to 5 - very much.

Measure: Peak score on modified Flu PRO

Time: 6 months
465 Nitazoxanide for Moderate to Severe COVID-19 Pneumonia: a Multicenter, Randomized, Placebo-controlled, Double-Blind Clinical Trial

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.

NCT04561219
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Pneumonia, Viral
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Compare the intubation rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by percentage.

Measure: Orotracheal intubation rate

Time: 14 days

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed free of mechanical ventilation, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Mechanical ventilation free days

Time: 14 days

Secondary Outcomes

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the hospital, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Hospitalisation days

Time: 14 days

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the ICU, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: ICU days

Time: 14 days

Description: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed with the support of oxygen nasal cannula, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Intranasal oxygen support days

Time: 14 days

Description: Compare the mortality rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 14 days; verified by clinical evolution; quantified by absolute number.

Measure: Mortality rate

Time: 14 days

Description: Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.

Measure: Days with fever

Time: 14 days

Description: Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.

Measure: Days with cough

Time: 14 days

Description: Reduction in the duration of dyspnea of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.

Measure: Days with dyspnea

Time: 14 days

Description: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.

Measure: Radiologic findings

Time: Day1

Description: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.

Measure: Radiologic findings

Time: Day7

Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.

Measure: Cardiologic findings

Time: Day1

Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.

Measure: Cardiologic findings

Time: Day7

Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: C-reactive protein - absolute number

Time: Day 1

Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: C-reactive protein serum levels

Time: Day 3

Description: To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: C-reactive protein serum levels

Time: Day 7

Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Lactate dehydrogenase (LDH) serum levels

Time: Day 1

Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Lactate dehydrogenase (LDH) serum levels

Time: Day 3

Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Lactate dehydrogenase (LDH) serum levels

Time: Day 7

Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Troponin serum levels

Time: Day 1

Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Troponin serum levels

Time: Day 3

Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Troponin serum levels

Time: Day 7

Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Electrolytes serum levels

Time: Day 1

Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Electrolytes serum levels

Time: Day 3

Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Electrolytes serum levels

Time: Day 7

Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Glucose serum levels

Time: Day 1

Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Glucose serum levels

Time: Day 3

Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Glucose serum levels

Time: Day 7

Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Renal function

Time: Day 1

Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Renal function

Time: Day 3

Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Renal function

Time: Day 7

Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Coagulogram

Time: Day 1

Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Coagulogram

Time: Day 3

Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Coagulogram

Time: Day 7

Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Liver function panel

Time: Day 1

Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Liver function panel

Time: Day 3

Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Liver function panel

Time: Day 7

Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Ferritin

Time: Day 1

Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Ferritin

Time: Day 3

Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Ferritin

Time: Day 7

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: D-dimer

Time: Day 1

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: D-dimer

Time: Day 3

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: D-dimer

Time: Day 7

Description: To evaluate blood cell count of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, for 7 days; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Blood cell count

Time: 7 days

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Inflammatory mediators

Time: Day 1

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Inflammatory mediators

Time: Day 3

Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.

Measure: Inflammatory mediators

Time: Day 7

Other Outcomes

Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage.

Measure: Adverse events - percentage

Time: Day 14

Description: Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by absolute number.

Measure: Adverse events - absolute number

Time: Day 14

Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.

Measure: Treatment discontinuation rate - absolute number

Time: Day 14

Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.

Measure: Treatment discontinuation rate - percentage

Time: Day 14
466 A Randomized, Double-Blind, Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Ribavirin (RBV) and Nitazoxamide (NTZ)Versus Placebo in SARS-CoV-2 Virus Infected Participants (DuACT)

This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 48 hours prior to testing.

NCT04563208
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: Placebo
  2. Drug: DuACT
MeSH:Coronavirus Infections Severe A Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of decline in viral load over the 10 days after randomization between participants treated with RBV and NTZ for COVID-19 and placebo

Measure: Rate of decline in viral load

Time: 10 days

Secondary Outcomes

Description: Time to resolution of viral load, defined by reduction of virus below LLOQ and maintaining it for 2 days.

Measure: Time to resolution of viral load

Time: 28 days

Description: Comparison of proportion of subjects who are asymptomatic and symptomatic at day 10

Measure: Comparison of proportion of subjects who are asymptomatic and symptomatic

Time: 10 days

Description: To assess the rate of decline in viral load over days 3 and 6 after randomization

Measure: Rate of decline in viral load

Time: Days 3 and 6

Description: Assess change in modified National Early Warning System-2 items on a scale of 0 to 20. HIgher scores meaning greater clinical risk.

Measure: Change in modified NEWS-2

Time: 28 days

Description: Proportion of subjects with treatment emergent adverse events leading to study drug discontinuation

Measure: Proportion of subjects with treatment emergent adverse events

Time: 28 days
467 Convalescent Plasma for Passive Immunization in COVID-19 ICU Patients: An Interventional Study

Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms

NCT04565197
Conditions
  1. SARS-CoV Infection
Interventions
  1. Biological: convalescent plasma
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical Improvement of COVID-19 patients by giving them passive immunization

Measure: clinical outcome after plasma therapy

Time: 10 days

Secondary Outcomes

Description: Overall survival of COVID-19 patients after plasma administration.

Measure: Clinical response to treatment

Time: 10 days
468 Corona Virus Infection Among Liver Transplant Recipients: A Multicenter Study

A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020. The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on. Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic. Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm. Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2. The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia. They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases. Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization. Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.

NCT04565782
Conditions
  1. SARS-CoV Infection
  2. Corona Virus Infection
  3. Liver Transplant Recipient
  4. COVID-19
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: The occurrence of corona virus infection (confirmed or suspected) among liver transplant recipients

Time: 1 month

Secondary Outcomes

Measure: The presence of Neutralizing Ab against SARS-Corona virus 2 among liver transplant recipients whether who give symptoms for corona virus or asymptomatic and who accept to give blood sample

Time: 2 month
469 Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that we determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. We have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), we will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; we will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.

NCT04566965
Conditions
  1. Covid19
  2. Coronavirus
  3. SARS-CoV Infection
Interventions
  1. Diagnostic Test: SARS-CoV-2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR.

Measure: The 12-month cumulative incidence of acquired COVID infection in the study cohort.

Time: Weekly for 12 months
470 A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single -Ascending and Multiple Doses of an Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY)

The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants. The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.

NCT04567810
Conditions
  1. Covid19
Interventions
  1. Drug: anti-SARS-CoV-2 IgY
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of participants with treatment-related adverse events

Time: up to 21 days

Secondary Outcomes

Measure: Number of Participants With Vital Sign Findings Reported as TEAEs

Time: up to 21 days

Description: Clinically significant in the judgement of the investigator.

Measure: Number of Participants With Clinically Significant Findings in Physical Examinations

Time: up to 21 days

Description: Clinically significant in the judgement of the investigator.

Measure: Number of Participants With Clinically Significant Changes From Baseline in ECG Data

Time: up to 21 days

Description: Clinically significant in the judgement of the investigator.

Measure: Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

Time: up to 21 days

Measure: Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY

Time: up to 21 days
471 A Phase II, Single-center, Double-blind, Randomized Placebo-controlled Trial to Explore the Efficacy and Safety of Intravenous Melatonin in Patients With COVID-19 Admitted to the Intensive Care Unit (MelCOVID Study)

There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.

NCT04568863
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Coronavirus Infection
Interventions
  1. Drug: Melatonin intravenous
  2. Drug: Placebo intravenous
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Mortality in each study group represented in frequency and time-to-event at day 28 after randomization

Measure: Mortality

Time: one month
472 Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)

To assess the safety and tolerability of inhaled molgramostim nebuliser solution in patients with COVID-19 pneumonia.

NCT04569877
Conditions
  1. Severe Acute Respiratory Syndrome (SARS) Pneumonia
  2. COVID-19 Pneumonia
Interventions
  1. Drug: Molgramostim nebuliser solution
  2. Other: Placebo nebuliser solution
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Need for mechanical ventilation within 15 days after randomization

Measure: Mechanical ventilation

Time: During 15 days

Secondary Outcomes

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

Measure: Clinical status of subject at day 15 and day 29 (on a 7-point ordinal scale):

Time: At day 15 and day 29

Description: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] will be measured at day 0 (day before first dose), day 1-9, and day 15

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: At day 0 (day before first dose), day 1-9, and day 15

Description: Need for oxygen supply (l/min) to reach peripheral oxygen saturation of 98%

Measure: Oxygen supply

Time: At day 0, day 1-7, day 8-9 (24 hours/48 hours post dose) and day 15

Description: Clinical parameter (4 times daily): temperature (°C degree)

Measure: Clinical parameter: temperature

Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15

Description: Clinical parameter (4 times daily): blood pressure (mmHg)

Measure: Clinical parameter: blood pressure

Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15

Description: Clinical parameter (4 times daily): hear beat (beats per minute)

Measure: Clinical parameter: heart beat

Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15

Description: Clinical parameter (4 times daily): respiratory rate (breaths per minute)

Measure: Clinical parameter: respiratory rate

Time: Max. 48 hours before day 0, at day 0, day 1-7, day 8-9 and day 15

Description: Presence of Severe acute respiratory syndrome coronavirus 2 nucleic acid by PCR test in swabs or tracheal aspirates/bronchoalveolar lavage

Measure: Severe acute respiratory syndrome coronavirus 2 polymerase chain reaction (PCR)

Time: Max. 48 hours before day 0 and at day 8-9

Description: C-reactive protein test measures the amount of C-reactive protein in blood (mg/L)

Measure: Laboratory: C-reactive protein test

Time: At day 0, day 1-7, day 8-9 and day 15

Description: Ferritin test measures the amount of ferritin in the blood (ng/ml)

Measure: Laboratory: ferritin

Time: At day 0, day 1-7, day 8-9 and day 15

Description: Interleukin-6 test (IL-6) measures the amount of IL-6 in the blood (pg/ml)

Measure: Laboratory: Interleukin-6

Time: At day 0, day 1-7, day 8-9 and day 15

Description: Procalcitonin (PCT) test measures the amount of PCT in the blood in (μg/l)

Measure: Laboratory: procalcitonin

Time: At day 0, day 1-7, day 8-9 and day 15

Description: Occurrence of secondary bacterial pneumonia

Measure: Bacterial pneumonia

Time: At day 0, day 1-7, day 8-9 and day 15

Description: Days on vaso-active drugs in a 29-day period

Measure: Vaso-active drugs

Time: At day 29

Description: All-cause mortality

Measure: Mortality

Time: At day 29

Description: GM-CSF levels in serum

Measure: GM-CSF

Time: At day 0 and day 1-7
473 Predicting Favorable Outcomes in Hospitalized Covid-19 Patients

Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours

NCT04570488
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Adverse Event
Interventions
  1. Other: EPIC risk score display
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Reduction in days from first low-risk score to discharge

Measure: Reduction in days from first low-risk score to discharge

Time: 96 Hours

Secondary Outcomes

Description: Reduction in LOS for green patients that have not been in the ICU

Measure: Reduction in length of stay (LOS)

Time: 96 hours

Description: Reduction in GTD vs. LOS for all green patients discharged alive vs all patients discharged alive

Measure: Reduction in GTD vs. LOS

Time: 96 hours

Description: No change in 30 day re-ED presentation or hospital admission rate for cohort

Measure: No change in 30 day re-ED presentation or hospital admission rate for cohort

Time: 96 hours

Other Outcomes

Measure: Re-presentation to ED

Time: 96 hours

Measure: Readmission to hospital

Time: 96 hours

Measure: Mortality

Time: 96 hours

Measure: Postdischarge mortality

Time: 96 hours
474 Prospective, One Center, Four Groups, Open, Comparative, Controlled Study to Explore T Cells Response to SARS COV 2 Peptides by Metabolic Activity Method in Convalesce and Healthy Individuals Versus Antibody Response

The analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations. The purpose of this study is to evaluate the T cells reactivity to SARS COV 2 immunogenic selected peptides by Metabolic Activity Method in convalesce and healthy individuals and to compare it with Antibody response (ELISA) and clinical information

NCT04573348
Conditions
  1. Covid19
  2. Corona Virus Infection
Interventions
  1. Diagnostic Test: Savicell's ImmunoBiopsy™
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: T cells reactivity to SARS COV 2 immunogenic

Measure: Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with test results (MA/ELISA/PCR)

Time: week

Secondary Outcomes

Description: Antibody response (ELISA)

Measure: Prevalence of positive for SARS - COV2 - in healthy donors.

Time: week
475 A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition (START) - Assessment of COVID19 Penetrance in HCW and Non HCW in Kentucky

The co-primary objectives of this study are to: 1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection 2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals

NCT04573634
Conditions
  1. Covid19
  2. SARS-CoV Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test.

Measure: Prevalence of COVID-19

Time: 2 years

Secondary Outcomes

Description: Determine the average time point at which PCR conversion occurs following exposure.

Measure: PCR Conversion in Exposed Individuals

Time: 14 days
476 A Phase I/II Dose-escalation Multi Center Study to Evaluate the Safety of Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in coronaviruS pnEumonia and/or Lymphopenia

This is a phase I/II clinical trial using adoptive cell therapy with NK cells or memory T cells in patients affected by COVID-19. Severe cases with COVID-19 present a dysregulated immune system with T cell lymphopenia, specially NK cells and memory T cells, and a hyper-inflammatory state. This clinical trial proposes the use of cell therapy for the treatment of patients with worse prognosis due to SARS-CoV-2 infection (those with pneumonia and/or lymphopenia). This is an innovative and a non-pharmacological intervention.

NCT04578210
Conditions
  1. Corona Virus Infection
Interventions
  1. Biological: T memory cells and NK cells
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Lymphopenia
HPO:Lymphopenia Pneumonia

Primary Outcomes

Description: Any grade 3 or higher toxicity with an attribution of definitely or probably related to the infusion of the cells and any lower grade toxicity that increases to a grade 3 or higher as a direct result of the cell infusion.

Measure: Occurrence of DLTs in all patients during the study treatment, until 21 days after cell infusion and the MTD

Time: 3 months
477 Prevalence and Outcome of SARS-CoV-2 Infection in Solid Organ and Hematopoietic Cell Transplant Recipients: The COVITRA Study

This project will provide novel data using a large cohort of more than 3000 transplanted patients. Risk and protective factors for SARS-CoV-2 infection and COVID-19 disease severity will be identified. The proportion of patients who develop antibodies after infection will be revealed. In this way the presence of these antibodies can be evaluated as a test for prior infection. Our study additionally will demonstrate how long these antibodies remain present and whether they are protective against a new infection.

NCT04579471
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Transplantation Infection
Interventions
  1. Diagnostic Test: SARS-CoV-2 IgG
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Prevalence and risk-factors for SARS-CoV-2 infection

Measure: Prevalence and risk-factors for SARS-CoV-2 infection

Time: inclusion during 4 months

Description: Prevalence and risk-factors for COVID-19

Measure: Prevalence and risk-factors for COVID-19

Time: inclusion during 4 months

Secondary Outcomes

Description: Durability of IgG positivity/immunity

Measure: Durability of IgG positivity

Time: 12 months
478 Understanding Immunity to the Flu Vaccine in COVID-19 Patients

The purpose of this study is to measure immunity to the flu vaccine over time in patients who had COVID-19. Adults who have been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

NCT04579588
Conditions
  1. Corona Virus Infection
  2. Flu Vaccine
  3. Immunity
Interventions
  1. Biological: Flu shot
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Testing immunity to the flu vaccine over time

Time: 6 months
479 Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance

This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.

NCT04581889
Conditions
  1. Severe Acute Respiratory Syndrome
Interventions
  1. Other: Diagnostic test
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples

Measure: Incidence of SARS-CoV-2 infection in infants, children and adolescents

Time: 12 months

Secondary Outcomes

Description: Change of incidence of SARS-CoV-2 infection in children during 2020/2021

Measure: Incidence of SARS-CoV-2

Time: 12 months

Other Outcomes

Description: SARS-CoV-2 antibodies persistence in peripheral blood and saliva

Measure: SARS-CoV-2 antibody persistence

Time: 12 months

Description: Saliva samples as alternative for the detection of antibodies against SARS-CoV-2

Measure: Antibodies presence in saliva samples

Time: 18 months
480 Efficacy of Nicotine in Preventing COVID-19 Infection in Caregivers

The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. These patients represent a significant infection risk to the medical staff. According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form. Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection, especially in healthcare workers who are at high risk of infection.

NCT04583410
Conditions
  1. Covid19
  2. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Interventions
  1. Drug: Nicotine patch
  2. Drug: Placebo patch
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is the proportion of patients with at least one positive serology between W2 and W19. The time of S19 takes into account a seroconversion delay of 5 weeks in relation to the SARS-CoV2 contamination.

Measure: SARS-COV2 seroconversion between W0 and W19 after randomization

Time: Between week 0 and week 19

Secondary Outcomes

Measure: Proportion of documented symptomatic COVID-19 infection

Time: Week 8, Week16

Description: This is the proportion of patients with at least one positive serology between W2 and W16.

Measure: SARS-COV2 seroconversion

Time: Week 16

Description: Asymptomatic COVID-19 infection is defined as SARS-CoV2 seroconversion at Week 19 without symptoms suggestive of COVID until the end of Week 16 to take in account of the two weeks of incubation period

Measure: Asymptomatic COVID-19 infection proportion at week 14

Time: Week 14

Description: documented infection (positive SARS-CoV2 PCR test and / or suggestive chest CT scan and / or seroconversion) whose first symptoms appeared before W8 and W16 respectively, and requiring hospitalization or home oxygen therapy, or having resulted in death

Measure: Proportion of severe COVID-19 infection

Time: Week 8, Week16

Measure: Number of sick leaves for a COVID-19 infection

Time: Week 16

Measure: Number of days off during sick leaves for a COVID-19 infection

Time: Week 16

Measure: Proportion of AE, SAE

Time: From inclusion and week 25

Measure: Intensity and frequency of nausea, dizziness, feeling of empty head, headache, vomiting

Time: Week 25

Measure: Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination

Time: Week 25

Measure: Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine

Time: Week 25

Measure: Mean score of Desire to smoke defined by French Tobacco Craving scale

Time: Week 25

Measure: Mean score of Withdrawal symptoms scale

Time: Week 25

Measure: Dosage of cotinine in the urine

Time: Week 8 and 25

Measure: Mean score of Fatigue Numeric rating scale

Time: Week 2, week 8, week 16

Measure: Weight

Time: Week 8, week 16, week 25

Measure: Mean score of Hospital anxiety and depression scale

Time: Week 2, week 8, week 16

Measure: Mean score of Insomnia severity scale

Time: Week 2, week 8, week 16

Measure: Positive and negative syndrome scale

Time: Week 2, week 8, week 16
481 Studies on the Differential Expression of Cytokines, Transcriptome and miRNA in the Context of COVID-19 Infection in Egyptian Community

The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.

NCT04583566
Conditions
  1. Corona Virus Infection
Interventions
  1. Genetic: COVID-19 Diagnostic and Assessment Tests
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The investigators will analysis total gene expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole transcriptome will be extracted and processed for analysis (about 25000 genes) using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).

Measure: Differential gene expression profile.

Time: 3 months

Description: The investigators will analysis total miRNA expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole miRNA expression will be extracted and processed for analysis using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).

Measure: Differential miRNA expression profile.

Time: 3 months

Description: This assay will be done on plasma of patients. The investigators will analysis the different cytokine profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using xMAP (Multi-Analyte Profiling) technology & Luminex 200. The obtained data will be analyzed using statistical software to study the different profile between the selected participants. The obtained data will be also correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).

Measure: Multiplex Cytokine assay

Time: 3 months
482 Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.

This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.

NCT04584658
Conditions
  1. Dysphagia
  2. Dysphonia
  3. Subglottic Stenosis
  4. Voice Disorders
  5. Swallowing Disorder
  6. Covid19
  7. SARS (Severe Acute Respiratory Syndrome)
  8. SARS Pneumonia
  9. Quality of Life
  10. SARS-CoV-2 Infection
Interventions
  1. Diagnostic Test: Fibreoptic Endoscopic Evaluation of Swallowing (FEES)
  2. Diagnostic Test: Videofluoroscopy
  3. Other: Dysphagia Handicap Index (DHI)
  4. Other: Voice Symptom Scale (VoiSS)
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Deglutition Disorders Dysphonia Hoarseness Voice Disorders Disease
HPO:Dysphagia Dysphonia Hoarse voice Oral-pharyngeal dysphagia Weak voice

Primary Outcomes

Description: Based on therapy outcome measures from FEES, VoiS

Measure: Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Time: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Secondary Outcomes

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)

Time: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.

Time: t = day 5, day 10, day 14, day 21 - For in-patients only.

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: Relationship between severity of dysphonia and/or dysphagia with grade of ARDS

Time: t = day 0 and 9 months

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: Relationship between severity of dysphonia and/or dysphagia with length of intubation

Time: t = day 0 and 9 months

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation

Time: t = day 0 and 9 months

Description: Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28

Measure: Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months.

Time: t = day 0, 1 month and 9 months.

Description: Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).

Measure: Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months

Time: t = day 0, 1 month and 9 months
483 Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus

Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients aged 18-65 years old. All mouthrinses are commercially available and will be used according to on-label instructions. Patients will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a one minute mouthwash. Saliva samples will be collected from patients at 15 minute intervals thereafter up to an hour (15, 30, 45 and 60 minutes). The samples will be stored and used for real-time reverse transcription polymerase chain reaction (RT-PCR) detection of viral SARS-CoV-2 RNA and viral infectivity assays. Patients will also complete a short-survey on the taste and experience of using the mouthwash. This study involves 480 subject participants and one, 75-90 minute visit.

NCT04584684
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV-2 Infection
Interventions
  1. Drug: 1.5-2% w/v Hydrogen Peroxide
  2. Drug: 0.12% Chlorhexidine Gluconate
  3. Drug: 21% Ethanol plus essential oils
  4. Drug: 1% w/v Povidone-iodide
  5. Drug: 0.075% Cetylpyridinium Chloride
  6. Other: Saline
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 15 Minutes

Time: Baseline, 15 minutes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 30 Minutes

Time: Baseline, 30 Minutes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 45 Minutes

Time: Baseline, 45 Minutes

Description: Determination of qPCR of inactivity of SARS-CoV-2 cellular infectivity in COVID+ patient saliva

Measure: Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 60 Minutes

Time: Baseline, 60 Minutes
484 An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years

The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age

NCT04587219
Conditions
  1. Coronavirus Infection
Interventions
  1. Biological: Gam-COVID-Vac
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days

Time: at days 0, 21, 28, 42

Description: Determination of Number of Participants With Adverse Events

Measure: Number of Participants With Adverse Events

Time: through the whole study, an average of 180 days

Secondary Outcomes

Description: Determination of virus neutralizing antibody titer

Measure: Changing of of virus neutralizing antibody titer

Time: at days 0, 28, 42

Description: Determination of antigen-specific cellular immunity

Measure: Changing of antigen-specific cellular immunity level

Time: Time Frame: at days 0,28
485 An Observational Cohort Study to Determine Late Outcomes and Immunological Responses After Infection With SARS-CoV-2 in Children With and Without Multisystem Inflammatory Syndrome (MIS-C)

The primary objectives of this study are: - To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and - To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.

NCT04588363
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  2. Multisystem Inflammatory Syndrome in Children (MIS-C)
  3. Coronavirus Disease 2019 (COVID-19)
Interventions
  1. Other: SARS-CoV-2 and/or MIS-C Exposure
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).

Measure: Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation

Time: 6 Months Post Illness Presentation (Enrollment)

Secondary Outcomes

Description: Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).

Measure: Proportion of Participants with Coronavirus Disease 2019 (COVID-19)-Related Death after Multisystem Inflammatory Syndrome in Children (MIS-C) at 1 Year Post Illness Presentation

Time: 1 Year Post Illness Presentation (Enrollment)

Description: The occurrence of death in participants regardless of relationship to Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

Measure: All-Cause Mortality

Time: 1 Year Post Illness Presentation (Enrollment)

Description: The occurrence of SARS-CoV-2 related death in participants.

Measure: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality

Time: 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of Participants who require: Hospitalization subsequent to enrollment as an outpatient for SARS-CoV-2/COVID-19 related illness and/or MIS-C, or Rehospitalization after discharge from their initial admission for SARS-CoV-2/COVID-19 related illness and/or MIS-C. Abbreviations: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Disease 2019 (COVID-19) Multisystem Inflammatory Syndrome in Children (MIS-C)

Measure: Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.

Measure: Coagulation Abnormality by D-Dimer Biomarker

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.

Measure: Coagulation Abnormality by Fibrinogen Biomarker

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.

Measure: Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of dysregulation involving the coagulation system by INR laboratory test.

Measure: Coagulation Abnormality by International Normalised Ratio (INR) Biomarker

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).

Measure: Coronary Artery Abnormalities

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.

Measure: Pulmonary Hypertension

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of cardiovascular system dysregulation by BNP laboratory test.

Measure: Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of cardiovascular system dysregulation by Troponin I laboratory test.

Measure: Cardiovascular System Dysregulation by Troponin I Biomarker

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of cardiac function by echocardiogram (Echo), a test that uses high frequency sound waves (ultrasound) to make pictures of the heart. The test is also referred to as a diagnostic cardiac ultrasound.

Measure: Cardiovascular System Dysregulation by Echocardiogram

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of cardiovascular system dysregulation(s) evaluated by standardized 12-lead electrocardiogram. ECG rhythms, intervals and voltages will be assessed. Cross reference: ECG and EKG are used interchangeably.

Measure: Cardiovascular System Dysregulation by Electrocardiogram (ECG)

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.

Measure: Pulmonary Abnormalities

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization by pulmonary function tests (spirometry without bronchodilators).

Measure: Pulmonary Function Characteristics

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests

Measure: Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

Measure: Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of liver/metabolic function by the following laboratory tests: alkaline phosphatase alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT).

Measure: Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT)

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of liver/metabolic function by serum total bilirubin laboratory test.

Measure: Hepatic/Metabolic Biomarker: Total Bilirubin

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Characterization of neurologic sequelae of infection/disease.

Measure: Neurologic Abnormalities

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Identified by and characterized during standard of care assessments.

Measure: Other End Organ and/or functional abnormalities Occurring After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection/ Coronavirus Disease 2019 (COVID-19) and/or Multisystem Inflammatory Syndrome in Children (MIS-C)

Time: Up to 1 Year Post Illness Presentation (Enrollment)

Description: Assessment of health-related quality of life (HRQOL) after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/ Coronavirus Disease 2019 (COVID-19) and/or multisystem inflammatory syndrome in children (MIS-C). The Pediatric Quality of Life Inventory is a series of assessment instruments designed to measure the health-related quality of life of children. The PedsQL 4.0 provides an opportunity for the assessment of both overall (generic) quality of life as well as disease-specific quality of life. The PedsQL 4.0 Generic Core Scales are appropriate for assessing health-related quality of life in both healthy and chronically ill children. The four scales making up this generic battery include Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items).

Measure: Health Related Quality of Life

Time: Up to 1 Year Post Illness Presentation (Enrollment)
486 Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.

NCT04590274
Conditions
  1. Covid19
  2. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Drug: Hydroxychloroquine
  2. Dietary Supplement: Vitamins and Minerals
  3. Drug: Azithromycin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.

Measure: Percentage of individuals who develop COVID-19 symptoms

Time: 6 months from study start
487 Safety, Tolerability and Efficacy of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

NCT04590547
Conditions
  1. Pneumonitis
  2. SARS-CoV Infection
Interventions
  1. Drug: GLS-1027
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Incidence of serious adverse events relative to treatment group

Time: 56 days

Measure: Incidence of progression to WHO Classification of ≥6 to include intubation with mechanical ventilation, need for ECMO, or death relative to treatment group

Time: 56 days

Secondary Outcomes

Measure: Assess the number of days requiring ICU care relative to treatment group

Time: 56 days

Measure: Assess the number of days of mechanical ventilation relative to treatment group

Time: 56 days
488 Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients

Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.

NCT04594330
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: virgin coconut oil (VCO)
  2. Other: placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8)

Measure: Ordinal scale for measuring clinical improvement by the World Health Organization (WHO)

Time: 14 days

Description: Duration of symptoms (fever, respiratory rate or shortness of breath, and cough) that is calculated according to the start of VCO or placebo administration until symptoms disappear, obtained based on anamnesis and physical examination

Measure: Clinical symptoms improvement, determined with interview and examination

Time: 14 days

Description: Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10)

Measure: Pain as side effects of the drugs, measured by Visual Analog Scale

Time: 14 days

Description: Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction.

Measure: Allergic reaction severity in mild, moderate, or severe

Time: 14 days

Secondary Outcomes

Description: leucocyte count, measured in 1000/micro liter

Measure: Laboratory outcome of leucocyte count

Time: 14 days

Description: lymphocyte count, measured in percentage

Measure: Laboratory outcome of lymphocyte count

Time: 14 days

Description: Neutrophil count, measured in percentage

Measure: Laboratory outcome of neutrophil count

Time: 14 days

Description: neutrophil to lymphocyte ratio, in scale

Measure: Laboratory outcome of neutrophil to lymphocyte ratio, in scale

Time: 14 days

Description: D-dimer measured in microgram/Liter

Measure: Laboratory outcome of D-dimer

Time: 14 days

Description: TNF-alpha, measured in pg/ml

Measure: Laboratory outcome of TNF-alpha

Time: 14 days

Description: CRP value measured in qualitative value

Measure: Laboratory outcome of CRP value

Time: 14 days

Description: IL-6 value measured in pg/ml

Measure: Laboratory outcome of IL-6

Time: 14 days

Description: Ferritin value measured in mcg/liter

Measure: Laboratory outcome of ferritin

Time: 14 days

Description: procalcitonin in microgram/liter

Measure: Laboratory outcome of procalcitonin

Time: 14 days

Description: chest radiology outcome, measured as improvement of infiltrate based on expert assessment in day 1 and 14

Measure: chest radiology outcome, measured as improvement of infiltrate based on expert assessment

Time: 14 days
489 Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device

This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).

NCT04595903
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
Interventions
  1. Device: Hemopurifier
MeSH:Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Safety and tolerability

Measure: Incidence of treatment emergent adverse events

Time: Day 1 (Date of Consent) to Day 28

Description: Safety and tolerability with adverse event graded at 2 or higher

Measure: Incidence of device related adverse events

Time: Day 1 (Date of Consent) to Day 14

Description: Safety and tolerability

Measure: Incidence of serious adverse events

Time: Day 1 (Date of Consent) to Day 28

Secondary Outcomes

Description: Length of ICU stay in days

Measure: Length if Stay in ICU

Time: Day 1 (Date of Consent) to Day 28

Description: Number of deaths during hospitalization

Measure: In-hospital mortality

Time: Day 1 (Date of Consent) to Day 28

Description: Number of days without ventilatory support

Measure: Days free of ventilatory dependency

Time: Day 1 (Date of Consent) to Day 28

Description: Number of days without vasopressor support

Measure: Vasopressor-free days

Time: Day 1 (Date of Consent) to Day 28

Description: SOFA scoring system predicts the clinical outcome of critically ill patients.

Measure: Sequential Organ Failure Assessment (SOFA)

Time: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)

Description: Measures the severity of disease for adult patients admitted to an ICU

Measure: Acute Physiology and Chronic Health Evaluation (APACHE)

Time: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)

Description: Measures viral exposure and levels of circulating virus

Measure: SARS CoV-2 RNA levels in plasma and nasopharyngeal samples

Time: Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinued

Description: Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.

Measure: Total lymphocyte count

Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)

Description: Measurement of inflammatory marker levels play a role in systemic vasculitis and cytokine mediated coagulation disorders as the principal actors of multi organ failure in patients with severe COVID-19 complication.

Measure: C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests

Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)

Description: Measurement of D-dimer levels as levels are elevated in patients with COVID-19 and correlate with disease severity, are a reliable prognostic marker for in-hospital mortality.

Measure: D-dimer

Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)

Description: Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.

Measure: Troponin-T

Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)

Description: Measures the levels of SARS-CoV-2 RNA captured in the filter

Measure: Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges

Time: Until study completion, 1 week or for the duration of ICU admission

Description: Measures the levels of viral particles captured in the filter

Measure: Evaluation of viral particle load post-treatment Hemopurifier cartridges

Time: Until study completion, 1 week or for the duration of ICU admission
490 SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida

The overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health.

NCT04596579
Conditions
  1. Coronavirus Infection
Interventions
  1. Diagnostic Test: SARS-CoV-2 Antibody Analysis
  2. Diagnostic Test: Weck-cel Swab Collection
  3. Behavioral: Web Based Questionnaire
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.

Measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit

Time: At study start

Description: Participants who tested positive for SARS-CoV-2 antibodies at first study visit will be tested for antibodies to SARS-CoV-2 again at 4 weeks.

Measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit

Time: At 4 weeks

Description: Participants who tested positive for SARS-CoV-2 antibodies at second study visit will be tested for antibodies to SARS-CoV-2 again at 3 months.

Measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit

Time: At 3 months
491 A Prospective, Randomized, Adaptive Phase II/III Clinical Trial, Controlled, Open-label, 3-arms, Parallel, Multi-centred, Chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19

Protocol summary Title A Prospective, randomized, adaptive phase II/III clinical trial, controlled, open-label, chemoprevention, 3-arms, parallel, multi-centred, to A Prospective, randomized, clinical trial, controlled, open-label, 3-arms, parallel, multi-centred, chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19 Study Periods & Duration of Treatment Study Duration: 6 months Approval (IRB and regulatory bodies) 1 month Recruitment and follow-up: 3 months Analysis, report writing and submission of publications 1 month This study is a parallel study of one period with an expected duration of treatment (for each subject) of 28 days, Objectives - To evaluate if hydroxychloroquine with the proposed dose can provide potent chemoprophylaxis against the development of COVID-19 positive patients in subjects who had primary exposure to COVID-19 positive patients. - To measure the incidence of potential adverse drug reaction rates for giving hydroxychloroquine for prevention of COVID-19 amongst close contacts - To provide early analysis of results and redefine sample size accordingly. - identifying subjects most likely to benefit during the phase II and focusing recruitment efforts on them during phase III - stopping one arm or the whole trial at an early stage for success or lack of efficacy based on phase II study results Design Prospective, Randomized, open-label, three-arm, parallel, adaptive phase II/III controlled study in which subjects will be randomly assigned in a 1:1:1 ratio as per the following: Arm-1: hydroxychloroquine 800mg (400mg twice daily) given orally on day 1, (loading dose) hydroxychloroquine. Then 400mg (200mg 2 tablets) on day 2,3, 4 and 5. Arm-2: hydroxychloroquine 400mg (200mg twice daily) Given orally first day (loading dose), then 200mg once daily on day 2,3, 4 and 5. Arm-3: No Intervention- SARS-CoV-2 surveillance Standard control measures in the country of interest such as self isolation, good personal hygiene and good nutrition.

NCT04597775
Conditions
  1. SARS-CoV Infection
Interventions
  1. Drug: hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Study will seek to find direct correlation between the administration of Hydroxychloroquine and incidence of COVID-19: A reduced positive RT-PCR samples in subjects who were exposed to COVID-19patients. Positive RT-PCR samples in close contacts on day 14 of randomization.

Measure: Incidence rate of COVID-19 on day 14 according to positive results of RT-PCR rate at day 14

Time: 14 days

Description: Safety and adverse events (AEs) incidence rate at day 14

Measure: Safety and adverse events (AEs) incidence rate at day 14

Time: 14 days

Secondary Outcomes

Description: Positive IgM antibodies

Measure: IgM antibodies positive rate for COVID-19 at day 28

Time: 28 days

Description: Positive at 28 days

Measure: Incidence rate of COVID-19 on day 28 according to positive results of RT-PCR rate at day 28

Time: 28 days

Description: Safety and adverse events (AEs) incidence rate on day 28

Measure: Safety and adverse events (AEs) incidence rate on day 28

Time: 28 days
492 Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)

This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

NCT04598581
Conditions
  1. Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
Interventions
  1. Radiation: Low Dose Radiation Therapy (LD-RT)
  2. Other: Sham irradiation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Ventilator free days (VFD)

Measure: Ventilator free days (VFD)

Time: at day 15 after LD-RT

Secondary Outcomes

Description: Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)

Measure: Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)

Time: at day 5, 10, 15, 28 after LD-RT

Description: Overall mortality

Measure: Overall mortality

Time: at day 15 and 28 after LD-RT

Description: Change in levels of ferritin (ng/ml)

Measure: Change in levels of ferritin (ng/ml)

Time: up to day 15 after LD-RT

Description: Change in levels of c-reactive protein (mg/l)

Measure: Change in levels of c-reactive protein (mg/l)

Time: up to day 15 after LD-RT

Description: Change in levels of white blood cell counts (number of white blood cells per volume of blood)

Measure: Change in levels of white blood cell counts (number of white blood cells per volume of blood)

Time: up to day 15 after LD-RT
493 Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients

There is currently no known treatment for COVID19. Active smokers are infrequent among patients with COVID-19 which has led our team to hypothesize that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR). In fact, nAChR possess the ability to modulate ACE2 expression, the cellular doorway for SARS-CoV2. nAChR modulation by the virus would be responsible for the numerous clinical signs observed in COVID-19, including the cytokine storm manifested in intensive care hyperinflammatory patients. Based on epidemiological data and experimental data from scientific literature, our team hypothesize that nicotine could inhibit the penetration and propagation of SARS-CoV2. Our team also claim that nicotine could attenuate the hyperinflammatory response and cytokine storm leading to acute respiratory failure and a probable multi-organ failure associated with COVID19.

NCT04598594
Conditions
  1. Covid19
  2. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Interventions
  1. Drug: Patch, Nicotine
  2. Drug: Patch, Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Mortality

Time: Day 28

Secondary Outcomes

Measure: Mortality

Time: Day 60

Description: Without reintubation or death in the following 48 hours for tracheotomized patients: alive and not ventilated for 48 hours (with death and LATA in competitive risks).

Measure: Time before successful extubation

Time: Day 60

Measure: Number of days living without invasive mechanical ventilation

Time: Day 28

Description: This is a ranked composite score that incorporates death and days free from mechanical ventilation through day 28, calculated in such a manner that death constitutes a worse outcome than fewer days off the ventilator.16 Time free from mechanical ventilation was calculated as the number of days between successful liberation from the ventilator and study day 60. Each patient was compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better

Measure: Composite score incorporating death and the number of days living without mechanical ventilation

Time: Day 60

Description: measured each day from day 1 to day 14

Measure: Mean evolution of blood gases

Time: Day 1 to Day 14

Description: measured each day from day 1 to day 14

Measure: Mean evolution of Tidal Volume (ventilator parameters)

Time: Day 1 to Day 14

Description: measured each day from day 1 to day 14

Measure: Mean evolution of respiratory rate (ventilator parameters)

Time: Day 1 to Day 14

Description: measured each day from day 1 to day 14

Measure: Mean evolution of Positive Expiratory Pressure (ventilator parameters)

Time: Day 1 to Day 14

Description: measured each day from day 1 to day 14

Measure: Mean evolution of plateau pressure (ventilator parameters)

Time: Day 1 to Day 14

Description: measured each day from day 1 to day 14

Measure: Mean evolution of fraction of inspired oxygen (ventilator parameters)

Time: Day 1 to Day 14

Description: A higher score indicate a worse outcome

Measure: Evolution of the Sequential Organ Failure Assessment (SOFA) score and its components by organ

Time: Day 1 to Day 28

Measure: Number of days alive without organ failure

Time: Day 28, day 60

Measure: Duration of hospitalization in intensive care unit

Time: From day 1 up to 3 months

Measure: Duration of hospitalization in hospital

Time: From day 1 up to 3 months

Measure: Number of days alive and out of the ICU and hospital

Time: Day 28, day 60

Description: samples taken on D7 and D14 or the day of discharge from intensive care unit if before D14

Measure: Evolution of viral load

Time: Day 7, Day 14 or day of ICU discharge if before day 14

Measure: Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination

Time: 2 weeks after treatment decrease, 8 weeks after treatment decrease

Measure: Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine

Time: 2 weeks after treatment decrease, 8 weeks after treatment decrease

Measure: Mean score of Desire to smoke defined by French Tobacco Craving scale

Time: 2 weeks after treatment decrease, 8 weeks after treatment decrease

Measure: Mean score of Withdrawal symptoms scale

Time: 2 weeks after treatment decrease, 8 weeks after treatment decrease

Measure: Mean score of Hospital anxiety and depression scale

Time: 2 weeks after treatment decrease, 8 weeks after treatment decrease

Measure: Post traumatic stress disorder scale

Time: 2 weeks after treatment decrease, 8 weeks after treatment decrease

Measure: Mean score of Insomnia severity scale

Time: 2 weeks after treatment decrease

Measure: Cotinin rate in blood

Time: 8 weeks after treatment decrease
494 Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate

The main objective of this study is to assess if analysis of exhaled breath condensate (EBC) can provide useful prognostic markers for admission to the intensive care unit (ICU) due to acute respiratory insufficiency among patients with Coronavirus disease 2019 (COVID-19). Additionally, to give a characterization of the lung damage caused by COVID-19 by analysis of daily blood samples. The hypothesis is that the protein content of the EBC from COVID-19 patients who require admission to the ICU differs from the EBC from COVID-19 patients with uncomplicated hospitalization, potentially providing diagnostic markers of COVID-19 related pulmonary damage.

NCT04598620
Conditions
  1. Covid19
  2. Corona Virus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome is prediction of admission to ICU in hospitalized COVID-19 patients by use of one or more novel biomarkers in the EBC

Measure: Prediction of admission to ICU in hospitalized COVID-19 patients

Time: 1 year

Secondary Outcomes

Description: In a sub-study, we will collect the daily blood samples for analysis in order to investigate the pathophysiology in COVID-19, and for standardization and validation of putative EBC markers in the blood.

Measure: Pathophysiology in COVID-19 patients

Time: 1 year
495 A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection

This is a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate SARS-CoV-2 infected patients and safety during after study drug injection.

NCT04602000
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Biological: CT-P59/Placebo
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Proportion of patient with negative conversion in nasopharyngeal swab specimen based on reverse transcription quantitative polymerase chain reaction(RT-qPCR)or cell culture at each visit.

Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II)

Time: Up to Day 14

Description: Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture

Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II)

Time: Up to Day 14

Description: Time to clinical recovery

Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II)

Time: Up to Day 14

Description: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection

Measure: To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II)

Time: Up to Day 28

Description: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection

Measure: To evaluate the therapeutic efficacy CT-P59 for Part 2 (Phase III)

Time: Up to Day 28

Secondary Outcomes

Description: Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection.

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of patients with all-cause mortality

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Time to clinical recovery

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Duration of fever defined as the last day in the patient diary on which the temperature >38°C (100.4°F) is recorded, or a potentially antipyretic drug (acetaminophen or ibuprofen) is taken

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of patients with hospital admission due to SARS-CoV-2 infection

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of mechanical ventilation due to SARS-CoV-2 infection

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of patients requiring additional prescription medication due to SARS-CoV-2 infection

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture

Measure: To evaluate the overall efficacy of CT-P59 for Part 1 and 2

Time: Up to Day 14 and 28

Description: Proportion of patients reporting Adverse events (AEs, including serious adverse events)

Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2

Time: Up to Day 90

Description: Proportion of patients reporting Adverse events of special interest (Infusion related reactions, hypersensitivity and anaphylactic reactions)

Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2

Time: Up to Day 90

Description: Incidence of ADE (Antibody Dependent Enhancement)

Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2

Time: Up to Day 90

Description: Proportion of patients with anti-drug antibodies Immunogenicity

Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2

Time: Up to Day 90

Description: Proportion of patients with anti-drug antibodies S evere Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection related signs and symptoms.

Measure: To evaluate the overall safety of CT-P59 for Part 1 and 2

Time: Up to Day 90

Description: Viral shedding in nasopharyngeal swab specimen based on RT-qPCR and cell culture

Measure: To evaluate virology for part 1 and part 2

Time: Up to Day 90

Description: Genotype and phenotype of SARS-CoV-2 viral isolates

Measure: To evaluate virology for part 1 and part 2

Time: Up to Day 90

Description: Viral serology for SARS-CoV-2 antibody

Measure: To evaluate virology for part 1 and part 2

Time: Up to Day 90
496 Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)

Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.

NCT04602260
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Mobility Limitation
  4. Frailty
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Frailty Mobility Limitation
HPO:Difficulty walking

Primary Outcomes

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version

Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version

Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function), and at 3,6,9 and 12-months post hospital discharge

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version

Time: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)

Description: The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

Measure: Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity

Time: 3,6,9 and 12-months post hospital discharge

Secondary Outcomes

Description: The SPPB combines the results of gait speed over 3 meters, the 5-repetition chair-stand, and a progressive balance test to assess lower extremity function.

Measure: Change in Short Physical Performance Battery (SPPB)

Time: 3,6,9 and 12-months post hospital discharge

Description: The CFS is an interview-based scale wherein the assessor may ask the patient questions about things such as their independence or physical abilities to determine where the patient falls along the 9-point scale, from 1 (Very Fit) to 9 (Terminally Ill).

Measure: Change in Clinical Frailty Scale (CFS) for participants over 60 years of age

Time: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function ), and at 3,6,9 and 12-months post hospital discharge

Description: The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation as measured by spirometry.

Measure: Change in Forced Expiratory Volume (FEV1)

Time: 3,6,9 and 12-months post hospital discharge

Description: The amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry. FVC is the total amount of air exhaled during the FEV test.

Measure: Change in Forced Vital Capacity (FVC)

Time: 3,6,9 and 12-months post hospital discharge

Description: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value.

Measure: Change in Forced Expiratory Volume Percentage (FEV1%)

Time: 3,6,9 and 12-months post hospital discharge

Description: The BDI rates the severity of dyspnea at a single point in time (baseline) based on a 24-item interviewer administered rating scale.

Measure: Baseline Dyspnea Index (BDI)

Time: 3 months post hospital discharge

Description: Measures changes in dyspnea severity from the baseline as established by the BDI.

Measure: Change in Transition Dyspnea Index (TDI)

Time: 6,9 and 12-months post hospital discharge

Description: The PHQ-9 is a self-rating instrument for depression based on nine questions that the patient responds to by indicating how much they have been bothered by these symptoms over the last two weeks.

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

Time: 3,6,9 and 12-months post hospital discharge

Description: The FIM assesses the functional status of a person based on the level of assistance the person requires.

Measure: Change in Functional Independence Measure (FIM)

Time: 3 and 6 months post hospital discharge

Description: The IES-R is a 22-item self-report measure that asks questions about subjective distress caused by traumatic events. Each item is rated on a 5-point scale, from 0 ("not at all") to 4 ("extremely").

Measure: Change in Impact of Event Scale - Revised (IES-R)

Time: 3,6,9 and 12-months post hospital discharge

Description: The EQ-5D-5L is a generic and well-established instrument for describing health status or disease-specific outcome measures. It defines health in terms of five dimensions: Mobility, Self- Care, Usual Activities, Pain/Discomfort, and Anxiety/ Depression. The response options are of five levels, from no, slight, moderate, severe, to extreme problems

Measure: Change in Health status (EQ-5D-5L)

Time: 3,6,9 and 12-months post hospital discharge
497 Communication in ICU During COVID-19: Multinational, Multicentric Cross-sectional Survey (ComICU)

This study explores the actual situation of communication during the Coronavirus disease 2019 (COVID-19) pandemic in the South Asia and Middle East region. The purpose is to assess the effect of the limited visitor policy during the COVID-19 pandemic, on the pattern of interaction of critically ill patients to their kin/ guardian and doctor-family members communication. Primary objective of this study are as follows: 1. Explore the changes in communication pattern with limited contact during the COVID-19 pandemic. 2. Assess the methods of informed consent in Intensive care units (ICUs) during the same period

NCT04602351
Conditions
  1. COVID-19
  2. Severe Acute Respiratory Syndrome Coronavirus 2
  3. Severe Acute Respiratory Syndrome
Interventions
  1. Behavioral: Communication
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Using a questionnaire the changes in visiting policy for family members or friends will be recorded from last year (before COVID-19 pandemic). This will include, visiting policy, visiting hours and their change after pandemic at the time of study (November 2020).

Measure: Changes in the pattern of family members visiting process

Time: 12 months

Description: Through a questionnaire, the process of communication between HCWs and family members or friends before pandemic (November 2019) and November 2020 will be recorded. This will include the responsible HCW for communication, place of communication and method of communication (in person versus electronic)

Measure: Changes in process of communication between health care workers(HCWs) and family members

Time: 12 months

Secondary Outcomes

Description: Through a questionnaire, the process of informed consent for procedures and end of life (EOL) or do not attempt to resuscitation (DNAR) in ICU will be collected and its change in last 12 months (from November 2019 to November 2020)

Measure: Changes in process of informed consent in ICU

Time: 12 months
498 Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial

Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications. Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation. An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers. Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease. Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.

NCT04602507
Conditions
  1. Covid19
  2. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Ivermectin
  2. Other: Placebo
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Cumulative incidence of ICU admission.

Measure: Admission to the intensive care unit.

Time: 21 days

Secondary Outcomes

Description: Duration of hospitalization (days).

Measure: Hospital length of stay.

Time: 21 days

Description: 21-day mortality.

Measure: Mortality rate.

Time: 21 days

Description: Number of days in ICU.

Measure: ICU length of stay.

Time: 21 days

Description: Number of days with mechanical ventilator.

Measure: Length of stay in ventilator time.

Time: 21 days

Description: Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.

Measure: Adverse effects of ivermectin.

Time: 21 days
499 Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved. If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19. However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

NCT04603755
Conditions
  1. SARS-CoV Infection
  2. Acute Respiratory Distress Syndrome
Interventions
  1. Device: Electrical Impedance tomography
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: The percentage of derecruitment of dependent areas will be measured every day with Electrical Impedance Tomography. The response to prone position will be assessed every day.

Measure: Coefficient of correlation between the percentage of derecruitment of dependent areas (measured with Electrical Impedance Tomography) and the response to prone position

Time: Up to 7 days
500 Evaluation of Self-Collected Saliva Samples Without Viral Transport Media for SARS-CoV-2 Testing Via RT-PCR

This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) using self-collected saliva as the specimen. We will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. We will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube.

NCT04604145
Conditions
  1. SARS-CoV Infection
  2. Polymerase Chain Reaction
  3. Laboratory Testing
Interventions
  1. Diagnostic Test: SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percent positive agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).

Measure: Percent positive agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples

Time: within 1 day of SARS-CoV-2 testing

Description: Percent negative agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).

Measure: Percent negative agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples

Time: within 1 day of SARS-CoV-2 testing

Description: Percent overall agreement between self-collected saliva samples (evaluated on the Eppendorf Thermal Cycler PCR system) and healthcare-worker collected nasopharyngeal samples (evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® as the gold standard).

Measure: Percent overall agreement between self-collected saliva samples and healthcare-worker collected nasopharyngeal samples

Time: within 1 day of SARS-CoV-2 testing
501 A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo

New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.

NCT04605588
Conditions
  1. SARS-CoV Infection
  2. Covid19
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Placebo Nitazoxanide
  3. Drug: Ribavirin
  4. Drug: Placebo Ribavirin
  5. Drug: Hydroxychloroquine
  6. Drug: Placebo Hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: qPCR measured via nasal swab

Measure: Rate of decline in viral load over the 10 days after randomization

Time: 10 days after randomization
502 Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia

The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia

NCT04606407
Conditions
  1. Viral Pneumonia
  2. Nitric Oxide
  3. Respiratory Disease
  4. Pneumonia, Viral
  5. Inhaled Nitric Oxide
  6. Covid19
  7. SARS-CoV Infection
Interventions
  1. Device: LungFit™
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases
HPO:Pneumonia

Primary Outcomes

Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Measure: incidence of Serious Adverse Events

Time: 30 days

Secondary Outcomes

Description: Time to fever resolution

Measure: fever resolution

Time: Baseline to 30 days

Description: Number of patients requiring admission to ICU

Measure: ICU admission

Time: Baseline to 30 days

Description: Time until patient no longer requires supportive oxygen

Measure: Oxygen support

Time: Baseline to 30 days

Description: b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower

Measure: Stable room air saturation

Time: Baseline to 30 days
503 Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan on Outcomes of Coronavirus Infection?

SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that we call "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response. ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARB, losartan, limits lung injury in murine influenza H7N9 and decreases viral titre and RNA. We have a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARB, losartan) to decrease the mortality of hospitalized COVID-19 patient.

NCT04606563
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: Losartan
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Mortality

Time: 28 days

Secondary Outcomes

Measure: Hospital Mortality

Time: up to 6 months

Description: Location within hospital (ICU or wards)

Measure: ICU Admission

Time: up to 6 months

Measure: days alive and free of vasopressors, ventilation, and renal replacement therapy

Time: up to 14 days

Description: Sequential Organ Failure Assessment (SOFA) score

Measure: SOFA score

Time: 28 days

Description: Use of inotropic agents and increase(s) of of troponin and/or NT-proBNP from admission level

Measure: Acute cardiac injury

Time: 6 months

Description: Severe adverse effects of ARBs and mortality

Measure: Severe adverse events

Time: 6 months

Measure: Mortality

Time: at 1, 3 and 6 months
504 Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus: a Dilemma

There is little information on the characteristics of airborne severe acute respiratory syndrome coronavirus containing aerosols, their concentration, or their infectivity.The aim was to determine airborne severe acute respiratory syndrome coronavirus transmission, their infectivity in different areas such as patient's room and in medical staff área.

NCT04609774
Conditions
  1. Coronavirus Disease (COVID-19)
Interventions
  1. Other: Severe Acute Respiratory Syndrome CoronaVirus 2 detection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Detection of Severe Acute Respiratory Syndrome CoronaVirus 2 RNA by Real Time Polymerase Chain Reaction and cell culture

Measure: Airborne transmission of Severe Acute Respiratory Syndrome CoronaVirus 2

Time: 9 moths
505 Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia

The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia. Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.

NCT04609865
Conditions
  1. Acute Respiratory Distress Syndrome (ARDS)
  2. COVID-19
  3. Corona Virus Infection
Interventions
  1. Drug: Lidocaine 2%
  2. Drug: Control
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: PaO2/FiO2 ratio

Measure: alveolar-capillary gas exchange after two days of treatment

Time: At 48 hours after the first treatment administration

Secondary Outcomes

Description: PaO2/FiO2 ratio : a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: alveolar-capillary gas exchange From day 0 to day 21 or until coming out of intensive care

Time: From day 0 to day 21 or until coming out of intensive care

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Ventilator-free days

Time: At day 28 and at day 90

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Ferritin

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : bicarbonates

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : CRP

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : LDH

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : IL-6

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Tropo HS

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : Triglycerides

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Measure the effects of Intravenous Lidocaine on Biomarkers : CBC with lymphocytes count

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Antithrombotic activity of Intravenous Lidocaine on platelets

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Antithrombotic activity of Intravenous Lidocaine on ACT ratio

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Antithrombotic activity of Intravenous Lidocaine on fibrinogen

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Antithrombotic activity of Intravenous Lidocaine on D-Dimers

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Antithrombotic activity of Intravenous Lidocaine on TEG

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Antithrombotic activity of Intravenous Lidocaine on thromboembolic events

Time: At Day 0, day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Plasma concentration of albumin and Lidocaine

Time: 4 hours after first administration, at day 2, day 7, day 14 and at day 21

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Blood pressure in mmHg will be measured

Measure: Search for hemodynamic dysfynction: Blood pressure measurement in mmHg

Time: daily from day one to day 14

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Cardiac frequency in beats per minute will be assessed

Measure: Search for hemodynamic dysfynction: Cardiac frequency in beats per minute will be assessed

Time: daily from day one to day 14

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Sinus rythm will be assessed

Measure: Search for hemodynamic dysfynction: Sinus rythm will be assessed

Time: daily from day one to day 14

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. Vasopressors and inotropes drugs use will be reported

Measure: Search for hemodynamic dysfynction: Vasopressors and inotropes drugs use will be reported

Time: daily from day one to day 14

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19. EKG : PR, QRS, QTc intervals in ms will be measured

Measure: Search for hemodynamic dysfynction: EKG : PR, QRS, QTc intervals in ms will be measured

Time: daily from day one to day 14

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: ICU ileus: laxation response

Time: daily from Day 0 to Day 28

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Opioids, sedative and curare sparing effect (drugs dosage)

Time: daily from Day 0 to Day 28

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Evaluate the impact of Lidocaine IV on ICU outcomes : re-intubation

Time: From Day0 to Day28 and at Day90

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Evaluate the impact of Lidocaine IV on ICU outcomes : ICU length of stay

Time: From Day0 to Day28 and at Day90

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Evaluate the impact of Lidocaine IV on ICU outcomes : ICU complications

Time: From Day0 to Day28 and at Day90

Description: a comparison will be made between Lidocaine and control groups in patients with acute respiratory distress syndrome (ARDS) due to Covid-19 and in patients with ARDS without Covid-19.

Measure: Cough at extubation time or in the 24 hours after extubation or weaning from respiratory support (in case of tracheostomy)

Time: extubation day
506 Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protects individual privacy but promotes rapid dissemination and implementation of knowledge.

NCT04610515
Conditions
  1. Covid19
  2. ME/CFS
  3. SARS COV2
  4. Novel Coronavirus Infection
  5. Neurocognitive Disorders
  6. Cardiovascular Diseases
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Cardiovascular Diseases Neurocognitive Disorders
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Description: determine the risk of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in those with symptoms of SARSCOV2 infection with vs. without a positive confirmatory test.

Measure: Incident myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Time: 18 months post enrollment

Secondary Outcomes

Description: Count of ambulatory care and/or ED visits post enrollment as obtained from the EMR

Measure: Ambulatory care and/or ED visits post enrollment

Time: 18 months post enrollment

Description: Count of hospitalizations post enrollment as obtained from the EMR

Measure: Hospitalizations post enrollment

Time: 18 months post enrollment

Description: death during hospital admission as determined by data from the EMR

Measure: Death during hospital admission

Time: 18 months post enrollment

Description: Hospital-free survival as determined by data from the EMR

Measure: Hospital-free survival

Time: 18 months post enrollment

Description: ICU-free survival as determined by data from the EMR

Measure: ICU-free survival

Time: 18 months post enrollment
507 EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois. Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled. Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks. There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.

NCT04611230
Conditions
  1. Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: SARS-CoV-2 infection prior to enrollment is assessed by Immunoglobulin G (IgG) serology testing and/or self-reported diagnosis.

Measure: Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection

Time: Baseline (Week 0)

Description: SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing.

Measure: Percentage of Participants With Current SARS-CoV-2 Infection

Time: Baseline (Week 0)

Description: Incidence of SARS-CoV-2 Infection is assessed by positive PCR test, positive IgG serology test or COVID-19 diagnosis.

Measure: Percentage of Participants With Incidence of SARS-CoV-2 Infection

Time: Up to Approximately 9 months

Secondary Outcomes

Description: Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded.

Measure: Percentage of Participants With COVID-19 Hospitalization

Time: Up to approximately 9 months

Description: Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.

Measure: Percentage of Participants With Influenza and COVID-like Illness

Time: Up to approximately 9 months

Description: The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.

Measure: Time to Infection

Time: Up to approximately 9 months

Description: The analysis for overall time to symptom onset will be conducted using the Kaplan-Meier method.

Measure: Time to Symptom Onset

Time: Up to approximately 9 months

Description: The analysis for overall time to symptom resolution will be conducted using the Kaplan-Meier method.

Measure: Time to Symptom Resolution

Time: Up to approximately 9 months

Description: Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L)

Measure: Change in Quality of Life (QOL)

Time: Up to approximately 9.5 months
508 A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years

This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Up to 30,000 participants will take part in the study.

NCT04611802
Conditions
  1. SARS-CoV Infection
  2. Covid19
Interventions
  1. Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

Measure: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)

Time: Day 28 to Day 750

Secondary Outcomes

Description: Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

Measure: Participants with Symptomatic Moderate or Severe COVID-19

Time: Day 28 to Day 750

Description: Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.

Measure: Participants with Any Symptomatic COVID-19

Time: Day 28 to Day 750

Description: Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and Month 3.

Measure: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)

Time: Day 0 to Day 105

Description: Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and Month 3.

Measure: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)

Time: Day 0 to Day 105

Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and Month 3.

Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs

Time: Day 0 to Day 105

Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and Month 3.

Measure: Serum IgG Antibody Levels Expressed as GMFRs

Time: Day 0 to Day 105

Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and Month 3.

Measure: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs

Time: Day 0 to Day 105

Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and Month 3.

Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs

Time: Day 0 to Day 105

Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.

Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points

Time: Day 165 to Day 750

Description: Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.

Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points

Time: Day 165 to Day 750

Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.

Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points

Time: Day 165 to Day 750

Description: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.

Measure: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points

Time: Day 165 to Day 750

Description: Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.

Measure: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points

Time: Day 165 to Day 750

Description: Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.

Measure: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points

Time: Day 165 to Day 750

Description: Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.

Measure: Description of Course, Treatment and Severity of COVID-19

Time: Day 28 to Day 750

Description: Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).

Measure: Reactogenicity Incidence and Severity

Time: Day 0 to Day 27

Description: Number of participants with mild, moderate, or severe MAAEs through Day 49.

Measure: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49.

Time: Day 0 to Day 49

Description: Number of participants with mild, moderate, or severe AEs through Day 49.

Measure: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49.

Time: Day 0 to Day 49

Description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through Month 12.

Measure: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12.

Time: Day 0 to Day 375

Description: Number of participants with mild, moderate, or severe SAEs through Month 12.

Measure: Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12.

Time: Day 0 to Day 375

Description: Number of participants with mild, moderate, or severe AESIs through Month 12.

Measure: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12.

Time: Day 0 to Day 375

Description: Number of participants with mild, moderate, or severe SAEs from Month 12 to Month 24.

Measure: Incidence and Severity of SAEs from Month 12 to Month 24.

Time: Day 360 to Day 750

Description: Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine from Month 12 to Month 24.

Measure: Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24.

Time: Day 360 to Day 750

Description: Number of participants with mild, moderate, or severe AESIs attributed to study vaccine from Month 12 to Month 24.

Measure: Incidence and Severity of AESIs from Month 12 to Month 24.

Time: Day 360 to Day 750

Description: Number of participants who died during the study due to any cause.

Measure: Deaths Due to Any Cause

Time: Day 0 to Day 750

Description: Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or Months 3, 6, 12, 18 and 24 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.

Measure: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points

Time: Day 0 to Day 750

Description: Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.

Measure: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point

Time: Day 0 to Day 750
509 Phase III, Random-Open, Clinical Trials on the Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

The benefit of the research is to provide information regarding the efficacy and safety of Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a reference for policy recommendations regarding the use of Favipiravir as an antiviral drug for the treatment of Covid-19.

NCT04613271
Conditions
  1. Infectious Disease
  2. SARS-CoV Infection
  3. Covid19
Interventions
  1. Drug: Favipiravir
  2. Drug: Azithromycin
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement measured by no sign & symptom and RTPCR negative from baseline to Day 3

Measure: Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative

Time: until 3 days

Secondary Outcomes

Description: Duration of hospitalization is defined as the number of days in the hospital until Day 19, and descriptive statistics (number of subjects, mean, standard deviation, median, minimum, maximum) are given for each administration group.

Measure: Duration of hospitalization

Time: until 19 days
510 Prevalence and Incidence of Antibodies Against SARS-CoV-2 in Children Measured for One Year in Belgium: a Sero-epidemiological Prospective Cohort Study

Based on studies in China, Iceland, the Netherlands and Italy it seems that children are less affected by SARS-CoV-2 infections and play a lesser role in the dissemination of the SARS-CoV-2 virus. It is unclear to which extend this is due to lesser exposure or an inherent decreased susceptibility to become infected. The low reported number of cases in children can be partially explained by the lower testing rates in the pediatric population. To get insight in the transmission of SARS-CoV-2 virus in school-aged children it is necessary to compile data on infection of SARS-CoV-2 virus in the child and (pre-)adolescent population. The main objective of this study is to determine the sero-prevalence and sero-conversion of antibodies against SARS-CoV-2 in a sample of school-aged children (primary and secondary school) in Belgium at different time points. Additionally this study will gain insight in the incidence of SARS-CoV-2, the proportion of asymptomatic infections with SARS-CoV-2 and the role of COVID-19 infection in household members. It will give us the possibility to investigate potential risk factors for infection. The study population includes primary and secondary school children from two predefined age groups (8-9 and 13-14 years old). These two groups are chosen because studies have shown more pronounced symptoms of infection and disease depending on age and because transmission dynamics also vary by age. The study population will be recruited in all Belgian schools including Brussels-Capital, Flemish and Walloon Region (including the German speaking community). The study is a prospective cohort study. In total there will be 3 testing points with 3 months between each point. The sample size calculation indicated the inclusion of 41 randomly selected primary and 41 secondary schools and in each school 20 randomly selected pupils of the defined age groups. Parents/legal child caregiver will complete a questionnaire at each of the testing points providing basic socio-demographic characteristics (at baseline only) and risk-behavior and health characteristics including presence of symptoms during the time since the previous testing point (at each of the testing points). The questionnaire will be completed through a secured online application during the same week as the child had the saliva sample for serological testing taken. Saliva samples will be sent to the Sciensano laboratory for serological analysis. The child's parent/legal caregiver will be informed of the serological result. Study data will guide the Belgian policy makers in their advices to limit circulation of SARS-CoV-2 in Belgium and more specifically in their advice on measures for school-age children. This data might also be used to guide health authorities that have to decide on vaccination strategies once a vaccine is available; to decide whether children should be included for vaccination to create herd immunity or not.

NCT04613817
Conditions
  1. SARS-CoV-2
  2. SARS-CoV Infection
  3. Covid19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Change in percentage of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested

Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years

Time: "Month 1", "Month 4" and "Month 7"

Description: Change in the absolute numbers of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested

Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years

Time: "Month 1", "Month 4" and "Month 7"

Description: Change in percentage of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested

Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years

Time: "Month 1", "Month 4" and "Month 7"

Description: Change in the absolute numbers of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested

Measure: Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years

Time: "Month 1", "Month 4" and "Month 7"

Description: Change in the percentage of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years

Time: "Month 4" and "Month 7"

Description: Change in the percentage of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years

Time: "Month 4" and "Month 7"

Description: Change in the absolute number of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years

Time: "Month 4" and "Month 7"

Description: Change in the absolute number of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

Measure: Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years

Time: "Month 4" and "Month 7"

Secondary Outcomes

Description: Proportion (%) infected children by probable exposure (probable or confirmed COVID-19 case in family or school), risk behavior and by health characteristics (co-morbidities, presence of symptoms, use of medications).

Measure: Potential risk factors for the infection

Time: "Month 1", "Month 4" and "Month 7"

Description: Percentage of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months

Measure: The proportion of asymptomatic cases among new cases that develop during a period of 7 months

Time: "Month 1", "Month 4" and "Month 7"

Description: Absolute number of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months

Measure: The proportion of asymptomatic cases among new cases that develop during a period of 7 months

Time: "Month 1", "Month 4" and "Month 7"
511 Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial

The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.

NCT04615052
Conditions
  1. Covid19
  2. SARS (Severe Acute Respiratory Syndrome)
  3. SARS-CoV Infection
Interventions
  1. Other: Exercise training
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Higher score means better outcome.

Measure: Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 12 weeks.

Time: Baseline and 12 weeks.

Secondary Outcomes

Description: Higher score means worse outcome.

Measure: Change from baseline on fatigue evaluated by the fatigue severity scale at 12 weeks.

Time: Baseline and 12 weeks.

Description: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

Measure: Change from baseline on lipid profile at 12 weeks.

Time: Baseline and 12 weeks.

Description: Fasting serum concentrations of glucose and insulin.

Measure: Change from baseline on insulin sensitivity at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on inflammatory cytokine IL-1 at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on inflammatory cytokine IL-1ra at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on inflammatory cytokine IL-6 at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on inflammatory cytokine IL-10 at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on inflammatory cytokine TNF-alpha at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on C-reactive Protein at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on Creatine Kinase at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline body fat assessed by Dual-energy absorptiometry at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on waist circumference at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on hip circumference at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on body weight at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on muscular strength assessed by handgrip test at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on muscular function assessed by Timed-Stand Test at 12 weesks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on muscular function assessed by Timed-Up and Go Test at 12 weeks.

Time: Baseline and 12 weeks.

Description: Higher score means worse outcome.

Measure: Change from baseline on anxiety symptoms assessed by Back Scale at 12 weeks.

Time: Baseline and 12 weeks.

Description: Higher score means worse outcome.

Measure: Change from baseline on depression symptoms assessed by Back Scale at 12 weeks.

Time: Baseline and 12 weeks.

Description: Higher score means worse outcome.

Measure: Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 12 weeks.

Time: Baseline and 12 weeks.

Measure: Change from baseline on resting blood pressure assessed by an automated device at 12 weeks.

Time: Baseline and 12 weeks.
512 Methylene Blue-mediated Photodisinfection for SARS-CoV-2 in the Upper Respiratory Tract

The study proposes to test photodisinfection (PDF) on SARS-CoV-2 in the nose. The study will use Health Canada approved Steriwave™ Nasal Decolonization (ND) in he nostril of patients infected with SARS-CoV-2. Participants are swabbed for SARS-CoV-2 before and after the PDF treatment. For the study, a small group of healthcare workers who have tested positive for SARS-CoV-2 will be included. They will not undergo the treatment but will need to swab their noses multiple times over the next 5 days. This nil group will provide the effect (if any) of swabbing SARS-CoV-2 levels in the nose.

NCT04615936
Conditions
  1. COVID-19
  2. Corona Virus Infection
  3. SARS-CoV 2
Interventions
  1. Other: Methylene-Blue Photodisinfection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The main endpoint is microbiological; RT-qPCR will be conducted on the pre and post treatment swabs and the change in cycle threshold value will be measured

Measure: RT-qPCR

Time: 30 minutes
513 Pilot Study of the Use of IVIG in Patients With Severe COVID-19 Infections Requiring Mechanical Ventilation and to Assess Their Biological Responses to IVIG Therapy

The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.

NCT04616001
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Drug: IVIG
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Assess hospital length of stay after mechanical ventilation

Measure: Hospital length of stay

Time: Up to 60 days

Secondary Outcomes

Description: Analyze the blood to assess the human metabolome and proteome in patients with COVID-19 receiving IVIG including production of inflammatory and anti-inflammatory cytokines, markers of endothelial injury, and coagulation using Mass Spectrometry

Measure: Human metabolome and proteome

Time: Up to 60 days
514 Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)

For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS. The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).

NCT04619368
Conditions
  1. Human ARDS
  2. Coronavirus Infection
Interventions
  1. Other: Follow up calls
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care

Measure: Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care

Time: month 12

Secondary Outcomes

Description: psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

Measure: psychological disorders measured by QIDS

Time: Month 3

Description: psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

Measure: psychological disorders measured by STAI-YA

Time: Month 3

Description: psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

Measure: psychological disorders measured by QIDS

Time: Month 6

Description: psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

Measure: psychological disorders measured by STAI-YA

Time: Month 6

Description: psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

Measure: psychological disorders measured by QIDS

Time: Month 12

Description: psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

Measure: psychological disorders measured by STAI-YA

Time: Month 12

Description: Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life

Measure: quality of life by EQL-5

Time: Month 3

Description: Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life

Measure: quality of life by EQL-5

Time: Month 6

Description: Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life

Measure: quality of life by EQL-5

Time: Month 12

Description: nutritional status measured by Nutritional Risk Screening 2002

Measure: nutritional status

Time: Month 3

Description: nutritional status measured by Nutritional Risk Screening 2002

Measure: nutritional status

Time: Month 6

Description: nutritional status measured by Nutritional Risk Screening 2002

Measure: nutritional status

Time: Month 12
515 A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.

NCT04621461
Conditions
  1. Corona Virus Infection
Interventions
  1. Dietary Supplement: Zinc Sulfate 220 MG
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit

Measure: Number of participants hospitalized and/or requiring repeat emergency room visits

Time: 21 days

Description: If hospitalized, number of participants admitted to the ICU, and number of days in the ICU

Measure: Number of participants admitted to the Intensive care unit (ICU)

Time: 30 days

Description: If placed on ventilator, number of days on a ventilator

Measure: Number of participants on a ventilator

Time: 30 days

Secondary Outcomes

Description: Total number of deaths in the cohort.

Measure: All-cause mortality

Time: Up to 30 days

Description: Time at which the patient is completely symptom free.

Measure: Time to resolution of COVID-19 symptoms

Time: Evaluated at day 2, 6, day 14, and day 21

Description: Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)

Measure: Severity of symptoms

Time: Evaluated at day 2, 6, day 14, and day 21
516 A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19

Primary Objective: • To evaluate overall safety and tolerability of SIR1-365 in patients with severe COVID-19 Secondary Objectives: - To assess the clinical efficacy of SIR1-365 in patients with severe COVID-19 - To assess the effects of SIR1-365 on multiple inflammatory biomarker levels including C-reactive protein (CRP), ferritin, lymphocyte and neutrophil counts, cytokines, and chemokines - To assess the effects of SIR1-365 on biomarkers indicative of target engagement in patients with severe COVID-19 - To assess the effects of SIR1-365 on biomarkers indicative of kidney injury in patients with severe COVID-19 - To assess the effects of SIR1-365 on biomarkers indicative of cardiovascular endothelial cell damage in patients with severe COVID-19 - To characterize plasma pharmacokinetics (PK) of SIR1-365 in patients with severe COVID-19

NCT04622332
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: SIR1-365
  2. Drug: Matching Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Primary Safety Endpoint

Measure: Proportion of patients with any TEAEs during the treatment period

Time: Baseline to Day 14

Secondary Outcomes

Description: Secondary Safety Endpoint

Measure: Proportion of patients with any AEs, SAEs and drug-related AEs during the study

Time: Baseline to Day 14 and Day 28

Description: Secondary Safety Endpoint

Measure: Proportion of patients with clinically significant abnormality in clinical laboratory tests and ECG during the study

Time: Baseline to Day 14 and Day 28

Description: Clinical Efficacy Endpoint

Measure: Change from Baseline to Day 7 and Day 14 in PaO2/FiO2 ratio

Time: Baseline to Day 7 and Day 14

Description: Clinical Efficacy Endpoint

Measure: Time to improvement of oxygenation defined as oxygen saturation (pulse oximetry) >93% and increased ≥1% from Baseline breathing only room air in the 48 hours preceding the measurement during the study

Time: Baseline to Day 28

Description: Clinical Efficacy Endpoint

Measure: Number of days without oxygen use during the study

Time: Baseline to Day 28

Description: Clinical Efficacy Endpoint

Measure: Proportion of patients with clinical improvement defined as a reduction of 2 points in the WHO ordinal scale during the study

Time: Baseline to Day 28

Description: Clinical Efficacy Endpoint

Measure: Number of days hospitalized during the study

Time: Baseline to Day 28

Description: Clinical Efficacy Endpoint

Measure: Proportion of patients free of respiratory failure during the study

Time: Baseline to Day 28

Description: Clinical Efficacy Endpoint

Measure: All-cause mortality rate during the study

Time: Baseline to Day 28

Description: Inflammatory Biomarker Measure

Measure: Change from Baseline to Day 7 and to Day 14 in plasma CRP level

Time: Baseline to Day 7 and to Day 14

Description: Inflammatory Biomarker Measure

Measure: Time to reach 50% reduction from Baseline in plasma CRP level during the treatment period

Time: Baseline to Day 14

Description: Inflammatory Biomarker Measure

Measure: Number of the patients to reach 50% reduction from Baseline in plasma CRP level during the treatment period

Time: Baseline to Day 14

Description: Inflammatory Biomarker Measure

Measure: Change from Baseline to Day 7 and Day 14 in serum cytokine levels

Time: Baseline to Day 7 and Day 14

Description: Biomarker Assessment for Target Engagement

Measure: Change from Baseline to Day 7 and Day 14 in plasma pRIP1 and pMLKL levels

Time: Baseline to Day 7 and Day 14

Description: Biomarker Assessment for Kidney Injury

Measure: Change from Baseline to Day 7 and Day 14 in urine NGAL and KIM-1 levels

Time: Baseline to Day 7 and Day 14

Description: Assessment of PK profile

Measure: Plasma drug levels

Time: Baseline to Day 7 and Day 14
517 A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and SARS-CoV-2 Infection

Prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection

NCT04623138
Conditions
  1. Covid19
  2. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To develop a database of physiological and behavioral data via wearable devices and self-reported questionnaires (e.g.,symptoms) combined with laboratory confirmation of SARS- CoV-2 infection.

Measure: Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection

Time: Through study completion, an average of 7 months

Description: Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.

Measure: Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data

Time: Through study completion, an average of 7 months

Description: Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection.

Measure: Development of analytical models for real-time COVID-19 surveillance at the individual and population levels

Time: Through study completion, an average of 7 months

Secondary Outcomes

Description: Model performance and accuracy characteristics of the analytical models on hold out data sets

Measure: Performance of the analytical models for real-time COVID-19 surveillance at the individual and population levels.

Time: Through study completion, an average of 7 months
518 Adaptive Study to Demonstrate Efficacy and Safety of Metformin Glycinate for the Treatment of Hospitalized Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb

The purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.

NCT04625985
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Drug: Metformin Glycinate
  2. Drug: Placebo oral tablet
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Description: Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate

Measure: Viral load

Time: Day 0 to Day 28 or patient discharge day

Description: Clinical status assessed by measurement of consciousness level: alertness

Measure: consciousness level

Time: Day 0 to Day 28 or patient discharge day

Description: Clinical status assessed by measurement of axillary body temperature in °C: <37.2.

Measure: temperature

Time: Day 0 to Day 28 or patient discharge day

Description: Clinical status assessed by measurement of systolic blood pressure in mmHg: >90.

Measure: systolic blood pressure

Time: Day 0 to Day 28 or patient discharge day

Description: Clinical status assessed by measurement of oxygen saturation in %: >90.

Measure: Oxigen saturation

Time: Day 0 to Day 28 or patient discharge day

Description: Clinical status assessed by measurement of heart rate in beats per minute: <100 bpm.

Measure: Heart rate

Time: Day 0 to Day 28 or patient discharge day

Description: Clinical status assessed by measurement of respiratory rate in breaths per minute: <24 bpm,

Measure: respiratory rate

Time: Day 0 to Day 28 or patient discharge day

Description: Assess length of hospitalization

Measure: Days of hospitalization

Time: Day 0 to Day 28 or patient discharge day

Description: Assess length of supplementary oxygen

Measure: Days of supplementary oxygen if applies

Time: Day 0 to Day 28 or patient discharge day

Description: Assess length of mechanical ventilation

Measure: Days of supplementary mechanical ventilation

Time: Day 0 to Day 28 or patient discharge day

Secondary Outcomes

Description: Assess by incidence of Grade 3, Grade 4, and Serious Adverse Events (AEs)

Measure: Toxicity of study drug assessed by incidence of adverse events (grade 3 or 4)

Time: Day 0 to Day 28 or patient discharge day

Description: Changes in serum levels from security laboratories compared to baseline levels and between groups.

Measure: Changes in laboratory test results

Time: Day 0 to Day 28 or patient discharge day
519 International Registry of Healthcare Workers Exposed to COVID-19 Patients

The International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global), is an international registry of approximately 10,000 healthcare workers in low- and middle-income countries experiencing increasing numbers of COVID-19 cases and commensurate increased exposure to the SARS-CoV-2 virus among their healthcare worker populations.

NCT04626076
Conditions
  1. SARS-CoV Infection
  2. Covid19
Interventions
  1. Other: Comparative Observational Cohort Study
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Occurrence of SARS-CoV-2 infection among HCWs caring for COVID-19 patients, in terms of time, geography, healthcare setting, type of HCW.

Time: 12 weeks

Secondary Outcomes

Measure: Occurrence of SARS-CoV-2 uninfected HCWs

Time: 12 weeks

Measure: Occurrence of SARS-CoV-2 infection with ambulatory status and no limitation of activities

Time: 12 weeks

Measure: Occurrence of SARS-CoV-2 infection with ambulatory status and limitation of activities

Time: 12 weeks

Measure: Occurrence of hospitalization due to COVID-19 illness with mild disease

Time: 12 weeks

Measure: Occurrence of hospitalization due to COVID-19 illness with severe disease

Time: 12 weeks

Measure: Occurrence of all-cause mortality

Time: 12 weeks

Measure: Type of prophylactic treatments by dose, frequency and duration, overall and by country/region/site

Time: 12 weeks
520 Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.

The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.

NCT04626089
Conditions
  1. Severe Acute Respiratory Syndrome Coronavirus 2
  2. Metabolic Syndrome
  3. Type 2 Diabetes
Interventions
  1. Drug: metformin glycinate
  2. Drug: Placebo oral tablet
MeSH:Coronavirus Infections Severe Acute Resp Severe Acute Respiratory Syndrome Diabetes Mellitus, Type 2 Metabolic Syndrome Syndrome
HPO:Type II diabetes mellitus

Primary Outcomes

Description: Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate

Measure: Viral Load

Time: Day 0 to Day 8 or patient discharge day

Secondary Outcomes

Description: Assess length of supplementary oxygen

Measure: Days of supplementary oxygen if apply

Time: Day 0 to day 28 or patient discharge day

Description: Assess length of mechanical ventilation

Measure: Days of supplementary mechanical ventilation if apply

Time: Day 0 to day 28 or patient discharge day

Description: Assess length of hospitalization

Measure: Days of Hospitalization

Time: Day 0 to day 28 or patients discharge day

Description: Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate

Measure: Normalization of fever

Time: Day 0 to day 28 or patient discharge day

Description: Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate

Measure: Normalization of oxigen saturation

Time: Day 0 to day 28 or patient discharge day

Description: Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate

Measure: Number of deaths

Time: Day 0 to day 28 or patient discharge day

Description: Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl

Measure: Change in Serum creatinine levels

Time: Day 0 to day 28 or patients discharge day

Description: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l

Measure: Change in serum Troponin I

Time: Day 0 to day 28 or patients discharge day

Description: Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l

Measure: Change in serum aspartate aminotransferase levels

Time: Day 0 to day 28 or patients discharge day

Description: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l

Measure: Change in serum Creatine kinase-MB levels

Time: Day 0 to day 28 or patients discharge day

Description: Assess by incidence of grade 3, grade 4 and Serious adverse events

Measure: Incidence of adverse event

Time: Day 0 to day 28 or patients discharge day
521 The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C. In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.

NCT04627233
Conditions
  1. Covid19
  2. Treatment
  3. Corona Virus Infection
Interventions
  1. Drug: Human Ezrin Peptide 1 (HEP1)
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Time to clinical improvement of disease symptoms

Time: 7 days

Measure: Duration of Hospitalization

Time: 28 days

Measure: Duration of artificial ventilation

Time: 28 days

Secondary Outcomes

Description: Range 0-40

Measure: CT Severity score

Time: 28 days

Measure: CBC

Time: 28 days

Measure: IL-1

Time: 28 days

Measure: IL-6

Time: 28 days

Measure: TNF

Time: 28 days

Measure: CRP

Time: 28 days
522 Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020

Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

NCT04627623
Conditions
  1. Covid19
  2. Respirato
  3. Respiratory Tract Infections
  4. Severe Acute Respiratory Syndrome
  5. Corona Virus Infection
  6. RNA Virus Infections
  7. Virus Disease
  8. Respiratory Tract Disease
Interventions
  1. Diagnostic Test: IgM and IgG antibodies assay
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections RNA Virus Infections Respiratory Tract Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.

Measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population.

Time: 8 months

Secondary Outcomes

Description: Prevalence of asymptomatic cases into seropositive population

Measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies

Time: 8 months
523 Double-Blind, Randomized, Placebo-Controlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects

The study is a double-blind, randomized, placebo-controlled, adaptive design, multi-center, Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects.

NCT04629703
Conditions
  1. Covid19
  2. SARS (Severe Acute Respiratory Syndrome)
  3. SARS Pneumonia
  4. SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  5. Pneumonia
  6. Pneumonia, Viral
Interventions
  1. Drug: Fostamatinib
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Progression to severe/critical disease within 29 days of first dose of study treatment

Measure: Progression to severe/critical disease within 29 days of first dose of study treatment

Time: 29 days

Secondary Outcomes

Description: Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29

Measure: Proportion of subjects transferred into the intensive care unit (ICU) or who died prior to Day 29

Time: 29 days

Description: Total number of calendar days hospitalized through Day 29

Measure: Total number of calendar days hospitalized through Day 29

Time: 29 days
524 A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

NCT04631666
Conditions
  1. SARS-CoV Infection
Interventions
  1. Biological: human monoclonal antibody DZIF-10c (Group 1A-2D)
  2. Other: Placebo (NaCl 0.9%) (Group 2D)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: 3 Month

Description: Reactogenicity Events occurring during the first week after study drug administration will be separately summarized based on their relationship to the study drug.

Measure: Incidence of Reactogenicity Adverse Events [Safety and Tolerability]

Time: 1. Week

Secondary Outcomes

Description: AUC0-672 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 672 hours (Day 28))

Measure: Pharmacokinetic parameter AUC0-672

Time: 0 to 672 hours

Description: AUC0-504 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 504 hours) in healthy volunteers

Measure: Pharmacokinetic parameter tmax

Time: 0 to 504 hours

Description: AUC0-inf (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 extrapolated to infinity)

Measure: Pharmacokinetic parameter AUC0-inf

Time: 3 Month

Description: Cmax (maximum measured concentration of DZIF-10c in serum)

Measure: Pharmacokinetic parameter Cmax

Time: 3 Month

Description: t1/2 (the terminal elimination half-life of DZIF-10c in serum)

Measure: Pharmacokinetic parameter t1/2

Time: 3 Month

Description: CL (total clearance of DZIF-10c in serum following i.v. administration)

Measure: Pharmacokinetic parameter CL

Time: 3 Month

Description: Vss (volume of distribution at steady state following i.v. administration)

Measure: Pharmacokinetic parameter Vss

Time: 3 Month

Description: Vz (volume of distribution during the terminal phase following i.v. administration)

Measure: Pharmacokinetic parameter Vz

Time: 3 Month

Description: The frequency of participants with antibodies and magnitude of antibodies targeting DZIF-10c will be calculated and described in tables.

Measure: Anti-Drug Antibodies

Time: 3 Month

Description: Viral Shedding Determined by qRT-PCR in nasopharyngeal swabs

Measure: Viral Shedding nasopharyngeal

Time: Day 0-28

Description: Viral Shedding Determined by qRT-PCR in oropharyngeal swabs

Measure: Viral Shedding oropharyngeal

Time: Day 0-28

Description: Frequency of viral shedding by as determined by successful isolation of infectious virus in virus isolation assays will be analysed by visit at baseline and at days 1 and 3 (Groups 2C-2D).

Measure: Viral Shedding Determined by the Isolation of Infectious Virus

Time: Day 0-3

Description: Levels of subgenomic SARS-CoV-2 mRNA will be determined swab samples by qRT-PCR (Groups 2C-2D).

Measure: Viral Replication Determined by Subgenomic SARS-CoV-2 mRNA

Time: 3 Month

Description: The frequency of unplanned hospitalizations and medically-attended contacts deemed to be related to COVID-19 by the Investigator will be described (Groups 2C-2D).

Measure: Frequency of COVID-19-related hospitalizations and medically-attended contacts

Time: 3 Month

Description: The duration of COVID-19-related symptoms will be described based on participants's self-assessment documented on patient diaries.

Measure: Duration of COVID-19 symptoms

Time: 3 Month

Description: SARS-CoV-2-reactive B cells and T cells are evaluated as number of participants with reactive cells and as activity of reactive cells. This analysis only takes place in SARS-CoV-2-infected individuals (2C, 2D).

Measure: Activity and Frequency of SARS-CoV-2-reactive immune responses

Time: 3 Month
525 A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected individuals

NCT04631705
Conditions
  1. SARS-CoV Infection
Interventions
  1. Biological: human monoclonal antibody DZIF-10c (Group 1A-2D)
  2. Other: Placebo (NaCl 0.9%) (Group 2D)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Primary target variables are (S)AEs and Adverse Events of Special Interest (AESIs)

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: 3 Month

Description: Reactogenicity Events occurring during the first week after study drug administration will be separately summarized based on their relationship to the study drug.

Measure: Incidence of Reactogenicity Adverse Events [Safety and Tolerability]

Time: 1. Week

Secondary Outcomes

Description: AUC0-672 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 672 hours (Day 28))

Measure: Pharmacokinetic parameter AUC0-672

Time: 0 to 672 hours

Description: AUC0-504 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 504 hours) in healthy volunteers

Measure: Pharmacokinetic parameter tmax

Time: 0 to 504 hours

Description: AUC0-504 (the area under the concentration-time curve of DZIF-10c in serum over the time interval from 0 to 504 hours) in healthy volunteers

Measure: Pharmacokinetic parameter AUC0-inf

Time: 0 to 504 hours

Description: Cmax (maximum measured concentration of DZIF-10c in serum)

Measure: Pharmacokinetic parameter Cmax

Time: 3 Month

Description: t1/2 (the terminal elimination half-life of DZIF-10c in serum)

Measure: Pharmacokinetic parameter t1/2

Time: 3 Month

Description: CL (total clearance of DZIF-10c in serum following i.v. administration)

Measure: Pharmacokinetic parameter CL

Time: 3 Month

Description: Vss (volume of distribution at steady state following i.v. administration)

Measure: Pharmacokinetic parameter Vss

Time: 3 Month

Description: Vz (volume of distribution during the terminal phase following i.v. administration)

Measure: Pharmacokinetic parameter Vz

Time: 3 Month

Description: The frequency of participants with antibodies and magnitude of antibodies targeting DZIF-10c will be calculated and described in tables.

Measure: Anti-Drug Antibodies

Time: 3 Month

Description: Viral Shedding Determined by qRT-PCR in nasopharyngeal swabs

Measure: Viral Shedding nasopharyngeal

Time: Day 0-28

Description: Viral Shedding Determined by qRT-PCR in oropharyngeal swabs

Measure: Viral Shedding oropharyngeal

Time: Day 0-28

Description: Frequency of viral shedding by as determined by successful isolation of infectious virus in virus isolation assays will be analysed by visit at baseline and at days 1 and 3 (Groups 2C-2D).

Measure: Viral Shedding Determined by the Isolation of Infectious Virus

Time: Day 0-3

Description: Levels of subgenomic SARS-CoV-2 mRNA will be determined swab samples by qRT-PCR (Groups 2C-2D).

Measure: Viral Replication Determined by Subgenomic SARS-CoV-2 mRNA

Time: 3 Month

Description: The frequency of unplanned hospitalizations and medically-attended contacts deemed to be related to COVID-19 by the Investigator will be described (Groups 2C-2D).

Measure: Frequency of COVID-19-related hospitalizations and medically-attended contacts

Time: 3 Month

Description: The duration of COVID-19-related symptoms will be described based on participants's self-assessment documented on patient diaries.

Measure: Duration of COVID-19 symptoms

Time: 3 Month

Description: SARS-CoV-2-reactive B cells and T cells are evaluated as number of participants with reactive cells and as activity of reactive cells. This analysis only takes place in SARS-CoV-2-infected individuals (2C, 2D).

Measure: Activity and Frequency of SARS-CoV-2-reactive immune responses

Time: 3 Month
526 A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial of Intravenous Zotatifin in Adults With Mild or Moderate Coronavirus Disease 2019 (COVID-19)

To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.

NCT04632381
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Zotatifin
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence of Treatment Emergent Adverse Events and Serious Adverse Events

Measure: Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events

Time: 52 days

Description: Adverse Events of Special Interest to be assessed: Incidence of hospitalizations incidence of cytokine release syndrome hemophagocytic lymphohistiocytosis acute respiratory distress syndrome need for oxygen supplementation

Measure: Safety as assessed by the incidence of adverse events of special interest:

Time: 52 days

Description: Changes as assessed by respiration rate

Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by heart rate

Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by oxygen saturation

Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by temperature

Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by blood pressure

Measure: Tolerability as assessed by changes in vital signs from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by physical exam

Measure: Tolerability as assessed by changes in clinical symptoms from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by serum chemistry

Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by hematology

Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by coagulation

Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)

Time: 22 days

Description: Changes as assessed by urinalysis

Measure: Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)

Time: 22 days

Secondary Outcomes

Description: Defined as the time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from swab specimen

Measure: Time to viral load undetectability;

Time: 22 days

Description: Assessed by swab specimen

Measure: Proportion of patients with SARS-CoV-2 viral load below the level of detectability;

Time: 22 days

Description: Assessed by swab specimen

Measure: Mean change in SARS-CoV-2 viral load;

Time: 22 days

Description: Defined as resolution of symptoms on the WHO 9-point ordinal scale for clinical improvement.

Measure: The time to clinical resolution;

Time: 52 days

Description: Concentrations at end of infusion, end of dosing interval, and on defined timepoint periods.

Measure: Zotatifin plasma concentrations

Time: 15 days

Other Outcomes

Description: Time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from daily samples

Measure: Time to viral load undetectability

Time: 22 days

Description: Assessed from daily saliva and anterior nasal samples

Measure: Proportion of patients below the limit of detection

Time: 22 days

Description: Assessed from daily saliva and anterior nasal samples

Measure: Mean change in viral load in saliva and nasal samples

Time: 22 days

Description: Assessed from plasma collected

Measure: Mean change in viral load in plasma

Time: 22 days

Description: Assessed by plaque-based or comparable assay

Measure: Assessment and quantification of infectious virus

Time: 22 days

Description: According Virus Analysis Plan

Measure: Virus resistance

Time: 22 days

Description: Assessed in change from baseline to post infusion

Measure: Change in the WHO 9-point ordinal scale for clinical improvement

Time: 38 days
527 Serological Diagnostics of COVID-19 and Risk Factors for Infection Among Different Groups of Health Care Workers at Surgical Division at Tertiary Hospital

All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.

NCT04635592
Conditions
  1. SARS-CoV Infection
Interventions
  1. Diagnostic Test: SARS-CoV2 nasal swab
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers

Measure: positive nasal swab and serological test

Time: 2 months

Secondary Outcomes

Description: Relation of positive SARS-CoV2 tests to history of contacts with COVID-19 infected patients since the beginning of pandemia

Measure: Relation of positive SARS-CoV2 tests to risky contact history

Time: 8 months
528 Randomized Phase IIA Clinical Trial to Compare the Efficacy of Ivermectin Versus Placebo to Obtain Negative PCR Results in Patients With Early Phase COVID-19

SAINT-PERU is a triple-blind, randomized controlled trial with two parallel groups to compare the efficacy of ivermectin versus placebo to obtain negative PCR results in patients with early phase COVID-19. The trial is currently planned at a single center in Lima.

NCT04635943
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. SARS-CoV Infection
Interventions
  1. Drug: Ivermectin
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment

Measure: Proportion of patients with a positive SARS-CoV-2 PCR.

Time: 7 days post-treatment

Secondary Outcomes

Description: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab

Measure: Mean viral load

Time: Baseline and on days 4, 7, 14 and 21

Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial

Measure: Fever and cough progression

Time: Up to and including day 21

Description: Proportion of participants with positive IgG at day 21

Measure: Seroconversion at day 21

Time: Up to and including day 21

Description: Proportion of drug-related adverse events

Measure: Proportion of drug-related adverse events

Time: 7 days post treatment

Measure: Levels of IgG, IgM and IgA

Time: Up to and including day 21

Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry

Measure: Frequency of innate immune cells

Time: Up to and including day 7

Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry

Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells

Time: Up to and including day 7

Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)

Measure: Results from cytokine Human Magnetic 30-Plex Panel

Time: Up to and including day 21

Description: Proportion and parasitic load of intestinal helminths by quantitative Kato-katz and Baerman method

Measure: Presence of intestinal helminths

Time: Baseline and on day 14.
529 Restoring Non-Emergent Cardiovascular Care in the Peri-COVID 19 Era

Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures

NCT04636021
Conditions
  1. Corona Virus Infection
Interventions
  1. Diagnostic Test: COVID-19 testing
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures

Time: Through 30 day follow up period

Secondary Outcomes

Measure: Patient perception of the effect of pre and post procedure COVID-19 testing on risk of contracting COVID-19 while hospitalized for an elective outpatient procedure.

Time: Through 30 day follow up period
530 Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial)

Low-dose glucocorticoid treatment is the only intervention shown to significantly reduce mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support. In particular, a large UK randomized controlled trial (RECOVERY trial) demonstrated the efficacy of dexamethasone at a dosage of 6mg/day for 10 days in reducing mortality compared to usual therapy, with a greater impact on patients requiring mechanical ventilation (36% reduction) or oxygen therapy (18% reduction) than on those who did not need respiratory support (doi: 10.1056/NEJMoa2021436). However, there is still paucity of information guiding glucocorticoid administration in severe pneumonia/ARDS and no evidence of the superiority of a steroid drug -nor of a therapeutic scheme- compared to the others, which led to a great heterogeneity of treatment protocols and misinterpretation of available findings. In a recent longitudinal observational study conducted in Italian respiratory high-dependency units, a protocol with prolonged low-dose methylprednisolone demonstrated a 71% reduction in mortality and the achievement of other secondary endpoints such as an increase in ventilation-free days by study day 28 in a subgroup of patients with severe pneumonia and high levels of systemic inflammation (doi: 10.1093/ofid/ofaa421). The treatment was well tolerated and did not affect viral shedding from the airways. In light of these data, the present study aims to compare the efficacy of a methylprednisolone protocol and that of a dexamethasone protocol based on previous evidence in increasing survival by day 28, as well as in reducing the need and duration for mechanical ventilation, among hospitalized patients requiring noninvasive respiratory support (oxygen supplementation and/or noninvasive ventilation).

NCT04636671
Conditions
  1. Covid19
  2. Viral Pneumonia Human Coronavirus
  3. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: Methylprednisolone
  2. Drug: Dexamethasone
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Survival proportion at 28 days in both arms

Measure: Survival

Time: 28 days

Secondary Outcomes

Description: Number of days free from mechanical ventilation (either noninvasive or invasive) by study day 28 in both arms

Measure: Reduction in the need for mechanical ventilation

Time: 28 days

Description: Number of days of hospitalization for patients discharged alive in both arms

Measure: Length of hospitalization

Time: From date of randomization until the date of hospital discharge, assessed up to 60 days

Description: Proportion of patients requiring tracheostomy in both arms

Measure: Need for tracheostomy

Time: Day 28

Description: C-reactive protein level (mg/L) at study day 3, 7 and 14 in both arms

Measure: Reduction in systemic inflammation markers

Time: Day 3, 7 and 14

Description: PaO2/FiO2 ratio (mmHg) at study day 3, 7 and 14 in both arms

Measure: Amelioration of oxygenation

Time: Day 3, 7 and 14

Description: WHO clinical progression scale at study day 3, 7 and 14 in both arms

Measure: Disease progression

Time: Day 3, 7 and 14
531 An Event-Driven, Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy, Safety, Immunogenicity, Lot-to-Lot Consistency of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Adults≥18 Yrs of Age

The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152.

NCT04641481
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Biological: BBV152
  2. Biological: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: (RT-PCR positive) symptomatic cases of COVID-19.

Measure: First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19.

Time: Day 42 to Month 12

Secondary Outcomes

Description: (RT-PCR positive) symptomatic cases of COVID-19.

Measure: First occurence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint.

Time: Day 42 to Month 12

Description: (RT-PCR positive) severe symptomatic cases of COVID-19.

Measure: Virologically confirmed (RT-PCR positive) severe cases of COVID-19

Time: Day 42 to Month 12

Description: (RT-PCR positive) symptomatic cases of COVID-19

Measure: Virologically confirmed COVID-19 cases of any severity occurring among participants 18 through 59 years of age and ≥60 years of age.

Time: Day 42 to Month 12

Description: (RT-PCR positive) asymptomatic/symptomatic cases of COVID-19.

Measure: Virologically confirmed COVID-19 asymptomatic and symptomatic cases occurring from two weeks after the second vaccination.

Time: Day 42 to Month 12

Description: Solicited, Unsolicited, Serious Adverse Events

Measure: Reactogenicity and Safety

Time: Day 42 to Month 12

Description: Reported by participant/documented in hospital records throughout the trial.

Measure: The occurrence of enhanced respiratory disease episodes.

Time: Day 42 to Month 12

Description: Assessed based Wild-type SARS-CoV-2 Specific Neutralizing Antibody (nAb)

Measure: Immunogenicity: Lot-to-Lot consistency of three consecutive GMP Lots

Time: Day 0 to Day 42

Description: Specific Neutralizing Antibody (nAb)

Measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

Time: Day 0 to Month 12
532 Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure

This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 6178 participants.

NCT04642638
Conditions
  1. Coronavirus Infection
  2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  3. COVID-19 Disease
Interventions
  1. Drug: INO-4800
  2. Device: CELLECTRA® 2000
  3. Drug: Placebo
  4. Device: CELLECTRA® 2000
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay

Time: Baseline up to Day 393

Measure: Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay

Time: Baseline up to Day 393

Measure: Phase 3: Percentage of Participants With Virologically-confirmed COVID-19 Disease

Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

Secondary Outcomes

Measure: Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions

Time: From time of consent up to 28 days post-dose 2 (up to Day 56)

Measure: Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs)

Time: From time of consent up to 28 days post-dose 2 (up to Day 56)

Measure: Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)

Time: Baseline up to Day 393

Measure: Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)

Time: Baseline up to Day 393

Measure: Phase 3: Percentage of Participants With Death From All Causes

Time: Baseline up to Day 393

Measure: Phase 3: Percentage of Participants With Non-Severe COVID-19 Disease

Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

Measure: Phase 3: Percentage of Participants With Severe COVID-19 Disease

Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

Measure: Phase 3: Percentage of Participants With Death From COVID-19 Disease

Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

Measure: Phase 3: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infections

Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

Measure: Phase 3: Days to Symptom Resolution in Participants With COVID-19 Disease

Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

Measure: Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay

Time: Baseline up to Day 393

Measure: Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay

Time: Baseline up to Day 393
533 Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial

Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.

NCT04643678
Conditions
  1. Covid19
  2. Pneumonia
  3. Cytokine Release Syndrome
  4. Corona Virus Infection
  5. Viral Infection
Interventions
  1. Drug: Anakinra
  2. Other: Standard of Care
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Defined as WHO Clinical Progression score of <6 [patient alive, not requiring invasive, non-invasive, or high flow oxygen therapy, vasopressors, dialysis or Extracorporeal membrane oxygenation (ECMO)].

Measure: Treatment Success at day 14

Time: Day 14

Secondary Outcomes

Description: Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]

Measure: Change in WHO Clinical Progression Score

Time: Day 7

Description: Time to ICU admission up to 28 days

Measure: Time to ICU admission

Time: Day 28

Description: Incidence of adverse events up to 28 days

Measure: Incidence of Adverse Events

Time: Day 28

Description: Length of hospital stay up to 28 days

Measure: Length of hospital stay

Time: Day 28

Description: All-cause mortality rate at hospital discharge or at 28 days, whichever is first

Measure: All-cause Mortality

Time: Day 28
534 Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools. The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.

NCT04644159
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
  2. Covid19
Interventions
  1. Other: Human biological samples
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: Description of the serological status of individuals

Measure: Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.

Time: 2 years

Secondary Outcomes

Description: Detection over time the specific T cell response to the SARS-CoV-2 virus.

Measure: Presence of specific T cell response to the SARS-CoV-2

Time: 2 years
535 A Multi-centre, Randomised, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland

Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes. The aim of the study is to answer the following questions: 1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)? 2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects? 3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result? A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*. Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19. * to measure the level of cytokines involved in cell-mediated immunity process

NCT04648800
Conditions
  1. Covid19
  2. BCG Vaccination Reaction
  3. SARS-CoV Infection
Interventions
  1. Drug: BCG-10 vaccine
  2. Drug: 0.9% saline
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: shock - when catecholamines are required despite initial fluid resuscitation severe respiratory failure - the need for non-invasive or invasive ventilation severe renal failure - the need for renal replacement therapy (for undialysed individuals, i.e. with end-stage renal failure (ESRD)

Measure: death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia)

Time: throughout the period of 18 months from inclusion

Secondary Outcomes

Description: Present symptoms (determined in the Telephone Contact Card) appear to indicate a possible SARS-CovV-2 infection

Measure: Onset of clinical symptoms of COVID-19

Time: 12 weeks from the date of the third visit - V3

Description: based on anti SARS-CoV-2 IgG serological tests

Measure: asymptomatic SARS-CovV-2 infection

Time: 12 weeks from the date of the third visit - V3

Description: the need for hospitalisation and its duration

Measure: Hospitalisation

Time: 12 weeks from the date of the third visit - V3

Description: the need for hospitalisation in the ICU and its duration

Measure: ICU Hospitalisation

Time: 12 weeks from the date of the third visit - V3

Description: requiring passive oxygen therapy to eliminate the symptom or maintain saturation >92%

Measure: Dyspnoea

Time: 12 weeks from the date of the third visit - V3
536 AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19

The study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline).

NCT04649775
Conditions
  1. Corona Virus Infection
  2. Respiratory Rate
  3. Hypoxia
  4. Covid19
Interventions
  1. Device: AirFLO2
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Tachypnea Hypoxia
HPO:Hypoxemia Tachypnea

Primary Outcomes

Description: Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio inspired oxygen- P:F ratio (PaO2:FiO2), a higher value indicates better oxygenation. Range 20 to 500.

Measure: Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio

Time: change from baseline compared to one to six hours after initial device intervention

Secondary Outcomes

Description: Improved symptoms related to dyspnea as measured by the change in the Modified Medical Research Council (MMRC).. Range 0 to 4 with lower values being better.

Measure: Subject dyspnea symptoms

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Improved symptoms related to cough as measured by the change in Leicester Cough Questionnaire (LCQ) questionnaire, score range 3-21, a higher score indicates better quality of life.

Measure: Subject cough symptoms

Time: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients

Description: Improve subjective symptoms related to cough as measured by the change in St George Respiratory Questionnaire (SGRC) questionnaire, score range 0-100, a higher score indicates worse quality of life.

Measure: Subject respiratory symptoms

Time: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients

Description: Reduce risk of respiratory deterioration as measured by change from baseline to end of hospitalization (discharge or patient death) to high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or invasive ventilation

Measure: Reduced risk progression of respiratory deterioration

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Reduced intensive care unit (ICU) transfer risk, as measured by a change from baseline to end of hospitalization of ICU admission.

Measure: Reduced risk of ICU transfer

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death)

Measure: Reduced risk for intubation

Time: baseline to end of hospitalization, (discharge from hospital, or death, 1 - 30 days range)

Description: Reduced hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.

Measure: Reduced hospitalization length of stay

Time: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)

Description: Increased patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)

Measure: Increased patient survival to discharge

Time: baseline to end of hospitalization, (discharge from hospital- 1 - 30 days expected range)
537 Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial

As a direct consequence of the COVID-19 pandemic, it is assumed that the number of patients with COVID-19-related disabilities will increase significantly. Patients with mild, severe, and critical forms of the disease show long-term sequelae in different systems (respiratory, muscular, psychological, cognitive etc.). Persistent dyspnea is a frequently described symptom after the acute phase of the disease. Coupled with reduced oxygen saturation, an increased risk of developing lung fibrosis has been observed. Specialized rehabilitation medicine (e.g. pulmonary rehabilitation) might counteract these long-term consequences and therefore seems to be a promising approach to treat long-term COVID-19 consequences. Further, there is scarce evidence about COVID-19 specific rehabilitation contents. It was suggested to use treatment regimes in analogy to patients with idiopathic pulmonary fibrosis. There is evidence that pulmonary rehabilitation improves physical performance, quality of life and reduces anxiety and depression symptoms in patients with idiopathic pulmonary fibrosis and other chronic respiratory diseases. Since impairments related to idiopathic pulmonary fibrosis also play an important role in COVID-19, the aim of this study is to evaluate the short and medium-term effects of a standardized 3-week pulmonary rehabilitation program. The results will be analyzed within the two cohorts (mild/moderate and severe/critical COVID 19) as well as between the two cohorts for the primary outcome. Furthermore, the effects of pulmonary rehabilitation will be compared with a retrospective cohort of idiopathic pulmonary fibrosis.

NCT04649918
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Pulmonary Rehabilit
  4. Pulmonary Rehabilitation
  5. Quality of Life
Interventions
  1. Other: pulmonary rehabilitation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: measure in meter

Measure: Change in 6-minute walk distance

Time: Day 1 and day 21 of pulmonary rehabilitation

Secondary Outcomes

Description: measure provided in seconds

Measure: change in endurance shuttle walk distance

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: measure provided in % predicted

Measure: Change in Diffusion capacity of the lungs for Carbon monoxide

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: measure provided in % predicted

Measure: Change in Forced Vital Capacity

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: measure provided in % predicted

Measure: Change in total lung capacity

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: score ranges from 0 to 30 with lower score indicating higher cognitive impairment

Measure: change in Montreal cognitive assessment test

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: score ranges from 0 to 100 with higher scores indicating better Quality of life

Measure: change in short-form 36 question health survey

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: A questionnaire designed to measure self-reported physical, mental and social health and wellbeing. Higher scores represent worse symptomatology in relation to the mean value of 50 points with a standard deviation of 10 points.

Measure: change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: score ranges from 0 to 21 with higher scores indicating more severe anxiety

Measure: Change in the scale of general anxiety disorder - 7 questionnaire (GAD-7)

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: score ranges from 0 to 27 with higher scores indicating more severe depression

Measure: Change in the scale of the patient health questionnaire - Depression (PHQ-D)

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: patients will be asked if they still perceive COVID-19 related dyspnea: answer possibilities yes or no

Measure: Change in prevalence of COVID-19 related dyspnea

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: patients will be asked if they still perceive COVID-19 related cough: answer possibilities yes or no

Measure: Change in prevalence of COVID-19 related cough

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: patients will be asked if they still perceive COVID-19 related cognitive impairment: answer possibilities yes or no

Measure: Change in prevalence of COVID-19 related cognitive impairment

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: patients will be asked if they still perceive COVID-19 related loss of appetite: answer possibilities yes or no

Measure: Change in prevalence of COVID-19 related loss of appetite

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: scale from 1 (worst) to 10 (best)

Measure: Change in general perceived well-being

Time: Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation

Description: in mg/l

Measure: change in D-Dimer level

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: in mg/l

Measure: change in c-reactive protein level

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: in g/l

Measure: change in leukocytes level

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: in g/dl

Measure: change in hemoglobin level

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: in pg/ml

Measure: change in troponin level

Time: Day 1 and day 21 of pulmonary rehabilitation

Description: in pg/ml

Measure: change in pro-brain natriuretic peptide level

Time: Day 1 and day 21 of pulmonary rehabilitation
538 Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative

Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath. In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

NCT04649931
Conditions
  1. SARS (Severe Acute Respiratory Syndrome)
  2. Covid19
Interventions
  1. Device: Ion Mobility Spectrometry (IMS)
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Measure: SARS-CoV-2 related volatile organic compounds (VOC)

Time: 1 hour after breath gas sampling

Secondary Outcomes

Measure: To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)

Time: within 1 hour
539 Surfactant Protein Genetic Variants in COVID-19 Infection

Surfactant protein plays important role in innate immunity against respiratory viral infections. However, investigators have shown that the surfactant protein polymorphisms are associated with severity of various pulmonary diseases such as respiratory syncytial virus (RSV), tuberculosis, pediatric acute lung injury. COVID-19 virus gains entry through the respiratory system and responsible for death due to acute respiratory failure. There is a considerable heterogeneity in presentation of COVID-19 infection from asymptomatic patients to severe infection requiring intensive care and some may die. Considering reports of COVID-19 related deaths/severe disease in the same family, it is possible that genetics play an important role in severity of COVID-19 infection. Investigators propose to study the association of surfactant proteins in COVID-19 patients. Key Objectives: a) Characterize genetic markers within the surfactant protein genes in COVID-19 positive patients, b) To determine if there is a correlation between certain genetic markers and the severity of COVID-19 infection which may be used as a prognostic marker, c) To correlate genetic markers with immune studies.

NCT04650191
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: Identification of genetic variants
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Correlation of surfactant protein genetic variants with severity of COVID-19 infection

Time: 12 months
540 Efficacy and Safety of Ozonised Oil (HOO) as Adjuvant Nutrition Supplement in COVID-19 Patients With Mild-to-Moderate Disease - HOO-COVID Project

The anti-viral efficacy of ozone against RNA viruses is already established. Ozone gas have been already proposed as possible therapy for Covid-19 infection with insofar limited success. The development of ozonized oil (HOO) solved this problems making ozone highly stable and bioavailable due to its bound with the lipid carrier. HOO administration is totally noninvasive occurring by oral administration of pills or as nasal spray. HOO regimen could be proposed as complimentary therapeutic treatment for Covid-19 infection, without the need of any modifications of the established standard therapeutic protocols. This complimentary treatment, could be helpful to (a) decrease the severity of the diseases lowering the number of Covid-19 patients requiring high-intensity therapies; (b) fasten qPCR negativization after disease and time-span of hospital recovery. The objective of this study is to investigates the effectiveness of combined use of "HOO capsules" and "HOO oropharyngeal and nasal spray" as a therapeutic supplement in the treatment of patients with confirmed COVID-19, who are moderately ill.

NCT04651387
Conditions
  1. SARS-CoV Infection
Interventions
  1. Dietary Supplement: Ozonized oil (HOO
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The study is aimed at defining if HOO therapy decreases the viral load of SARS-CoV-2 at day 7.

Measure: Viral load of SARS-CoV-2

Time: up to one week

Secondary Outcomes

Description: The temporal profile of viral load at baseline, day 7, 14 and 28

Measure: The temporal profile of viral load of SARS-CoV-2

Time: up to four weeks

Description: The proportion of patients with virological clearance at day 14 and 28

Measure: The proportion of patients with virological clearance

Time: up to four weeks

Description: Increasing SaO2, day 7, 14 and 28

Measure: SaO2

Time: up to four weeks

Description: The hospitalization duration stay

Measure: hospitalization stay

Time: through study completion, an average of 3 months

Description: Intensive care admission and time to

Measure: Intensive care

Time: through study completion, an average of 3 months

Description: The COVID-19 Severity Score at day 14 and 28 Score definition: 1 is "no limitation of activities"; 2 is "limitation of activities"; 3 is "hospitalized, no oxygen therapy"; 4 is " hospitalized, oxygen by mask or nasal prongs"; 5 is "non-invasive ventilation or high-flow oxygen"; 6 is "intubation and mechanical ventilation"; 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

Measure: COVID-19 Severity Score

Time: up to four weeks

Description: Death occurred during hospitalization.

Measure: in-hospital mortality

Time: through study completion, an average of 3 months
541 Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts

- organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23 - Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25 - Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27 - Additional study using this technique is warranted to look at reliability and cost-28 effectiveness

NCT04652648
Conditions
  1. Covid19
  2. Hydroxychloroquine
  3. Coronavirus Infection
  4. Transmission
  5. Prophylaxis
Interventions
  1. Drug: Hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.

Measure: COVID-19 symptom development with positive PCR test

Time: within 14 days

Secondary Outcomes

Description: Development of a positive coronavirus PCR test without symptoms by Day 14

Measure: Positive coronavirus PCR test without symptoms

Time: By Day 14 (end of study)

Description: hospital admission for COVID-19 symptoms by Day 14

Measure: Hospital admission for COVID-19

Time: within 14 days of study entry

Description: Death due to COVID-19 within 14 days of study entry

Measure: Death by Day 14

Time: within 14 days of study entry

Description: All-cause discontinuation of study medication or study withdrawal by Day 14

Measure: HCQ discontinuation or study withdrawal

Time: within 14 days of study entry

Description: overall symptom severity at Day 7 and Day 14

Measure: Symptom severity at specified time points

Time: at Day 7 and at Day 14 from study entry

Description: household attack rate at study entry

Measure: COVID -19 rate at study entry

Time: Day 1 of study

Description: documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy

Measure: EKG changes during study

Time: Day 1 thru Day 14 of study
542 COMBO Trial: Camostat With Bicalutamide for COVID-19

This will be a randomized, open-label study to determine if camostat or camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat (Arm 2) or with camostat and bicalutamide (Arm 3).

NCT04652765
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Coronavirus Infection
Interventions
  1. Drug: Camostat Mesilate
  2. Drug: Bicalutamide 150 mg
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28

Measure: Number of participants requiring hospitalization

Time: up to 28 days

Secondary Outcomes

Measure: Number of participants experiencing symptoms

Time: up to 21 days

Description: Number of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)

Measure: Number of drug-related adverse events

Time: up to 60 days

Description: Number of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)

Measure: Number of drug-related serious adverse events

Time: up to 60 days

Description: Number of participants deceased.

Measure: All-cause mortality

Time: up to 60 days

Other Outcomes

Description: Number of calendar days in the hospital

Measure: Duration of hospitalization

Time: up to 60 days

Measure: Number of participants requiring upgrade to intermediate care unit (IMC)

Time: up to 60 days

Description: Number of calendar days in IMC unit

Measure: Duration of IMC stay

Time: up to 60 days

Measure: Number of participants requiring upgrade to intensive care unit (ICU)

Time: up to 60 days

Description: Number of calendar days in ICU

Measure: Duration of ICU stay

Time: up to 60 days

Measure: Number of participants requiring mechanical ventilation

Time: up to 60 days

Description: Number of calendar days requiring mechanical ventilation

Measure: Duration on mechanical ventilation

Time: up to 60 days
543 SARS-Cov2 (COVID-19) Infection and Reinfection Through the Analysis of a RT-PCR Results Database

The SARS-Cov2 pandemic remains associated with many concerns. One of the them is the real frequency of likely re-infection and subsequently the level of protection conferred by the acquired immunity following primary-infection. We propose to analyze a large set of laboratory data produced since the early beginning of the SARS-Cov2 spread in the French population to identify recurrent infection events and, more generally, gain insight about infection kinetics.

NCT04653844
Conditions
  1. Covid-19
  2. SARS-CoV Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: SARS-CoV-2 reinfection rate

Measure: SARS-CoV-2 reinfection rate

Time: 1 day
544 Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases

The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing

NCT04655612
Conditions
  1. COVID-19
  2. SARS-CoV Infection
  3. Rheumatoid Arthritis
  4. Spondyloarthritis
  5. Ankylosing Spondylitis
  6. Psoriatic Arthritis
MeSH:Infection Communicable Diseases Spondylitis Coronavirus Infections Severe Acute Respiratory Syndrome Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic Spondylitis, Ankylosing Rheumatic Diseases Spondylarthritis Collagen Diseases
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

Measure: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

Time: 1 day

Secondary Outcomes

Description: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.

Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.

Time: 1 day

Description: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

Time: 1 day

Description: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics

Measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics

Time: 1 day
545 A Phase III, Randomized, Double -Blind, Placebo-controlled Trial to Evaluate Immunogenicity and Safety of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection in the United Arab Emirates

This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

NCT04656613
Conditions
  1. Covid19
  2. SARS-CoV Infection
Interventions
  1. Biological: Gam-COVID-Vac
  2. Other: placebo
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 , 120±14 and 180±14 days after the first dose

Measure: SARS-CoV-2 glycoprotein-specific antibodies titer

Time: 42±4 , 120±14 and 180±14 days

Description: Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4, 120±14 and 180±14 days after the first dose

Measure: Seroconversion rate

Time: 42±4, 120±14 and 180±14 days

Description: Interferon gamma concentration in response to S protein after re-stimulation with the SARS-CoV-2 glycoprotein in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose

Measure: IFN-gamma antigen-specific release

Time: 28±4 days

Description: The number of proliferating CD4 and CD8 cells in response to antigen stimulation in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose

Measure: CD4+/CD8+ proliferating cells

Time: 28±4 days

Description: Geometric mean virus-neutralizing antibodies titer in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 and 120±14 days after the first dose

Measure: Virus-neutralizing antibodies titer

Time: 42±4 and 120±14 days

Secondary Outcomes

Description: Incidence and severity of adverse events in trial subjects within 4 & 6 months after injecting the first dose of the study vaccine/placebo.

Measure: Incidence and severity of adverse events

Time: within 4 & 6 months
546 Expanded Access to ZofinTM (OrganicellTM Flow) for the Treatment of Patients With Mild to Moderate COVID-19 Due to SARS-Cov-2 for Outpatient and Inpatient Population

This expanded access protocol will provide access to the investigational product ZofinTM (OrganicellTM Flow) for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease.

NCT04657406
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: ZofinTM (OrganicellTM Flow)
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

547 Hospitalization or Outpatient ManagEment of Patients With Suspected or Confirmed SRAS-CoV-2 Infection: the Revised HOME-CoV Score Study.

In the context of COVID-19 pandemic, identifying low-risk patients who can be safely treated at home and high-risk patients requiring hospitalization or even intensive care is crucial for Emergency Departments. Thanks to a consensus of experts using the Delphi method, we previously defined the HOME-CoV rule. The HOME-CoV rule consists of 8 items precluding home treatment for patients consulting in the Emergency Department (ED) with confirmed or highly suspected mild to moderate COVID-19. It has been validated in a prospective study, patients with a negative rule having a very-low rate of invasive ventilation or death within the 7 days following ED presentation (HOME-CoV study, NCT: 02811237). Using logistic regression, we revised the HOME-CoV rule in order to define a score allowing. The revised HOME-CoV score comprises 7 criteria and, retrospectively assessed in the database of the HOME-CoV study, it exhibits promising performances. A revised HOME-CoV score < 2 had a sensitivity of 0.93 (0.84 to 0.98), a specificity of 0.60 (0.58 to 0.61) and negative predictive value of 1.00 (0.99 to 1.00); and a score > 4 had a sensitivity of 0.41 (0.28 to 0.54), a specificity of 0.93 (0.92 to 0.94) and a positive predictive value of 0.11 (0.07 to 0.16). The present study aims to prospectively validate the revised HOME-CoV score, firstly, in identifying a subgroup of COVID-19 patients with a low risk of evolution to severe COVID-19 and who could be safely treated at home. For this purpose, we will perform an interventional multicentric prospective pragmatic cohort study with implementation of the revised HOME-CoV score to triage COVID-19 patients.

NCT04657471
Conditions
  1. Coronavirus Infection
Interventions
  1. Other: revised HOME-CoV score
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The rate of patients with evolution to severe COVID-19 within 7 days after inclusion among patients with a revised HOME-CoV score <2. Severe COVID-19 is defined as a WHO-OSCI≥5, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7), or all-cause death (8). The revised HOME-CoV score strategy will be considered as safe if the rate of patients who experienced a WHO-OSCI≥5, will be ≤0.5% with an upper limit of the 95% confidence interval ≤1%.

Measure: The safety of the revised HOME-CoV score strategy for home treatment

Time: 7 days

Secondary Outcomes

Description: The rate of patients treated at home,i.e., discharged home within 24 hours following inclusion.

Measure: The efficacy of the revised HOME-CoV score strategy for home treatment

Time: 24 hours

Description: the rate of patients treated at home, i.e., discharged home within 24 hours following inclusion, among patients with a revised HOME-CoV score <2

Measure: The applicability of the revised HOME-CoV score strategy for home treatment

Time: 24 hours

Description: The rate of patients with a revised HOME-CoV score < 2 and treated at home who were not subsequently hospitalized within the 7 days following inclusion.

Measure: The reliability of the revised HOME-CoV score strategy for home treatment

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs. 7 days

Measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥5.

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥6 within the 7 days following inclusion, i.e., intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.

Measure: The predictive performances of the revised HOME-CoV score of evolution towards a COVID-19 with a WHO-OSCI≥6

Time: 7 days

Description: The rate of patients who dead within the 7 days following inclusion The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.

Measure: The predictive performances of the revised HOME-CoV score of evolution towards a fatal COVID-19

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC), sensitivity, specificity, negative likelihood ratio, positive likelihood ratio, negative predictive value and positive predictive value with <2 and >4 as cutoffs.

Measure: Subgroup analysis in patients with confirmed COVID-19 (positive SARS-CoV2 RT-PCR) of the predictive performances of the revised HOME-CoV score

Time: 7 days

Description: The rate of patients with a WHO-OSCI≥5 within the 7 days following inclusion, i.e., high flow nasal oxygen therapy or non-invasive ventilation (5), intubation and invasive ventilation (6), other vital support (7) or all-cause death (8). The following parameters will be calculated: the area under the receiving operating curve (AUROC)

Measure: The predictive performances of the revised HOME-CoV score as compared to those of other prognostic scores for COVID-19

Time: 7 days

Description: The rate of symptomatic and objectively confirmed deep venous thromboembolism or pulmonary embolism, and of unexplained sudden death occurring within the 7 days following ED admission.

Measure: Venous thrombo-embolism in COVID-19 patients (ancillary study)

Time: 7 days
548 A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Exploratory Efficacy and Safety Study of Glenzocimab in SARS-Cov-2-related Acute Respiratory Distress Syndrome

A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study to evaluate the efficacy and safety of glenzocimab in ARDS.

NCT04659109
Conditions
  1. SARS-CoV Infection
  2. Acute Respiratory Distress Syndrome
  3. COVID-19
  4. ARDS
Interventions
  1. Drug: glenzocimab
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acu Acute Lung Injury Syndrome

Primary Outcomes

Description: Progression from moderate to severe assessed at Day 4 is a composite failure endpoint defined as the occurrence of at least one of the following failure events : Respiratory rate (RR) ≥ 30/min, or Oxygen Saturation (SpO2) ≤ 93% in resting state, or Oxygen Pressure/ Inspired fraction (PaO2/FiO2) ≤ 200mmHg Death occurring prior to or on Day 4

Measure: Progression from moderate to severe respiratory distress assessed at Day 4

Time: Day 4

Secondary Outcomes

Measure: All cause mortality at day 40

Time: Day 40 (maximum)

Description: WHO COVID-19 Ordinal Scoring Scale is 9 point ordinal scale

Measure: WHO-COVID-19 Scale

Time: Up to Day 40

Description: Determines the degree of illness of a patient and prompts critical care intervention (recommended by NHS over original NEWS): total possible score ranges from 0 to 20. The higher the scores the greater the clinical risk.

Measure: NEWS-2 Scale

Time: Up to Day 40

Description: Respiratory Rate status defined as:: o Normal:<20/min, Mild:20/min≤RR<24/min, Moderate:24/min≤RR<30/min, o Severe:≥30/min, Death.

Measure: Respiratory Rate status (RR)

Time: Up to Day 40

Description: Hypoxemia status defined as:: o Normal:>300mmHg, Mild: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg, Moderate:100mmHg Measure: Hypoxemia status

Time: Up to Day 40

Description: SpO2 status defined as: o Normal:>95% Mild:93% Measure: SpO2 status

Time: Up to Day 40

Measure: CHEST CT-Scan (or in exceptional cases, chest radiogram)

Time: Day 4

Measure: Oxygen-free days

Time: Up to Day 40

Measure: Admission to the ICU

Time: Up to Day 40

Measure: ICU-free days

Time: Up to Day 40

Measure: Hospital-free days

Time: Up to Day 40

Measure: Clinical recovery and Time to Clinical recovery

Time: Up to Day 40

Measure: Cure and Time-to-cure

Time: Up to Day 40

Measure: Incidence, nature and severity of Adverse Events, SAEs, SUSARs and Treatment-Emergent Adverse Events (TEAEs)

Time: Up to Day 40

Measure: Incidence of bleeding-related events

Time: Up to Day 40

Measure: Incidence of hypersensitivity reactions

Time: Up to Day 40

Measure: Changes from baseline on blood pressure

Time: Up to Day 40

Measure: Changes from baseline on heart rate

Time: Up to Day 40

Measure: Changes from baseline on NFS

Time: Up to Day 40

Measure: Changes from baseline on INR/PTT

Time: Up to Day 40

Measure: Changes from baseline on platelet count

Time: Up to Day 40

Measure: Changes from baseline on plasma fibrinogen level

Time: Up to Day 40

Measure: Changes from baseline on plasma D-Dimers level

Time: Up to Day 40

Measure: Changes from baseline on serum-glucose level

Time: Up to Day 40

Measure: Changes from baseline on urea level

Time: Up to Day 40

Measure: Changes from baseline on creatinemia

Time: Up to Day 40

Measure: Changes from baseline on LFTs (ASAT/ALAT)

Time: Up to Day 40

Measure: Changes from baseline on CRP level

Time: Up to Day 40

Measure: Changes from baseline on LDH level

Time: Up to Day 40

Measure: Changes from baseline on IL6 level

Time: Up to Day 40

Measure: Changes from baseline on Tnt

Time: Up to Day 40

Measure: Changes from baseline on NT proBNP

Time: Up to Day 40

Measure: Changes from baseline on procalcitonin level

Time: Up to Day 40

Measure: Changes from baseline on ferritin level

Time: Up to Day 40

Description: Changes in one or several of the usual ECG parameters compared to baseline or screening, i.e. sinusal rhythm, cardiac axis, QRS value, QT/QTc segment, Wave direction, and any abnormality.

Measure: ECG over the course of the study versus screening

Time: Up to Day 40
549 Remote Ischemic Conditioning as an Adjunct Therapy for Severe COVID-19 Disease: a Prospective Randomized Pilot Study

This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.

NCT04659460
Conditions
  1. COVID
  2. Corona Virus Infection
  3. Acute Lung Injury
  4. Ischemia Limb
  5. Acute Respiratory Distress Syndrome
Interventions
  1. Device: Remote Ischemic Conditioning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury

Primary Outcomes

Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: Interleukin 1-Beta (IL-1B) (pg/mL)

Time: Through study completion - up to 12 months

Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: Interleukin 6 (IL-6) (pg/mL)

Time: Through study completion - up to 12 months

Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

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

Time: Through study completion - up to 12 months

Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: Tumour Necrosis Factor Alpha (TNFa) (pg/mL)

Time: Through study completion - up to 12 months

Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: Neutrophil to Lymphocyte Ratio (NLR) (absolute neutrophils/lymphocytes)

Time: Through study completion - up to 12 months

Description: Serum concentration, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: Serum Ferritin (ng/mL)

Time: Through study completion - up to 12 months

Description: Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: International Normalized Ratio (INR)

Time: Through study completion - up to 12 months

Description: Standard coagulation parameter, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point)

Measure: Prothrombin Time (PTT)

Time: Through study completion - up to 12 months

Description: ROTEM coagulation assessment using the commercial ROTEM device traditionally used for the assessment of coagulopathy, to be collected immediately before RIC treatment, treatment plus 6 hours, treatment plus 12 hours, treatment plus 24 hours, and treatment plus 48 hours (+/- 1 hour at each 0+ time point).

Measure: Rotational Thromboelastometry (ROTEM)

Time: Through study completion - up to 12 months

Secondary Outcomes

Description: Number of continuous calendar days or partial calendar days including treatment with invasive ventilation.

Measure: Total duration of mechanical ventilation (number of days)

Time: Through study completion - up to 12 months

Description: Number of continuous calendar days or partial calendar days admitted to an acute care hospital.

Measure: Intensive Care Unit Length of Stay (number of days)

Time: Through study completion - up to 12 months

Description: Number of continuous calendar days or partial calendar days admitted to an acute care hospital.

Measure: Hospital Length of Stay (number of days)

Time: Through study completion - up to 12 months
550 Prospective Studies in School-aged Children and Adolescents With COVID-19 Treated at HCFMUSP

This is a protocol aimed at children and adolescents contaminated with COVID, treated at the Hospital das Clínicas, University of Sao Paulo, Brazil (HCFMUSP), in the recovery phase. The study aims to evaluate the spectrum of pathogenic lesions of the virus not only in the respiratory system, but digestive, immunological, neurological and others. Clinical, evolutionary, laboratory and functional parameters will be used.

NCT04659486
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. SARS (Severe Acute Respiratory Syndrome)
  4. SARS-CoV Infection
Interventions
  1. Behavioral: Home-based exercise training
MeSH:Infection Communicable Diseases Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The instrument was translated and validated for the Brazilian population

Measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)

Time: Change from Baseline at 3 months

Description: The instrument was translated and validated for the Brazilian population

Measure: Quality of Life assessed by the Pediatric Quality of Life Inventory (Peds-QoL)

Time: Change from Baseline at 6 months

Secondary Outcomes

Description: Aims to investigate the mechanisms that lead to dyspnea and, consequently, intolerance to physical effort

Measure: Flow-volume loop assessed by spirometry

Time: Baseline, 3 months, 6 months

Description: It will also be assessed for school-age children (7-10 years old) and adolescents (11-18 years old) and by their primary caregiver

Measure: Health-related quality of life assessed by the Pediatric Outcomes Data Collection Instrument

Time: Baseline, 3 months, 6 months, 12 months

Measure: Complete blood count (hemoglobin, leukocyte, lymphocyte and platelet count)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Inflammatory markers (C-reactive protein, fibrinogen, D-dimer and ferritin);

Time: Baseline, 3 months, 6 months,12 months

Measure: Lactate dehydrogenase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Aspartate and alanine aminotransferase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Serum urea and creatinine

Time: Baseline, 3 months, 6 months, 12 months

Measure: Triglycerides

Time: Baseline, 3 months, 6 months, 12 months

Measure: Creatinine phosphokinase (CK)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Amilase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Lipase

Time: Baseline, 3 months, 6 months, 12 months

Measure: Troponin T

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pro-BNP

Time: Baseline, 3 months, 6 months, 12 months

Description: Patchy ground-glass opacities, crazy-paving pattern, and localization and pattern of large, confluent or small nodular lesions will be assessed

Measure: Lung abnormalities will be assessed by pulmonary computed tomography

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to assess systolic and diastolic function

Measure: Systolic and diastolic function will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to search for valve dysfunction

Measure: Valve dysfunction will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to search for pericardial effusion

Measure: Pericardial effusion will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Conventional transthoracic echocardiogram with color Doppler to search for aspects of the coronary arteries

Measure: Coronary arteries will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Echocardiogram with two-dimensional speckle-tracking technique to identify subclinical changes suggestive of ischemia or myocarditis

Measure: Ischemia will be assessed by echocardiogram

Time: Baseline, 3 months, 6 months, 12 months

Description: Baseline levels of cytokines IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-y, and IL-17A in serum samples will be tested by flow cytometry using the CBA technique (Cytometric bead array, BD Biosciences)

Measure: Immunocompetence, including thymic function

Time: Baseline, 3 months, 6 months, 12 months

Measure: Leukogram will be assessed by leukocyte and lymphocyte counts

Time: Baseline, 3 months, 6 months,, 12 months

Description: T cell lineages: CD3CD4, CD3CD8, naive cells (CD45RA+), memory cells (CD45RA-), effector cells (CD38+HLADR+)

Measure: Immunophenotyping of lymphocytes T cell lineages will be evaluated by flow cytometry

Time: Baseline, 3 months, 6 months, 12 months

Description: B cell lineages: CD19, naive cells (CD27-), memory cells (CD27+), plasmablasts (CD27+CD38+CD138-), (plasmocytes CD27+CD38+CD138+)

Measure: Immunophenotyping of lymphocytes B cell lineages will be evaluated by flow cytometry

Time: Baseline, 3 months, 6 months, 12 months

Description: NK cells: (CD3-CD16+CD56+), degranulated: CD107a+

Measure: Immunophenotyping of lymphocytes NK cells will be evaluated by flow cytometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Serum levels of anti-Streptococcus pneumoniae IgG antibodies

Time: Baseline, 3 months, 6 months, 12 months

Description: The antipneumococcal antibody titer against 6 polysaccharides (serotypes 1, 5, 6B, 9V, 14, and 18C) will be analyzed by ELISA. The seroconversion criteria is IgG values > 1.3 mg/mL for each polysaccharide assessed

Measure: Anti-pneumococcal vaccine response will be assessed by ELISA

Time: Baseline, 3 months, 6 months, 12 months

Description: TRECs evaluate the peripheral function of the thymus from cells that have recently been released, using the RT-PCR technique

Measure: Evaluation of the thymus by the determination of TRECs (Thymic recent emigrant cells or T-cell receptor excision circles)

Time: Baseline, 3 months, 6 months, 12 months

Description: (anti-thyroperoxidase antibodies, anti-thyroglobulin)

Measure: Changes in frequency of the autoantibodies of the thyroid gland

Time: Baseline, 3 months, 6 months, 12 months

Measure: Changes in frequency of the anti-GAD antibody will be assessed using immunoprecipitation

Time: Baseline, 3 months, 6 months, 12 months

Measure: Changes in frequency of the anti-islet antibody of Langerhans will be assessed using indirect fluorescence

Time: Baseline, 3 months, 6 months, 12 months

Measure: Changes in frequency of the anti-insulin antibody will be assessed by radioimmunoassay

Time: Baseline, 3 months, 6 months, 12 months

Measure: Diagnosis of thyroid dysfunction will be assessed by thyroid profile (TSH, free T4 and T3)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Diagnosis of type 1 diabetes mellitus will be assessed by the metabolic profile (fasting glucose, glycated hemoglobin and C peptide)

Time: Baseline, 3 months, 6 months,, 12 months

Measure: Linear growth will be assessed by using a standardized stadiometer, calculating standard deviation, growth curves, and growth speed

Time: Baseline, 3 months, 6 months, 12 months

Measure: Development of puberty will be assessed according to the criteria of Tanner and Marshall in adolescents in the prepubertal age group

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone age will be assessed using non-dominant hand and wrist radiography

Time: Baseline, 12 months

Measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the region of the lumbar spine

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the region of the lumbar spine

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the proximal femur

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the proximal femur

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral density will be assessed by Bone densitometry (DXA) in the whole body

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone mineral content will be assessed by Bone densitometry (DXA) in the whole body

Time: Baseline, 3 months, 6 months, 12 months

Measure: Body composition (visceral adipose tissue) will be assessed by Bone densitometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Body composition (lean mass) will be assessed by Bone densitometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Body composition (fat mass) will be assessed by Bone densitometry

Time: Baseline, 3 months, 6 months, 12 months

Measure: Bone biochemical and bone remodeling markers (calcium, phosphorus, 25OH alkaline phosphatase vitamin D, PTH, CTX, P1NP)

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk used during the "timed up and go" test

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 6-minute walk test

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by an Actigraph (3D accelerometer) model G-Walk during the 10 meter gait test

Time: Baseline, 3 months, 6 months, 12 months

Measure: Pediatric gait assessment will be assessed by musculoskeletal ultrasound

Time: Baseline, 3 months, 6 months, 12 months

Description: According to the gene sequence studied, the analysis will be performed using the Sanger sequencing technique with capillary electrophoresis in a 3130 automatic sequencer (Applied Biosystems). The genetic polymorphisms of the ABO system gene (rs505922), two polymorphisms of the OPRM1 gene (rs1799971 and rs1799972) and a polymorphism of the BDNF gene (rs6265) will be investigated, with possible contributions to the risk of impaired gait.

Measure: Genetic Polymorphism Analysis will be assessed by salting out methodology followed by q-PCR (Real-time PCR) using the TaqMan assay using Step One Plus equipment

Time: Baseline, 3 months, 6 months, 12 months

Description: This is an 18-item parent questionnaire for children and adolescents (18 years and younger). This rating scale includes positive "weaknesses" and negative "strengths" scoring, assessing symptoms of Attention-Deficit/Hyperactivity Disorder. Parents are asked to compare their child's behavior in a variety of settings over the past month to other children on a 7-point: 3-Far below, 2-Below, 1-Slightly below, 0-Average, -1-Slightly average, -2-Above, -3-Far above. Higher scores indicate greater symptomology

Measure: Mental health will be assessed by the "Strengths and Weaknesses of Attention-deficit/hyperactivity disorder (ADHD) symptoms and Normal behaviors"

Time: Baseline, 3 months, 6 months, 12 months

Description: The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire, and includes 25 items on psychological attribute: emotional symptoms (5 items), conduct problems (5 items) hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behaviour (5 items). Higher scores indicate greater difficulties

Measure: Mental health will be assessed by the "Strengths and Difficulties Questionnaire"

Time: Baseline, 3 months, 6 months, 12 months

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress (7 items each subscale). Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores for the total DASS-total scale range between 0 and 120. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".

Measure: Mental health will be assessed by the "Depression, Anxiety and Stress Scale"

Time: Baseline, 3 months, 6 months, 12 months

Description: ActivPAL will be used for 7 days for at least 10 hours/day

Measure: Physical activity levels assessed by ActivPAL

Time: Baseline, 3 months, 6 months, 12 months

Description: 24-hour recalls will be assessed on three non-consecutive days (two weekdays, and one weekend). Online Dietbox will be used.

Measure: Food consumption levels assessed by food records

Time: Baseline, 3 months, 6 months, 12 months

Description: Baseline blood flow measurements will be assessed in the brachial artery

Measure: Blood flow will be assessed using a Doppler Ultrasound

Time: Baseline, 3 months, 6 months, 12 months

Description: Flow-mediated vasodilation (VMF) will be assessed in the brachial artery

Measure: Endothelial function will be assessed using a Doppler Ultrasound

Time: Baseline, 3 months, 6 months, 12 months
551 Lung Ultrasound in COVID-19 Infection Screening for Patients With Indication of Emergency Surgery

The first case of COVID-19 was identified on December 19 and the world is actually experiencing a pandemic. The surgical procedure in patients with SARS-CoV-2 infection involves the exposure of other patients and the group of health workers who face the care of the patient. Thus, screening with lung ultrasound is an alternative to identify patients with an established or suspected infection that requires urgent surgery. Therefore, the aim of this study is to determinate the operational characteristics of lung ultrasound during the screening process for SARS-CoV-2 infection in patients with an indication for urgent surgery.

NCT04661631
Conditions
  1. Ultrasonography
  2. Lung Diseases
  3. Surgical Procedure
  4. Covid19
  5. Severe Acute Respiratory Syndrome Coronavirus 2
Interventions
  1. Diagnostic Test: Lung ultrasound
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases
HPO:Abnormal lung morphology

Primary Outcomes

Description: To identify the best cut-off point from lung ultrasound that allows the discrimination of suspected cases of active SARS-CoV-2 infection in patients undergoing an emergency surgical procedure since May 2020 at Fundación Valle del Lili Hospital, Cali, Colombia.

Measure: The best cut-off point for lung ultrasound to discriminate suspected cases of active SARS-CoV-2 infection

Time: 14 days

Secondary Outcomes

Description: Identify the prevalence of active SARS-CoV-2 infection in the group of patients undergoing an emergency surgical procedure.

Measure: Prevalence of active SARS-CoV-2 infection

Time: 14 days

Description: Calculate the operational characteristics of lung ultrasound for the diagnosis of SARS-CoV-2 infection in the studied group of patients.

Measure: Operational characteristics of lung ultrasound

Time: 14 days

Description: Calculate the operational characteristics of each of suspicious lung ultrasound findings for the diagnosis of SARS-CoV-2 infection in the group of patients studied

Measure: Operational characteristics of each of suspicious lung ultrasound findings

Time: 14 days

Description: Identify the cut-off point resulting from the lung ultrasound score that discriminates between patients with suspected active SARS-CoV-2 infection.

Measure: Cut-off point resulting from the lung ultrasound score

Time: 14 days
552 Predicting Severity and Disease Progression in Influenza-like Illness

Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

NCT04664075
Conditions
  1. Influenza
  2. SARS (Severe Acute Respiratory Syndrome)
  3. Respiratory Viral Infection
  4. Respiratory Tract Infections
  5. Infection, Bacterial
  6. Infection Viral
  7. Covid19
  8. RNA Virus Infections
Interventions
  1. Biological: Respiratory infections
MeSH:Infection Communicable Diseases Respiratory Tract Infections Bacterial Infections Influenza, Human Virus Diseases Severe Acute Respiratory Syndrome Coronavi Coronavirus Infections RNA Virus Infections Disease Progression
HPO:Respiratory tract infection

Primary Outcomes

Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

Measure: Describe the aetiology of influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.

Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

Secondary Outcomes

Description: Cytokine levels (in pg/mL) will be measured in plasma and nasal lining fluid samples by MesoScale Discovery

Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults

Time: Day 0 to Day 28
553 Expert Statements on Infection Control in Intensive Care Unit for Severe Acute Respiratory Syndrome Coronavirus 2

The investigators aim to develop expert consensus statements on infection control management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in intensive care units (ICU).

NCT04665960
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. SARS Pneumonia
  4. Coronavirus Infection
  5. Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Survey questionnaire with seven point Likert scale (1-3 means disagreement and 5-7 means agreement) and multiple choice statements

Measure: Consensus using participating experts opinions.

Time: 30 days
554 Evaluation of Impaired Sedation in Patients With Moderate to Severe COVID-19 ARDS

This study focuses on the evaluation of various factors repeatedly discussed in relation to the impaired sedation of intubated ventilated COVID-19 patients. The sedation response of >100 moderately to severely affected COVID-19 ARDS was evaluated. The sedation level was measured at the bedside using the Richmond Agitation and Sedation Scale and ventilator synchrony. The evaluation was performed according to the static evaluation plan with respect to age, storage therapy and organ failure.

NCT04667936
Conditions
  1. Prone Position
  2. Severe Acute Respiratory Syndrome Coronavirus 2
  3. Hypnotics and Sedatives
  4. Pulmonary Ventilation
Interventions
  1. Other: Treatment group
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of positioning therapys during treatment

Measure: Position therapy

Time: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.

Description: Measurement is performed using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm])

Measure: Agitation and sedation level

Time: 30 minutes after study enrolment

Description: Change of sedation level using the Richmond Agitation and Sedation Scale (RASS, range: -5[Unarousable] to +4 [Combative], normal condition=0 [Alert and calm])

Measure: Agitation and sedation level

Time: Change in average dosage within 8 hours.

Description: Applied dosage of sufentanil (measured in µg/kg/h)

Measure: Application of opioid analgesic

Time: 30 minutes after study enrolment

Description: Applied dosage of sufentanil (measured in µg/kg/h)

Measure: Change of application of opioid analgesic

Time: Change in average dosage within 8 hours.

Description: Applied dosage of remifentanil (measured in µg/kg/min)

Measure: Application of opioid analgesic

Time: 30 minutes after study enrolment

Description: Applied dosage of remifentanil (measured in µg/kg/min)

Measure: Change of application of opioid analgesic

Time: Change in average dosage within 8 hours.

Description: Applied dosage of midazolam (measured in mg/kg/h)

Measure: Application of sedative

Time: 30 minutes after study enrolment

Description: Applied dosage of midazolam (measured in mg/kg/h)

Measure: Change in sedative dosage applied

Time: Change in average dosage within 8 hours.

Description: Applied dosage of propofol (measured in mg/kg/h)

Measure: Application of sedative

Time: 30 minutes after study enrolment

Description: Applied dosage of propofol (measured in mg/kg/h)

Measure: Change in sedative dosage applied

Time: Change in average dosage within 8 hours.

Description: Applied dosage of lormetazepam (measured in mg/kg/min)

Measure: Application of sedative

Time: 30 minutes after study enrolment

Description: Applied dosage of lormetazepam (measured in mg/kg/min)

Measure: Change in sedative dosage applied

Time: Change in average dosage within 8 hours.

Description: Applied dosage of clonidine (measured in µg/kg/h)

Measure: Application of sedative

Time: 30 minutes after study enrolment

Description: Applied dosage of clonidine (measured in µg/kg/h)

Measure: Change in sedative dosage applied

Time: Change in average dosage within 8 hours.

Description: Applied dosage of Dexmethomidine (measured in µg/kg/h)

Measure: Application of sedative

Time: 30 minutes after study enrolment

Description: Applied dosage of Dexmethomidine (measured in µg/kg/h)

Measure: Change in sedative dosage applied

Time: Change in average dosage within 8 hours.

Description: Applied dosage of esketamine (measured in mg/kg/h)

Measure: Application of sedative

Time: 30 minutes after study enrolment

Description: Applied dosage of esketamine (measured in mg/kg/h)

Measure: Change in sedative dosage applied

Time: Change in average dosage within 8 hours.

Description: Age (in years)

Measure: Patient Characteristics

Time: The data is recorded at the time of enrolment

Description: Height (in centimeters)

Measure: Patient Characteristics

Time: The data is recorded at the time of enrolment

Description: Weight (in kilograms)

Measure: Patient Characteristics

Time: The data is recorded at the time of enrolment

Secondary Outcomes

Description: The necessity and application of a renal replacement procedure is documented

Measure: Need for renal replacement therapy

Time: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.

Description: The necessity and application of an extracorporeal oxygenation procedure (ECMO) is documented

Measure: Need for extracorporeal membrane oxygenation (vvECMO)

Time: Data collection is performed at the date of death from any cause or discharge up to 10 weeks.
555 Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)

COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.

NCT04668196
Conditions
  1. Covid19
  2. Acute Respiratory Failure
  3. Corona Virus Infection
Interventions
  1. Device: High-flow nasal cannula treatment
  2. Device: Continuous positive airway pressure (CPAP) treatment
  3. Device: Noninvasive ventilation treatment
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency

Primary Outcomes

Description: Death or endotracheal intubation

Measure: Treatment failure

Time: 28 days within noninvasive respiratory support initiation

Secondary Outcomes

Measure: 28-day mortality

Time: 28 days within noninvasive respiratory support initiation

Description: Any death during hospital stay

Measure: Hospital mortality

Time: Until 28 days from noninvasive respiratory support initiation

Measure: Endotracheal intubation

Time: 28 days within noninvasive respiratory support initiation

Description: Time between admission and discharge from hospital or death in hospital

Measure: Duration of hospital stay

Time: Until 28 days from noninvasive respiratory support initiation
556 A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants

This is a Phase 2, randomized, placebo-controlled, and observer-blind study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses (at two different dose levels), separated by 28 days or as 1 dose In adults 18 years of age and older

NCT04668339
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Corona Virus Infection
Interventions
  1. Biological: ARCT-021 single dose priming
  2. Biological: ARCT-021 two lower dose priming
  3. Biological: ARCT-021 two higher dose priming
  4. Biological: Placebo (two doses), priming
  5. Biological: Randomized booster
  6. Biological: Placebo booster
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Adverse events reported daily in a diary that reflect common symptoms or findings at the injection site following vaccination

Measure: Percentages of participants reporting solicited local adverse events

Time: for 7 days following each dose administration

Description: Adverse events reported daily in a diary that reflect generalized symptoms following vaccination

Measure: Percentages of participants reporting solicited systemic adverse events

Time: for 7 days following each dose administration

Description: spontaneously reported adverse events

Measure: Percentages of participants reporting adverse events

Time: 28 days following each dose administration

Description: unsolicited adverse events that meet the definition of serious

Measure: Percentages of participants reporting serious adverse events

Time: Day 0 to Day 388

Description: unsolicited adverse events that lead to healthcare provider visit

Measure: Percentages of participants reporting medically attended adverse events

Time: Day 0 to Day 388

Description: unsolicited adverse events associated with new diagnosis of chronic disease

Measure: Percentages of participants reporting new onset of chronic disease

Time: Day 0 to Day 388

Description: chemistry and hematology

Measure: Percentages of participants with abnormal chemistry and hematology values

Time: Day 0 to Day 215

Description: neutralizing antibody response

Measure: SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs

Time: Day 0 to Day 388

Description: neutralizing antibody response

Measure: Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs

Time: Through Day 388

Description: neutralizing antibody response

Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels

Time: Through Day 388

Secondary Outcomes

Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

Measure: SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels, expressed as GMCs

Time: Day 0 to Day 388

Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

Measure: Changes in SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs

Time: Through Day 388

Description: SARS-CoV-2 anti S1, RBD, N binding antibody responses

Measure: Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels

Time: Through Day 388
557 Community Collaboration to Combat COVID-19

This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.

NCT04673292
Conditions
  1. Coronavirus Infection
Interventions
  1. Behavioral: Fixed site standard of care testing
  2. Behavioral: Community-based, mobile van testing
  3. Behavioral: Self-collected, home-based testing
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (in days) from randomization to the receipt of Coronavirus infection (SARS-CoV-2) testing results by the participant.

Measure: Time to receipt of SARS CoV-2 testing results

Time: Measured in days from randomization up to 30 days after randomization

Secondary Outcomes

Description: Proportion of those who complete a survey who agree to be randomized to a SARS-CoV-2 testing modality.

Measure: Acceptance of SARS CoV-2 viral testing assessed by proportion of participants who complete a survey

Time: Measured from baseline survey completion to enrollment within 30 days of completion of baseline survey

Description: Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.

Measure: Uptake of SARS CoV-2 testing as assessed by proportion of participants who complete testing

Time: Measured from randomization to testing completion (within 20 days of randomization)

Description: Time (In days) to completion of SARS CoV-2 testing from randomization.

Measure: Time to completion of SARS CoV-2 testing

Time: Measured from randomization to testing completion (Within 20 days of randomization)

Description: Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.

Measure: Time from SARS CoV-2 testing to receipt of results

Time: Measured from testing completion to receipt of results (within 10 days of testing)
558 A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)

This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.

NCT04674189
Conditions
  1. Coronavirus
  2. Covid19
  3. SARS-CoV-2
  4. Severe Acute Respiratory Syndrome
Interventions
  1. Biological: CVnCoV Vaccine
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Number of Participants with Medically-attended Adverse Events

Time: Day 29 to Day 211

Measure: Intensity of Medically-attended Adverse Events per Investigator's Assessment

Time: Day 29 to Day 211

Measure: Number of Participants with Medically-attended Adverse Events Considered Related to Trial Vaccine

Time: Day 29 to Day 211

Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

Time: Day 29 to Day 393

Measure: Intensity of Serious Adverse Events (SAEs) per Investigator's Assessment

Time: Day 29 to Day 393

Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

Time: Day 29 to Day 393

Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

Time: Day 29 to Day 393

Measure: Intensity of Adverse Events of Special Interest (AESIs) per Investigator's Assessment

Time: Day 29 to Day 393

Measure: Number of Participants with One or More Serious Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

Time: Day 29 to Day 393

Measure: Number of Participants with Death due to a Serious Adverse Event (SAE)

Time: Day 29 to Day 393

Measure: Number of Participants with Adverse Events (AEs) Leading to Vaccine Withdrawal or Study Disctontinuation

Time: Day 29 to Day 393

Measure: Number of Participants with Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Local Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

Time: 7 days after vaccination

Measure: Duration of Solicited Systemic Adverse Events

Time: 7 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events

Time: 28 days after vaccination

Measure: Intensity of Unsolicited Adverse Events per the Investigator's Assessment

Time: 28 days after vaccination

Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

Time: 28 days after vaccination

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Measure: Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum

Time: Days 1, 29, 43, 57, 120, 211 and 393

Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of participants who tested seronegative on prior to vaccination on Day 1.

Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies

Time: Days 1, 29, 43, 57, 120, 211 and 393

Secondary Outcomes

Measure: Number of Participants that Contract COVID-19 of Any Severity

Time: Day 1 to Day 393

Measure: Number of Participants that Contract Mild, Moderate, Severe and Moderate to Severe COVID-19

Time: Day 1 to Day 393

Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at prior to vaccination on Day 1 and Day 43.

Measure: Number of Participants Seroconverting to the Nucleocapsid (N) Protein of SARS-SoV-2

Time: Day 1, 43, 211 and 393

Measure: Burden of Disease (BoD) Score Based on First Episodes of Virologically-confirmed Cases of COVID-19

Time: Day 1 to Day 393

Description: Measured by a virus neutralizing assay in a subset of participants.

Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

Time: Days 1, 29, 43, 57, 120, 211 and 393

Description: Measured by a virus neutralizing assay in a subset of participants.

Measure: Number of Participants Seroconverting to SARS-CoV-2

Time: Days 1, 29, 43, 57, 120, 211 and 393

Description: Measured by a virus neutralizing assay in a subset of participants.

Measure: Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2

Time: Days 43, 57, 120, 211 and 393
559 Utility of Empiric Antibiotics on Admission for Non-intubated Patients With Novel Coronavirus Diseases 2019 (COVID-19): A Retrospective Cohort Study of Electronic Health Records

This retrospective analysis of inpatient data obtained from administrative and electronic medical records will investigate the role of empiric antibiotics on admission on the mortality for non-intubated patients presenting with Novel Coronavirus Diseases 2019 (COVID-19) associated pneumonia without extra-pulmonary sources of infection or septic shock.

NCT04674410
Conditions
  1. Covid19
  2. Coronavirus Infection
  3. Pneumonia
Interventions
  1. Drug: Antibiotic
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Death during the hospitalization or discharge to hospice

Measure: In-Hospital Mortality or discharge to hospice

Time: From time of admission to death during the hospitalization or discharge to hospice

Secondary Outcomes

Description: Mechanical ventilation initiated after 48 hours into the admission as a marker of clinical deterioration and its relationship to receipt of empiric antibiotic

Measure: Rates of Mechanical Ventilation

Time: From 48 hours post admission to discharge or death

Description: Identify the risk of C. difficile infection on patients according to empiric therapy status as captured by diagnosis codes not present-on-admission

Measure: Rates of C. difficile infection

Time: not present-on-admission

Description: As a marker of morbidity and and its relationship to receipt of empiric antibiotic therapy

Measure: Length of stay for survivors

Time: From admission to discharge (not to hospice)

Description: As a marker of clinical deterioration and its relationship to receipt of empiric antibiotic therapy among patients who did not require ICU admission upon arrival

Measure: Rates of ICU Admission

Time: From 48 hours post admission to discharge

Description: Identify the risk of acute kidney injury according to empiric therapy status as captured by diagnosis codes not present-on-admission

Measure: Rates of Acute Kidney Injury

Time: not present-on-admission

Description: For patients in hospital for at least 5 days

Measure: Days free of antibiotics

Time: 5 days from admission to discharge or primary outcome

Description: As above, as captured by diagnosis codes not present-on-admission

Measure: Rates of secondary infections due to antibiotic resistant pathogens

Time: not present-on-admission
560 A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)

The purpose of this study is to evaluate the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults.

NCT04677660
Conditions
  1. Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Interventions
  1. Biological: TAK-919
  2. Biological: Placebo
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered an investigational medicinal product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs are defined as injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.

Measure: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination

Time: Up to Day 7 after each vaccination

Description: Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, nausea/vomiting, chills, and fever.

Measure: Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination

Time: Up to Day 7 after each vaccination

Description: Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.

Measure: Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination

Time: Up to Day 28 after each vaccination

Description: An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.

Measure: Percentage of Participants with Serious AE (SAE) until Day 57

Time: Up to Day 57

Measure: Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57

Time: Up to Day 57

Measure: Percentage of Participants with Any AE Leading to Discontinuation of Vaccination

Time: Up to Day 57 (up to discontinuation of vaccination)

Measure: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57

Time: Up to Day 57

Measure: Percentage of Participants with SARS-CoV-2 Infection until Day 57

Time: Up to Day 57

Description: GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57

Time: Day 57

Description: GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57

Time: Day 57

Description: SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the limit of detection (LOD) to equal to or above LOD, OR, >= 4-fold rises from baseline.

Measure: Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57

Time: Day 57

Secondary Outcomes

Measure: Percentage of Participants with SAE throughout the Trial

Time: Up to Day 394

Measure: Percentage of Participants with MAAEs throughout the Trial

Time: Up to Day 394

Measure: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial

Time: Up to Day 394

Measure: Percentage of Participants with SARS-CoV-2 Infection throughout the Trial

Time: Up to Day 394

Description: GMT of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: GMT of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394

Time: Day 29, Day 43, Day 209 and Day 394

Description: GMFR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein.

Measure: GMFR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394

Time: Day 29, Day 43, Day 209 and Day 394

Description: SCR of serum bAb against SARS-CoV-2 will be measured by ligand-binding assay specific to the SARS-CoV-2 S protein. SCR is defined at percentage of participants with a change from below the LOD to equal to or above LOD, OR, >= 4-fold rises from baseline.

Measure: SCR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394

Time: Day 29, Day 43, Day 209 and Day 394

Description: GMT of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.

Measure: GMT of serum neutralizing antibody (nAb) against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394

Time: Day 29, Day 43, Day 57, Day 209, and Day 394

Description: GMFR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus.

Measure: GMFR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394

Time: Day 29, Day 43, Day 57, Day 209, and Day 394

Description: SCR of serum nAb against SARS-CoV-2 will be measured by assay specific to wild-type virus. SCR is defined at percentage of subjects with a change from below the lower limit of quantification (LLOQ) to equal to or above LLOQ, OR, >= 4-fold rises from baseline.

Measure: SCR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394

Time: Day 29, Day 43, Day 57, Day 209, and Day 394
561 Clinical Trial to Evaluate the Efficacy of an Iota-Carrageenan Nasal Spray to Reduce Symptoms Caused by SARS-CoV-2 and Other Respiratory Viruses in Healthcare Workers Managing COVID-19 Patients

This is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.

NCT04681001
Conditions
  1. Respiratory Viral Infection
  2. Common Cold
  3. Severe Acute Respiratory Syndrome (SARS) Pneumonia
  4. COVID-19
  5. Corona Virus Disease
Interventions
  1. Device: Coldamaris pro, nasal spray
MeSH:Infection Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections Common Cold Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: daily assessment of subjective COVID-19 symptom score

Measure: Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary

Time: 84 days

Secondary Outcomes

Description: weekly assessment of SARS-CoV-2, Influenza A, Human Metapneumovirus, Influenza A - subtype H1, Adenovirus, Influenza A - subtype H3, Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B, Parainfluenza 3, Parainfluenza 4, Coronavirus HKU1, Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila

Measure: Nasal swabs for analysis of viruses by PCR

Time: 84 days

Description: beginn and end of trial

Measure: Serology of antibodies against SARS-CoV-2

Time: 84 days

Description: weekly nasal swabs for analysis of viruses

Measure: Number of viral co-infections dedected by PCR

Time: 84 days
562 Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.

NCT04681430
Conditions
  1. Corona Virus Infection
  2. SARS-CoV-2 Infe
  3. SARS-CoV-2 Infection
  4. SARS-CoV-2 PCR Test Positive
  5. SARS-CoV-2 Acute Respiratory Disease
Interventions
  1. Biological: Convalescent plasma
  2. Drug: Camostat Mesilate
  3. Drug: Placebo for Camostat Mesilate
  4. Other: Standard of Care (SoC)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28

Measure: WHO ordinal Covid-19 scale up to day 28

Time: up to and including day 28

Secondary Outcomes

Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8

Measure: Cumulative number WHO categories 4b-8

Time: day 8, day 14, day 56 and day 90

Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a

Measure: Cumulative number WHO categories 3-4a

Time: day 8, day 14, day 28, day 56 and day 90

Description: Cumulative number of participants not hospitalized at day 90

Measure: Not hospitalized

Time: at day 90

Description: All-cause mortality at day 90

Measure: All-cause mortality

Time: at day 90

Description: Number of patient with SARS-CoV-2 reinfection up to day 90

Measure: Reinfection

Time: up to day 90

Description: Number of patient with secondary sclerosis cholangitis at day 90

Measure: Secondary sclerosing cholangitis (SSC)

Time: at day 90

Description: Number of patient with COVID-19 associated chronic pulmonary disease

Measure: chronic pulmonary disease as sequelae from COVID-19

Time: at day 90

Description: The proportion of patients with remdesivir therapy

Measure: patients with remdesivir treatment

Time: up to day 90

Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

Measure: COVID-19 WHO status of patients at start of remdesivir treatment

Time: up to day 90

Description: The proportion of patients on dexamethasone therapy

Measure: patients with dexamethasone treatment

Time: up to day 90

Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

Measure: COVID-19 WHO status of patients at start of dexamethasone treatment

Time: up to day 90

Description: Time to resolution of COVID-19 related symptoms (e.g. fever)

Measure: resolution of COVID-19 symptoms

Time: until day of resolution up to day 90

Description: Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)

Measure: negative SARS-CoV-2-PCR test

Time: until day of first negative test up to day 90

Description: Duration of oxygen therapy (in days)

Measure: Oxygen therapy

Time: number of days with oxygen therapy up to day 90

Description: Frequency of occurrence of COVID-19 pneumonia

Measure: COVID-19 pneumonia

Time: up to day 90

Description: Percentage of participants in each group with need for mechanical ventilation

Measure: Percentage of participants requiring mechanical ventilation

Time: up to day 90

Description: Number of ventilation days per participant up to day 90

Measure: Number of ventilation days per participant up to day 90

Time: up to day 90

Description: Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)

Measure: hospital stay and intensive care

Time: up to day 90

Description: All-cause mortality at day 28

Measure: Mortality

Time: at day 28

Description: Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up

Measure: SAEs

Time: up to day 90

Description: Cumulative incidence of grade 3/4 Adverse Events (AE) per group

Measure: Grade 3/4 AEs

Time: up to day 90

Description: SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 antibody IgA concentrations

Time: on day 8, day 14, day 90

Description: SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 antibody IgG concentrations

Time: on day 8, day 14, day 90

Description: SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90

Measure: SARS-CoV-2 neutralizing antibody titers

Time: on day 8, day 14, day 90

Description: Number of screening failures due to the lack of a suitable plasma preparation

Measure: Plasma treatment screening failures

Time: up to day 8 (End of treatment)
563 Cereset Research To Reduce Stress And Anxiety In Healthcare Workers In The Time Of COVID-19

The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress and anxiety in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

NCT04682197
Conditions
  1. Health Personnel
  2. Stress
  3. Anxiety
  4. Insomnia
  5. Hyperarousal
  6. Corona Virus Infection
  7. Covid19
Interventions
  1. Device: Cereset Research
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Sleep Initiation and Maintenance Disorders Anxiety Disorders
HPO:Insomnia

Primary Outcomes

Description: The Impact of Event Scale- Revised Scale assess intrusion, avoidance, and hyperarousal. The scale includes five new questions in addition to the original Impact of Event Scale created by Mardi Horowitz. Scores range from 0 to 88. Total scores ranging between 24-43 suggest that PTSD is a clinical concern; scores between 33-38 suggest best cutoff for probably PTSD; and scores of 39 and above suggest suppressed immune system functioning. The higher the score, the larger the impact of recent stress. There are three subscales evaluating intrusion avoidance, and hyperarousal.

Measure: Change in Impact of Event Scale-Revised (IES-R)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Secondary Outcomes

Description: The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.

Measure: Change in Insomnia Severity Index (ISI)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression.

Measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.

Measure: Change in Generalized Anxiety Disorder-7 (GAD-7)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.

Measure: Change in PTSD Checklist for Civilians (PCL-C)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.

Measure: Change in Perceived Stress Scale (PSS)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).

Measure: Change in Quality of Life Scale (QOLS)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.

Measure: Change in Interpersonal Support Evaluation List (ISEL-12)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.

Measure: Change in Multiple Ability Self-Report Questionnaire (MASQ)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
564 Efficacy of Mega Dose Vitamin C in Critically Ill COVID-19 Patients

Vitamin C (ascorbic acid) is a water-soluble vitamin having anti-inflammatory, immunomodulatory, anti-oxidative, antithrombotic and antiviral properties. Considering these effects vitamin C should have beneficial impact in patients suffering from sepsis and acute respiratory distress syndrome (ARDS). The current study is designed to assess the beneficial effects of Vitamin C in COVID-19 infected patients.

NCT04682574
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Vitamin C
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)

Time: 2 to 7 days

Secondary Outcomes

Description: duration of hospital stay

Measure: Hospital stay

Time: 2 weeks
565 Randomized Controlled Clinical Study (RCT) Phase 3 of the Safety and Efficacy of Hypochlorous Acid in the Prophylaxis of Healthcare Personnel at High Risk of Infection by SARS-CoV2 (COVID19) Versus Placebo

The pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level. In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.

NCT04684550
Conditions
  1. SARS-CoV Infection
  2. Covid19
  3. Infection Viral
Interventions
  1. Drug: Stabilized hypochlorous acid
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Description: Number of participants who get COVID19 infection during the application of S-HClO

Measure: Prevention of infection by COVID19

Time: Through study completion, an average of 6 months

Secondary Outcomes

Description: Determine the occurrence of ADR by the use of S-HClO

Measure: Adverse drug reaction (ADR)

Time: Through study completion, an average of 6 months

Description: Determine the frequency of seroconversion due to COVID 19

Measure: Seroconversion

Time: Through study completion, an average of 6 months

Description: Number of participants who fell ill from COVID-19 and was not hospitalized

Measure: Hospitalization

Time: Through study completion, an average of 6 months

Description: Number of participants who fell ill from COVID-19 and was hospitalized in ICU

Measure: ICU

Time: Through study completion, an average of 6 months
566 Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients

In current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization

NCT04686760
Conditions
  1. Corona Virus Infection
Interventions
  1. Drug: Nitroglycerin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen

Time: 5-7 days

Measure: Oxygen demand

Time: 5-7 days

Secondary Outcomes

Measure: Duration of hospital stay

Time: 15 days
567 Multicenter, Randomized, Blind, Placebo-controlled Clinical Study of III Phase on Assessment of Preventive Efficiency, Safety and Immunogenicity QazCovid-in®-Vaccine Against COVID-19 in Healthy Adult Volunteers

Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers

NCT04691908
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Vaccine Adverse Reaction
Interventions
  1. Biological: QazCovid-in®-vaccine against COVID-19
  2. Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)

Measure: Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)

Time: at days 0, 21, 42, 90, 180

Description: The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination.

Measure: To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo

Time: at days 0, 21, 42, 90, 180

Description: The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination

Measure: Frequency of confirmed cases of COVID-19

Time: through study completion, an average of 6 months

Secondary Outcomes

Description: Determination of the level of production of intracellular cytokines by antigen-activated T-lymphocytes

Measure: Changing of antigen-specific cellular immunity level

Time: at days 0, 90, 180

Description: Frequency of adverse reaction in the seven days following each immunization per age group

Measure: Frequency of adverse events up to seven days after immunization

Time: Seven days after each immunization

Description: Frequency of adverse reaction in the 21 days following each immunization per age group

Measure: Frequency of adverse events up to 21 days after immunization

Time: 21 days after each immunization

Description: Incidence of serious adverse events during the study

Measure: Incidence of serious adverse events during the study

Time: throughout the study, an average of 6 months

HPO Nodes

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes

Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

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