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Coronavirus Infections (787) Severe Acute Respiratory Syndrome (538) Infection (447) Pneumonia (358) Communicable Diseases (191) Respiratory Distress Syndrome, Adult (179) Acute Lung Injury (142) Respiratory Distress Syndrome, Newborn (141) (127) Syndrome (123) Virus Diseases (88) Depression (78) Pneumonia, Viral (77) Critical Illness (67) Anxiety Disorders (49) Disease (40) Respiratory Tract Infections (38) Neoplasms (36) Stress Disorders, Post-Traumatic (36) Wounds and Injuries (35) Emergencies (34) Cardiovascular Diseases (33) Diabetes Mellitus (33) Inflammation (33) Stress Disorders, Traumatic (31) Stress, Psychological (30) Depressive Disorder (29) Lung Injury (29) Acute Kidney Injury (27) Respiratory Tract Diseases (27) Hypoxia (26) Mental Disorders (26) Thrombosis (25) Hypertension (24) Lung Diseases (24) Influenza, Human (22) Disease Progression (21) Olfaction Disorders (20) Arthritis (19) Respiration Disorders (19) Sclerosis (19) Burnout, Psychological (18) Diabetes Mellitus, Type 2 (18) Embolism (18) Fibrosis (18) Multiple Sclerosis (18) Thromboembolism (18) HIV Infections (16) Pulmonary Embolism (16) Respiratory Aspiration (16) Stroke (16) Blood Coagulation Disorders (15) Cognitive Dysfunction (15) Hemostatic Disorders (15) Pulmonary Disease, Chronic Obstructive (15) Pulmonary Fibrosis (15) Arthritis, Rheumatoid (14) Autism Spectrum Disorder (14) Chronic Disease (14) Heart Diseases (14) Kidney Diseases (14) Lung Diseases, Interstitial (14) Lung Diseases, Obstructive (14) Asthma (13) Brain Injuries (13) Chronic Pain (13) Myocardial Infarction (13) Substance-Related Disorders (13) Heart Failure (12) Lung Neoplasms (12) Venous Thrombosis (12) Autistic Disorder (11) Colitis (11) Colitis, Ulcerative (11) Crohn Disease (11) Dyspnea (11) Infarction (11) Obesity (11) Ulcer (11) Diabetes Mellitus, Type 1 (10) Pregnancy Complications (10) Rheumatic Diseases (10) Brain Injuries, Traumatic (9) Burnout, Professional (9) Coronary Artery Disease (9) Cystic Fibrosis (9) Depression, Postpartum (9) Feeding and Eating Disorders (9) Inflammatory Bowel Diseases (9) Liver Diseases (9) Myocarditis (9) Parkinson Disease (9) Pneumonia, Ventilator-Associated (9) Pulmonary Valve Insufficiency (9) Renal Insufficiency, Chronic (9) Respiratory Syncytial Virus Infections (9) Alzheimer Disease (8) Carcinoma (8) Collagen Diseases (8) Dementia (8) Frailty (8) Hematologic Neoplasms (8) Ischemia (8) Overweight (8) Problem Behavior (8) Psychotic Disorders (8) Sepsis (8) Venous Thromboembolism (8) Vitamin D Deficiency (8) Alcoholism (7) Convalescence (7) Coronary Disease (7) Infertility (7) Kidney Failure, Chronic (7) Musculoskeletal Pain (7) Myocardial Ischemia (7) Parasomnias (7) Spinal Cord Injuries (7) Acute Coronary Syndrome (6) Alcohol Drinking (6) Breast Neoplasms (6) Child Development Disorders, Pervasive (6) Deglutition Disorders (6) Dyssomnias (6) Fatigue (6) Immune System Diseases (6) Leukemia (6) Lupus Erythematosus, Systemic (6) Lymphoma (6) Lymphopenia (6) Neurologic Manifestations (6) Osteoarthritis (6) Pediatric Obesity (6) Psoriasis (6) RNA Virus Infections (6) Renal Insufficiency (6) Shock (6) Autoimmune Diseases (5) Brain Diseases (5) Bronchiectasis (5) Carcinoma, Non-Small-Cell Lung (5) Colorectal Neoplasms (5) Coronaviridae Infections (5) Delirium (5) Depressive Disorder, Major (5) Disease Susceptibility (5) Fibromyalgia (5) Gastroparesis (5) Hypersensitivity (5) Immunologic Deficiency Syndromes (5) Metabolic Syndrome (5) Mobility Limitation (5) Multiple Organ Failure (5) Neoplasm Metastasis (5) Nervous System Diseases (5) Occupational Stress (5) Osteoarthritis, Knee (5) (5) Premature Birth (5) Prostatic Neoplasms (5) Schizophrenia (5) Sleep Apnea Syndromes (5) Sleep Apnea, Obstructive (5) Toxemia (5) Triple Negative Breast Neoplasms (5) Acquired Immunodeficiency Syndrome (4) Adenoviridae Infections (4) Anemia, Sickle Cell (4) Appendicitis (4) Arthritis, Psoriatic (4) Atrial Fibrillation (4) Attention Deficit Disorder with Hyperactivity (4) Behavior, Addictive (4) Body Weight (4) Coinfection (4) Colonic Neoplasms (4) Cross Infection (4) Death (4) Dermatitis (4) Disseminated Intravascular Coagulation (4) Embolism and Thrombosis (4) Endometriosis (4) Head and Neck Neoplasms (4) Heart Arrest (4) Hemorrhage (4) Hypertension, Pulmonary (4) Intestinal Diseases (4) Liver Cirrhosis (4) Malnutrition (4) Metabolic Diseases (4) Migraine Disorders (4) Mycobacterium Infections (4) Pancreatic Neoplasms (4) Panic Disorder (4) Peripheral Arterial Disease (4) Postoperative Complications (4) Prediabetic State (4) Signs and Symptoms, Respiratory (4) Sjogren's Syndrome (4) Sleep Initiation and Maintenance Disorders (4) Systemic Inflammatory Response Syndrome (4) Thrombophilia (4) Tobacco Use Disorder (4) Vascular Diseases (4) Weight Loss (4) Amyotrophic Lateral Sclerosis (3) Arrhythmias, Cardiac (3) Asymptomatic Diseases (3) Carcinoma, Renal Cell (3) Cardiomyopathies (3) Celiac Disease (3) Cerebral Palsy (3) Chilblains (3) 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(3) Sleep Wake Disorders (3) Spondylarthritis (3) Taste Disorders (3) Ventricular Dysfunction (3) Ventricular Dysfunction, Left (3) Acute Disease (2) Ageusia (2) Agoraphobia (2) Alopecia (2) Alpha 1-Antitrypsin Deficiency (2) Angina Pectoris (2) Anxiety, Separation (2) Apnea (2) Arteritis (2) Asymptomatic Infections (2) Atherosclerosis (2) Back Pain (2) Bacteremia (2) Bacterial Infections (2) Behcet Syndrome (2) Bipolar Disorder (2) Caliciviridae Infections (2) Cataract (2) Clinical Deterioration (2) Clostridium Infections (2) Cognition Disorders (2) Communicable Diseases, Emerging (2) Compassion Fatigue (2) Compulsive Personality Disorder (2) Congenital Abnormalities (2) Conjunctivitis (2) Diabetic Nephropathies (2) Diarrhea (2) Drug-Related Side Effects and Adverse Reactions (2) Emphysema (2) Endocarditis (2) Endocrine System Diseases (2) Eye Diseases (2) Fatty Liver (2) Fistula (2) Fractures, Stress (2) Ganglion Cysts (2) Gastroenteritis (2) Gastroesophageal Reflux (2) Glioblastoma (2) Gout (2) Healthcare-Associated Pneumonia (2) Heart Failure, Systolic (2) Hematologic Diseases (2) Hepatitis (2) Hepatitis A (2) Hepatitis C (2) Hyperglycemia (2) Hyperkinesis (2) Hyperphagia (2) Hypertension, Pregnancy-Induced (2) Hypotension (2) Hypoventilation (2) Intervertebral Disc Degeneration (2) Ischemic Attack, Transient (2) Jaundice (2) Joint Diseases (2) Leukemia, Myeloid, Acute (2) Liver Failure (2) Low Back Pain (2) Lymphedema (2) Lymphoproliferative Disorders (2) Macular Degeneration (2) Meningitis (2) Meningitis, Meningococcal (2) Mood Disorders (2) Multiple Myeloma (2) Muscle Spasticity (2) Muscular Dystrophies (2) Mutism (2) Mycoses (2) Myelodysplastic Syndromes (2) Myeloproliferative Disorders (2) Myofascial Pain Syndromes (2) Myositis (2) Necrosis (2) Neoplasms, Plasma Cell (2) Nerve Degeneration (2) Neurocognitive Disorders (2) Neurodevelopmental Disorders (2) Nidovirales Infections (2) Non-alcoholic Fatty Liver Disease (2) Noncommunicable Diseases (2) Nutrition Disorders (2) Obesity, Morbid (2) Obsessive-Compulsive Disorder (2) Oral Manifestations (2) Pain, Postoperative (2) Pancreatitis (2) Phobia, Social (2) Phobic Disorders (2) Pneumonia, Pneumocystis (2) Pre-Eclampsia (2) Pulmonary Eosinophilia (2) Purpura, Thrombocytopenic, Idiopathic (2) Recurrence (2) Respiratory Sounds (2) Rupture (2) Sarcoidosis (2) (2) Scleroderma, Systemic (2) Shock, Septic (2) Small Cell Lung Carcinoma (2) Spinal Diseases (2) Sprains and Strains (2) Stillbirth (2) Suicidal Ideation (2) Suicide (2) Tachycardia (2) Temporomandibular Joint Disorders (2) Temporomandibular Joint Dysfunction Syndrome (2) Thoracic Diseases (2) Thrombocytopenia (2) Trauma and Stressor Related Disorders (2) Tuberculosis (2) Urinary Bladder, Overactive (2) Urinary Tract Infections (2) Uterine Cervical Neoplasms (2) Uveitis (2) Vision Disorders (2) Vision, Low (2) Yellow Fever (2) Abruptio Placentae (1) Acalculous Cholecystitis (1) (1) Acute Lung Injur (1) Adenocarcinoma (1) Adjustment Disorders (1) Adrenal Insufficiency (1) Alcohol Drinking in College (1) Alcohol-Related Disorders (1) Alcoholic Intoxication (1) Altitude Sickness (1) Alveolitis, Extrinsic Allergic (1) Amblyopia (1) Anemia, Aplastic (1) Aneurysm (1) Aneurysm, Ruptured (1) Angina, Stable (1) Angioedema (1) Angioedemas, Hereditary (1) Anorexia (1) Anorexia Nervosa (1) Aortic Valve Stenosis (1) Arthritis, Juvenile (1) Aspergillosis (1) Aspergillosis, Allergic Bronchopulmonary (1) Asphyxia Neonatorum (1) Asthenopia (1) Atrioventricular Block (1) Atrophy (1) Autonomic Nervous System Diseases (1) Barotrauma (1) Biliary Tract Neoplasms (1) Birth Weight (1) Blister (1) Body Weight Changes (1) Bone Diseases, Metabolic (1) Bone Marrow Diseases (1) Bradycardia (1) Brain Concussion (1) Breast Cancer Lymphedema (1) Bronchial Diseases (1) Bronchiolitis (1) Bronchitis (1) Bronchitis, Chronic (1) Bronchopulmonary Dysplasia (1) Brucellosis (1) Bruxism (1) Bulimia (1) Calculi (1) Carcinoma, Hepatocellular (1) Carcinoma, Ovarian Epithelial (1) Carcinoma, Small Cell (1) Carcinoma, Squamou (1) Carcinoma, Squamous Cell (1) Cardiotoxicity (1) Cardiovascular Abnormalities (1) Cellulitis (1) Cerebral Hemorrhage (1) Cerebrovascular Disorders (1) Chest Pain (1) Chlamydia Infections (1) Cholangiocarcinoma (1) Cholangitis (1) Cholecystitis (1) Cholecystitis, Acute (1) Chorea (1) Chronic Traumatic Encephalopathy (1) Ciliary Motility Disorders (1) Colonic Diseases (1) (1) Communication Disorders (1) Compulsive Behavior (1) Consciousness Disorders (1) Constipation (1) Constriction, Pathologic (1) Conversion Disorder (1) (1) Coronary Restenosis (1) Coronary Stenosis (1) (1) Cough (1) Coxsackievirus Infections (1) Cryopyrin-Associated Periodic Syndromes (1) (1) Deafness (1) Death, Sudden, Cardiac (1) Dehydration (1) Dental Calculus (1) Dental Plaque (1) Depressive Disorder, Treatment-Resistant (1) DiGeorge Syndrome (1) Diabetic Foot (1) Diabetic Neuropathies (1) Digestive System Neoplasms (1) Diphtheria (1) Down Syndrome (1) Drug Overdose (1) Dyskinesias (1) Dyspareunia (1) Dysphonia (1) Eclampsia (1) Emergence Delirium (1) Encephalitis (1) Endophthalmitis (1) Endotoxemia (1) Enterocolitis, Pseudomembranous (1) Enuresis (1) Eosinophilic Esophagitis (1) Epilepsy (1) Esophageal Fistula (1) Esophageal and Gastric Varices (1) Esophagitis (1) Esophagitis, Peptic (1) Eye Infections (1) Fabry Disease (1) Facial Pain (1) Familial Mediterranean Fever (1) Femoral Neck Fractures (1) Fetal Growth Retardation (1) Fetal Membranes, Premature Rupture (1) Fever of Unknown Origin (1) Food Hypersensitivity (1) Foot Ulcer (1) Fractures, Closed (1) Gait Disorders, Neurologic (1) Gastrointestinal Stromal Tumors (1) Gaucher Disease (1) Genetic Diseases, Inborn (1) Genetic Predisposition to Disease (1) Gestational Weight Gain (1) Gingivitis, Necrotizing Ulcerative (1) Glomerulonephritis, IGA (1) Headache Disorders, Secondary (1) Hearing Loss (1) Hearing Loss, Conductive (1) Heart Block (1) Heart Failure, Diastolic (1) Heart Murmurs (1) Helminthiasis (1) Hematoma (1) Hematoma, Subdural (1) Hematoma, Subdural, Chronic (1) Hemoglobinopathies (1) Hepatitis B (1) Hepatitis, Alcoholic (1) Hereditary Autoinflammatory Diseases (1) Herpes Labialis (1) Herpes Zoster (1) Hoarseness (1) Hodgkin Disease (1) Hyaline Membrane Disease (1) Hyperaldosteronism (1) Hypercapnia (1) Hyperphosphatemia (1) Hyperplasia (1) Hypersensitivity, Immediate (1) Hypokalemia (1) Hyponatremia (1) Hypoparathyroidism (1) Iatrogenic Disease (1) (1) Infant, Newborn, Diseases (1) (1) Infec (1) Infect (1) Infecti (1) Infertility, Female (1) Infertility, Male (1) Intellectual Disability (1) Intermittent Claudication (1) Intestinal Atresia (1) Intracranial Aneurysm (1) Intracranial Hypertension (1) Intracranial Thrombosis (1) Jaundice, Obstructive (1) Keratoconjunctivitis (1) Keratosis (1) Keratosis, Actinic (1) Kidney Calculi (1) Language Disorders (1) Leishmaniasis (1) Leukemia, Lymphocytic, Chronic, B-Cell (1) Leukemia, Myeloid (1) Leukemia, Myelomonocytic, Acute (1) Leukemia, Myelomonocytic, Chronic (1) Liver Cirrhosis, Biliary (1) Lyme Disease (1) Lymphocytosis (1) Lymphoma, B-Cell (1) Lymphoma, Mantle-Cell (1) Macrophage Activation Syndrome (1) Malaria (1) Maternal Death (1) Maxillofacial Injuries (1) May-Thurner Syndrome (1) Memory Disorders (1) Meningococcal Infections (1) Menorrhagia (1) Menstruation Disturbances (1) Microvascular Rarefaction (1) Mitochondrial Diseases (1) Molluscum Contagiosum (1) Monoclonal Gammopathy of Undetermined Significance (1) Mouth, Edentulous (1) Movement Disorders (1) Mucositis (1) Multiple Chronic Conditions (1) Muscular Atrophy (1) Muscular Dystrophy, Duchenne (1) Myalgia (1) Myocardial Reperfusion Injury (1) Nasal Polyps (1) Needlestick Injuries (1) Neonatal Sepsis (1) Neoplastic Cells, Circulating (1) Nephritis (1) Neurobehavioral Manifestations (1) Neuromuscular Diseases (1) Neuromyelitis Optica (1) Obsessive Behavior (1) Olfactory Nerve Injuries (1) Orbital Cellulitis (1) Oropharyngeal Neoplasms (1) Osteoarthritis, Hip (1) Osteochondritis (1) Osteomyelitis (1) Otitis (1) Otitis Media (1) Otitis Media with Effusion (1) Overwei (1) Pain (1) Pain, Intractable (1) Pain, Procedural (1) Papillomavirus Infections (1) Paraproteinemias (1) Paresis (1) Peanut Hypersensitivity (1) Perinatal Death (1) Periodontal Diseases (1) Peripheral Nervous System Diseases (1) Peritoneal Neoplasms (1) Pharyngeal Diseases (1) Pneumon (1) Pneumonia, Bacterial (1) Polyps (1) Pregnancy in Diabetics (1) Preleukemia (1) Presbyopia (1) Primary Dysautonomias (1) Primary Myelofibrosis (1) Prostatic Hyperplasia (1) Protein Deficiency (1) Protein-Energy Malnutrition (1) Psychophysiologic Disorders (1) Puerperal Infection (1) Pulmonary Alveolar Proteinosis (1) Pulmonary Aspergillosis (1) Pulmonary Atelectasis (1) Rabies (1) Radiculopathy (1) Rectal Neoplasms (1) Reperfusion Injury (1) Respiratory Distress Syndrom (1) Respiratory Distress Syndrome, Newbor (1) Respiratory Hypersensitivity (1) Retinal Vein Occlusion (1) Sarcoidosis, Pulmonary (1) Sarcopenia (1) Schizophrenia Spectrum and Other Psychotic Disorders (1) Scleroderma, Localized (1) (1) Self-Injurious Behavior (1) Sexually Transmitted Diseases (1) Sexually Transmitted Diseases, Bacterial (1) Shock, Cardiogenic (1) Short Bowel Syndrome (1) Signs and Symptoms, Digestive (1) Skin Abnormalities (1) Skin Diseases (1) Skin Manifestations (1) Skin Neoplasms (1) Skull Fractures (1) Sleep Apnea, Central (1) Soft Tissue Neoplasms (1) Somatoform Disorders (1) Spinal Cord Diseases (1) Spinal Dysraphism (1) Spinal Stenosis (1) Spondylolisthesis (1) Status Epilepticus (1) Stomatitis (1) Stress Disorders (1) Stress Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Superinfection (1) Syncope (1) Syncope, Vasovagal (1) Tachycardia, Sinus (1) Tachycardia, Ventricular (1) Thalassemia (1) Thrombophlebitis (1) Thrombotic Microangiopathies (1) Torsades de Pointes (1) Tourette Syndrome (1) Trauma, Nervous System (1) Trichuriasis (1) Tuberculosis, Pulmonary (1) Urinary Bladder Neoplasms (1) Urinary Bladder, Underactive (1) Urinary Incontinence (1) Urinary Retention (1) Urogenital Neoplasms (1) Urologic Diseases (1) Urticaria (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Venous Insufficiency (1) Ventricular Dysfunction, Right (1) Virus (1) Voice Disorders (1) Von Willebrand Diseases (1) Vulvar Neoplasms (1) Weight Gain (1) Xerostomia (1) beta-Thalassemia (1)

D007239: Infecti

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 (822)


Name (Synonyms) Correlation
drug1775 Hydroxychloroquine Wiki 0.23
drug2916 Placebo Wiki 0.21
drug1511 Favipiravir Wiki 0.20
Name (Synonyms) Correlation
drug2981 Placebo oral tablet Wiki 0.11
drug3074 Presatovir Wiki 0.09
drug1776 Hydroxychloroquine (HCQ) Wiki 0.08
drug4335 Zinc Wiki 0.08
drug1795 Hydroxychloroquine Sulfate Wiki 0.08
drug1960 Interferon Beta-1B Wiki 0.08
drug2176 Losartan Wiki 0.08
drug274 Anakinra Wiki 0.08
drug1396 Enoxaparin Wiki 0.08
drug1620 Gam-COVID-Vac Wiki 0.07
drug2029 Ivermectin Wiki 0.07
drug1509 Famotidine 20 MG Wiki 0.07
drug2977 Placebo on a 0- and 28-day schedule Wiki 0.07
drug1334 Ebselen Wiki 0.07
drug2512 Nasopharyngeal swab Wiki 0.07
drug2837 Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki 0.07
drug1781 Hydroxychloroquine + azithromycin Wiki 0.07
drug2779 PLACEBO Wiki 0.07
drug2321 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.07
drug2190 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.07
drug4263 Volatile Organic Compounds analysis Wiki 0.07
drug1467 Expressive writing Wiki 0.07
drug4405 blood samples Wiki 0.07
drug1549 Flow cytometric analysis Wiki 0.07
drug1807 Hydroxychloroquine Sulfate Tablets Wiki 0.07
drug3746 Standard of care treatment Wiki 0.07
drug1673 HB-adMSCs Wiki 0.07
drug1554 Fluoxetine Wiki 0.07
drug1519 Favipiravir Placebo Wiki 0.07
drug1459 Exposure Wiki 0.07
drug3459 SARS-Cov2 testing Wiki 0.07
drug1799 Hydroxychloroquine Sulfate 200 MG Wiki 0.07
drug1730 High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.07
drug2800 PUL-042 Inhalation Solution Wiki 0.07
drug4013 Thymalfasin Wiki 0.07
drug2155 Lopinavir / Ritonavir Wiki 0.06
drug4249 Vitamin C Wiki 0.06
drug4251 Vitamin D Wiki 0.06
drug1047 Convalescent Plasma Wiki 0.06
drug3502 Saline Wiki 0.06
drug927 Clazakizumab Wiki 0.06
drug1127 DAS181 Wiki 0.06
drug4187 VPM1002 Wiki 0.05
drug4754 standard therapy Wiki 0.05
drug4719 self-administered questionnaire Wiki 0.05
drug3740 Standard of care (SOC) Wiki 0.05
drug492 BNT162b1 Wiki 0.05
drug4025 Tocilizumab Wiki 0.05
drug421 Azithromycin Wiki 0.05
drug3728 Standard of Care Wiki 0.05
drug2575 No intervention Wiki 0.05
drug3255 Racial/Ethnic Frame Wiki 0.05
drug1267 Drug COVID19-0001-USR Wiki 0.05
drug476 BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki 0.05
drug928 Clazakizumab 12.5 mg Wiki 0.05
drug4726 serology test Wiki 0.05
drug1293 Dysphagia Handicap Index (DHI) Wiki 0.05
drug1412 EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki 0.05
drug4008 Throat swab sample for measuring current infection with SARS-CoV-2 Wiki 0.05
drug2504 Nasal Swab Wiki 0.05
drug1505 Facial mask Wiki 0.05
drug325 Antioxidation Therapy Wiki 0.05
drug46 21% Ethanol plus essential oils Wiki 0.05
drug1951 Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs Wiki 0.05
drug3673 Sofusbuvir + Daclastavir 60 mg Wiki 0.05
drug4305 Whole Exome Sequencing Wiki 0.05
drug2564 Nitric Oxide-Releasing Drug Wiki 0.05
drug1830 Hyperbaric Oxygen Therapy Wiki 0.05
drug2189 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki 0.05
drug3598 Serum SARs COV 2 IGg screening in health care workers Wiki 0.05
drug2441 Mucodentol Wiki 0.05
drug2863 Performance of the test antigenic and test RT-PCR Wiki 0.05
drug1803 Hydroxychloroquine Sulfate 600 mg once a day Wiki 0.05
drug1815 Hydroxychloroquine plus Nitazoxanide Wiki 0.05
drug1051 Convalescent Plasma 2 Units Wiki 0.05
drug4091 Treatment with Dexmedetomidine Wiki 0.05
drug3652 Snorkel-based improvised personal protective equipment Wiki 0.05
drug2201 Low nitrite/NDMA meals Wiki 0.05
drug1215 Dietary Intervention Wiki 0.05
drug1434 Examine the impact of COVID-19 during pregnancy Wiki 0.05
drug908 Chloroquine analog (GNS651) Wiki 0.05
drug1224 Diffusing capacity of carbon monoxide Wiki 0.05
drug4260 VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki 0.05
drug3184 Quantitative analysis of anti-SARS-CoV-2-antibodies Wiki 0.05
drug1954 Inspiratory training device Wiki 0.05
drug3077 Presence of specific anti-SARS-CoV-2 antibodies Wiki 0.05
drug4454 decisions of limitations and stop processing Wiki 0.05
drug1283 Duodenal biopsy Wiki 0.05
drug2456 MySafeRx Inspire Flex Wiki 0.05
drug2571 No Messaging Wiki 0.05
drug961 Cognitive testing Wiki 0.05
drug1699 Health warning leaflet Wiki 0.05
drug1477 EyeQue Insight Wiki 0.05
drug51 2: Usual practice + SYMBICORT RAPIHALER Wiki 0.05
drug4142 Umbilical cord derived mesenchymal stem cells Wiki 0.05
drug1686 HOME-CoV rule implementation Wiki 0.05
drug3402 Ruconest Wiki 0.05
drug1603 GO2 PEEP MOUTHPIECE Wiki 0.05
drug3040 Povidone-Iodine Wiki 0.05
drug1494 FSD201 Wiki 0.05
drug2457 MySafeRx Inspire Plus Wiki 0.05
drug1668 Guided online support program Wiki 0.05
drug4199 Vancomycin Wiki 0.05
drug4562 lung ultrasound (LUS) Wiki 0.05
drug2539 Next generation Sequencing (NGS) analysis Wiki 0.05
drug2293 Matched Placebo Hydroxychloroquine Wiki 0.05
drug4798 vaccine BCG Wiki 0.05
drug2702 Online instruction Wiki 0.05
drug2370 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.05
drug4680 pulse oximeter Wiki 0.05
drug495 BNT162c2 Wiki 0.05
drug3856 T3 solution for injection Wiki 0.05
drug2856 Penn Microbiome Therapy - 001 Wiki 0.05
drug2559 Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki 0.05
drug2508 NasoVAX Wiki 0.05
drug4646 peripheral blood draw Wiki 0.05
drug4430 collection of mucosal lining fluid Wiki 0.05
drug4681 qRT-PCR and serology Wiki 0.05
drug1231 Digoxin Wiki 0.05
drug1264 Doxycyclin Wiki 0.05
drug2938 Placebo Daclatasvir 60 mg Wiki 0.05
drug3665 Sofosbuvir + Daclatasvir 120 mg Wiki 0.05
drug2900 Physical exercise Wiki 0.05
drug383 Atazanavir and Dexamethasone Wiki 0.05
drug1514 Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine Wiki 0.05
drug2243 MPT0B640 Wiki 0.05
drug4131 Ulinastatin Wiki 0.05
drug1759 Huaier Granule Wiki 0.05
drug2596 Non-Anchoring Strategy Control Wiki 0.05
drug354 Ascorbic Acid Wiki 0.05
drug1417 Escin Wiki 0.05
drug3251 RUTI® vaccine Wiki 0.05
drug1252 Doctor Spot Wiki 0.05
drug698 CGB-S-100 Wiki 0.05
drug4257 Vitamins Wiki 0.05
drug2247 MRI (heart, brain, lungs, kidney) Wiki 0.05
drug40 1: discontinuation of RAS blocker therapy Wiki 0.05
drug2997 Placebo: Hydroxychloroquine Wiki 0.05
drug1709 Hemanext One Wiki 0.05
drug1684 HLX70 Wiki 0.05
drug1779 Hydroxychloroquine + Metabolic cofactor supplementation Wiki 0.05
drug2637 Nutrition Wiki 0.05
drug251 Alisporivir Wiki 0.05
drug1457 Expiratory training device Wiki 0.05
drug2468 NA-831 and Atazanavir Wiki 0.05
drug1489 FLOW intervention Wiki 0.05
drug840 Canine odor detection of Volatile Organic Compounds Wiki 0.05
drug1688 HPV vaccine, Gardasil 9 Wiki 0.05
drug1675 HCQ & AZ Wiki 0.05
drug123 ARBOX Wiki 0.05
drug1388 Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 Wiki 0.05
drug1871 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.05
drug1540 Fit test Wiki 0.05
drug4395 biological samples collection Wiki 0.05
drug1802 Hydroxychloroquine Sulfate 400 mg twice a day Wiki 0.05
drug3769 Standard-titer Convalescent COVID-19 plasma (CCP2) Wiki 0.05
drug3063 Prediction Market Wiki 0.05
drug1478 F-652 Wiki 0.05
drug1400 Enoxaparin Higher Dose Wiki 0.05
drug2686 Omnibiotic AAD Wiki 0.05
drug935 Clinical examination Wiki 0.05
drug1793 Hydroxychloroquine Pre-Exposure Prophylaxis Wiki 0.05
drug4811 washed microbiota transplantation Wiki 0.05
drug2215 Lung Function Test Wiki 0.05
drug35 18F-αvβ6-BP Wiki 0.05
drug72 6 minute walk test Wiki 0.05
drug1178 Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki 0.05
drug3781 Sterile Normal Saline for Intravenous Use Wiki 0.05
drug1367 Emapalumab Wiki 0.05
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drug3785 Stool collection Wiki 0.05
drug3766 Standard treatment for COVID-19 Wiki 0.05
drug1777 Hydroxychloroquine (placebo) Wiki 0.05
drug2475 NGM621 Wiki 0.05
drug1791 Hydroxychloroquine Oral Product Wiki 0.05
drug4742 spirometry Wiki 0.05
drug2727 Oropharyngeal Swab Wiki 0.05
drug1289 Duty Frame Wiki 0.05
drug4343 Zithromax Oral Product Wiki 0.05
drug2192 Low dose Interferon-beta 1a Wiki 0.05
drug498 BTL-TML-COVID Wiki 0.05
drug1672 HB-adMSC Wiki 0.05
drug2989 Placebo- 0.10 mg/kg Wiki 0.05
drug1557 Fluvoxamine Wiki 0.05
drug929 Clazakizumab 25 mg Wiki 0.05
drug3738 Standard of care Wiki 0.05
drug605 Blood sample Wiki 0.04
drug4510 hydroxychloroquine Wiki 0.04
drug4406 blood sampling Wiki 0.04
drug3319 Remdesivir Wiki 0.04
drug4687 questionnaire Wiki 0.04
drug2998 Placebos Wiki 0.03
drug1600 GLS-5300 Wiki 0.03
drug2487 NORS (Nitric Oxide Releasing Solution) Wiki 0.03
drug1435 Exebacase Wiki 0.03
drug4793 unfractionated Heparin Wiki 0.03
drug1874 IVIG Wiki 0.03
drug800 CT-P59 Wiki 0.03
drug3510 Saline solution Wiki 0.03
drug2043 Ivermectin and Doxycycline Wiki 0.03
drug1339 Eculizumab Wiki 0.03
drug2506 Nasal swab Wiki 0.03
drug1301 EDP1815 Wiki 0.03
drug3596 Serology test for COVID-19 Wiki 0.03
drug3363 Rifampicin Wiki 0.03
drug2732 Other Wiki 0.03
drug4408 blood test Wiki 0.03
drug2463 N-acetylcysteine Wiki 0.03
drug343 Arbidol Wiki 0.03
drug3634 Sirolimus Wiki 0.03
drug1564 Follow up Wiki 0.03
drug1746 Home exercise Wiki 0.03
drug3399 Routine care for COVID-19 patients Wiki 0.03
drug1362 Electronic questionnaire Wiki 0.03
drug3922 Telehealth Wiki 0.03
drug3193 Questionnaire Administration Wiki 0.03
drug1398 Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki 0.03
drug4402 blood draw Wiki 0.03
drug3431 SARS-CoV-2 diagnostic rapid test Wiki 0.03
drug3055 Practice details Wiki 0.03
drug3036 Postcard Wiki 0.03
drug1052 Convalescent Plasma Transfusion Wiki 0.03
drug907 Chloroquine Sulfate Wiki 0.03
drug3686 Spirometry Wiki 0.03
drug4006 Throat swab Wiki 0.03
drug253 Allocetra-OTS Wiki 0.03
drug3256 Radiation therapy Wiki 0.03
drug1718 Hepatitis A vaccine Wiki 0.03
drug4603 nasopharyngeal swab Wiki 0.03
drug2041 Ivermectin Pill Wiki 0.03
drug555 Bicalutamide 150 Mg Oral Tablet Wiki 0.03
drug1539 Fisetin Wiki 0.03
drug1789 Hydroxychloroquine 200 Mg Oral Tablet Wiki 0.03
drug12 0.9% Saline Wiki 0.03
drug315 Antibiotics Wiki 0.03
drug841 Cannabidiol Wiki 0.03
drug2070 Ketogenic diet Wiki 0.03
drug3252 Rabeprazole Wiki 0.03
drug2888 Phone call Wiki 0.03
drug502 Bacille Calmette-Guérin (BCG) Wiki 0.03
drug3600 Serum testing Wiki 0.03
drug1667 Guduchi Ghan Vati Wiki 0.03
drug2461 N-Acetyl cysteine Wiki 0.03
drug1788 Hydroxychloroquine - Weekly Dosing Wiki 0.03
drug833 Camostat Mesylate Wiki 0.03
drug3060 Prazosin Wiki 0.03
drug3248 RTB101 Wiki 0.03
drug1447 Exercise training Wiki 0.03
drug4389 basic treatment Wiki 0.03
drug3192 Questionnaire Wiki 0.03
drug4607 no intervention Wiki 0.03
drug1193 Dexamethasone Wiki 0.03
drug3719 Standard care Wiki 0.03
drug4403 blood sample Wiki 0.03
drug2174 Lopinavir/ritonavir Wiki 0.03
drug3204 Questionnaires Wiki 0.03
drug1039 Control group Wiki 0.03
drug3566 Selinexor Wiki 0.03
drug4256 Vitamin Super B-Complex Wiki 0.03
drug2560 Nitric Oxide Gas Wiki 0.03
drug493 BNT162b2 Wiki 0.03
drug3243 RT-PCR Wiki 0.03
drug3942 Telmisartan Wiki 0.03
drug1993 Interview Wiki 0.03
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drug4482 exhaled breath sampling Wiki 0.03
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drug455 BCG vaccine Wiki 0.03
drug2094 LY3832479 Wiki 0.03
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drug3090 Probiotic Wiki 0.03
drug3813 Supportive Care Wiki 0.03
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drug912 Chloroquine phosphate Wiki 0.03
drug1306 EIDD-2801 Wiki 0.03
drug3588 Serological test Wiki 0.03
drug4650 placebo Wiki 0.02
drug2552 Nitazoxanide Wiki 0.02
drug3341 Reslizumab Wiki 0.02
drug163 AZD1222 Wiki 0.02
drug3938 Telerehabilitation Wiki 0.02
drug3928 Telemedicine Wiki 0.02
drug599 Blood draw Wiki 0.02
drug2170 Lopinavir/Ritonavir Wiki 0.02
drug4373 anti-SARS-CoV-2 convalescent plasma Wiki 0.02
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drug4172 Usual care Wiki 0.02
drug187 Acalabrutinib Wiki 0.02
drug3361 Ribavirin Wiki 0.02
drug2567 Nivolumab Wiki 0.02
drug2374 Midazolam Wiki 0.02
drug545 Best Practice Wiki 0.02
drug1116 Cyclosporine Wiki 0.02
drug3532 Sarilumab Wiki 0.02
drug2220 Lung ultrasound Wiki 0.02
drug2338 Mepolizumab Wiki 0.02
drug1060 Convalescent plasma Wiki 0.02
drug4253 Vitamin D3 Wiki 0.02
drug2093 LY3819253 Wiki 0.02
drug2729 Oseltamivir Wiki 0.02
drug3764 Standard treatment Wiki 0.02
drug832 Camostat Mesilate Wiki 0.02
drug2365 Methylprednisolone Wiki 0.01

Correlated MeSH Terms (151)


Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.65
D045169 Severe Acute Respiratory Syndrome NIH 0.31
D018352 Coronavirus Infections NIH 0.27
Name (Synonyms) Correlation
D012141 Respiratory Tract Infections NIH 0.18
D014777 Virus Diseases NIH 0.17
D003333 Coronaviridae Infections NIH 0.11
D012327 RNA Virus Infections NIH 0.10
D003428 Cross Infection NIH 0.09
D018357 Respiratory Syncytial Virus Infections NIH 0.09
D000163 Acquired Immunodeficiency Syndrome NIH 0.07
D030341 Nidovirales Infections NIH 0.07
D021821 Communicable Diseases, Emerging NIH 0.07
D058345 Asymptomatic Infections NIH 0.07
D009410 Nerve Degeneration NIH 0.07
D004066 Digestive System Diseases NIH 0.05
D004408 Dysgeusia NIH 0.05
D018184 Paramyxoviridae Infections NIH 0.05
D005767 Gastrointestinal Diseases NIH 0.05
D014808 Vitamin D Deficiency NIH 0.05
D011014 Pneumonia NIH 0.05
D030361 Papillomavirus Infections NIH 0.05
D006685 Hoarseness NIH 0.05
D000071074 Neonatal Sepsis NIH 0.05
D000070627 Chronic Traumatic Encephalopathy NIH 0.05
D001997 Bronchopulmonary Dysplasia NIH 0.05
D055732 Pulmonary Aspergillosis NIH 0.05
D008589 Meningococcal Infections NIH 0.05
D008595 Menorrhagia NIH 0.05
D006929 Hyperaldosteronism NIH 0.05
D001228 Aspergillosis NIH 0.05
D001229 Aspergillosis, Allergic Bronchopulmonary NIH 0.05
D011488 Protein Deficiency NIH 0.05
D054559 Hyperphosphatemia NIH 0.05
D028361 Mitochondrial Diseases NIH 0.05
D055154 Dysphonia NIH 0.05
D004314 Down Syndrome NIH 0.05
D015163 Superinfection NIH 0.05
D011645 Puerperal Infection NIH 0.05
D011649 Pulmonary Alveolar Proteinosis NIH 0.05
D063806 Myalgia NIH 0.05
D066087 Perinatal Death NIH 0.05
D005879 Tourette Syndrome NIH 0.05
D014832 Voice Disorders NIH 0.05
D003384 Coxsackievirus Infections NIH 0.05
D004660 Encephalitis NIH 0.05
D004761 Enterocolitis, Pseudomembranous NIH 0.05
D000309 Adrenal Insufficiency NIH 0.05
D007008 Hypokalemia NIH 0.05
D006560 Herpes Labialis NIH 0.05
D055501 Macrophage Activation Syndrome NIH 0.05
D063130 Maternal Death NIH 0.05
D007251 Influenza, Human NIH 0.04
D006331 Heart Diseases NIH 0.04
D008173 Lung Diseases, Obstructive NIH 0.04
D011024 Pneumonia, Viral NIH 0.04
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.04
D012140 Respiratory Tract Diseases NIH 0.04
D007676 Kidney Failure, Chronic NIH 0.04
D003327 Coronary Disease NIH 0.04
D015658 HIV Infections NIH 0.04
D016638 Critical Illness NIH 0.03
D019965 Neurocognitive Disorders NIH 0.03
D008585 Meningitis, Meningococcal NIH 0.03
D008581 Meningitis, Mening NIH 0.03
D000075902 Clinical Deterioration NIH 0.03
D014552 Urinary Tract Infections NIH 0.03
D009181 Mycoses NIH 0.03
D009101 Multiple Myeloma NIH 0.03
D003015 Clostridium Infections NIH 0.03
D000013 Congenital Abnormalities NIH 0.03
D009220 Myositis NIH 0.03
D016470 Bacteremia NIH 0.03
D001424 Bacterial Infections NIH 0.03
D000073296 Noncommunicable Diseases NIH 0.03
D004696 Endocarditis NIH 0.03
D017250 Caliciviridae Infections NIH 0.03
D001714 Bipolar Disorder NIH 0.03
D054219 Neoplasms, Plasma Cell NIH 0.03
D013577 Syndrome NIH 0.03
D004417 Dyspnea NIH 0.03
D011251 Pregnancy Complications, Infectious NIH 0.03
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.03
D000690 Amyotrophic Lateral Sclerosis NIH 0.03
D012640 Seizures NIH 0.03
D058070 Asymptomatic Diseases NIH 0.03
D016472 Motor Neuron Disease NIH 0.03
D003139 Common Cold NIH 0.03
D054990 Idiopathic Pulmonary Fibrosis NIH 0.03
D002318 Cardiovascular Diseases NIH 0.02
D020141 Hemostatic Disorders NIH 0.02
D001778 Blood Coagulation Disorders NIH 0.02
D004630 Emergencies NIH 0.02
D012127 Respiratory Distress Syndrome, Newborn NIH 0.02
D055371 Acute Lung Injury NIH 0.02
D003643 Death, NIH 0.02
D004211 Disseminated Intravascular Coagulation NIH 0.02
D009164 Mycobacterium Infections NIH 0.02
D000755 Anemia, Sickle Cell NIH 0.02
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.02
D000257 Adenoviridae Infections NIH 0.02
D006470 Hemorrhage NIH 0.02
D015535 Arthritis, Psoriatic NIH 0.02
D009369 Neoplasms, NIH 0.02
D004194 Disease NIH 0.02
D012120 Respiration Disorders NIH 0.02
D012128 Respiratory Distress Syndrome, Adult NIH 0.02
D005356 Fibromyalgia NIH 0.02
D007153 Immunologic Deficiency Syndromes NIH 0.02
D004198 Disease Susceptibility NIH 0.02
D001927 Brain Diseases NIH 0.02
D000857 Olfaction Disorders NIH 0.02
D009362 Neoplasm Metastasis NIH 0.02
D014115 Toxemia NIH 0.02
D018450 Disease Progression NIH 0.02
D003680 Deglutition Disorders NIH 0.02
D007154 Immune System Diseases NIH 0.02
D011565 Psoriasis NIH 0.02
D008171 Lung Diseases, NIH 0.02
D055370 Lung Injury NIH 0.02
D000066553 Problem Behavior NIH 0.02
D018805 Sepsis NIH 0.02
D019337 Hematologic Neoplasms NIH 0.02
D000070642 Brain Injuries, Traumatic NIH 0.02
D050177 Overweight NIH 0.02
D009205 Myocarditis NIH 0.02
D011665 Pulmonary Valve Insufficiency NIH 0.02
D010300 Parkinsonian NIH 0.02
D015212 Inflammatory Bowel Diseases NIH 0.02
D003324 Coronary Artery Disease NIH 0.02
D003550 Cystic Fibrosis NIH 0.02
D011248 Pregnancy Complications NIH 0.01
D003424 Crohn Disease NIH 0.01
D008175 Lung Neoplasms NIH 0.01
D001930 Brain Injuries, NIH 0.01
D059350 Chronic Pain NIH 0.01
D017563 Lung Diseases, Interstitial NIH 0.01
D001172 Arthritis, Rheumatoid NIH 0.01
D007674 Kidney Diseases NIH 0.01
D011658 Pulmonary Fibrosis NIH 0.01
D053120 Respiratory Aspiration NIH 0.01
D020521 Stroke NIH 0.01
D005355 Fibrosis NIH 0.01
D009103 Multiple Sclerosis NIH 0.01
D012598 Scoliosi NIH 0.01
D001168 Arthritis NIH 0.01
D006973 Hypertension NIH 0.01
D000860 Hypoxia NIH 0.01
D040921 Stress Disorders, Traumatic NIH 0.01
D007249 Inflammation NIH 0.01
D014947 Wounds and Injuries NIH 0.01
D013313 Stress Disorders, Post-Traumatic NIH 0.01

Correlated HPO Terms (58)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.18
HP:0002180 Neurodegeneration HPO 0.07
HP:0100512 Low levels of vitamin D HPO 0.05
Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.05
HP:0002905 Hyperphosphatemia HPO 0.05
HP:0003811 Neonatal death HPO 0.05
HP:0002900 Hypokalemia HPO 0.05
HP:0000846 Adrenal insufficiency HPO 0.05
HP:0001618 Dysphonia HPO 0.05
HP:0001621 Weak voice HPO 0.05
HP:0000132 Menorrhagia HPO 0.05
HP:0003326 Myalgia HPO 0.05
HP:0002383 Encephalitis HPO 0.05
HP:0006517 Intraalveolar phospholipid accumulation HPO 0.05
HP:0040187 Neonatal sepsis HPO 0.05
HP:0000859 Hyperaldosteronism HPO 0.05
HP:0001609 Hoarse voice HPO 0.05
HP:0011024 Abnormality of the gastrointestinal tract HPO 0.04
HP:0006536 Pulmonary obstruction HPO 0.04
HP:0006510 Chronic pulmonary obstruction HPO 0.04
HP:0001287 Meningitis HPO 0.03
HP:0100584 Endocarditis HPO 0.03
HP:0100754 Mania HPO 0.03
HP:0100614 Myositis HPO 0.03
HP:0006775 Multiple myeloma HPO 0.03
HP:0002098 Respiratory distress HPO 0.03
HP:0006802 Abnormal anterior horn cell morphology HPO 0.03
HP:0007354 Amyotrophic lateral sclerosis HPO 0.03
HP:0001928 Abnormality of coagulation HPO 0.02
HP:0001626 Abnormality of the cardiovascular system HPO 0.02
HP:0005521 Disseminated intravascular coagulation HPO 0.02
HP:0001250 Seizure HPO 0.02
HP:0007018 Attention deficit hyperactivity disorder HPO 0.02
HP:0002664 Neoplasm HPO 0.02
HP:0000458 Anosmia HPO 0.02
HP:0002721 Immunodeficiency HPO 0.02
HP:0001298 Encephalopathy HPO 0.02
HP:0003765 Psoriasiform dermatitis HPO 0.02
HP:0002015 Dysphagia HPO 0.02
HP:0002088 Abnormal lung morphology HPO 0.02
HP:0100806 Sepsis HPO 0.02
HP:0000708 Behavioral abnormality HPO 0.02
HP:0002037 Inflammation of the large intestine HPO 0.02
HP:0001677 Coronary artery atherosclerosis HPO 0.02
HP:0012819 Myocarditis HPO 0.02
HP:0010444 Pulmonary insufficiency HPO 0.02
HP:0100280 Crohn's disease HPO 0.01
HP:0100526 Neoplasm of the lung HPO 0.01
HP:0012532 Chronic pain HPO 0.01
HP:0006515 Interstitial pneumonitis HPO 0.01
HP:0001370 Rheumatoid arthritis HPO 0.01
HP:0001909 Leukemia HPO 0.01
HP:0000077 Abnormality of the kidney HPO 0.01
HP:0002206 Pulmonary fibrosis HPO 0.01
HP:0001297 Stroke HPO 0.01
HP:0001369 Arthritis HPO 0.01
HP:0000822 Hypertension HPO 0.01
HP:0012418 Hypoxemia HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 450 clinical trials


1 Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19

The principal objective is to determine the impact of phenelzine on the activation phenotype of T cells and myeloid cells during SARS-CoV2 infection

NCT04590222
Conditions
  1. SARS-CoV2 Infection
Interventions
  1. Other: blood sample
MeSH:Infec Infection

Primary Outcomes

Description: evaluate the levels of the activation of T cells and myeloid cells after phenelzine exposure by the levels of the % of DR+ CD38+ T cells and CD14+dim CD16+ monocytes.

Measure: levels of lymphocytes T DR + CD38 + and of monocytes CD14 dim + CD16 +.

Time: through study completion, an average of 1 year

Secondary Outcomes

Description: evaluate the levels of the expression of immune checkpoints on T cells by flow cytometry

Measure: level of immune checkpoints

Time: through study completion, an average of 1 year

Description: evaluate the modification of functional capacities of T cells by cytokines production, and proliferation, after mitogenic and antigen recall stimulations including SARS-CoV-2 antigens

Measure: cytokine production and proliferation

Time: through study completion, an average of 1 year

Description: assess if there is an impact of phenelzine on the activation levels of neutrophils

Measure: levels of neutrophils

Time: through study completion, an average of 1 year

Description: Determine if the immune responses in obese patients (a strong risk factor for severe Covid19) can be modulated in the same way compared with lean patients

Measure: level of immune responses in obese patients

Time: through study completion, an average of 1 year

Description: Determine if the immune responses can be modulated in the same way in men and in women (men being affected by more severe disease)

Measure: level of immune responses for men and women

Time: through study completion, an average of 1 year
2 A Two-arm Randomized Double-blind Study With COVID19-0001-USR Administered Via Nebulization to Patients With Mild and/or Moderate Severe Acute Respiratory Syndrome (SARS-COV-2) Infection to Decrease Viral Load

Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.

NCT04595136
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Drug: Drug COVID19-0001-USR
  2. Drug: normal saline
MeSH:Infect Infection Communicable Diseases

Primary Outcomes

Description: COVID19-0001-USR 1% nebulized pathway changes viral load of SARS-COV-2 virus (COVID19) in the upper and lower airways if started during the initial phase of infection

Measure: Change on viral load results from baseline after using COVID19-0001-USR via nebulization

Time: Treatment Period of 7 days
3 A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.

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

Primary Outcomes

Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.

Measure: Time to clinical worsening

Time: RCT (approximately 15 days)

Secondary Outcomes

Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.

Measure: clinical deterioration on a Likert-type scale (1-6)

Time: RCT (approximately 15 days)

Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.

Measure: clinical deterioration measured by number of days

Time: RCT (approximately 15 days)

Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.

Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe)

Time: RCT (approximately 15 days)
4 Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases

Background: - Increased clinical attention has been paid to the evaluation and management of bioterrorism-related illness (such as anthrax infection) and emerging infectious diseases (such as Severe Acute Respiratory Syndrome [SARS] and new strains of influenza). However, evaluation and treatment data for these illnesses are often limited because human infections to date have been relatively limited. Further knowledge about diseases of bioterrorism concern and emerging infectious diseases may lead to more effective forms of therapy to prevent disease-related illnesses and deaths. Objectives: - To apply standardized, documented, and carefully monitored evaluation and treatment methods for bioterrorism- and biodefense-related illnesses and emerging infectious diseases at the National Institutes of Health Clinical Center. Eligibility: - Individuals at least 2 years of age who have confirmed or suspected infection by a biodefense or bioterrorism agent, or an emerging infectious disease agent. - Individuals at least 2 years of age who have confirmed or suspected exposure to a biodefense or bioterrorism agent, an emerging infectious disease agent, or who have close exposure to an individual who is suspected of being infected with one of these agents. - Health care workers who are involved in medical treatment of the abovementioned infected or exposed individuals. Design: - All eligible persons will have an initial screening evaluation to determine the circumstances of possible infectious exposure (e.g., where, when, and how exposed), current medical condition and medical care given, and any aspects of medical history that might be relevant to the exposure. - Participants may be seen in an outpatient clinic or in the Special Clinical Studies Unit (SCSU) at the National Institutes of Health (NIH). The NIH SCSU is a hospital ward specially designed to minimize the risk of spreading infection to others. - Upon admission, participants will provide blood and urine samples, have an electrocardiogram to measure heart activity, and have specific tests or procedures associated with the particular infectious agent. - Participants who develop illnesses will be treated with the standard of care for known diseases or with experimental measures, depending on the nature of the illness. Separate consent may be required for these treatments. - Participants will remain on this study for at least 1 year following the period of active evaluation and treatment. Participants may be asked to come to the NIH outpatient clinic on a periodic basis for medical evaluations and blood tests, and may be asked to keep a diary card to record any unusual signs or symptoms of possible infection.

NCT01200953
Conditions
  1. Occupational Accidents
  2. Incubation Period, Infectious Disese
MeSH:Communicable Diseases Infection Communicable Diseases, Emerging

Primary Outcomes

Description: Determination of sustained absence of disease-specific symptoms and signs.

Measure: Symptoms and signs

Time: 1 year
5 Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT01302418
Conditions
  1. QIAGEN ResPlex II Advanced Panel
  2. Influenza A
  3. Respiratory Syncytial Virus Infections
  4. Infection Due to Human Parainfluenza Virus 1
  5. Parainfluenza Type 2
  6. Parainfluenza Type 3
  7. Parainfluenza Type 4
  8. Human Metapneumovirus A/B
  9. Rhinovirus
  10. Coxsackie Virus/Echovirus
  11. Adenovirus Types B/C/E
  12. Coronavirus Subtypes 229E
  13. Coronavirus Subtype NL63
  14. Coronavirus Subtype OC43
  15. Coronavirus Subtype HKU1
  16. Human Bocavirus
  17. Artus Influenza A/B RT-PCR Test
  18. Influenza B
Interventions
  1. Device: artus Influenza A/B RT-PCR Test
MeSH:Infection Communicable Diseases Virus Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections

Primary Outcomes

Description: The presence of Influenza A or Influenza B virus.

Measure: Detection of Respiratory Viruses

Time: Specimens will be taken within 5 days of the appearance of symptoms.
6 Viral Infections in Healthy and Immunocompromised Hosts

Background: - Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development. Objectives: - To collect samples and data from individuals who have been exposed to or have contracted viral infections. Eligibility: - Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases. - Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate. Design: - Participants will be pre-screened to determine if they meet the eligibility criteria for the trial. - If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies. - Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing. - Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection. - Treatment is not offered under this study.

NCT01306084
Conditions
  1. Anogenital Herpes
  2. COVID-19
  3. Herpes Labialis
MeSH:Infection Virus Diseases Herpes Labialis

Primary Outcomes

Description: January 2031

Measure: Sample collection, analysis of immune function, or review of tissue bx or clinical rpts from outside labs in designated pop. w/ viral, suspected, or recovered from a viral infection or a close contact of people w/or suspected to have a viral inf...

Time: open-ended
7 SEA022 Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study.

Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.

NCT01546935
Conditions
  1. Influenza
Interventions
  1. Drug: Oseltamivir
MeSH:Infection Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection

Primary Outcomes

Description: Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.

Measure: Viral clearance

Time: 5-10 days

Description: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life

Measure: Pharmacokinetics of Oseltamivir

Time: Day 0 and Day 9

Secondary Outcomes

Description: Time to viral clearance on a throat swab, assessed by RT PCR. The time to no detectable influenza virus by culture for the throat swab. Change in viral load (log10 copies/mL) over time for all virological samples (lower limit of detection: 1000 copies/mL) Viral susceptibility of cultured influenza virus to antiviral drugs at baseline and post treatment, assessed by genotypical and phenotypical analyses

Measure: Viral end points

Time: 5-10 days

Description: Time to fever clearance In hospital mortality and mortality by follow up Time to death Time to trans cutaneous O2 saturation of ≥ 95% on room air Clinical course: pneumothorax, encephalitis/encephalopathy Number of days in hospital Number of days ventilated

Measure: Clinical Efficacy Endpoints

Time: 5-10 days

Description: Documented serious adverse events (SAEs) and relationships to oseltamivir AEs leading to drug withdrawal Grade 3 & 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir Skin rashes of any grade Changes in haematological and biochemical parameters over time

Measure: Safety Endpoints

Time: 5-10 days
8 Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study: A Randomized Controlled Trial of the Efficacy of HPV Vaccination in Preventing Transmission of HPV Infection in Heterosexual Couples

Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina, and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have been proven to be highly effective in preventing the acquisition of HPV infection and the genital precancerous lesions caused by it. However, we do not know yet if a previously infected individual, once vaccinated, would be less infective to her or his sexual partner. We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination (TRAP-HPV) study to answer this question. It will include 500 sexually active couples* (total of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It will be a randomized placebo-controlled, double-blinded intervention trial. Study participants will be followed up to 12 months. Behavioural and biological data will be collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment. The results of this trial will be invaluable in informing policies regarding vaccination of women and men.

NCT01824537
Conditions
  1. Human Papillomavirus Infection
Interventions
  1. Biological: HPV vaccine, Gardasil 9
  2. Biological: Hepatitis A vaccine
MeSH:Infection Papillomavirus Infections

Primary Outcomes

Description: Reduction in HPV type concordance (for the four target types) will be the main outcome evaluable as per the above group contrasts. These comparisons will be done with due attention to the enrolment virological status of the individuals. For instance, it is expected that a Avaxim-treated woman who is positive for HPV 6 in the oral specimen but negative for this type in the vaginal specimen may derive benefit if her partner receives Gardasil, even if he is HPV-6 positive in the penile sample. The assumption is that protection via vaccination is pan-mucosal, via transudation of neutralizing antibodies; this protection may mediate transmission.

Measure: The primary outcome will be the reduction of HPV DNA positivity for the target HPV vaccine types (i.e., HPVs 6, 11, 16, and 18) in multiple anatomic sites in the placebo-treated sexual partners of persons who received Gardasil.

Time: At months 2, 4, 6, 9 and 12.
9 A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections

Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually emerge and require new investigations to understand pathogen biology and pathogenesis in the host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health and the economy are also increasing. Current alerts sent out by the Ministry of Health (about the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely reflect advances in science, which have allowed novel pathogens to be identified. Because of its geography, Singapore is vulnerable to new pathogens through importation or the global travel of its citizens. Hence we must be ever ready to meet unexpected challenges anytime. On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force which has in place many plans that can be activated should there be a large-scale epidemic. What is missing thus far is a program that will enable us to perform scientific studies in the setting of an epidemic. Hence in this study, we will, in collaboration with the Program in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii) characterize viruses (not necessarily novel but emerging and re-emerging) that are raising concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize immune responses to such viruses in healthcare workers as well as patients (those affected by these viruses and those exposed to the affected). The techniques that will be used will be those not routinely available in a hospital's service labs. Some patients will remain undiagnosable with the best available technology. Since new laboratory tools that can detect previously undiagnosed pathogens may become available in the future, the study also aims to archive specimens from patients whose illnesses remain undiagnosed.

NCT01979705
Conditions
  1. Prospective Studies
MeSH:Infection

Primary Outcomes

Description: Clinical data collection through case records, and interview of patients or next-of-kin or friend in the event information is unavailable or incompletely documented in the case records. Sample collection will be performed according to the following frequency: First day of enrolment: blood draw (by weight) not more than 20ml, nasal (and/or nasopharyngeal ) and/or throat swab, stool and urine sample. On days 2, 3, 5, 7, 10, 14 and 28: blood (by weight) not more than 10 ml, nasal (and/or nasopharyngeal l) and/or throat swab, stool and urine sample. On D28, blood (by weight) not more than 20ml, will be drawn as most immune response changes manifest by then. If available, urine and stool sample will be collected. If the subject is intubated, endotracheal aspirate will replace nasal and throat swab. Sample collection for research will be done at the same time as samples for clinical testing as far as possible, to minimize patient discomfort.

Measure: Detecting of Novel Pathogens

Time: Day 1 - Day 28 of recruitment
10 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

NCT02135614
Conditions
  1. Respiratory Syncytial Virus Infection
Interventions
  1. Drug: Presatovir
  2. Drug: Presatovir placebo
MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5

Time: Baseline to Day 5

Secondary Outcomes

Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5

Time: Baseline to Day 5

Measure: Number of Hospitalization-Free Days Following Presatovir Administration

Time: Up to Day 28

Description: The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.

Measure: Rate of Unplanned Medical Encounters

Time: Up to Day 28
11 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

NCT02254408
Conditions
  1. Respiratory Syncytial Virus
Interventions
  1. Drug: Presatovir
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9

Time: Baseline; Day 9

Description: A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: Primary RSV lower respiratory tract infection (LRTI) Secondary bacterial LRTI LRTI due to unusual pathogens Lower respiratory tract complication of unknown etiology

Measure: Percentage of Participants Who Developed a Lower Respiratory Tract Complication

Time: Up to Day 28

Secondary Outcomes

Description: Participants were considered to have an event if either condition is met: Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or; Participant dies prior to or on Day 28

Measure: Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality

Time: Up to Day 28
12 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

NCT02254421
Conditions
  1. Respiratory Syncytial Virus Infection
Interventions
  1. Drug: Presatovir
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.

Measure: Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9

Time: Baseline to Day 9

Secondary Outcomes

Measure: Number of Supplemental O2-Free Days Through Day 28

Time: Up to Day 28

Measure: Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28

Time: Up to Day 28

Measure: Percentage of All-Cause Mortality Among Participants Through Day 28

Time: Up to Day 28
13 A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients

The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.

NCT02351180
Conditions
  1. Lung Transplant Infection
Interventions
  1. Drug: Inhaled beclomethasone
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Virus Diseases

Primary Outcomes

Measure: Freedom from new or progressive chronic lung allograft dysfunction

Time: 180 days

Measure: Death

Time: 180 days

Secondary Outcomes

Measure: Respiratory virus symptom score

Time: 7 days

Measure: Acute rejection

Time: 180 days

Measure: Lymphocytic bronchiolitis

Time: 180 days

Measure: Donor-specific antibodies

Time: 180 days

Measure: Chronic lung allograft dysfunction

Time: 365 days
14 A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

NCT02534350
Conditions
  1. Respiratory Syncytial Virus (RSV)
Interventions
  1. Drug: Presatovir
  2. Drug: Placebo
MeSH:Infection Virus Diseases

Primary Outcomes

Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set

Time: Up to 7 days

Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median

Time: Up to 7 days

Secondary Outcomes

Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7

Time: Up to 7 days

Description: FEV1 is defined as forced expiratory volume in the first second.

Measure: Percent Change From Study Baseline in FEV1% Predicted Value

Time: Baseline; Day 28
15 Analysis of Human to Human Transmission of Middle East Respiratory Syndrom Coronavirus (MER-CoV) and Infection Control Experiences in a Medical Institution of South Korea

This study aimed to analysis the characteristics of MERS transmission and the effect of our institutional personal protective equipment on the controlling the MERS at a tertiary Korean Hospital.

NCT02605109
Conditions
  1. Viral Infection
Interventions
  1. Other: Risk of MERS infection
MeSH:Infection Virus Diseases

Primary Outcomes

Measure: Numbers of infected patient

Time: Serologic confimred MERS case within 4 weeks after contacting to a case patients
16 Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims.

The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management. This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.

NCT02868541
Conditions
  1. Acute Respiratory Infection
Interventions
  1. Other: Naso pharyngeal swab
MeSH:Infection Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Measure: The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj

Time: up to 3 years
17 International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.

NCT03039621
Conditions
  1. Acute Respiratory Viral Infections
Interventions
  1. Drug: Ergoferon
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Virus Diseases

Primary Outcomes

Description: Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

Measure: Time to Alleviation of All ARVI Symptoms.

Time: 14 days of observation.

Secondary Outcomes

Description: Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).

Measure: Time to Normalization of Body Temperature.

Time: 14 days of observation.

Description: Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.

Measure: Time to Alleviation of Flu-like Nonspecific Symptoms.

Time: 14 days of observation.

Description: Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.

Measure: Time to Alleviation of Respiratory Symptoms.

Time: 14 days of observation.

Description: Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

Measure: Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.

Time: On days 2-6 of the observation period.

Description: Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.

Measure: ARVI Severity.

Time: On days 2-6 of the observation period.

Description: Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).

Measure: Percentage of Recovered Patients.

Time: On days 2-6 of the observation period.

Description: Based on patient diary data. The number of intakes of prescribed antipyretics.

Measure: Rates of Antipyretics Use Per Patient.

Time: On days 1- 5 of the treatment period.

Description: Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).

Measure: Percentage of Patients With Worsening of Illness.

Time: 14 days of observation peiod.
18 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
19 Genome-wide CRISPR Screen for Host Factors Associated With Norovirus Infections in Stem Cell-derived Human Intestinal Enteroid Model

The primary objective in this study is to establish a list of host cellular proteins that mediate norovirus infection. Norovirus is one of the most common pathogens attributed to diarrheal diseases from unsafe food. It is also the primary cause of mortality among young children and adults in foodborne infections. Norovirus is not just a foodborne burden. In a recent meta-analysis, norovirus accounts for nearly one-fifth of all causes of (including person-to-person transmission) acute gastroenteritis in both sporadic and outbreak settings and affects all age groups. Undoubtedly, norovirus is of paramount public health concern in both developed and developing countries. Research efforts to better understand norovirus pathobiology will be necessary for targeted intervention. From Middle East respiratory syndrome coronavirus to Zika virus, efforts to identify host factors important for mediating virus infection has always been a research priority. Such information will shed light on potential therapeutic targets in antiviral intervention. Norovirus virus-host interaction studies have been hampered by the lack of a robust cell culture model in the past 20 years. In 2016, norovirus has finally been successfully cultivated in a stem cell-derived three-dimensional human gut-like structure called enteroid or mini-gut. In this study, intestinal stem cells will be isolated from duodenal biopsies collected from participants, followed by differentiation into mini-guts. Genome-wide genetic screening for host essential and restrictive factors will be performed on infected mini-guts by knockout CRISPR and gain-of-function CRISPR SAM, respectively. Shortlisted candidates will undergo preliminary functional validation in cell lines. These data will provide insights into potential therapeutic targets against norovirus infection.

NCT03342547
Conditions
  1. Gastrointestinal Infection
Interventions
  1. Procedure: Duodenal biopsy
  2. Procedure: Saliva
MeSH:Infection Communicable Diseases Caliciviridae Infections

Primary Outcomes

Description: Viability of enteroids as determined by microscopy

Measure: Establishment of human intestinal stem cell-derived enteroids

Time: An average of three months
20 A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection

The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).

NCT03656510
Conditions
  1. Respiratory Syncytial Virus Infections
Interventions
  1. Drug: JNJ-53718678
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Virus Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: RSV viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by the RSV viral load as measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

Measure: Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

Time: Baseline through Day 5

Secondary Outcomes

Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Measure: RSV Viral Load and Change from Baseline Over Time

Time: Baseline through Day 21

Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.

Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

Time: Baseline through Days 3, 8 and 14

Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

Measure: Time to Undetectable RSV Viral Load

Time: Up to 21 days

Description: Proportion of participants with undetectable RSV viral load will be reported.

Measure: Proportion of Participants with Undetectable RSV Viral Load at each timepoint

Time: Up to 21 days

Description: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS)

Time: Up to 21 days

Description: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Measure: Severity of RSV Disease Assessed by PRESORS

Time: Up to 21 days

Description: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

Measure: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

Time: Baseline up to 21 days

Description: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

Measure: Change from Baseline in Clinician PRESORS Scores

Time: Baseline up to 21 days

Description: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

Measure: Time to Resolution of RSV Symptoms

Time: Up to 21 days

Description: Time to improvement based on general questions on overall health will be reported.

Measure: Time to Improvement on Overall Health

Time: Up to 21 days

Description: Proportion of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

Measure: Proportion of Participants with Improvement or Worsening of RSV Disease

Time: Up to 21 days

Description: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

Measure: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

Time: Up to 21 days

Description: Proportion of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

Measure: Proportion of Participants with Vital Sign Abnormalities

Time: Up to 28 days

Description: Proportion of participants with abnormal body temperature will be reported.

Measure: Proportion of Participants with Abnormal Body Temperature as Measured by the Parent(s)/Caregiver(s)

Time: Up to 28 days

Description: Proportion of participants who require (re)hospitalization during treatment and follow-up will be reported.

Measure: Proportion of Participants who Require (re)Hospitalization During Treatment and Follow-up

Time: Up to 21 days

Description: Time return to age-adjusted normal values for vital signs (heart rate, respiratory rate, and/or blood oxygen) for participants with risk factors for severe RSV Disease will be recorded.

Measure: Time Return to Age-Adjusted Normal Values for vital signs (Heart Rate, Respiratory Rate, and/or Blood Oxygen) for Participants with Risk Factors for Severe RSV Disease

Time: Up to 21 days

Description: Time to discharge (from initial admission and from initiation of treatment) will be recorded for Cohort 1 only.

Measure: Cohort 1: Time to Discharge

Time: Up to 21 days

Description: Proportion of participants who require to be admitted to the ICU will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require to be Admitted to Intensive Care Unit (ICU)

Time: Up to 21 days

Description: In the event that a participant requires ICU, admission, the duration of need for ICU stay will be reported for Cohort 1 only.

Measure: Cohort 1: Duration of ICU Stay

Time: Up to 21 days

Description: Proportion of participants who require supplemental oxygen will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion Participants who Require Supplemental Oxygen

Time: Up to 21 days

Description: Duration of the oxygen supplementation in participants requiring will be reported for Cohort 1 only.

Measure: Cohort 1: Duration of Supplemental Oxygen

Time: Up to 21 days

Description: Proportion of participants who require non-invasive ventilator support (for example [e.g], continuous positive airway pressure) status will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require Non-invasive Ventilator Support

Time: Up to 21 days

Description: Proportion of participants who require invasive ventilator support (e.g, endotracheal-mechanical ventilation) will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Require Invasive Mechanical Ventilation Support

Time: Up to 21 days

Description: Duration of non-invasive ventilator support (e.g, continuous positive airway pressure) to deliver oxygen will be measured for Cohort 1 only.

Measure: Cohort 1: Duration of Non-invasive Ventilator Support

Time: Up to 21 days

Description: Duration of invasive ventilator support (e.g, endotracheal-mechanical ventilation) to deliver oxygen will be measured for Cohort 1 only.

Measure: Cohort 1: Duration of Invasive Ventilator Support

Time: Up to 21 days

Description: Proportion of participants who need (defined by <50% of normal oral intake) hydration and/or feeding by IV administration or nasogastric tube will be reported for Cohort 1 only.

Measure: Cohort 1: Proportion of Participants who Need Hydration and/or Feeding by Intravenously (IV) Administration or Nasogastric Tube

Time: Up to 21 days

Description: Time to clinical stability is defined as the time from initiation of study treatment until the time at which the following criteria are met: Time to return to age-adjusted normal values for otherwise healthy and pre-RSV infection status for participants with risk factor for severe RSV disease (heart rate, respiratory rate, blood oxygen level), no more oxygen supplementation or otherwise healthy participants and with risk factor(s) for severe RSV disease and no more intravenously (IV)/nasogastric tube feeding/hydration) in otherwise healthy participants or return to pre-RSV status of IV/nasogastric tube feeding/hydration in participants with risk factor for severe RSV disease for Cohort 1 only.

Measure: Cohort 1: Time to Clinical Stability with Clinical Stability Evaluated by the Investigator

Time: Up to 21 days

Description: Time from initiation of study treatment until SpO2 >=92 percentage (%) and SpO2 >= 95% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms will be reported for Cohort 1 only.

Measure: Cohort 1: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) >= 92% and SpO2 >= 95% on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms

Time: Up to 21 days

Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Measure: Percentage of Participants with Adverse Events

Time: Up to 28 days

Description: Percentage of participants with abnormal laboratory (serum chemistry, hematology and urinalysis) findings will be reported.

Measure: Percentage of Participants with Abnormal Laboratory Findings

Time: Up to 28 days

Description: Percentage of participants with abnormal ECGs findings will be reported.

Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 21 days

Description: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

Measure: Plasma Concentrations of JNJ-53718678

Time: Days 1 and 3

Description: Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.

Measure: Medical Resource Utilization

Time: Up to 28 days

Description: Acceptability and palatability of the JNJ-53718678 formulation will be assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing.

Measure: Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)

Time: Day 8

Description: Number of participants with changes in the RSV F-gene compared with baseline sequences will be assessed by sequencing of the viral genome.

Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences

Time: Up to 21 days
21 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

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

Primary Outcomes

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

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

Time: by Day 28

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

Time: Day 14

Secondary Outcomes

Measure: All-cause mortality rate (main study)

Time: at Day 28

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

Time: by Day 21

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

Time: Days 10, 14, 21, 28

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

Time: by Day 28

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

Time: by Days 14, 21, 28 and 35

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

Time: through Day 35

Measure: Total number of inpatient days (main study)

Time: up to Day 35

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

Time: at Day 28

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

Time: at Day 35

Measure: All-cause mortality rate (main study)

Time: at Day 35

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

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

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

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

Measure: Time to RTRA

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

Measure: Time to Clinical stability

Time: Day 14, Day 21, Day 28

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

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

Measure: Time to Clinical deterioration

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

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

Time: Day 14, Day 21, Day 28

Measure: Time to Death (all causes)

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

Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

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

Primary Outcomes

Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

Time: within 6 weeks (42 days)

Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

Time: 4 weeks (28 days) post-delivery

Secondary Outcomes

Description: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.

Measure: Incidence of chorioamnionitis

Time: prior to delivery

Description: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.

Measure: Incidence of endometritis

Time: within 42 days post-delivery

Description: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).

Measure: Incidence of other infections

Time: within 42 days post-delivery

Description: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.

Measure: Incidence of use of subsequent maternal antibiotic therapy

Time: after randomization to 42 days post-delivery

Description: Time from drug administration until initial discharge after delivery (time may vary by site).

Measure: Maternal initial hospital length of stay

Time: within 42 days post-delivery

Description: Maternal readmissions within 42 days of delivery

Measure: Incidence of maternal readmissions

Time: within 42 days post-delivery

Description: Maternal admission to special care units

Measure: Incidence of maternal admission to special care units

Time: within 42 days post-delivery

Description: Maternal unscheduled visit for care

Measure: Incidence of maternal unscheduled visit for care

Time: within 42 days post-delivery

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

Measure: Incidence of maternal GI symptoms

Time: within 42 days post-delivery

Description: Maternal death due to sepsis using the Global Network algorithm for cause of death

Measure: Incidence of maternal death due to sepsis

Time: within 42 days post-delivery

Description: Incidence of other neonatal infections.

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

Time: within 42 days post-delivery

Description: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).

Measure: Neonatal initial hospital length of stay

Time: within 28 days of delivery

Description: Neonatal readmissions within 42 days of delivery

Measure: Incidence of neonatal readmissions

Time: within 42 days of delivery

Description: Neonatal admission to special care units

Measure: Incidence of neonatal admission to special care units

Time: within 28 days of delivery

Description: Neonatal unscheduled visit for care

Measure: Incidence of neonatal unscheduled visit for care

Time: within 42 days post-delivery

Description: Neonatal death due to sepsis using the Global Network algorithm for causes of death

Measure: Incidence of neonatal death due to sepsis

Time: within 28 days of delivery

Description: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.

Measure: Incidence of pyloric stenosis within 42 days of delivery

Time: within 42 days of delivery
23 Usefulness of White Blood Cell Count (WBCC) During Infection: a Comparison Between Hospitalized Geriatric and Young Groups.

In the general population, increased WBCC and neutrophil count are widely used as markers for infection during inflammatory states 1. However, 32% of geriatric patients with an infection do not develop an increase in WBCC 2. The hypothesis is that with inflammation, geriatric patients have a misadapted response of the immune system (IS) 3. Our recent retrospective study 4 has shown that total and differential WBCC were not correlated with infection in a geriatric hospitalized population. Therefore, WBCC does not seem to be a reliable marker for infection in geriatric hospitalized patients. The neutrophil/lymphocyte ratio, and CRP, seem to be better markers. the aim of the study to investigate this hypothesis prospectively and assess the role of aging and chronic diseases (such as cardiovascular diseases (CVD) and risk factors (CVRF) 5, cytomegalovirus (CMV) infection 6, periodontitis 7, onychomycosis 8 ) in this process and assess the role of a geriatric assessment. To assess the usefulness of WBCC in the diagnosis of infection in geriatric patients and to address the contribution of ongoing chronic co-morbidities and age to WBCC-kinetics during an acute inflammatory syndrome, young and geriatric hospitalized patients with an inflammatory syndrome with and without infection will be compared

NCT03943277
Conditions
  1. White Blood Cells Engulfing Red Blood Cells
Interventions
  1. Other: No intervention, observational study
MeSH:Infection

Primary Outcomes

Description: observation of WBCC is correlated with infection by older patient

Measure: Usefulness of white blood cell count (WBCC) during infection in geriatric patient

Time: 1.5 years
24 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 Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases 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
25 A Phase II, Randomized Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Severe or Severe-Complicated/Fulminant Clostridium Difficile Infection

This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).

NCT03970200
Conditions
  1. Severe Clostridium Difficile Infection
  2. Severe-Complicated/Fulminant Clostridium Difficile Infection
Interventions
  1. Drug: Penn Microbiome Therapy - 001
  2. Drug: Penn Microbiome Therapy - 002
  3. Drug: Penn Microbiome Therapy - 003
  4. Drug: Antibiotics
MeSH:Infection Communicable Diseases Clostridium Infections Enterocolitis, Pseudomembranous

Primary Outcomes

Description: The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 24 hours: If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved Ileus/megacolon either noted as resolved by any provider documentation or not noted WBC<15,000 cells/uL Serum creatinine decreased, unchanged, or increased by ≤0.2 mg/dL over 24 hours (if not receiving continuous renal replacement therapy (CRRT) or hemodialysis (HD)) Lactate ≤2.2 mmol/L (if measured by clinical care team) No vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin) Temperature <38.5 °C and ≥35.6°C < 8 bowel movements per day and < 600 mL unformed stool (if volume recorded) Meeting fewer than 3 systemic inflammatory response syndrome (SIRS) criteria

Measure: Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products.

Time: 7 Days

Secondary Outcomes

Description: All-cause mortality at 30- and 60-days following last FMT Colectomy or diverting ileostomy within 30 days after last FMT Cumulative days of hospitalization from enrollment until 30 days after FMT Cumulative days in intensive care unit from enrollment until 30 days after last FMT Bacteremia from enrollment until 30 days after last FMT Repeat hospital admission within 60 days of discharge from index hospitalization

Measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0

Time: 180 Days

Measure: Frequency solicited adverse events (AEs) as assessed by CTCAE V5.0

Time: 180 Days

Measure: Frequency serious adverse events (SAEs) as assessed by CTCAE V5.0

Time: 180 Days

Measure: Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0

Time: 180 Days
26 PREDICT 2: Personalized Responses to Dietary Composition Trial 2

Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.

NCT03983733
Conditions
  1. Diabetes
  2. Heart Diseases
  3. Diet Habit
  4. Diet Modification
  5. Microbial Colonization
  6. Healthy
  7. Obesity
  8. Metabolism
Interventions
  1. Other: Dietary Intervention
MeSH:Communicable Diseases Infection Heart Diseases

Primary Outcomes

Description: Species count in fecal sample

Measure: Gut microbiome species richness

Time: 1 Day

Description: Measurement of blood lipids

Measure: Lipids

Time: 3 days

Description: Measurement of blood glucose

Measure: Glucose

Time: 11 days

Description: Record of sleep pattern using a wearable device (i.e. fitness watch)

Measure: Sleep

Time: 10 days

Description: Record of physical activity using a wearable device (i.e. fitness watch)

Measure: Physical activity

Time: 10 days

Description: Record of hunger and appetite patterns using a digital app

Measure: Hunger and appetite assessment

Time: 10 days

Secondary Outcomes

Description: C-peptide

Measure: Glucose metabolism

Time: 3 days

Description: Weighed food log

Measure: Dietary assessment

Time: 10 days

Description: Weight (kg)

Measure: Anthropometry

Time: 1 day

Description: Height (cm)

Measure: Anthropometry

Time: 1 day

Description: Hip and waist circumference (cm)

Measure: Anthropometry

Time: 1 day

Description: Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)

Measure: Metabolomics by NMR analysis

Time: 1 day

Description: Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.

Measure: Dietary assessment

Time: 1 month

Description: Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.

Measure: Covid-19 symptom assessment

Time: 6 months

Other Outcomes

Description: Self-reported in-app question on daily frequency of adherence (categorical)

Measure: Adherence (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on hunger levels (categorical)

Measure: Hunger (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on weight (lbs)

Measure: Weight (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app Bristol Stool chart questoin (categorical)

Measure: Bristol Stool Category (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on bowel frequency

Measure: Bowel Frequency (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on energy levels (categorical)

Measure: Energy (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on alertness (categorical)

Measure: Alertness (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on stress (categorical)

Measure: Stress (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on mood (categorical)

Measure: Mood (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)

Description: Self-reported in-app question on daily frequency of activity (categorical)

Measure: Activity (in sub-cohort)

Time: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)
27 A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

NCT04056611
Conditions
  1. Respiratory Syncytial Virus Infections
Interventions
  1. Drug: JNJ-53718678 250 mg
  2. Drug: Placebo
  3. Drug: JNJ-53718678 125 mg
MeSH:Infection Virus Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: The proportion of participants who develop RSV LRTI through Visit Day 28 per the Endpoint Adjudication Committee (EAC) assessment will be reported.

Measure: Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

Time: Up to Day 28

Secondary Outcomes

Description: The proportion of participants who develop RSV-associated LRTC through Visit Day 28 per the EAC's assessment will be reported.

Measure: Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC)

Time: Up to Day 28

Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Measure: Number of Participants with Adverse Events (AEs)

Time: Up to 49 days

Description: Percentage of participants with abnormal clinical laboratory findings will be reported.

Measure: Percentage of Participants with Abnormal Clinical Laboratory Findings

Time: Up to 49 days

Description: Percentage of participants with abnormal ECGs findings will be reported.

Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 49 days

Description: Percentage of participants with abnormal vital signs findings will be reported.

Measure: Percentage of Participants with Abnormal Vital Signs Findings

Time: Up to 49 days

Description: The proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

Time: Up to 49 days

Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, (all-cause mortality) will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality)

Time: Up to 49 days

Description: Proportion of participants progressing to death (all-cause mortality), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

Time: Up to 49 days

Description: Proportion of participants progressing to death (all-cause mortality) will be reported.

Measure: Proportion of Participants Progressing to Death (All-cause Mortality)

Time: Up to 1 year

Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

Time: Up to 49 days

Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) will be reported.

Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)

Time: Up to 49 days

Description: Number of supplemental O2 free days will be reported.

Measure: Number of Supplemental Oxygen (O2) Free Days Through Day 28

Time: Through Day 28

Description: Incidence of supplemental oxygen requirement in participants will be reported.

Measure: Incidence of Supplemental Oxygen Requirement

Time: Up to 28 days

Description: Duration of supplemental oxygen requirement in participants will be reported.

Measure: Duration of Supplemental Oxygen

Time: Up to 28 days

Description: Change from baseline in respiratory rate as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Respiratory Rate

Time: Baseline up to 49 days

Description: Change from baseline in heart rate as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Heart Rate

Time: Baseline up to 49 days

Description: Change from baseline in SpO2 as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2)

Time: Baseline up to 49 days

Description: Change from baseline in body temperature as measured by the investigator during scheduled visits will be reported.

Measure: Change from Baseline in Body Temperature

Time: Baseline up to 49 days

Description: Proportion of participants hospitalized (of participants who were not hospitalized at baseline) will be reported.

Measure: Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline)

Time: Up to 1 year

Description: Proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) will be reported.

Measure: Proportion of Participants Re-hospitalized

Time: Up to 1 year

Description: Total length of hospital stay (time in hospital from first dosing) will be reported.

Measure: Total Length of Hospital Stay

Time: Up to 49 days

Description: Total time in the ICU (time in ICU from first dosing) will be reported.

Measure: Total Time in the Intensive Care Unit (ICU)

Time: Up to 49 days

Description: Incidence of Grade 3 and Grade 4 AEs will be assessed by system organ class where Grade 3: Severe and Grade 4: Life-threatening.

Measure: Incidence of Grade 3 and Grade 4 Adverse Events (AEs)

Time: Up to 49 days

Description: Incidence of respiratory AEs will be reported.

Measure: Incidence of Respiratory AEs

Time: Up to 49 days

Description: Incidence of thoracic-related AEs will be reported.

Measure: Incidence of Thoracic-related AEs

Time: Up to 49 days

Description: Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

Measure: Incidence of Antibiotic use in Participants who Develop and in Those who do not Develop RSV LRTI or RSV-Associated LRTC per the EAC's Assessment

Time: Up to 49 days

Description: Time to resolution of symptoms, assessed through an instrument for participant-reported symptoms (RiiQ Symptom Scale) will be reported.

Measure: Time to Resolution of Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale

Time: Up to 49 days

Description: Change from baseline in severity of symptoms reported by participants in the RiiQ symptom scale through Day 28 will be reported.

Measure: Change from Baseline in Severity of Symptoms Reported by Participants in the RiiQ Symptom Scale Through Day 28

Time: Baseline up to Day 28

Description: Time to resolution of respiratory illness, through the PGI-S Scale, will be reported.

Measure: Time to Resolution of Respiratory Illness as Assessed by Patient Global Impression of Severity (PGI-S) Scale

Time: Up to 49 days

Description: Change from baseline in PGI-H scale through Day 28 will be reported.

Measure: Change from Baseline in Patient Global Impression of Health (PGI-H) Scale Through Day 28

Time: Baseline up to Day 28

Description: Change from baseline in PGI-C scale through Day 28 will be reported.

Measure: Change from Baseline in Patient Global Impression of Change (PGI-C) Scale Through Day 28

Time: Baseline up to Day 28

Description: AUC (0-24h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose.

Measure: Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-53718678

Time: Up to 24 hours postdose (on Days 1 and 8)

Description: Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.

Measure: Trough Plasma Concentration (Ctrough) of JNJ-53718678

Time: Predose on Days 1 and 8

Description: Cmax is defined as the maximum observed plasma concentration of JNJ-53718678 in the dosing interval.

Measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

Time: Day 1

Description: The potential association of plasma concentration-time data of JNJ-53718678 with antiviral activity (RSV viral kinetics) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Antiviral Activity

Time: Up to 49 days

Description: The potential association of plasma concentration-time data of JNJ-53718678 with selected safety (including AEs and laboratory abnormalities) parameters will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Safety Parameters

Time: Up to 49 days

Description: The potential association of plasma concentration-time data of JNJ-53718678 with clinical outcomes (proportion of participants developing LRTI) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Clinical Outcomes

Time: Up to 49 days

Description: RSV viral load and change from baseline over time will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in the mid-turbinate nasal swab specimens.

Measure: RSV Viral Load and Change from Baseline Over Time

Time: Baseline up to Day 28

Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.

Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 8, 11, 15, 22 and 28

Time: Baseline up to Days 8, 11, 15, 22 and 28

Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

Measure: Time to Undetectable RSV Viral Load

Time: Up to 49 days

Description: Proportion of participants with undetectable RSV viral load at each time point throughout the study will be reported.

Measure: Proportion of Participants with Undetectable RSV Viral Load at Each Timepoint

Time: Up to 49 days

Description: Change from baseline for the HRQOL assessment as assessed through the EQ-5D-5L through Day 28 will be reported.

Measure: Change from Baseline for the Health-related Quality of Life (HRQOL) as Assessed by 5-level EuroQol 5-Dimension (EQ-5D-5L) Through Day 28

Time: Baseline up to Day 28

Description: Change from baseline for the HRQOL assessment as assessed through RiiQ impact scales through Day 28 will be reported.

Measure: Change from Baseline for the HRQOL as Assessed by RiiQ Impact Scales Through Day 28

Time: Baseline up to Day 28

Description: Change from baseline in the RSV F gene sequence will be reported.

Measure: Change from Baseline in the RSV F Gene Sequence

Time: Baseline up to 49 days
28 Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial

In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.

NCT04244591
Conditions
  1. COVID-19 Infections
Interventions
  1. Drug: methylprednisolone therapy
  2. Other: Standard care
MeSH:Infection

Primary Outcomes

Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 7 days after randomization

Description: Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 14 days after randomization

Secondary Outcomes

Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

Measure: The difference of PaO2/FiO2 between two groups

Time: 7 days after randomization

Description: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 7 days after randomization

Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 7 days after randomization

Description: PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.

Measure: The difference of PaO2/FiO2 between two groups

Time: 14 days after randomization

Description: Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.

Measure: Lower Sequential Organ Failure Assessment (SOFA) score

Time: 14 days after randomization

Description: Percentage of patients requiring Mechanical ventilation support

Measure: Mechanical ventilation support

Time: 14 days after randomization

Description: Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract

Measure: Clearance of noval coronavirus

Time: 14 days after randomization

Description: All-cause mortality

Measure: All-cause mortality

Time: 30 days after randomization
29 Washed Microbiota Transplantation for Patients With 2019-nCoV Infection: a Randomized, Double-blind, Placebo-controlled Study

Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.

NCT04251767
Conditions
  1. COVID-19 Complicated With Refractory Intestinal Infections
Interventions
  1. Other: washed microbiota transplantation
  2. Other: placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following): (1) Respiratory distress,respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%;(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following): (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.

Measure: Number of participants with improvement from severe type to common type

Time: 2 weeks
30 A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection

The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .

NCT04252885
Conditions
  1. Coronavirus Infections
Interventions
  1. Drug: Lopinavir and Ritonavir Tablets
  2. Drug: Arbidol
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

Measure: The rate of virus inhibition

Time: Day 0, 2, 4, 7, 10, 14 and 21

Secondary Outcomes

Description: Body temperature will be followed everyday during time frame.

Measure: The disease prorogation-temperature

Time: Day 0 till day 21

Description: Respiratory rate will be followed everyday during time frame.

Measure: The disease prorogation-respiratory function 1

Time: Day 0 till day 21

Description: Oxygen saturation of blood will be followed everyday during time frame.

Measure: The disease prorogation-respiratory function 2

Time: Day 0 till day 21

Description: Chest imaging will be taken at each time point.

Measure: The disease prorogation-respiratory function 3

Time: Day 0, 4, 7, 10, 14 and 21

Other Outcomes

Description: Blood pressure and heart rate will be followed everyday during time frame.

Measure: Patients health condition-routine test

Time: Day 0 till day 21

Description: Liver function will be assessed as AST, ALT and TBIL at each time point.

Measure: Patients health condition-liver function

Time: Day 0, 4, 7, 10, 14 and 21

Description: Kidney function will be assessed as eGFR and creatine clearance rate at each time point.

Measure: Patients health condition-kidney function

Time: Day 0, 4, 7, 10, 14 and 21

Description: Blood routine and myocardial enzyme will be measured at each time point.

Measure: Patients health condition-other blood routine test

Time: Day 0, 4, 7, 10, 14 and 21

Description: Flow cytometry classification and counting and cytokines will be measured at each time point.

Measure: Patients health condition-blood routine test

Time: Day 0, 4, 7, 10, 14 and 21
31 Registry Study on the Efficacy of a Self-test and Self-alert Applet in Detecting Susceptible Infection of COVID-19 --a Population Based Mobile Internet Survey

The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1,2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.

NCT04256395
Conditions
  1. Susceptibility to Viral and Mycobacterial Infection
Interventions
  1. Other: mobile internet survey on self-test
MeSH:Infection Communicable Diseases Mycobacterium Infections Disease Susceptibility

Primary Outcomes

Description: after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system

Measure: positive number diagnosed by national guideline in the evaluated population

Time: 5 months

Secondary Outcomes

Description: after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores

Measure: distribution map of evaluated people

Time: 5 month

Description: after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.

Measure: Effect of medical guidance by designated feedback questionnaire

Time: 5 month

Description: after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion.

Measure: mental scale of relief the mental anxiety and avoid unnecessary outpatient

Time: 5 month
32 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
33 A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children

The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.

NCT04270383
Conditions
  1. 2019-nCoV
MeSH:Infection

Primary Outcomes

Description: Percentage

Measure: The cure rate of 2019-nCoV.

Time: 6 months

Description: Percentage

Measure: The improvement rate of 2019-nCoV.

Time: 6 months

Measure: The incidence of long-term adverse outcomes.

Time: 6 months

Secondary Outcomes

Description: Days

Measure: Duration of fever

Time: 2 weeks

Description: Days

Measure: Duration of respiratory symptoms

Time: 2 weeks

Description: Days

Measure: Duration of hospitalization

Time: 2 weeks

Measure: Number of participant(s) need intensive care

Time: 2 weeks

Measure: Number of participant(s) with acute respiratory distress syndrome

Time: 2 weeks

Measure: Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.

Time: 2 weeks

Measure: Number of participant(s) who died during the trial

Time: 10 months
34 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
35 Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus

In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells (DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine (LV-SMENP) will be investigated.

NCT04276896
Conditions
  1. Pathogen Infection Covid-19 Infection
Interventions
  1. Biological: Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs
MeSH:Infection

Primary Outcomes

Description: A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).

Measure: Clinical improvement based on the 7-point scale

Time: 28 days after randomization

Description: Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.

Measure: Lower Murray lung injury score

Time: 7 days after randomization

Secondary Outcomes

Description: Number of deaths during study follow-up

Measure: 28-day mortality

Time: Measured from Day 0 through Day 28

Description: Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.

Measure: Duration of mechanical ventilation

Time: Measured from Day 0 through Day 28

Description: Days that a participant spent at the hospital. Multiple hospitalizations are summed up.

Measure: Duration of hospitalization

Time: Measured from Day 0 through Day 28

Description: Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.

Measure: Proportion of patients with negative RT-PCR results

Time: 7 and 14 days after randomization

Description: Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).

Measure: Proportion of patients in each category of the 7-point scale

Time: 7,14 and 28 days after randomization

Description: Proportion of patients with different inflammation factors in normalization range.

Measure: Proportion of patients with normalized inflammation factors

Time: 7 and 14 days after randomization

Description: Frequency of vaccine/CTL Events

Measure: Frequency of vaccine/CTL Events

Time: Measured from Day 0 through Day 28

Description: Frequency of Serious vaccine/CTL Events

Measure: Frequency of Serious vaccine/CTL Events

Time: Measured from Day 0 through Day 28
36 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.
37 A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China

Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.

NCT04279899
Conditions
  1. Neonatal Infection
  2. Perinatal Problems
  3. Infectious Disease
MeSH:Communicable Diseases Infection

Primary Outcomes

Measure: The death of newborns with COVID-19

Time: The date of discharge,an average of 4 weeks after the admission

Description: Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.

Measure: The SARS-CoV-2 infection of neonates born to mothers with COVID-19

Time: within 7days after the admission

Secondary Outcomes

Description: The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.

Measure: The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19

Time: Infants ( ≥35 weeks)are at 6 months after birth;Infants(< 35weeks) are at a corrected age of 6 months.

Description: The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).

Measure: The small for gestational age newborns in the neonates born to mothers with COVID-19

Time: at birth

Description: The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days

Measure: The preterm delivery of neonates born to mothers with COVID-19

Time: at birth

Description: Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese

Measure: The disease severity of neonates with COVID-19

Time: through study completion, estimated an average of 2 weeks
38 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
39 The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

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

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

Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

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

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

Time: 30 days

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

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

Time: 30 days
40 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
41 An Open Clinical Trial to Evaluate Ganovo(Danoprevir ) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.

NCT04291729
Conditions
  1. COVID-19
Interventions
  1. Drug: Ganovo+ritonavir+/-Interferon nebulization
MeSH:Infection

Primary Outcomes

Description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen

Measure: Rate of composite adverse outcomes

Time: 14 days

Secondary Outcomes

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

Measure: Time to recovery

Time: 14 days

Description: Rate of no fever

Measure: Rate of no fever

Time: 14 days

Description: Rate of no cough

Measure: Rate of no cough

Time: 14 days

Description: Rate of no dyspnea

Measure: Rate of no dyspnea

Time: 14 days

Description: Rate of no requiring supplemental oxygen

Measure: Rate of no requiring supplemental oxygen

Time: 14 days

Description: Rate of undetectable New coronavirus pathogen nucleic acid

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: 14 days

Description: Rate of mechanical ventilation

Measure: Rate of mechanical ventilation

Time: 14 days

Description: Rate of ICU admission

Measure: Rate of ICU admission

Time: 14 days

Description: Rate of serious adverse event

Measure: Rate of serious adverse event

Time: 14 days
42 A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.

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

Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

Description: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

Measure: Percent change of subjects return to baseline oxygen requirement

Time: 7 days
43 COVID-19 Seroconversion Among Medical and Paramedical Staff in Emergency, ICU and Infectious Disease Services During the 2020 Epidemic

The epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.

NCT04304690
Conditions
  1. Sars-CoV2
Interventions
  1. Other: blood sample
MeSH:Communicable Diseases Infection Emergencies

Primary Outcomes

Description: Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.

Measure: Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff

Time: 3 months

Secondary Outcomes

Description: "Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient."

Measure: Identification of risk factors for seroconversion

Time: 3 months

Description: "Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet. The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies."

Measure: Quantify the proportion of asymptomatic infections among staff who have seroconverted

Time: 3 months

Description: "Description of symptomatic infections Clinical manifestations associated with seroconversion. On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "

Measure: " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome "

Time: 3 months
44 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
45 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
46 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 Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: baseline, 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in PROMIS Dyspnea Severity

Time: baseline, 10 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
47 Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.

NCT04312009
Conditions
  1. Corona Virus Infection
  2. Acute Respiratory D
  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 Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in PROMIS Dyspnea Severity

Time: 10 days

Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Disease Severity Rating

Time: 10 days

Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Blood Day 9

Time: 9 days

Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Blood Day 15

Time: 15 days
48 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
49 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Adults who have tested positive for SARS-CoV-2 infection and who do not require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome

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

Primary Outcomes

Description: To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection and, 2) who do not require supplemental oxygen (Ordinal Scale for Clinical Improvement 3 or less) at the time of enrollment. The primary endpoint is the difference in the proportion of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

Measure: Severity of COVID-19

Time: 28 days

Secondary Outcomes

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

Measure: SARS-CoV-2 infection

Time: 28 days

Description: To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

Measure: Severity of COVID-19 over 14 days

Time: 14 days

Description: To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score. The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening.

Measure: Severity of COVID-19 symptoms

Time: 28 days

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

Measure: ICU admission

Time: 28 days

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

Measure: Mechanical Ventilation

Time: 28 days

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

Measure: Mortality

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

Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

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

Primary Outcomes

Description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.

Measure: Severity of COVID-19

Time: 28 days

Secondary Outcomes

Description: Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

Measure: Incidence of SARS-CoV-2 infection

Time: 28 days

Description: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

Measure: Incidence of SARS-CoV-2 infection

Time: 14 days

Description: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.

Measure: Severity of COVID-19

Time: 14 days

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

Measure: ICU admission

Time: 28 days

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

Measure: Mechanical ventilation

Time: 28 days

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

Measure: Mortality

Time: 28 days
51 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
52 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
53 Effect of Counseling Between Pregnant Women During Corona Infection

Corona virus is known as covid 19 And is transmitted through droplet infection

NCT04317365
Conditions
  1. Respiratory Tract Infections
Interventions
  1. Other: Women receiving extra remembering by healthcare
MeSH:Infection Respiratory Tract Infections
HPO:Respiratory tract infection

Primary Outcomes

Description: The number of pregnant women who have awareness about the disease

Measure: The number of pregnant women who know the exact symptoms of the disease

Time: Within one month
54 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)
55 Pandemic Response Network: Duke Community Health Watch

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives. - First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll. - Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation. - Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population. The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).

NCT04320862
Conditions
  1. COVID-19
  2. SARS-CoV-2
  3. Coronavirus
  4. Influenza -Like Illness
  5. Lower Resp Tract Infection
  6. Upper Resp Tract Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

Measure: Number of participants requiring mechanical ventilation

Time: 2 months

Measure: Number of deceased participants

Time: 2 months
56 Non-contact Endoscopy at Covid-19 Outbreak

The COVID-19 outbreak and spread throughout the world now constitutes a global public health emergency. Direct contact between doctors and patients in daily practice bears potential risk of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.

NCT04320953
Conditions
  1. Gastrointestinal Disease
  2. Infectious Disease
Interventions
  1. Device: Non-contact MCE system
MeSH:Communicable Diseases Infection Gastrointestinal Diseases Digestive System Diseases
HPO:Abnormality of the gastrointestinal tract

Primary Outcomes

Description: Maneuvarability of the remote control MCE system

Measure: Technical success

Time: During the procedure

Secondary Outcomes

Description: Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

Measure: Clinical success

Time: During the procedure

Description: Adverse events during and after the procedure

Measure: Adverse events

Time: During and within 2 weeks after the procedure
57 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
58 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
59 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
60 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
61 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
62 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
63 Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

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

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

Primary Outcomes

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

Measure: Biomarkers expression

Time: up to 30 days

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

Measure: Liver Biomarkers expression

Time: up to 30 days

Secondary Outcomes

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

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

Time: 60 days
64 Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death

This is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.

NCT04323631
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine
  2. Other: The control group will not receive hydroxychloroquine
MeSH:Infection Disease Progression

Primary Outcomes

Description: Number patients developing severe infection or death

Measure: Number patients developing severe infection or death

Time: within 28 days
65 Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

NCT04323761
Conditions
  1. SARS-CoV2 Infection
Interventions
  1. Drug: Remdesivir
MeSH:Infection Communicable Diseases

66 A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.

As shown by the data available, hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system to the presence of the virus, is considered to represent one of the most important negative prognostic factor in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The objective of this study is to investigate new possibilities to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.

NCT04324021
Conditions
  1. SARS-CoV-2
Interventions
  1. Biological: Emapalumab
  2. Biological: Anakinra
MeSH:Infection

Primary Outcomes

Description: Defined as the proportion of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)

Measure: Treatment success

Time: Up to Day 15

Secondary Outcomes

Description: Measured in days

Measure: Time to mechanical ventilation

Time: Date of randomization to date of mechanical ventilation

Description: Measured in total score

Measure: Change from baseline in Modified Early Warning system score

Time: Baseline, Day 15

Description: Measured in percent (%)

Measure: Change from baseline in resting peripheral capillary oxygen saturation (SpO2)

Time: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15

Description: Measured in percent (%)

Measure: Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2)

Time: Baseline, Day 15

Description: Measured in local units

Measure: Change of pH in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of oxygen tension (pO2) in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of potassium in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of sodium in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of chloride in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of lactic acid in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of hemoglobin in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in l/min

Measure: Change from baseline in oxygen supplementation

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done

Measure: Change of findings of high-resolution computed tomography (CT) scan of the chest

Time: Screening, Day 15

Description: Measured in local units

Measure: Change from baseline in Ferritin

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in lactate dehydrogenase (LDH)

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in D-dimers

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in White Blood Cells with differential counts

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Red Blood Counts

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Hemoglobin

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Platelet count

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Fibrinogen

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Complement factors C3/C4

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Prothrombin time

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Cardiac troponin

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in aspartate aminotransferase (AST)

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in alanine aminotransferase (ALT)

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in total bilirubin levels

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in C-Reactive Protein

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Creatinine

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Confirmation of death

Measure: Overall survival

Time: Weeks 6 and 10

Description: Measured in days

Measure: Time to hospital discharge

Time: Weeks 6 and 10
67 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
68 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 Interstitial pneumonitis Interstitial pulmonary abnormality 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
69 Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.

NCT04326114
Conditions
  1. Disease, Infectious
  2. Respiratory Disease
  3. Safety Issues
  4. Effectiveness
Interventions
  1. Device: Inspiratory training device
  2. Device: Expiratory training device
MeSH:Communicable Diseases Infection Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Dichotomous categorical variable measured by "yes" or "no" responses

Measure: COVID-19 disease diagnosis

Time: Change from Baseline COVID-19 disease diagnosis at 8 weeks

Secondary Outcomes

Description: Dichotomous categorical variable measured by "slight" or "severe" responses

Measure: COVID-19 disease symptoms severity

Time: Change from Baseline COVID-19 disease symptoms severity at 8 weeks

Description: Polytomous categorical variable measured by adverse effects responses

Measure: Adverse effects

Time: Change from Baseline adverse effects at 8 weeks
70 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
71 Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol

7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population. 8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa . 12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks. 13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.

NCT04326400
Conditions
  1. Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.

Measure: COVID-19 App-based platform

Time: 6 months

Secondary Outcomes

Description: To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.

Measure: COVID-19 infection

Time: 6 months
72 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
73 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
74 PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study

Coronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death. Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR. It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors. It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.

NCT04327180
Conditions
  1. Infection Viral
  2. Coronavirus
  3. ARDS
  4. Pneumonia
MeSH:Infection Communicable Diseases Virus Diseases Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU

Time: within 24 hours of admission to ICU

Secondary Outcomes

Description: Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19

Measure: Coinfections

Time: during ICU stay, up to 28 days

Description: it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance)

Measure: Respiratory dysfunction requiring mechanical ventilation

Time: during ICU stay, up to 28 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) Score

Time: during ICU stay, up to 28 days

Description: APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%.

Measure: SAPS II score

Time: at admission

Description: The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained

Measure: Disseminated Intravascular Coagulation (DIC) score

Time: during ICU stay, up to 28 days

Measure: Number of days on vasopressive amines

Time: during ICU stay, up to 28 days

Measure: Occurrence of an event of venous or arterial thromboembolic disease

Time: during ICU stay, up to 28 days

Measure: Number of days with extra renal treatment (ERA)

Time: during ICU stay, up to 28 days

Measure: Number of patients alive after ICU stay less than 28 days will be tracked

Time: At 28 day

Description: measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality.

Measure: Short Form 36

Time: at 9 months +/- 3 months after ICU stay

Description: The scale allows to detect anxiety and depression using 14 items rated from 0-3. Measuring the long-term impact of confirmed COVID-19 infection

Measure: Hospital anxiety and depression scale (HADS)

Time: at 9 months +/- 3 months after ICU stay

Description: 22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection

Measure: Impact of Event Scale - revised (IES-R)

Time: at 9 months +/- 3 months after ICU stay

Description: Question the stressful experience or event, followed by 20 multiple-choice questions. Measuring the long-term impact of confirmed COVID-19 infection

Measure: Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)

Time: at 9 months +/- 3 months after ICU stay

Description: The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection

Measure: Modified Medical Research Council (MMRC) Dyspnea Scale

Time: at 9 months +/- 3 months after ICU stay

Measure: Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters

Time: until day 28 after admission of ICU

Description: Evolution of viral clearance in nasal and depp PCR during ICU

Measure: Viral clearance

Time: through study completion, an average of 28 days
75 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
76 Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial

Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic. In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients. As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers. The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo. Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:

NCT04328285
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo of Hydroxychloroquine
  3. Drug: Lopinavir and ritonavir
  4. Drug: Placebo of LPV/r Tablets
MeSH:Infection

Primary Outcomes

Description: An infection by SARS-CoV-2 is defined by either: a positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR a positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR a seroconversion to SARS-CoV-2 after randomization.

Measure: Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)

Time: Up to 2.5 months

Secondary Outcomes

Description: Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.

Measure: Evaluation of the occurrence of adverse events in each arm,

Time: Up to 2.5 months

Description: Number of treatment discontinuations in each arm

Measure: Evaluation of the discontinuation rates of the investigational drug in each arm,

Time: Up to 2 months

Description: Treatment adherence rate will be assessed by: measurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection the count of returned drugs at each visit.

Measure: Evaluation of the adherence of participants to study drug,

Time: Up to 2 months

Description: Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm. Symptomatic infection is defined as : a positive specific RT-PCR on a respiratory or non respiratory sample OR a thoracic CT scan with imaging abnormalities consistent with COVID-19. These investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.

Measure: Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,

Time: Up to 2.5 months

Description: Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm. Asymptomatic infection is defined as : a positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up OR as seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up

Measure: Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm

Time: Up to 2.5 months

Description: Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as : a positive specific RT-PCR on a respiratory sample OR a thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency > 30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 and/or lung infiltrates >50% (1).

Measure: Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.

Time: Up to 2.5 months

Description: Safety. Electrocardiogram (ECG)

Measure: corrected QT interval (ms)

Time: At baseline, at D2 (only for COVIDAXIS 1) and every week up to 2 months.
77 A Multi Center Randomized Open Label Trial on the Safety and Efficacy of Chloroquine for the Treatment of Hospitalized Adults With Laboratory Confirmed SARS-CoV-2 Infection in Vietnam

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19. We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. The study is funded and leaded by The Ministry of Health, Vietnam.

NCT04328493
Conditions
  1. SARS-CoV-2 Infecti
  2. SARS-CoV-2 Infection
  3. COVID-19
Interventions
  1. Drug: Chloroquine phosphate
MeSH:Infection

Primary Outcomes

Description: Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat/nose swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat/nose swabs.

Measure: Viral clearance time

Time: Up to 56 days post randomization

Secondary Outcomes

Description: The time since randomization to discharge between study groups

Measure: Lengh of hospital stay

Time: Up to 56 days post randomization

Description: The number of ventilator free days over the first 28 days of treatment

Measure: Ventilator free days

Time: first 28 days

Description: The number of oxygene free days over the first 28 days of treatment

Measure: Oxygene free days

Time: first 28 days

Description: The time to (all-cause) death following over the first 7, 10, 14, 28 and 56 days since randomization

Measure: Time to death

Time: first 7, 10, 14, 28 and 56 days since randomization

Description: The rates of serious adverse events, rates of grade 3 or 4 adverse events

Measure: Adverse events

Time: Over the first 28 days (due to the prolonged half-life of Chloroquine)

Description: Time since randomization to the first defervescence day

Measure: fever clearance time

Time: Up to 56 days post randomization

Description: WHO Ordinal outcome scale for COVID-19

Measure: Ordinal outcome scale

Time: Up to 56 days post randomization

Description: Development of ARDS defined by the Kigali criteria

Measure: Development of ARDS

Time: Up to 56 days post randomization
78 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
79 ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study

Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death. Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19. It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.

NCT04329195
Conditions
  1. History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection
Interventions
  1. Drug: 1: discontinuation of RAS blocker therapy
  2. Drug: 2: continuation of RAS blocker therapy
MeSH:Infection Cardiovascular Diseases
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Measure: Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)

Time: from day 0 to day 28 or hospital discharge

Secondary Outcomes

Measure: Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28

Time: at day 28

Measure: Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28.

Time: at days 7, 14 and 28

Measure: Number of days alive free of oxygen.

Time: from day 0 to day 28 or hospital discharge

Measure: Number of days alive outside hospital until day28

Time: at day28

Measure: Number of days alive free of intensive-care unit (ICU) admission or mechanical ventilation (invasive or non-invasive) until day28

Time: at day28

Measure: Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28

Time: at day28

Measure: Number of days alive free of ICU admission until day28

Time: at day28

Measure: Rate of all-cause mortality at day 28

Time: at day 28

Measure: Rate of cardiovascular death at day 28

Time: at day 28

Measure: Number of days alive free of acute kidney injury until hospital discharge

Time: at day 28 to hospital discharge
80 Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection

The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clínical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points. Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.

NCT04330495
Conditions
  1. COVID 19
  2. Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
Interventions
  1. Drug: Hidroxicloroquina
  2. Drug: Control group
MeSH:Infection

Primary Outcomes

Description: number of new cases divided by number of persons-time at risk

Measure: Incidence rate of new COVID-19 cases in both arms

Time: From day 14 after start of treatment up to the end of follow-up: week 27

Description: percentage of cases of COVID 19

Measure: Prevalence of COVID-19 cases in both arms

Time: 27 weeks after the beginning of the study

Description: Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death

Measure: Mortality rate secondary to COVID-19 cases in both groups

Time: 27 weeks after the beginning of the study

Description: percentage of patients who need admission in an ICU due to COVID 19 infection

Measure: Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups

Time: 27 weeks after the beginning of the study

Secondary Outcomes

Description: Presence and type of adverse events at this point.

Measure: Adverse events

Time: 12 weeks after the start of treatment

Description: Proportion of participants that drop out of study

Measure: Adverse events

Time: 27 weeks after the beginning of the study
81 Protective Role of Inhaled Steroids for Covid-19 Infection

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

NCT04331054
Conditions
  1. Covid-19 Infection
  2. Hospitalization in Respiratory Disease Department
Interventions
  1. Drug: 2: Usual practice + SYMBICORT RAPIHALER
  2. Other: 1: Usual practice
MeSH:Infection Communicable Diseases Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.

Measure: Time (in days) to clinical improvement within 30 days after randomization

Time: within 30 days

Secondary Outcomes

Measure: Mortality rate at D30

Time: At day30

Measure: Time (in days) from randomization to death

Time: up to 30 days after randomization

Measure: Number of days alive outside ICU within 30 days

Time: At day30

Measure: Number of days alive free of invasive or non-invasive ventilation within 30 days

Time: At day30

Measure: Number of days alive with oxygen therapy within 30 days

Time: At day30

Measure: Maximal oxygen rate within 30 days

Time: At day30

Measure: Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)

Time: at Day 7

Measure: Number of days alive outside hospital within 30 days

Time: at Day 30

Measure: Use of antibiotics for respiratory (proved or suspected) infection within 30 days

Time: at Day 30

Measure: Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)

Time: at Day 7

Measure: Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.

Time: up to 30 days after randomization
82 Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).

The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.

NCT04332016
Conditions
  1. Infection Viral
Interventions
  1. Other: biological samples collection
MeSH:Infection Virus Diseases

Primary Outcomes

Description: From blood samples: protein levels, whole genome sequence, transcriptomic analysis data. From upper respiratory samples: protein levels, virus transcriptomic analysis data. From stool: microbiota analysis data. From urine: protein level.

Measure: COVID-19 desease description

Time: Inclusion visit (Day 1)

Description: From blood samples: protein levels.

Measure: COVID-19 desease description

Time: Day 30 to 90
83 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
84 A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures

In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

NCT04333225
Conditions
  1. COVID-19
Interventions
  1. Drug: Hydroxychloroquine
MeSH:Infection

Primary Outcomes

Description: Rate of COVID-19 positive conversion on weekly nasopharyngeal (NP) sampling

Measure: Rate of COVID-19 positive conversion

Time: 7 weeks

Secondary Outcomes

Description: Time-to-first clinical event consisting of a persistent change for any of the following: One positive NP sample Common clinical symptoms of COVID-19 infection including fever, cough, and shortness of breath Less common signs and symptoms of COVID-19 infection including headache, muscle pain, abdominal pain, sputum production, and sore throat

Measure: Time-to-first clinical event

Time: 7 weeks

Other Outcomes

Description: Time-to-first clinical worsening event consisting of any of the following: Hospitalization for COVID-19 infection Intensive care unit admission for COVID-19 infection All cause death

Measure: Time-to-first clinical worsening event

Time: 7 weeks
85 Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy

Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. The main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.

NCT04333862
Conditions
  1. SARS-CoV-2
MeSH:Infection

Primary Outcomes

Description: To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy

Measure: Fraction of healthcare workers infected with SARS-CoV-2

Time: 90 days

Secondary Outcomes

Description: To compare the infection rate of hospitalized patients versus healthcare workers

Measure: Fraction of healthcare workers with COVID-19

Time: 90 days

Description: Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired.

Measure: Number of patients infected in the hospital

Time: 90 days

Description: To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection.

Measure: Development of SARS-CoV2 specific antibody repertoire

Time: 18 months
86 A Prospective, Controlled, Randomized, Multicenter Study to Compare the Efficacy of a Chloroquine Analog (GNS561), an Anti-PD-1 (Nivolumab), an Anti-NKG2A (Monalizumab), an Anti-interleukine-6 Receptor (Tocilizumab) and an Anti-C5aR (Avdoralimab) Versus Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.

A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of a chloroquine analog (GNS561), an anti PD-1 (nivolumab), an anti-NKG2A (monalizumab), an anti-C5aR (avdoralimab) and an anti-interleukine-6 receptor (tocilizumab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: - COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-PD1 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1:1). - COHORT 2 (moderate/severe symptoms): GNS561 vs anti-IL6 vs anti-C5aR vs standard of care (randomization ratio 1:1:1:1).

NCT04333914
Conditions
  1. SARS-CoV-2 (COVID-19) Infection
  2. Advanced or Metastatic Hematological or Solid Tumor
Interventions
  1. Drug: Chloroquine analog (GNS651)
  2. Drug: Nivolumab
  3. Drug: Tocilizumab
  4. Other: Standard of care
  5. Drug: Avdoralimab
  6. Drug: Monalizumab
MeSH:Infection Communicable Diseases Neoplasm Metastasis

Primary Outcomes

Description: 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.

Measure: 28-day survival rate

Time: 28 days from randomization

Secondary Outcomes

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

Measure: Time to clinical improvement

Time: 28 days from randomization

Description: Clinical status will be assessed using a 7-point ordinal scale : Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Clinical status

Time: Day 7, Day 14, Day 28

Description: Mean change in clinical status from baseline will be assessed using a 7-point ordinal scale.

Measure: Mean change in clinical status from baseline to days

Time: Day 7, Day 14, Day 28

Description: Overall survival will be defined by the time from date of randomization until date of death, regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Measure: Overall survival

Time: 3 months (i.e. at the the time of last patient last visit)

Description: The length of stay in Intensive Care Unit (from the date of admission in the Unit to the date of discharge).

Measure: Length of stay in Intensive Care Unit

Time: 3 months (i.e. at the the time of last patient last visit)

Description: The duration of mechanical ventilation or high flow oxygen devices (from the date of intubation to the stop date of mechanical ventilation or high flow oxygen)

Measure: Duration of mechanical ventilation or high flow oxygen devices

Time: 3 months (i.e. at the the time of last patient last visit)

Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)

Measure: Duration of hospitalization

Time: 3 months (i.e. at the the time of last patient last visit)

Measure: Rate of throat swab negativation

Time: Day 7, Day 14, Day 28

Measure: Quantitative SARS-CoV-2 virus in throat swab and blood samples

Time: Day 7, Day 14, Day 28

Measure: Rate of secondary infection by other documented pathogens

Time: Day 7, Day 14, Day 28 (if available)

Description: Changes from baseline in neutrophils count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Treatment-Emergent Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, New Safety Issues described using the NCI-CTC AE classification v5. Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).

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

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.

Measure: Cost-Effectiveness Analyses (CEA)

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in lymphocytes count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in platelets count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in hemoglobin count (g/dL)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in CRP count (mg/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in pro-inflammatory cytokine (IL6)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)
87 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
88 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
89 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
90 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

NCT04335552
Conditions
  1. SARS-CoV-2
Interventions
  1. Other: Standard of care
  2. Drug: Hydroxychloroquine
  3. Drug: Azithromycin
MeSH:Infection

Primary Outcomes

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

Measure: World Health Organization (WHO) ordinal scale measured at 14 days after enrollment

Time: Day 14

Secondary Outcomes

Measure: Rates of death during the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: Number of days on mechanical ventilation for patients who were on mechanical ventilation at baseline

Time: Baseline

Measure: Proportion of patients not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation during the index hospitalization

Time: Index hospitalization, up to 46 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 - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: WHO ordinal scale measured at 28 days after enrollment

Time: Day 28

Measure: Hospital length of stay in days for the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: Rates of all-cause study medication discontinuation

Time: Index hospitalization, up to 46 days

Measure: Rates of severe adverse events

Time: Day 14
91 Reduction in COVID-19 Infection Using Surgical Facial Masks Outside the Healthcare System

In the current COVID-19 pandemic with coronavirus, SARS-COV2, the Danish Health Authorities recommend using facial masks in the health care system when handling patients presumed or proven to be infected with the virus. However, the use of facial masks outside the health care system is not recommended by the Danish Health Authorities. Here, Health Authorities in other countries have different recommendations for the use of facial masks. Challenges when using facial masks outside the health care system include wearing the mask consistently, an efficacy of the mask of app. 8 hours necessitating a change of mask throughout the day, and that it is not sufficiently tight enough to safely keep the virus out. Moreover, the eyes (mucous membrane) remain exposed. Compliance could also be another challenge. SARS-COV2 is assumed to primarily enter the body via the mouth through respiratory droplets - or possibly through inhalation of aerosol containing the virus. From the mouth the virus is assumed to spread to the airways and the gastro-intestinal tract. SARS-COV2 is also known to be transmitted via physical contact, helped along by the fact that the virus can survive on surfaces for at least 72 hours. Touching such a contaminated surface can transfer the virus to the mouth via the hand - and thus lead to infection of the person. Facial masks are expected to protect against viral infection in two ways; 1. By reducing the risk of getting the virus in via the mouth or nose via respiratory droplets or aerosol 2. By reducing the transfer from virus-contaminated hands to the mouth or nose Hypothesis The use of surgical facial masks outside the hospital will reduce the frequency of COVID-19 infection. All participants will follow authority recommendations and be randomized to either wear facial masks or not. The participants will be screened for antibodies at study start and study end. They will perform swab-test if they experience symptoms during the study as well as the end of study.

NCT04337541
Conditions
  1. COVID-19
Interventions
  1. Other: Surgical facial mask
MeSH:Infection

Primary Outcomes

Description: Component 1 of primary endpoint: Positive oropharyngeal/nasal swab with SARS-CoV-2 (PCR) and/or

Measure: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:

Time: 1 month

Description: Component 2 of primary endpoint: Antibody test; Development of positive SARS-CoV-2 antibody test (IgM and/or IgG) during the study period and/or

Measure: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:

Time: 1 month

Description: Component 3 of primary endpoint: SARS-CoV-2 infection diagnosed in a hospital/health care facility

Measure: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3:

Time: 1 month

Secondary Outcomes

Description: Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus

Measure: Positive oropharyngeal/nasal swab (PCR);

Time: 1 month

Description: SAR-CoV-2, Para-influenza-virus type 1, Para-influenza-virus type 2, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1, Respiratory Syncytial-Virus A, Respiratory Syncytial-Virus B, Influenza A virus or Influenza B virus

Measure: Positive oropharyngeal/nasal swab (PCR);

Time: 1 month

Other Outcomes

Description: Returned swabs

Measure: Difference between the two study groups

Time: 1 month

Description: Psychological aspects of face mask wearing in the community

Measure: Discribtion of the face mask users psycological aspects of wearing face masks

Time: 1 month

Description: Cost-effectiveness analyses on the use of surgical face masks

Measure: Costs associated with wearing vs not wearing face masks

Time: 1 month

Description: Preference for self-conducted home swab vs. healthcare conducted swab at hospital or similar

Measure: Differences in the participants preferences

Time: 1 month

Description: Symptoms of COVID-19

Measure: Difference between the two study groups

Time: 1 month

Description: Self-assessed compliance with health authority guideline on hygiene

Measure: Difference between the two study groups with stratification between subgroups (age, gender, occupation, comorbidities)

Time: 1 month

Description: Willingness to wear face masks in the future

Measure: Discribtion of the face mask users willingness to wear face masks

Time: 1 month

Description: Healthcare diagnosed COVID-19 or identified SARS-CoV-2 infection as assessed by number of participants with antibodies against SARS-CoV-2, and/or positive maso/pharyngeal swab (PCR), mortality associated with COVID-19 and all cause mortality

Measure: Healthcare diagnosed COVID-19 between study groups

Time: 1 month

Description: Presence of bacteria: Mycoplasma pneumonia, Haemophilus influenza and Legionella pneumophila (to be obtained from registries when made available)

Measure: Hospital based diagnostics of bacteria between the two study groups

Time: 1 month

Description: Frequency of infected house-hold members between the two groups

Measure: Infection in the household between the two study groups

Time: 1 month

Description: Frequency of sick leave between the two groups (to be obtained from registries when made available)

Measure: Sick leave among participants beteeen the two study groups

Time: 1 month

Description: Predictors of primary outcome or its components

Measure: Predictors of primary outcome; age, gender, size of household, comorbidities, medications, social factors, occupation, mask compliance, compliance to general SARS-CoV-2 recommendations, hours outside home)

Time: 1 month
92 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
93 Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department

The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.

NCT04338828
Conditions
  1. COVID19
Interventions
  1. Drug: Nitric Oxide Gas
  2. Other: Inhaled Supplemental Oxygen
MeSH:Infection

Primary Outcomes

Description: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms

Measure: Rates of return visits to the ED

Time: 28 days

Secondary Outcomes

Description: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require hospitalization during their COVID-19 course

Measure: Inpatient hospitalizations required

Time: 28 days

Description: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to require intubation during their COVID-19 course

Measure: Rates of intubation

Time: 28 days

Description: Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to die of any cause within 28 days of their initial ED visit

Measure: Rates of mortality

Time: 28 days
94 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
95 Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection

This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.

NCT04339426
Conditions
  1. Covid19
Interventions
  1. Drug: Atovaquone/Azithromycin
MeSH:Infection

Primary Outcomes

Description: COVID-19 serology testing

Measure: Virology Cure Rate

Time: 10 days

Secondary Outcomes

Description: Measure incidence of diarrhea, vomiting, nausea and constipation

Measure: Incidence of GI adverse events

Time: 47 days

Description: 12-Lead ECG daily if QTc >500 msec

Measure: Cardiac Toxicity

Time: 10 days

Other Outcomes

Description: Measure blood counts

Measure: Changes in WBC w Diff, B cells, T cells, NK cells

Time: 10 days

Description: Measure changes in plasma cytokines throughout course of infection

Measure: Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a

Time: 10 days
96 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
97 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 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
98 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
99 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
100 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
101 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
102 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
103 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
104 A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.

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

Primary Outcomes

Description: Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.

Measure: Time to clinical worsening

Time: RCT (approximately 15 days)

Secondary Outcomes

Description: (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.

Measure: clinical deterioration on a Likert-type scale (1-6)

Time: RCT (approximately 15 days)

Description: (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.

Measure: clinical deterioration measured by number of days

Time: RCT (approximately 15 days)

Description: Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.

Measure: Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe)

Time: RCT (approximately 15 days)
105 The Role of Resistant Starch in COVID-19 Infection

This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.

NCT04342689
Conditions
  1. COVID-19
Interventions
  1. Drug: Dietary Supplement containing resistant starch
  2. Dietary Supplement: Placebo Starch
MeSH:Infection

Primary Outcomes

Description: Hospitalization for a COVID-19 related admission during the first month of follow up. Death prior to hospitalization thought to be secondary to COVID-19 will also be defined as an event.

Measure: Rates of hospitalization for a COVID-19 related complication

Time: One month from the start of treatment

Secondary Outcomes

Description: Time to clinical recovery will be defined by a return to normal body temperature (97-99 degrees F) as reported by the patient, and resolution of major presenting symptoms (myalgia, cough, shortness of breath, and GI symptoms) maintained for 72 hours. Patients will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via a pre-specified questionnaire. Patients will continue to be followed for an additional 3 months by electronic medical record review.

Measure: Time to clinical recovery (TTCR)

Time: One month from the start of treatment

Description: This score will be evaluated using a subjective self-reporting questionnaire around 8 symptoms, which include: shortness of breath at rest or exertion, fatigue, myalgia/muscle aces, fever, cough, headache, GI symptoms, inability to taste or smell. Subjects will rate each of their symptoms on an ordinal scale as follows: absent (0), mild (1), moderate (2), or severe (3). These symptom ratings will be added to define the symptom severity score with a possible score range of 0-24 points. Subjects will be called every 2 days for the first 14 days of the study, and then once weekly for the following 14 days to assess symptoms via this pre-specified questionnaire. Patients will continue to be followed for an additional 3 months via EHR review.

Measure: Symptom Severity Score

Time: One month from the start of treatment
106 A Study on the Prospective Cohort Library of Novel Coronavirus Pneumonia in Southeran

This is a multi-centre population-based follow-up study for all 504 patients with laboratory-confirmed COVID-19. This study establishes a standardized and structured clinical database to provide complete and multidimensional clinical diagnosis and treatment data of novel coronavirus pneumonia, which also support future epidemiological, infectious disease study and patients' prognosis, by collecting clinical data and the related data of patients with novel coronavirus pneumonia in Southern Zhejiang province.

NCT04342702
Conditions
  1. Follow-up
  2. COVID-19
  3. Infectious Diseases
  4. Respiratory
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: sum score of SF 36 form in each time frame

Measure: 36-Item Short Form Survey Instrument (SF-36)

Time: one month, three month, six month and one year after discharge, minimum score

Measure: the value of FEV1 by lung function test

Time: one month, three month, six month and one year after discharge

Measure: the ratio of FEV1 to FVC by lung function test

Time: one month, three month, six month and one year after discharge

Secondary Outcomes

Measure: the predicted value of FEV1 by lung function test

Time: one month, three month, six month and one year after discharge

Measure: the predicted ratio of FEV1 to FVC by lung function test

Time: one month, three month, six month and one year after discharge

Description: laboratory result

Measure: Lymphocyte value

Time: one month, three month, six month and one year after discharge

Description: laboratory result

Measure: Neutrophil value

Time: one month, three month, six month and one year after discharge

Description: laboratory result

Measure: DDI value

Time: one month, three month, six month and one year after discharge

Description: collect the number of applying ACEIs/ARBs medication and calculate the proportion

Measure: the proportion of applying ACEIs/ARBs medication

Time: from the date of hospital admission to the day of hospital discharge

Description: clinical symptoms

Measure: number of clinical symptoms after hospital discharge

Time: one month, three month, six month and one year after discharge

Measure: number of cases returning to positive result in RT-PCR test

Time: one month, three month, six month and one year after discharge

Measure: Number of positive outcome of IgG for antibody of COVID-19

Time: one month, three month, six month and one year after discharge
107 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
108 Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial

It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit. The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments. A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units. Patients will be randomly allocated 1:1 to either nivolumab or SoC.

NCT04343144
Conditions
  1. COVID19- Infection With SARS-CoV-2 Virus
Interventions
  1. Drug: Nivolumab Injection
MeSH:Infection

Primary Outcomes

Description: the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first

Measure: Time to clinical improvement

Time: day 14

Secondary Outcomes

Measure: Overall survival

Time: day 28

Measure: Overall survival

Time: day 90

Measure: Cumulative incidence of ICU admission

Time: day 28

Measure: Length of hospital stay

Time: day 90

Measure: Positive nasal PCR

Time: day 7

Measure: Incidence of adverse events

Time: day 28

Description: according to CTC AE-4.03

Measure: Incidence of grade 3-4 adverse events

Time: day 28

Description: range, from 0 (healthy) to 10 (death)

Measure: World Health Organisation (WHO) progression scale

Time: day 4, 7 and 14
109 Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

NCT04343183
Conditions
  1. COVID-19
Interventions
  1. Device: Hyperbaric Oxygen Therapy
MeSH:Infection

Primary Outcomes

Description: Compare rates of intubation between treatment and control groups

Measure: Decrease incidence of intubation by 30% or greater

Time: one month

Secondary Outcomes

Description: Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups

Measure: Decrease renal injury

Time: one month
110 Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection

- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. - Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. - Interim analysis will be permitted as described in the statistical section 8. - The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

NCT04343755
Conditions
  1. COVID-19
Interventions
  1. Biological: Convalescent Plasma
MeSH:Infection

Primary Outcomes

Description: Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients

Measure: For patients hospitalized for COVID-19 but not intubated

Time: 7 Days

Description: Mortality rate at 30 days from starting treatment for patients with COVID-19

Measure: Primary objective for patients with COVID-19 already intubated

Time: 30 Days

Secondary Outcomes

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. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.

Measure: Duration of hospitalization

Time: 60 Days

Description: The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.

Measure: Duration of mechanical ventilation

Time: 60 Days

Description: The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.

Measure: Time to symptoms resolution

Time: 60 Days

Description: Overall survival will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.

Measure: Overall survival

Time: 60 Days

Measure: Rate of virologic clearance by nasopharyngeal swab at day 10

Time: 60 Days

Measure: Impact of donor titers level on efficacy

Time: 60 Days

Measure: Impact of donor titers level on safety

Time: 60 Days

Measure: Recipient Anti-SARS-CoV2 titer assessment on days 0 (pre-infusion),3,10,30, 60

Time: 0, 3, 10, 30, and 60 Days
111 Pyridostigmine in Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 Infection

We will evaluate low-dose pyridostigmine as add-on therapy to best medical care in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and its related Coronavirus Disease 2019 (COVID-19) who require hospitalization. Our hypothesis is that, in comparison to the placebo, pyridostigmine will reduce in at least 10% a composite outcome [death; mechanical ventilation; >2 point-increase in the SOFA score) by day 28. We will also evaluate interleukin (IL)-6 kinetics during the first 14 days of in-hospital stay. It is estimated that 25-33% of patients hospitalized for COVID-19 are admitted to intensive care units (ICU) for severe hypoxemia. The reported mortality in those with severe disease ranges between 38% and 49%. So far, there is no pharmacological therapeutic (or else) strategy known to reduce morbidity and mortality in these patients. Mortality in COVID-19 appears to be mediated not necessarily by the direct effect of the infection, but by the disproportionate inflammatory response of the host. Pyridostigmine is an old drug that, by inhibiting acetylcholine-esterase, the enzymatic machinery that degrades acetylcholine (ACh), results in increased ACh bioavailability. ACh, in turn, ligates to nicotinic-alpha7 receptors in macrophages and T cells, resulting in reduced overactivation of these immune cells. In experimental murine sepsis, this family of drugs has resulted in reduced inflammation and mortality. Human evidence is scarce for severe inflammatory conditions. However, recent evidence from our group and others indicates that pyridostigmine has an immunomodulatory effect in people living with HIV, resulting in elevation of CD4+ T cell counts, decreased immune activation, and reduction in inflammatory mediators. Altogether, this suggests that ACh-esterase inhibitors may act as immunomodulators during viral infections, potentially reducing the inflammatory cascade (the so-called "cytokine storm") observed in critically ill COVID-19 patients. At the proposed dose (60mg/d), the rate of minor adverse events is less than 5% with no reported serious adverse effects. From that perspective, we consider that pyridostigmine can function as an immuno-modulator and reduce morbidity and mortality in COVID-19-stricken patients, with the added value of a safe pharmacological profile. Moreover, as an old drug, re-purposing it for a novel indication may be a simpler, more efficient approach than developing a novel one from the ground up.

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

Primary Outcomes

Description: Composite of death, Need for mechanical ventilation, or an increase of 2 or more points in the SOFA score

Measure: Critical condition or death

Time: 28 days

Description: Kinetics of circulating IL-6

Measure: IL-6

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

In this study invetigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 80 patients will be enrolled and randomly assigned in a 1:1:1 ratio to three study arms and received clazakizumab at a dose of 12.5 mg, 25 mg or placebo. Based on interim analysis, the remaining 10 subjects at NYU will be randomly assigned to a 1:1 ratio to two arms that will receive clazakizumab at a dose of 25 mg or placebo. The NYU site will serve as the central data management site for other centers who undertake this protocol. Other sites will enroll patients based on the two arm 1:1 randomization. 60 patients at outside sites are expected to enroll.

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

Primary Outcomes

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

Time: 60 days

Secondary Outcomes

Measure: Cumulative incidence of intubation

Time: 14 days

Measure: Time to extubation

Time: 14 days

Measure: Length of ICU stay

Time: 14 days

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

Time: 14 days

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

Measure: Patient Survival

Time: 28 days

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

Measure: Patient Survival

Time: 60 days
113 Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.

NCT04344327
Conditions
  1. Infection Viral
  2. Infection, Hospital
  3. COVID
MeSH:Infection Communicable Diseases Cross Infection Virus Diseases

Primary Outcomes

Description: Analysis of all-cause death in relation with clinical patient profile

Measure: Death rate

Time: Through study completion, an average of 4 weeks

Description: Correlation between clinical patient profile and transfer need to intensive care unit

Measure: Transfer to intensive care unit

Time: Through study completion, an average of 4 weeks

Description: Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile

Measure: Ventilation analysis

Time: Through study completion, an average of 4 weeks

Secondary Outcomes

Description: Description of clinical and biological patient profile leading to a worse prognosis

Measure: Construction of a predictive score for COVID-19 severe form

Time: Through study completion, an average of 4 weeks
114 Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus

The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo

NCT04344379
Conditions
  1. SARS-CoV-2 Infection
Interventions
  1. Drug: hydroxychloroquine
  2. Drug: azithromycin
  3. Drug: hydroxychloroquine placebo
MeSH:Infection

Primary Outcomes

Description: The number of hospital workers with a positive serology or a positive PCR within 40 days of follow-up.

Measure: To assess the impact of hydroxychloroquine and azithromycin on the prevention of SARS-CoV-2 contamination in hospital workers exposed to 40 days of treatment.

Time: 3 months

Secondary Outcomes

Description: Clinical signs suggesting SARS-2 CoV infection confirmed by positive endonasal PCR

Measure: Reducing clinical episodes due to suspected SARS-2 CoV infection confirmed by PCR

Time: 40 days

Description: number of seroconversion by serology between Day 0 and Day 40.

Measure: Reducing seroconversion for SARS-CoV-2 without any clinical sign

Time: 3 months

Description: number of cardiological severe adverse events assessed (ECG abnormalities : widening QT, ventricular arythmia, and cardiac arrests), other serious adverse events including hospitalizations, and deaths

Measure: Evaluation of drug tolerance in the study

Time: 40 days

Description: Number of work stoppages over the period

Measure: Evaluation on work stopping of hospital workers

Time: 40 days

Description: Plasmatic concentrations of treatments

Measure: Observance of treatment measured by plasmatic concentrations of hydroxychloroquine or azythromycine

Time: 40 days

Description: number of cardiac events, especialy ECG abnormalities (widening QT) due to treatments

Measure: Incidence of cardiologic events

Time: 40 days
115 Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 Infection

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.

NCT04344600
Conditions
  1. Sars-CoV2
Interventions
  1. Drug: Peginterferon lambda alfa-1a subcutaneous injection
  2. Other: Saline
MeSH:Infection

Primary Outcomes

Description: No evidence of SARS-CoV-2 infection at or before study day 28

Measure: Proportion of participants with no evidence of SARS-CoV-2 infection

Time: Up to 28 days

Description: Resolution of SARS-CoV-2 infection in the upper respiratory tract

Measure: Time (days) to no detection of SARS-CoV-2 in two upper respiratory samples

Time: Up to 14 days
116 An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.

NCT04345276
Conditions
  1. COVID-19
Interventions
  1. Drug: Danoprevir+Ritonavir
MeSH:Infection

Primary Outcomes

Description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen min without supplemental oxygen

Measure: Rate of composite adverse outcomes

Time: Within 10 days after administration

Secondary Outcomes

Description: Clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough, diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 30 breaths per min without supplemental oxygen).

Measure: Time to recovery

Time: Within 10 days after administration

Measure: Rate of no fever

Time: Within 10 days after administration

Measure: Rate of no cough

Time: Within 10 days after administration

Measure: Rate of no dyspnea

Time: Within 10 days after administration

Measure: Rate of no requiring supplemental oxygen

Time: Within 10 days after administration

Measure: Rate of undetectable New coronavirus pathogen nucleic acid

Time: Within 10 days after administration

Measure: Rate of mechanical ventilation

Time: Within 10 days after administration

Measure: Rate of ICU admission

Time: Within 10 days after administration

Measure: Rate of serious adverse event

Time: Within 10 days after administration
117 Correlative Study on Cancer Patients and Healthcare Professionals Exposed to SARS-CoV-2 Infection

Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics. The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

NCT04345315
Conditions
  1. COVID-19
  2. SARS-CoV-2
Interventions
  1. Other: serological test
  2. Other: Rapid molecular test
  3. Genetic: Next generation Sequencing (NGS) analysis
  4. Other: serum chemistry analysis
MeSH:Infection

Primary Outcomes

Description: Investigate the epidemiology of the infection in an asymptomatic population including both healthy individuals at high risk of infection and oncological patients by assessing the seroprevalence of IgG and IgM antibodies against the SARS-CoV-2

Measure: epidemiology

Time: 12 months

Secondary Outcomes

Description: IgG and IgM antibodies evaluation over time

Measure: Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation

Time: 12 months

Description: Make a comparison between different serological investigation methods and rapid molecular methods becoming available

Measure: methods comparison

Time: 24 months

Description: To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity

Measure: correlation between biochemical and coagulative factors with SARS-CoV-2 positivity.

Time: 24 months

Description: Building a phylogenetic map of an epidemic Italian macro-region

Measure: phylogenetic map

Time: 24 months

Description: Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19

Measure: interactions between the virus and host cells

Time: 24 months
118 Testing for COVID-19 Infection in Asymptomatic Persons

Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.

NCT04345510
Conditions
  1. COVID-19 Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: COVID-19 infection

Time: 6 weeks
119 An Open Randomized Study of the Effectiveness of the Drug Dalargin for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

The purpose of the study is to evaluate an effectiveness of the drug Dalargin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

NCT04346693
Conditions
  1. Acute Respiratory Tract Infection
  2. Acute Respiratory Insufficiency
  3. Pneumonia
  4. Septic Shock
  5. Hypoxemia
Interventions
  1. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
  2. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection
  3. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation
  4. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation
MeSH:Infection Respiratory Tract Infections Pneumonia Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia
HPO:Hypoxemia Pneumonia Pulmonary insufficiency Respiratory tract infection

Primary Outcomes

Description: Estimated by Polymerase chain reaction (PCR)

Measure: The change of viral load in patients with SARS-COVID-19.

Time: Upon patient inclusion in the study, after 96 hours and on the 10day;

Description: Assessed through the entire patient participation in the study

Measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS)

Time: up to 10 days

Description: The number of days a patient is hospitalized

Measure: Duration of hospitalization

Time: up to 10 days

Description: Early mortality from all causes will be estimated

Measure: The frequency of early mortality

Time: up to 30 days

Description: Late mortality from all causes will be estimated

Measure: The frequency of late mortality

Time: up to 90 days

Description: Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: Death; Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; Hospitalization extended, on non-invasive ventilation; Hospitalization is extended, needs additional oxygen; Hospitalization is extended, additional oxygen is not required; Discharged.

Measure: Clinical status at the time of completion of participation in the study

Time: an average of 10 days
120 CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

NCT04346797
Conditions
  1. SARS-CoV-2
  2. COVID19
Interventions
  1. Drug: Eculizumab
MeSH:Infection

Primary Outcomes

Description: Survival without needs of intubation, events considered are intubation or death

Measure: Survival without needs of intubation at day 14

Time: 14 days

Description: Change in organ failure at day 3, defined by the relative variation in Sequential Organ Failure Assessment score

Measure: Change in organ failure at day 3

Time: 3 days

Secondary Outcomes

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: Intubation free survival at day 14

Time: Day 14

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 days 4, 7 and 14

Time: 4, 7 and 14 days

Description: Overall survival

Measure: Survival at 14, 28 and 90 days

Time: 14, 28 and 90 days

Description: Time between inclusion and hospital discharge

Measure: Time to discharge

Time: 90 days

Description: Time between inclusion and oxygen supply independency

Measure: Time to oxygen supply independency

Time: 90 days

Description: Time between inclusion and negative viral excretion

Measure: Time to negative viral excretion

Time: 90 days

Description: Incidence of secondary infections (acquired pneumonia)

Measure: Incidence of secondary infections

Time: 90 days

Description: Vasopressor-free survival

Measure: Vasopressor-free survival

Time: 90 days

Description: Ventilator-free survival

Measure: Ventilator-free survival

Time: 90 days

Description: Number of ventilator-free days alive up to day 28

Measure: 28-day ventilator-free days

Time: 28 days

Description: Incidence of dialysis (renal replacement therapy)

Measure: Incidence of dialysis

Time: 90 days

Description: PaO2/FiO2 ratio

Measure: PaO2/FiO2 ratio

Time: days 4, 7, 14

Description: Number of patients with arterial blood pH of <7.25, with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

Measure: Rate of respiratory acidosis at day 4

Time: 4 days

Description: Time to ICU discharge

Measure: Time to ICU discharge

Time: 90 days
121 IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT

This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.

NCT04347798
Conditions
  1. Covid-19 Infection
  2. Rheumatoid Arthritis
  3. Psoriatic Arthritis
  4. Hydroxychloroquine
Interventions
  1. Other: Hydroxychloroquine/Chloroquine
MeSH:Infection Communicable Diseases Arthritis Arthritis, Rheumatoid Arthritis, Psoriatic
HPO:Arthritis Polyarticular arthritis Rheumatoid arthritis

Primary Outcomes

Description: Number of patients developing signs and symptoms of Covid-19 or other infections

Measure: Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group

Time: 12 months

Secondary Outcomes

Description: Number of patients developing Covid-19 infection

Measure: Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group

Time: 12 months

Description: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action

Measure: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action

Time: 12 months

Other Outcomes

Description: Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposure

Measure: Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients

Time: 6 months
122 Screening and Risk Assessment of Healthcare Workers and Infection Control in University and COVID-19 Quarantine Hospitals Using Real-time Geospatial Mapping for Emergency Healthcare Resource Mobilization and Management

A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.

NCT04348214
Conditions
  1. Coronavirus Disease (COVID-19)
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals

Measure: Risk categorization of healthcare workers

Time: 9 months

Description: To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.

Measure: COVID-19 infection rate among health care workers

Time: 9 months

Description: To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.

Measure: Risk factors for COVID-19 among health care workers

Time: 9 months

Description: To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.

Measure: Adherence of health care workers to infection prevention

Time: 9 months

Description: To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.

Measure: Validity of the available rapid serological test for detecting COVID-19 virus infection

Time: 9 months

Secondary Outcomes

Description: To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.

Measure: Clinical spectrum of COVID-19

Time: 9 months

Description: To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals

Measure: Effectiveness of infection prevention in the health care facility

Time: 9 months

Description: To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals

Measure: Emergency infection prevention and control needs

Time: 9 months

Description: To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.

Measure: Isolation rate and emergency health care worker replacement needs

Time: 9 months

Description: To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.

Measure: Rate of seroconversion

Time: 9 months
123 Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)

This study is a phase II, parallel, prospective, randomized, double-blind, placebo controlled trial. The present study will aim to address the efficacy and safety of acute administration of triiodothyronine on ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO.

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

Primary Outcomes

Description: The primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. The primary objective will be measured as percentage of patients successfully weaned after 30 days of follow-up.

Measure: Assessment of weaning from cardiorespiratory support

Time: 30 days

Secondary Outcomes

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

Measure: Assessment of hemodynamic status

Time: 30 days

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

Measure: Assessment of hemodynamic status

Time: 30 days

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

Measure: Assessment of hemodynamic status

Time: 30 days

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

Measure: Assessment of hemodynamic status

Time: 30 days

Description: Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of oxygen in mmHg)

Measure: Assessment of pulmonary function

Time: 30 days

Description: Pulmonary function will be assessed by arterial measurement of blood gases (arterial partial pressure of carbon dioxide in mmHg)

Measure: Assessment of pulmonary function

Time: 30 days

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

Measure: Assessment of pulmonary function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in aspartate aminotransferase (AST in IU/L) will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in alanine aminotransferase (ALT in IU/L) will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in gamma-glutamyl transpeptidase (γ-GT in IU/L) will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in bilirubin in mg/dL will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in fibrinogen in mg/dL will be measured.

Measure: Assessment of hepatic function

Time: 30 days

Description: Hepatic function will be assessed by laboratory measurements in blood. Changes in d-dimers in ng/ml will be measured.

Measure: Assessment of hepatic function

Time: 30 days

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

Measure: Assessment of renal function

Time: 30 days

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

Measure: Assessment of renal function

Time: 30 days

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

Measure: Assessment of renal function

Time: 30 days

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

Measure: Assessment of renal function

Time: 30 days

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

Measure: Assessment of cardiac function

Time: 30 days

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

Measure: Assessment of cardiac injury

Time: 30 days

Description: COVID-19 infection will be assessed by inflammatory indices in blood (white blood cells in number per μL)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by inflammatory indices in blood (CRP in mg/L)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by inflammatory indices in blood (erythrocyte sedimentation rate in mm/hr)

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

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

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: COVID-19 infection will be assessed by time needed (in days) for the patient to become negative in COVID-19

Measure: Assessment of the course of COVID-19 infection

Time: 30 days

Description: Number of participants with major (death, cardiac Arrest, electromechanical dissociation, pulmonary embolism, new myocardial infarction, stroke, pulmonary edema, cardiogenic shock and hypotension, septic shock, pulmonary embolism, serious bleeding) events be recorded during the follow up period

Measure: Assessment of clinical outcome and safety

Time: 30 days

Description: Number of participants with minor (myocarditis, Venous Thromboembolism, left Ventricular mural thrombus, renal failure, hepatic failure, stress ulcers, minor bleeding, paroxysmal supraventricular tachycardia and atrial fibrillation, rhythm disturbances) events will be recorded during the follow up period

Measure: Assessment of clinical outcome and safety

Time: 30 days
124 Assessment of COVID-19 Diagnostic Self-testing Using Virtual Point-of-care

The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic tests, like Coris Bioconcept Ag Respi-strip COVID-19 test, and LAMP-based molecular tests) in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support.

NCT04348864
Conditions
  1. Communicable Disease
  2. COVID-19
  3. Sars-CoV2
  4. Infectious Disease
  5. Coronavirus
  6. Virus
Interventions
  1. Diagnostic Test: COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support
  2. Other: Telemedicine
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test

Measure: Clinical accuracy of the antibody and antigen rapid tests compared to LAMP/PCR-based test result

Time: 1 year

Description: Accuracy refers to the amount of agreement between the results of the rapid tests and a clinical diagnosis of COVID-19

Measure: Clinical accuracy of the antibody and antigen rapid tests based on Clinical diagnosis

Time: 1 year

Description: Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician

Measure: Self-test interpretation of result vs expert clinical image interpretation of result

Time: 1 year

Secondary Outcomes

Description: Subjects will complete a survey to rate the testing procedure for ease of use and convenience. The survey will ask subjects to rate the ease of use on a scale from 1 (easiest procedure to complete and understand) to 10 (most complicated and confusing procedure)

Measure: Ease of self-testing procedure

Time: 1 year
125 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
126 Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

NCT04350086
Conditions
  1. COVID-19 Infection
  2. Sars-cov-2
  3. Respiratory Failure
  4. Palliative Situation
Interventions
  1. Drug: Treatment with Dexmedetomidine
MeSH:Infection Communicable Diseases Respiratory Insufficiency

Primary Outcomes

Description: Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.

Measure: Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.

Time: Day 30

Secondary Outcomes

Description: Overall survival time in days from inclusion.

Measure: Overall survival of patients on Dexmedetomidine

Time: Day 30

Description: The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.

Measure: Daily analgesic effect of Dexmedetomidine

Time: Day 30

Description: Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.

Measure: Other sedative pharmacological agents

Time: Day 30

Description: Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation

Measure: Average dosage required for Dexmedetomidine to achieve mild to moderate sedation

Time: Day 30
127 Emotional Burden of Healthcare Professionals and the Epidemic Related to Covid Infection 19 -

COVID-19 ( known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. The picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%. Its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition. In such a context, healthcare professionals assigned to COVID units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences. We would therefore like to describe, using validated tools, the emotional evolution of the care workers at the Limoges University Hospital and the Esquirol University Hospital faced with this new pandemic infection. An initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy

NCT04350099
Conditions
  1. Emotionnal Distress; COVID-19
Interventions
  1. Other: quetionnary
MeSH:Infection

Primary Outcomes

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 7 days,

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 15 days,

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 1 month

Description: Assessing the anxiety of health professionals using Anxiety Disorder Assessment (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Measure: anxiety

Time: 3 month
128 Austrian COVID-19 Registry (AGMT_COVID-19)

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

NCT04351529
Conditions
  1. Infectious Disease
  2. COVID-19
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Measure: Documentation of natural course and the therapeutic landscape of patients with COVID-19.

Time: 2 years
129 SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance

This is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.

NCT04352556
Conditions
  1. SARS-CoV-2 Infection
  2. Hematological Malignancies
MeSH:Infection Neoplasms Hematologic Neoplasms
HPO:Hematological neoplasm Leukemia Neoplasm

Primary Outcomes

Description: The percentage of HM patients with COVID-19 who died.

Measure: To evaluate mortality.

Time: At 2 months from study initiation

Description: We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.

Measure: To evaluate potential predictive biochemical parameters of mortality.

Time: At 2 months from study initiation

Description: We will assess the correlation between HM-related parameters at diagnosis of COVID [i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)] and mortality.

Measure: To evaluate potential predictive HM-related parameters of mortality.

Time: At 2 months from study initiation

Description: We will assess the correlation between COVID severity [mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)] and mortality

Measure: To evaluate COVID severity as predictive parameter of mortality.

Time: At 2 months from study initiation

Secondary Outcomes

Description: Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 < 300 and/or lung infiltrates > 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)

Measure: Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity

Time: At 6 months from study initiation

Description: Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.

Measure: Definition of complete clinical picture of COVID-19 in HM

Time: At 2 months from study initiation

Description: Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.

Measure: Evolution of HM

Time: At 2 months from study initiation

Description: Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).

Measure: To evaluate admission to ICU requiring mechanical ventilation or death per characteristics

Time: At 2 months from study initiation

Measure: Viral dynamics in infected HM patients

Time: At 12 months from study initiation
130 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
131 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
132 Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection

The Nancy Cov-H-AKI: study is a prospective, non-randomized, monocenter study performed in patients hospitalised for either the severe or the critical form of Covid-19. The main objective of the Nancy Cov-H-AKI study is to evaluate the association of variations (from inclusion to 72H post-inclusion) of 5 blood-based cardio-vascular-renal biomarkers selected a priori, cardiac (NT-proBNP), coagulation (D-dimers), related to the renin angiotensin aldosterone system (ACE2) and renal (Penkid, and NGAL) with the appearance of acute kidney injury KDIGO grade 1 or higher OR cardiac injury in patients hospitalised for either the severe or the critical form of Covid-19

NCT04354610
Conditions
  1. COVID 19
Interventions
  1. Procedure: Biological samples specific to research
  2. Procedure: Clinical examination
  3. Procedure: Telephone follow-up
MeSH:Infection

Primary Outcomes

Description: Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 2).

Measure: Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection

Time: From inclusion to hospital discharge, an average of 21 days

Description: Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 1)

Measure: Troponin greater than 99th percentile during hospitalization for Covid-19 infection

Time: From inclusion to hospital discharge, an average of 21 days

Secondary Outcomes

Description: Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) ((with Outcome 3 )

Measure: AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)

Time: From inclusion to hospital discharge, an average of 21 days

Description: Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) (with Outcome 3)

Measure: Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)

Time: From inclusion to hospital discharge, an average of 21 days

Description: AKI KDIGO grade 1 in hospitalisation

Measure: AKI KDIGO grade 1 or higher

Time: From inclusion to hospital discharge, an average of 21 days

Description: Association with troponin elevation >99th percentile during hospitalisation

Measure: Association with troponin elevation >99th

Time: From inclusion to hospital discharge, an average of 21 days

Description: Association with elevation of serum creatinine >30% during hospitalisation

Measure: Association with elevation of serum creatinine >30%

Time: From inclusion to hospital discharge, an average of 21 days

Description: With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital

Measure: With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)

Time: 3 months after discharge from hospital

Description: Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital

Measure: The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital

Time: From inclusion to three months after discharge from hospital

Description: Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital

Measure: The occurrence of death from any cause during hospitalisation and three months after discharge from hospital

Time: From inclusion to three months after discharge from hospital
133 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
134 Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.

To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals

NCT04354792
Conditions
  1. Immunologic Activity Alteration
Interventions
  1. Diagnostic Test: Serum SARs COV 2 IGg screening in health care workers
MeSH:Infection

Primary Outcomes

Description: health care workers who have positive IGg in seum

Measure: Number of IGg seropositive health care workers

Time: single measurement from each person collected over 2 months

Secondary Outcomes

Description: to know positive IGg persons and IGg negative persons to understand risk factors

Measure: Differentiation between low risk and high risk HCWs

Time: 2 months through out duration of study
135 An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection

This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.

NCT04354831
Conditions
  1. COVID-19
Interventions
  1. Biological: anti-SARS-CoV-2 convalescent plasma
MeSH:Infection

Primary Outcomes

Description: Overall mortality within 60 days

Measure: Overall Mortality within 60 days

Time: sixty days from infusion of plasma

Secondary Outcomes

Description: length of admission for COVID

Measure: Length of ICU stay during current admission for COVID

Time: Length of admission for COVID through study follow-up period, an average of 60 days
136 Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns

A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures. Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth. It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.

NCT04355234
Conditions
  1. Pregnancy
Interventions
  1. Diagnostic Test: identify SARS-CoV-2 infection by serology
  2. Biological: collection of biological samples
MeSH:Infection

Primary Outcomes

Description: Number of women who are positive for SARS-CoV-2

Measure: Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman

Time: at delivery

Secondary Outcomes

Description: Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications

Measure: Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications

Time: 2 months after delivery

Description: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: vaginal, anal, amniotic fluid and in the newborn: nasopharyngeal swabs, gastric aspiration, anal swab.

Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

Time: at delivery

Description: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: milk and stool samples and in the newborn: nasopharyngeal swabs, urine and stool.

Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

Time: 5 days after delivery

Description: Evaluation of gestational age at SARSCoV-2 infection by performing serology on monthly collected serum samples (samples collected for routine management of pregnancy).

Measure: Assessment of susceptibility to infection during the 3 trimesters of pregnancy

Time: 5 days after delivery

Description: Study of the methods of confinement by investigation

Measure: Evaluation of the confinement on the risk of exposure to the virus during pregnancy .

Time: 5 days after delivery

Description: A biobank will be carried out, including the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn

Measure: collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.

Time: 5 days after delivery

Description: Risk factors in uninfected women

Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.

Time: at delivery

Description: Risk factors in infected and symptomatic women.

Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.

Time: at delivery

Description: risk factors in newborns

Measure: Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.

Time: at delivery
137 Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil

This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.

NCT04355338
Conditions
  1. COVID-19
MeSH:Infection

Primary Outcomes

Description: Number of cases with serological/virological diagnosis for SARS-Co-2 infection

Measure: Incidence of SARS-CoV-2 infection

Time: 24 months

Description: Number of cases of symptomatic SARS-CoV-2 infection

Measure: Incidence of COVID-19

Time: 24 months

Secondary Outcomes

Description: Number of cases of hospitalization due to symptomatic SARS-Co-2 infection

Measure: Incidence of hospitalization due to COVID-19

Time: 24 years

Description: Level of neutralizing antibodies in participants with SARS-Co-2 infection

Measure: Level of neutralizing antibodies

Time: 24 months

Description: Positive serology for SARS-Co-2 infection at baseline

Measure: Previous SARS-CoV-2 infection

Time: 6 months

Other Outcomes

Description: Number of a new SARS-CoV-2 infection in an individual with a proven previous infection

Measure: Incidence of SARS-CoV-2 reinfection

Time: 24 months

Description: Number of COVID-19 cases requiring mechanical ventilation

Measure: Incidence of COVID-19 cases requiring mechanical ventilation

Time: 24 months

Description: Number of deaths due to COVID-19

Measure: Incidence of deaths due to COVID-19

Time: 24 months

Description: Number and description of sequels attributed to COVID-19

Measure: Incidence of sequels after COVID-19

Time: 24 months
138 Study of Immune Response During SARS-CoV-2 Infection

Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response. The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1

NCT04355351
Conditions
  1. New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2
Interventions
  1. Other: blood sampling
  2. Other: additional blood tubes
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.

Measure: Level of IFN-gamma after a non-specific stimulation of T lymphocytes

Time: 6 months
139 Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents

The purpose of this study is to provide weekly data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

NCT04355533
Conditions
  1. COVID-19 Infection
Interventions
  1. Biological: serology test
  2. Diagnostic Test: NG Biotech
  3. Biological: nasopharyngeal swab
  4. Biological: rectal swab
  5. Biological: saliva sample
MeSH:Infection

Primary Outcomes

Description: serology

Measure: Seroconversion against SARS-CoV2 in children

Time: at inclusion

Secondary Outcomes

Description: Serology, measure of Ab in children

Measure: Protective immunity

Time: at inclusion

Description: Serology in children

Measure: Measure of Ab antiN and Ab anti-S1/2

Time: at inclusion

Description: Serology in children

Measure: Neutralization activity

Time: at inclusion

Description: in children, qualitative and quantitative measure , in nasopharynx, saliva and stool

Measure: Positive qPCR in children

Time: at inclusion

Description: in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum

Measure: correlation between different Ab and qPCR and neutralization activity

Time: at inclusion

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: Day 7

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: Day 15

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: Day 30

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: At 6 months

Description: Serology, measure of Ab in PCR positive children

Measure: Protective immunity

Time: At 12 months

Description: Sars-Cov2 PCR in PCR positive children

Measure: duration of viral carriage in stool, saliva and or nasopharynx

Time: until 30 days post onset

Description: Serology in PCR positive children

Measure: correlation between antibody profile and viral clearance

Time: until 30 days post onset

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At Day 7

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At Day 15

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At Day 30

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At 6 months

Description: Immune cells in positive PCR children

Measure: Ab profile and memory of immunity

Time: At 12 months

Description: Serology and qPCR in positive PCR children

Measure: Transmission to other family members

Time: Until 30 days

Description: Clinical examination and questioning in positive PCR children

Measure: Presence of COVID-19 Symptom

Time: Until 12 months of follow-up

Description: Ancillary study: Serology in parents

Measure: seroconversion against SARS-CoV2 in parents

Time: at inclusion

Description: Ancillary study: Serology in parents

Measure: Measure of Ab antiN and Ab anti-S1 and neutralization activity

Time: at inclusion

Description: Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva

Measure: Positive qPCR in parents

Time: at inclusion

Description: Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum

Measure: correlation between different Ab and qPCR

Time: at inclusion

Description: Ancillary study: Serology in PCR positive parents

Measure: correlation between antibody profile and viral clearance

Time: until 30 days post onset

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at Day 7

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at Day 15

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at Day 30

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at 6 months

Description: Ancillary study: Immune cells in positive PCR parents

Measure: Ab profile and memory of immunity

Time: at 12 months

Description: Serology and qPCR in positive PCR parents

Measure: Transmission to other family members

Time: Until 30 days
140 Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)

Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.

NCT04356144
Conditions
  1. Disseminated Intravascular Coagulation
  2. Critical Illness
  3. Sars-CoV2
  4. Viral Infection
  5. Coagulation Disorder, Blood
  6. Covid19
Interventions
  1. Diagnostic Test: Thrombin Generation Assay (TGA)
  2. Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)
MeSH:Infection Virus Diseases Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation Critical Illness
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

Primary Outcomes

Description: nM;

Measure: ETP (AUC) without rhThrombomodulin (rhTM)

Time: 6 months

Description: nM;

Measure: ETP (AUC) with rhThrombomodulin (rhTM)

Time: 6 months

Description: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

Measure: ETP-ratio

Time: 6 months

Description: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

Measure: ETP-Normalisation

Time: 6 months
141 Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse: Cases of Synthetic Antimalarial Drugs and Anti-hypertensive Drugs

The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold. Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19. Treatments currently being investigated include: - Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS; - Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists. We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease. Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are - Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors). - Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities. This in order to: - To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD. - To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

NCT04356417
Conditions
  1. AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection
Interventions
  1. Other: - Synthetic anti-malarial drugs
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Participants as those with the emergency ICD-10 (international classification of diseases, 10th revision) code of U07.1 which was assigned to the disease diagnosis of COVID-19.

Measure: Identification of serious COVID-19 infections

Time: From 2020/01/01 to 2020/06/30

Secondary Outcomes

Measure: Pneumonia infections

Time: From 2020/01/01 to 2020/06/30

Measure: ICU stay

Time: From 2020/01/01 to 2020/06/30

Measure: Oro-tracheal intubation

Time: From 2020/01/01 to 2020/06/30

Measure: Death

Time: From 2020/01/01 to 2020/06/30
142 Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)

This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 60 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).

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

Primary Outcomes

Measure: Proportion of participants with an occurrence of hospitalization

Time: From inclusion (day0) to day 14

Description: Proportion of participants with an occurrence of death

Measure: Death

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 nasopharyngeal SARS-CoV-2 RT-PCR

Time: day 7 and day 14

Measure: Proportion of participants with a loss of autonomy evaluated by the ADL and IADL scale

Time: day 14 and day 28

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 and day 14

Description: Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia

Measure: Biochemical markers evolution

Time: from inclusion (day 0) to day 7 and day 14

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

Measure: Inflammatory markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of immunological markers in each group : B ans T Cells phenotypic profiles

Measure: Immunological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

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 14

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 14

Description: Plasma concentration of the study drugs at D7

Measure: Plasma concentration

Time: day 7

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
143 A Phase II Single-Center, Randomized, Open-Label, Safety and Efficacy Study of Etoposide in Patients With COVID-19 Infection

This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.

NCT04356690
Conditions
  1. COVID-19
Interventions
  1. Drug: Etoposide
MeSH:Infection

Primary Outcomes

Description: An 8 point ordinal scale will be used to assess pulmonary status consisting of the following values: 8= Death; 7= Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min); 6= Intubation and mechanical ventilation; 5= Non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4= Oxygen by mask or nasal prongs; 3= Hospitalization without oxygen supplementation; 2= Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skilled nursing facility (+/- supplemental oxygen); 1= Discharged to home without supplemental oxygen

Measure: Change in pulmonary status

Time: baseline, through study completion, an average of 45 days

Secondary Outcomes

Measure: Change in ferritin levels

Time: baseline, through study completion, an average of 45 days

Measure: Change in C-reactive protein levels

Time: baseline, through study completion, an average of 45 days

Measure: Change in d-dimer levels

Time: baseline, through study completion, an average of 45 days

Measure: Change in white blood cell count

Time: baseline, through study completion, an average of 45 days

Description: number of events

Measure: Incidence of serious adverse events

Time: baseline, through study completion, an average of 45 days

Measure: Overall survival

Time: Days 15, 30 and 60

Description: When calculating days of hospitalization, re-hospitalization or death occurring in the first 28 days should result in zero ascribed to time out of the hospital prior to readmission.

Measure: Length of hospitalization

Time: From date of enrollment until the date of extubation, assessed study completion, an average of 45 days

Measure: Duration of ventilation

Time: From date of enrollment until the date of extubation, assessed study completion, an average of 45 days

Description: Reintubations or death within 28 days will result in zero ascribed time off ventilator prior to reintubation

Measure: Ventilator free days

Time: baseline, through study completion, an average of 45 days

Measure: Improvement in arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)

Time: baseline, through study completion, an average of 45 days
144 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
145 Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection

The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.

NCT04357808
Conditions
  1. Covid-19
Interventions
  1. Drug: Sarilumab
  2. Other: Standar of care
MeSH:Infection

Primary Outcomes

Description: Score ranges 1-7 Death; Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized

Measure: Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation

Time: 7 days from enrolment

Description: Days from the date of enrolment to the date of discharge

Measure: Duration of hospitalisation (days)

Time: 30 days from enrolment

Description: Number of deaths

Measure: Death

Time: 30 days from enrolment

Secondary Outcomes

Description: Time to become afebrile for a minimum period of 48 hours, without antipyretics

Measure: Time to become afebrile (days)

Time: 30 days from enrolment

Description: Days from enrolment to non-invasive mechanical ventilation

Measure: Time to non-invasive mechanical ventilation (days)

Time: 30 days from enrolment

Description: Days from enrolment to invasive mechanical ventilation

Measure: Time to invasive mechanical ventilation (days)

Time: 30 days from enrolment

Description: Days from enrolment to supplementary oxygen therapy withdrawal

Measure: Time to independence from supplementary oxygen therapy (days)

Time: 30 days from enrolment

Description: Scale ranges 1-7: Death Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles. Hospitalized with oxygen supplement Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID) Hospitalized, without oxygen supplement and without the need for continued medical care Not hospitalized

Measure: Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation

Time: 14 days from enrolment

Other Outcomes

Description: Number of adverse events and number of patients with adverse events

Measure: Incidence of serious and non-serious adverse events.

Time: 30 days after enrolment

Description: Number of adverse reactions that requires discontinuation of any drug in the study

Measure: Discontinuation due to adverse reactions

Time: 30 days after enrolment
146 Classification of COVID-19 Infection in Posteroanterior Chest X-rays With Common Deep Learning Architectures

The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.

NCT04358536
Conditions
  1. COVID-19
Interventions
  1. Device: CovX
MeSH:Infection

Primary Outcomes

Description: Identification of COVID-19 infection from chest X-ray analysis

Measure: Identification of COVID-19

Time: Through study completion, an average of 2 months
147 A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

NCT04359680
Conditions
  1. COVID-19
  2. Viral Respiratory Illnesses
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Placebo
  3. Dietary Supplement: Vitamin Super B-Complex
MeSH:Infection

Primary Outcomes

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

Time: Up to 6 weeks

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

Time: Up to 6 weeks
148 Impact of SARS-CoV-2 Infection on the Incidence of Ventilator-acquired Infections

Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

NCT04359693
Conditions
  1. SARS-CoV 2
MeSH:Infection

Primary Outcomes

Description: the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis

Measure: Cumulative incidence of ventilator-associated lower respiratory tract infection

Time: from day 3 of mechanical ventilation to extubation or day 28 post-intubation.

Secondary Outcomes

Description: incidence of ventilator-associated tracheobronchitis

Measure: Cumulative incidence of ventilator-associated tracheobronchitis

Time: from day 3 of mechanical ventilation to extubation or day 28 post intubation

Description: incidence of ventilator-associated pneumonia

Measure: Cumulative incidence of ventilator-associated pneumonia

Time: from Day 3 of mechanical ventilation to extubation or day 28 post intubation.

Description: incidence of ICU-acquired bacteremia

Measure: the cumulative incidence of ICU acquired bacteremia diagnosed

Time: from ICU admission to extubation or Day 28.

Description: death in the ICU

Measure: ICU mortality

Time: at day 28

Description: death

Measure: Mortality

Time: at day 28

Description: number of days Under mechanical ventilation

Measure: the duration of mechanical ventilation

Time: from the start of mechanical ventilation to extubation or day 28 post intubation

Description: number of days in the ICU

Measure: Length of stay in Intensive Care Unit

Time: from admission to ICU until extubation or Day 28
149 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
150 Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial

Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .

NCT04360980
Conditions
  1. COVID-19
Interventions
  1. Drug: Colchicine Tablets
MeSH:Infection

Primary Outcomes

Description: increasing inflammatory status

Measure: CRPxN/R ratio change

Time: 2 weeks

Description: including change in fever or O2 Saturation

Measure: Clinical deterioration by the WHO definition

Time: 2 weeks

Description: change in RT-PCR

Measure: PCR Viral Load

Time: 2 weeks

Description: change in CT involvement

Measure: CT severity involvement index

Time: 2weeks

Secondary Outcomes

Description: change in LDH

Measure: LDH change

Time: 2 weeks
151 A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity

In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

NCT04361253
Conditions
  1. COVID
  2. Inf
  3. Infectious Disease
Interventions
  1. Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP)
  2. Biological: Standard Plasma (FFP)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.

Measure: Modified WHO Ordinal Scale (MOS) score

Time: Day 14
152 Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection - MARNEVO-Covid

Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

NCT04361344
Conditions
  1. COVID-19 Infection
  2. Encephalitis
Interventions
  1. Biological: blood samples
MeSH:Infection Communicable Diseases Encephalitis Nerve Degeneration
HPO:Encephalitis Neurodegeneration

Primary Outcomes

Description: Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.

Measure: Change of neurodegeneration markers level

Time: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).
153 Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

NCT04361552
Conditions
  1. Cerebrovascular Accident
  2. Chronic Obstructive Pulmonary Disease
  3. Chronic Renal Failure
  4. Coronary Artery Disease
  5. Diabetes Mellitus
  6. Malignant Neoplasm
  7. SARS Coronavirus 2 Infection
Interventions
  1. Other: Best Practice
  2. Biological: Tocilizumab
MeSH:Infection Neoplasms Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease
HPO:Chronic pulmonary obstruction Coronary artery atherosclerosis Neoplasm Pulmonary obstruction Stroke

Primary Outcomes

Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.

Measure: 7-day length of invasive mechanical ventilation (MV)

Time: Up to 7 days

Description: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: 30-day mortality rate

Time: Up to 30-day after randomization

Secondary Outcomes

Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of intensive care (ICU) transfer

Time: Up to 2 years

Description: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of invasive mechanical ventilation

Time: Up to 2 years

Description: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of tracheostomy

Time: Up to 2 years

Description: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test

Measure: Length of ICU stay

Time: Up to 2 years

Measure: Length of hospital stay

Time: Up 2 years
154 Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection: Search for Acquired Thrombophilia and Interferon-alpha Signature

Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood. The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.

NCT04361786
Conditions
  1. COVID 19
MeSH:Infection

Primary Outcomes

Description: Searching for presence or absence of abnormal acquired thrombophilic condition as antibodies, hemostasis disturbances. Presence or absence of thrombophilic markers in the blood

Measure: Biological acquired thrombophilia

Time: 1 day

Secondary Outcomes

Description: Dosing transcriptomic interferon signature in a blood sample. Presence or absence of interferon in the blood

Measure: Overexpression of interferon type I

Time: 1 day
155 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
156 National Cohort Study to Assess the Influence of COVID-19 Infection in Thromboembolic Venous Disease:

There is an urgent need to understand the outcomes of COVID-19 infected patients regarding the thromboembolic venous disease. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients, improving their clinical care. Interventions are needed to reduce both the incidence and severity of COVID-19. Although it shares characteristics with other similar viruses that also arose in outbreaks, the physiological mechanisms of the virus and its responses on the host are not yet fully known. There are indications that the clinical picture of this disease is in a procoagulant state, with possible increase in episodes of thromboembolic disease. This study aims to analyze the influence of COVID-19 on the incidence of deep vein thrombosis (DVT) in lower and upper limbs, and the variation in the clinical presentation of COVID-19, as well as to provide new evidence applicable to the clinical management of these patients and the establishment of prognostic factors that help early take therapeutic decisions. To this end, an observational, multicenter, national cohorts study will be carried out, sponsored by the Spanish Society of Angiology and Vascular Surgery (SEACV) and the Spanish Chapter of Phlebology and Linfology through its Vascular Research Network (RIV), which will collect demographic variables, comorability, concomitant treatment, analytical status and complementary and ultrasound diagnostic tests, parameters of clinical evolution, therapeutic and complications and mortality to 30 days. All national centers you wish to participate through a secure server that will be accessed through the SEACV and CEFyL website. The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

NCT04361981
Conditions
  1. COVID-19
Interventions
  1. Other: Deep Venous Disease Diagnostic
MeSH:Infection

Primary Outcomes

Description: Incidence of Deep Venous Disease events in patients with COVID-19 infection

Measure: Deep Venous Disease Incidence

Time: 30 days

Secondary Outcomes

Description: 30-days mortality in COVID-19 infection patients with a Deep Venous Disease event

Measure: 30-days mortality

Time: 30 days

Description: Rate of ICU admission in COVID-19 infection patients with a Deep Venous Disease event

Measure: ICU admission

Time: 30 days

Description: Type of anticoagulant treatment in COVID-19 infection patients with a Deep Venous Disease event

Measure: Anticoagulant treatment

Time: 30days
157 Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020

Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.

NCT04362124
Conditions
  1. COVID-19
Interventions
  1. Biological: vaccine BCG
  2. Other: Placebo
MeSH:Infection

Primary Outcomes

Description: Incidence of COVID-19 cases confirmed or probable in the study population

Measure: Primary outcome

Time: From date of randomization to 360 day of the study

Secondary Outcomes

Description: Incidence of severe or critical infection in COVID-19 cases

Measure: Secondary outcome

Time: From date to diagnosis to 1 month after

Description: Lethality of the infection in both groups

Measure: Secondary outcome

Time: From date to diagnosis to 1 month after

Description: Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination

Measure: Secondary outcome

Time: From date of randomization to 7 day of the study

Description: Prevalence of SARS-Cov-2 infection

Measure: Secondary outcome

Time: At baseline evaluation
158 Incidence of SARS-Cov2 Infection Among HCW in Lille University Hospital

The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure. The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.

NCT04362267
Conditions
  1. Sars-CoV2
Interventions
  1. Other: self-administered questionnaire
  2. Diagnostic Test: SARS-Cov2 testing
MeSH:Infection

Primary Outcomes

Measure: the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing

Time: at 14 weeks

Secondary Outcomes

Measure: the incidence of SARS- Cov2 infection Heath Care Worker diagnosed by the positivity of SARS-Cov2 RT-PCT and serological testing

Time: once every 14 days for an average of 14 weeks

Measure: Occupational exposures associated with the SARS-Cov2 infection

Time: once every 14 days for an average of 14 weeks

Measure: Environmental exposures associated with the SARS-Cov2 infection

Time: once every 14 days for an average of 14 weeks
159 Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection

Background: People who get infected with COVID-19 have an unpredictable risk to worsen and die. This makes it hard to decide who can quarantine at home and who should be treated at a hospital. Researchers think the risk may be related to how a person s B and T cells respond to the virus. B and T cells are the major components of a person s immune response. B and T cells responding to the virus with a favorable pattern may lead to recovery, and this favorable pattern may be helpful to establish. If people in a vaccine trial get this same favorable pattern when responding to a vaccine, this may be a useful early signal that the vaccine will be successful. Objective: To examine how immune cells respond to COVID-19 infection. Eligibility: Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or had COVID-19 in the past. Also, healthy donors with no suspected COVID-19 infection Design: Participants will be screened with medical record review. Participants will be tested with a research assay to determine who was infected with COVID-19 and who was not. This test will be used to understand research results, not to advise patients. Participants with active infection must be isolated, usually in a hospital. Other participants may give blood samples at NIH or at their local doctor s office or lab. Participants may give blood samples up to three times a week for a total of ten times, and may also give blood samples after starting a vaccine trial. Participants will be contacted by phone or email every 2 months for up to 2 years.

NCT04362865
Conditions
  1. COVID-19
MeSH:Infection

Primary Outcomes

Description: characterize immune response in patients with active or prior COVID-19 infection

Measure: Characterize immune response

Time: Ongoing

Secondary Outcomes

Description: determine if the B- or T-cell arm of the immune response is more active in responding to COVID-19 infection

Measure: B- and T-cell arm immune response

Time: Ongoing

Description: determine if there is a correlation between the pattern of immune response to COVID-19 and outcome in patients with acute or resolved infection

Measure: Immune response and outcome

Time: Ongoing
160 Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina

This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

NCT04362956
Conditions
  1. Covid19
  2. Pregnancy Related
  3. Neonatal Infection
MeSH:Infection

Primary Outcomes

Description: Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate

Measure: Vertical transmission

Time: 96 hours from birth

Description: Presence of IgG in umbilical cord

Measure: Neonatal protection due to maternal antibodies

Time: 24 weeks of gestation to birth

Secondary Outcomes

Description: Respiratory distress, hypothermia, poor feeding and others

Measure: Increase risk of neonatal morbidity

Time: up to 30 days of life

Measure: Increase risk of obstetric complications

Time: Up to 14 days of hospitalization
161 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
162 A Randomized Placebo-controlled Safety and Dose-finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection

In this study Investigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.

NCT04363502
Conditions
  1. Covid19
Interventions
  1. Drug: Clazakizumab
  2. Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: Serum CRP (measured in mg/dl) will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response

Measure: Change in C-reactive protein (CRP) level

Time: Up to 3 days
163 Prospective Analysis of Morbi-mortality of Patients With Cancers in Active Phase of Treatment Suspected or Diagnosed of a SARS-CoV-2 Infection

National multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer

NCT04363632
Conditions
  1. Sars-CoV2
  2. Cancer
MeSH:Infection

Primary Outcomes

Description: Mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative).

Measure: Mortality of cancer patients under active anticancer treatment

Time: 28 days after the date of the diagnostic procedure

Secondary Outcomes

Description: Overall survival will be defined as the time from the date of the first diagnostic procedure (either diagnostic test or chest imaging) to the date of death due to any cause.

Measure: Overall survival

Time: 6 months (i.e. at the the time of last patient last visit)

Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)

Measure: Hospitalizations

Time: 28 days after the date of the diagnostic procedure

Description: Cause of death, related or not to the COVID-19

Measure: Death

Time: 6 months (i.e. at the the time of last patient last visit)

Description: Associated complications described by their type

Measure: Complications

Time: 28 days after the date of the diagnostic procedure

Description: proportion of hospitalizations

Measure: Hospitalizations

Time: 28 days after the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in terms of demographics

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in type of tumor

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in type of anticancer treatment,

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure

Description: To describe accurately patients' characteristics in terms of comorbidities

Measure: Patients' characteristics

Time: At the date of the diagnostic procedure
164 Multi-centre EuRopean Study of MAjor Infectious Disease Syndromes (MERMAIDS) - Acute Respiratory Infections (MERMAIDS ARI) 2.0

Background Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER. Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions. Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care. Study design Prospective observational cohort study in selected European countries. Study population Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers: Tier 0 (Clinical data collection only) - Clinical data will be collected but no biological samples will be obtained for research purposes. Summary of the illness episode and outcome, including a selection of risk factors and comorbidities and medications. Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points. Tier 2 (Clinical data an extended biological sampling). Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission. Study Duration Scheduled 2 years and based on COVID-19 dynamics. Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.

NCT04364711
Conditions
  1. COVID-19
  2. SARS-CoV 2
MeSH:Communicable Diseases Infection

Primary Outcomes

Measure: Pneumonia Severity indexes

Time: 2 years

Measure: Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support

Time: 2 years

Measure: Hospital - and ICU/HCU length of stay

Time: 2 years

Measure: In-hospital mortality

Time: 2 years

Measure: Activities of daily life, quality of life, variations in home living status and employment status

Time: 2 years

Measure: Proportion of SARS-CoV2 positive patients

Time: 2 years
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 Infections Severe Acute Respira 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 Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.

This study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.

NCT04365725
Conditions
  1. COVID-19
Interventions
  1. Drug: Remdesivir
MeSH:Infection

Primary Outcomes

Description: Study the prognostic factors of the clinical course of patients on Day 15 under treatment with remdesivir. Clinical progress will be categorized using a 7-point ordinal scale.

Measure: Clinical course on Day 15.

Time: 15 days

Secondary Outcomes

Description: Explore the prognostic factors of the clinical course of patients on Day 3

Measure: Clinical course on Day 3.

Time: 3 days

Description: Explore the prognostic factors of the clinical course of patients on Day 8

Measure: Clinical course on Day 8

Time: 8 days

Description: Explore the prognostic factors of the clinical course of patients on Day11

Measure: Clinical course on Day 11.

Time: 11 days

Description: Explore the prognostic factors of the clinical course of patients on D29.

Measure: Clinical course on Day 29.

Time: 29 days

Description: Duration of treatment with remdesivir

Measure: Duration of treatment

Time: 29 days

Description: PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; Glasgow score; creatinine.

Measure: Sepsis-related Organ Failure Assessment score

Time: Day 3, 8, 11, 15 and 29

Description: Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir

Measure: Duration without mechanical ventilation

Time: 29 days

Description: Mortality at 29 days after initiation of treatment with remdesivir.

Measure: Mortality

Time: 29 days

Description: Evaluate the safety of the treatment with cumulative incidence of grade 3 and 4 adverse events (AEs).

Measure: cumulative incidence of grade 3 and 4 adverse events (AEs).

Time: 29 days
168 Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection: Prospective Randomized Controlled Trial

The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

NCT04365738
Conditions
  1. COVID-19
Interventions
  1. Other: Rehabilitation
MeSH:Infection

Primary Outcomes

Description: The Borg scale is a scale scored between 0-10, indicating the severity of dyspnea. 0 indicates no shortness of breath, 10 indicates severe shortness of breath

Measure: Dyspnea

Time: Baseline, up to 4 weeks

Secondary Outcomes

Description: Chest expansion was evaluated by measuring the difference between the maximum inspiration and maximum expiration from the level of xsphoid processus of the patients.

Measure: Chest expansion

Time: Baseline, up to 4 weeks

Description: Fatigue severity scale is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome

Measure: Fatigue severity

Time: Baseline, up to 4 weeks

Description: Patients were instructed and asked to give a score between 0-10 with 0 equating to no pain, 10 indicating severe pain

Measure: Visual Analog Scale for pain

Time: Baseline, up to 4 weeks

Description: The HAD scale is a short self administered questionnaire used to screen for anxiety and depression. The questionnaire consists of 14 items, seven each measuring anxiety and seven to measure depression. According to research literature, the cut-off point for elevated anxiety and depression as measured by the HAD scale is eight

Measure: Hospital anxiety and depression scale

Time: Baseline, up to 4 weeks
169 Evaluation of the Repercussions of the Coronavirus (Covid 19) Infection on Nutritional Health Status and Nutritional Care : an Observational French Cohort Study One Month After Their Discharge From Hospital

Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

NCT04365816
Conditions
  1. COVID-19
Interventions
  1. Other: Interview
MeSH:Infection

Primary Outcomes

Description: Self assessment on the SEFI (Self-Evaluation of Food Intake) scale at one month after hospital discharge: 0 corresponds to the worsen score (no ingesta) and 10 corresponds to the best (same ingesta than before the disease)

Measure: Evaluation of food intake at 1 month after discharge from hospital for COVID

Time: one month after hospital discharge

Secondary Outcomes

Description: Self-reported weight in kilograms, or in the absence of self-reported variations before the disease, during hospitalisation, at hospital discharge, one month after hospital discharge

Measure: Weight variation during the infection

Time: one month after hospital discharge

Description: Effect of these factors (anorexia, dysgeusia, Ear Nose and Throat pain, swallowing disorders, intestinal transit disorders...) on SEFI and weight

Measure: Clinical signs limiting food intake

Time: one month after hospital discharge

Description: Effect of these factors (supply difficulties, disease-related food disgust, limiting food habits or prior diet, hydration difficulties, need for help) on SEFI and weight

Measure: Factors limiting food intake

Time: one month after hospital discharge

Description: Effect of nutritional strategy and interventions that were implemented (nutritional advice, adapted meals, oral nutritional supplementation, enteral and parenteral nutrition during hospitalisation and one month after hospital discharge) on SEFI and weight

Measure: Implemented nutritional strategy

Time: one month after hospital discharge

Description: Effect of pre-existing chronic disorders (pulmonary, chronic inflammatory bowel disease, cardio-vascular disease, diabetes, obesity, cognitive disorders, immunodepression, cancer, inflammatory joint disorder) on SEFI and weight

Measure: Pre-existing chronic disorders

Time: one month after hospital discharge

Description: Quantifying unscheduled consultations or hospitalisations in the month following discharge from hospital

Measure: Covid-19 repercussions

Time: one month after hospital discharge
170 Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers

NCT04366154
Conditions
  1. COVID-19
  2. Cancer
Interventions
  1. Other: Questionnaire
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Proportion of patients with modification of the treatments administered

Measure: To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change in the rate of treatment administration

Measure: To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change in the number of cures administered

Measure: To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

Measure: To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Secondary Outcomes

Description: Score of questionnaires of Perceived Stress Scale [0-40 points]

Measure: Evaluate the perceived stress on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

Measure: Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of sleep disorders (ISI scale, 0-28 points)

Measure: Evaluate the sleep disorders on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of quality of life (FACT-G scale)

Measure: Evaluate the quality of life on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)

Measure: Evaluate the cognitive complaints on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of Perceived Stress Scale [0-40 points]

Measure: Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

Measure: Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)

Measure: Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of feeling of personal effectiveness (0-30 points)

Measure: Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months
171 Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection

Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.

NCT04366245
Conditions
  1. SARS-CoV 2
Interventions
  1. Biological: Hyperimmune plasma
  2. Drug: Standard of care for SARS-CoV-2 infection
MeSH:Infection

Primary Outcomes

Description: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

Measure: Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

Time: 30 days after enrollment

Measure: Efficacy: Death from any cause

Time: Day +21 after randomization

Measure: Efficacy: Need for mechanical ventilation

Time: Day +21 after randomization

Description: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.

Measure: Efficacy: Any of the following analytical data after 72h of randomization.

Time: Day +21 after randomization

Measure: Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level

Time: Day +21 after randomization

Secondary Outcomes

Measure: Efficacy. Mortality on days 14 and 28.

Time: Days 14 and 28.

Measure: Efficacy: Proportion of patients who required mechanical ventilation

Time: Until day 28

Description: IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.

Measure: Efficacy: Proportion of patients who develop analytical alterations.

Time: Day +21 after randomization.

Measure: Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.

Time: Day +21 after randomization

Measure: Efficacy: PCR negative for SARS-CoV-2

Time: On days 7 and 21

Description: Proportion of patients requiring treatment with Tocilizumab Sarilumab, Anakimra or other IL-6 or IL-1 antagonists, or corticosteroids at doses of methylprednisolone greater than 2 mg / Kg / day (or equivalent) and / or any investigational medication.

Measure: Efficacy: Proportion of patients requiring treatment.

Time: Until day 21.

Measure: Efficacy: Duration of hospitalization (days)

Time: Until day 21.

Measure: Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample

Time: At baseline and on day 21

Measure: Virology and immunological variables: Total antibody quantification

Time: At baseline and on days 3, 7 and 21

Measure: Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.

Time: Before infusion
172 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
173 COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients

The aims of this study is to define the genetic bases of COVID-19 related disease heterogeneity in frail population, to carry out a retrospective study on individuals w/wo symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis and on the presence of genetic profiling and to explore the therapeutic potential of the modulation of ACE2 expression.

NCT04367402
Conditions
  1. COVID-19
Interventions
  1. Other: BioMedomics COVID-19 IgM-IgG Rapid Test
MeSH:Infection

Primary Outcomes

Description: BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is immunochromatography based. The test card contains colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. When 10 microL of test sample is added to the sample well of the test cassette, the sample will move forward along the test card via capillary action. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the anti-human IgM antibody immobilized on the membrane, forming a red M line and indicating a positive result for the IgM antibody. If the sample contains IgG antibodies, the same thing happens, forming a red G line and indicating a positive result for the IgG antibody. If neither antibody is present, a negative result is displayed.

Measure: Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.

Time: 6 months

Secondary Outcomes

Description: By an in silico analysis, we found 2 missense variants in ACE2 gene annotated at residues 82 (rs766996587) and 355 (rs961360700) involved in PPIs with MAF<0.01. Variants in other residues of the ACE2 may affect protein structure and/or activity/localization, influence the binding of the spike protein and thus the virus ability to enter the respiratory tract.In light of its relevance in cell entry, pharmacological approaches aimed at modulating ACE2 expression, through the modulation of SIRT1 activity in the lung or by selective oligo antisense treatment, should help in counteracting COVID-19 infection. Annotated SNPs evaluation of the TMPRSS2 gene showed 4 exonic common polymorphisms (MAF>1%); of these, rs12329760 is a missense variant in the SRCR domain mediating PPI and ligand binding. Common SNPs are at the 3'UTR, possibly involved in regulating mRNA stability and several rare variants mapped in exons encoding the peptidase domain, potentially affecting protein activity.

Measure: ACE2 expression in patients with COVID-19 infection

Time: 6 months
174 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
175 Mapping Organ Health Following COVID-19 Disease Due to SARS-CoV-2 Infection

A prospective, longitudinal, observational cohort study looking at patients following COVID-19 disease using multi-parametric magnetic resonance imaging (MRI) to assess the degree and prevalence of organ injury.

NCT04369807
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: Outpatient MRI
MeSH:Infection

Primary Outcomes

Description: In patients recovering from COVID-19 disease: Characterise using summary statistics the prevalence and severity of organ volume change and damage to heart, kidneys and liver

Measure: Characterise prevalence and severity of organ volume change and damage (heart, kidneys and liver)

Time: 12 Months

Secondary Outcomes

Description: In patients recovering from COVID-19 disease: To characterise using summary statistics the prevalence and severity of organ volume change and damage in lung, pancreas and spleen

Measure: Characterise prevalence and severity of organ volume change and damage (lung, pancreas and spleen)

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Characterise liver damage as assessed by liver volume in liters, iron corrected T1 (cT1) in milliseconds, liver fat content as %, liver T2star in milliseconds (a correlate of liver iron content)

Measure: Change from Baseline in liver-specific biomarkers: volume, iron corrected T1(cT1), fat content and T2star

Time: 6 Months

Description: In patients recovering from COVID-19 disease: Characterise heart and spleen damage as assessed by liver volume in liters as well as kidney, liver and pancreas damage as assessed by volume in liters, iron corrected T1 (cT1) in milliseconds, fat infiltration as %, T2star in milliseconds (a correlate of liver iron content).

Measure: Change from Baseline in organ-specific biomarkers characterising organ volume change in the heart and spleen along with organ volume and damage in the kidney, liver and pancreas assessed by volume, iron corrected T1 (cT1) and fat infiltration

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by Dyspnea-12. Each question is assigned a value between: none, mild, moderate and severe and is used to assess breathing characteristics.

Measure: Change in patient reported outcome measured by the Dyspnea-12 questionnaire

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the St. George's Respiratory questionnaire. Each section comprises of questions in various formats allowing to assess which aspects of the illness cause the participant the most problems in daily life.

Measure: Change in patient reported outcome measured by the St. George's Respiratory questionnaire (SGRQ)

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Change in patient reported outcome measures collected to assess breathlessness and its effect on overall health and daily life assessed by the EQ-5D-5L questionnaire. Two main sections provide the opportunity to capture statements best describing a participant's daily health and a scale form 0 to 100 capturing self-reported health stats. (100 being the best health imaginable and vice versa)

Measure: Change in patient reported outcome measured by the EQ-5D-5L questionnaire

Time: 12 Months

Description: In patients recovering from COVID-19 disease: Difference from Baseline in degree of change in liver MR-derived biomarkers with and without known genetic variants associated with liver disease (e.g., PNPLA3) using a paired t-test (or non-parametric alternative)

Measure: Degree of change in liver MR-derived biomarkers

Time: 12 Months
176 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
177 Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial

Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.

NCT04370015
Conditions
  1. SARS-CoV-2
  2. Healthcare Workers
Interventions
  1. Drug: Hydroxychloroquine
  2. Drug: Placebo oral tablet
MeSH:Infection

Primary Outcomes

Description: Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm

Measure: Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period

Time: From date of randomization until study completion 12 weeks after treatment initiation

Description: To assess the presence or absence of side effects from HCQ treatment.

Measure: Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Secondary Outcomes

Description: Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.

Measure: Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Description: Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.

Measure: Clinical disease severity in confirmed SARS-CoV-2 participants

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Description: Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).

Measure: Incidence of any acute respiratory infection

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
178 Screening for SARS-CoV-2-Infections and Monitoring of Serological Responses to SARS-CoV-2 in Healthcare Workers

The main objectives of this study are 1) to establish the prevalence of SARS-CoV-2 in asymptomatic healthcare workers (HCWs) in an early phase of community spread as well as 2) to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in symptomatic and asymptomatic HCWs over time and 3) to improve the assessment of the immune response and its protective effect as well as the assessment of infectivity of affected HCWs and 4) to evaluate the value and significance of antibody formation and serological antibody tests and 5) to be able to evaluate possible future preventive and / or therapeutic approaches against SARS-CoV-2

NCT04370119
Conditions
  1. SARS-Cov-2
Interventions
  1. Diagnostic Test: Nasal swab
  2. Diagnostic Test: Serum testing
MeSH:Infection

Primary Outcomes

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 1 year

Secondary Outcomes

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 1 year

Other Outcomes

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 2 years

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 3 years

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 4 years

Description: Anti-SARS-COV2 S protein IgG ELISA

Measure: Number of people with detectable antibodies to SARS-COV2

Time: 5 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 2 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 3 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 4 years

Description: SARS-COV2 PCR

Measure: Number of people with detectable SARS-COV2 nucleic acid

Time: 5 years
179 VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity

Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.

NCT04370808
Conditions
  1. COVID-19
Interventions
  1. Other: Exposure
MeSH:Infection

Primary Outcomes

Measure: Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.

Time: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity.

Time: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Secondary Outcomes

Measure: Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.

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

Measure: Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.

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

Measure: Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.

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

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality.

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

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals.

Time: Through study completion, an average of 1 year.

Measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.

Time: Through study completion, an average of 3 months.
180 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
181 Prevalence of SARS-Cov2 Infection Among HCW in Lille University Hospital

The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.

NCT04371692
Conditions
  1. Sars-CoV2
Interventions
  1. Other: self-administered questionnaire
  2. Diagnostic Test: SARS-Cov2 testing
MeSH:Infection

Primary Outcomes

Measure: the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection

Time: at 2 months

Secondary Outcomes

Measure: the prevalence of SARS- Cov2 infection Health Care Worker with or without symptoms suggestive of a COVID-19 infection

Time: once week during 2 months

Measure: Occupational exposures associated with the SARS-Cov2 infection

Time: once week during 2 months

Measure: Environmental exposures associated with the SARS-Cov2 infection

Time: once week during 2 months

Measure: immunologic status of health Care Worker

Time: once week during 2 months

Measure: inflammatory biomarkers status of Health Care Worker

Time: once week during 2 months
182 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
183 Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)

This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.

NCT04372004
Conditions
  1. COVID-19
Interventions
  1. Diagnostic Test: diagnostic tests for COVID-19 infection
MeSH:Infection

Primary Outcomes

Description: Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection

Measure: detection of viral infection using serology and viral-RNA detection kits

Time: 1 day

Secondary Outcomes

Description: Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval

Measure: Temporal trend of antibodies in blood

Time: 1 month
184 Randomized, Double-Blind, Controlled Trial of Hydroxychloroquine vs Placebo as Post-Exposure Prophylaxis Against COVID-19 Infection

This is a prospective, double-blind, randomized, placebo-controlled study in two distinct cohorts to evaluate the efficacy and safety of hydroxychloroquine in the prevention of COVID-19 infection.

NCT04372017
Conditions
  1. COVID-19
  2. SARS-CoV 2
Interventions
  1. Drug: Hydroxychloroquine
  2. Dietary Supplement: Vitamin D
MeSH:Infection

Primary Outcomes

Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.

Measure: Cohort A: Percentage of COVID-19 exposed healthcare workers treated with hydroxychloroquine with a positive COVID-19 test.

Time: At enrollment completion outcome 1 will be analyzed.

Description: Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.

Measure: Cohort B: Percentage of COVID-19 exposed high-risk individuals treated with hydroxychloroquine with a positive COVID-19 test.

Time: At enrollment completion outcome 2 will be analyzed.
185 An Open-label, Prospective, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of ENKORTEN® as an Immunomodulatory Therapy, Within the Usual Therapeutically Established Protocol, for the Treatment of Patients With Moderate to Severe COVID-19 Infection

An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection

NCT04374032
Conditions
  1. COVID-19 Infection
Interventions
  1. Drug: metenkefalin + tridecactide
  2. Drug: The standard of care
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: The time of onset of improvement in the patient's clinical condition will be measured following the clinical objective and subjective signs and radiological indicators.

Measure: Time to onset of change in the patient's clinical condition

Time: 21 day

Description: At every examination/evaluation, all AEs, whether noticed by investigators and their associates in the trial, or spontaneously reported by the subjects, or given as answer to direct question, must be evaluated by the investigator and reported on case report forms for AE. AE will be recorded in the e-CRF. Three-degree scale will be used for assessment of AE's severity: mild, moderate, severe.

Measure: Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE

Time: 21 day

Secondary Outcomes

Description: To monitor the period of patient's hospitalization

Measure: Length of in-hospital stay

Time: 21 day

Description: To monitor the survival rate during the hospitalization

Measure: Survival rate

Time: 21 day

Description: To monitor the intubation frequency during the hospitalization

Measure: Intubation rate

Time: 21 day

Description: To monitor the levels of proinflammatory markers during the hospitalization (IL-6)

Measure: Proinflammatory markers levels

Time: 21 day
186 Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection

The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator. The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.

NCT04374461
Conditions
  1. Covid-19
Interventions
  1. Drug: N-acetylcysteine
  2. Other: Peripheral Blood
MeSH:Infection

Primary Outcomes

Measure: Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement

Time: 1 year

Measure: Arm B: number of patients who are discharged from the hospital due to clinical improvement

Time: 1 year
187 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
188 Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2

Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug better than recombinant human ACE2 Mahmoud ELkazzaz1 1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt. _____________________________________________________________________________________________ _______________________________________________________________________ B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular physiology and pathology, and is currently clinically evaluated to treat acute lung failure. Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis, B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. In vitro, recombinant B38-CAP protein catalyzed the conversion of angiotensin II to angiotensin 1-7, as well as other known ACE2 target peptides. Treatment with B38-CAP suppressed angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis in mice. Moreover, B38-CAP inhibited pressure overload-induced pathological hypertrophy, myocardial fibrosis, and cardiac dysfunction in mice. A study demonestrated that the bacterial B38-CAP as an ACE2-like carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein drugs for hypertension and heart failure. On the other hand, Treatment with recombinant human ACE2 protein (rhACE2), which is devoid of its membrane-anchored domain thus soluble, has been demonstrated to exhibit beneficial effects in various animal models including heart failure, acute lung injury, and diabetic nephropathy, and so forth. rhACE2 is currently tested in the clinic to treat ARDS and COVID-19 infected patients . Using cell cultures and organoids, researchers from the Karolinska Institutet in Sweden and the University of British Columbia (UBC) in Canada, showed that by adding a genetically modified variant of ACE2, called human recombinant soluble angiotensin-converting enzyme 2 (hrsACE2), COVID-19 was prevented from entering cells.The paper, published in Cell, shows that hrsACE2 had a dose dependent effect of viral growth of SARS-CoV-2 and was able to reduce it by a factor of 1,000 to 5,000 in cell cultures. Despite its beneficial effects, rhACE2 is a glycosylated protein and thus its preparation requires time- and cost-consuming protein expression system with mammalian or insect cells, which may not be advantageous in drug development and medical economy Although it had been reported that an immune response is associated with the chronic infusion of rhACE2 resulting in the degradation of rhACE226, this was not observed for B38-CAP; there were no antibodies against B38-CAP detectable in the serum of mice infused with B38-CAP for 2 weeks.B38-CAP is easily prepared with E. coli expression system and is cost effective. with therapeutic efficacy and less toxicity in mouse heart failure model. Implantation of B38-CAP-filled osmotic mini-pumps significantly suppressed Ang II-induced hypertension in conscious mice .without affecting the heart rate. These results indicate that B38-CAP antagonizes the vasopressor effect of Ang II. So the principle investigator expects and suggests that treating with cloned Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising COVID-19 infection- and lung injury preventing drug better than recombinant human ACE2 in addition to brsACE2, expected to lure the virus to attach itself to the copy instead of the actual cells… It distracts the virus from infecting the cells to the same degree and should lead to a reduction in the growth of the virus in the lungs and other organs. A study showed that recombinant B38-CAP protein downregulates Ang II levels in mice and antagonizes Ang II-induced hypertension, pathological cardiac hypertrophy, and myocardial fibrosis. We also show beneficial effects of B38-CAP on the pathology of pressure overload-induced heart failure in mice without overt toxicities.Finally the principal investigator expect that treatment with ACE2-like enzyme in bacteria B38-CAP may be do the same mechanism of rhACE2 in inhibiting COVID -19 and the other suggested mechanism is that injection of ACE2-like enzyme of bacteria B38-CAP in human body may down regulate human ACE2 which is the real receptor of COVID -19 and in the same time it will be resistant to COVID- spike protein because there seems a difference in substrate specificity between two enzymes. Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.

NCT04375046
Conditions
  1. COVID-19
Interventions
  1. Drug: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)
MeSH:Infection Lung Injury

Primary Outcomes

Description: Compare the time course of body temperature (fever) between two groups over time.

Measure: Time course of body temperature (fever)

Time: 14 days

Description: Compare viral load between two groups over time.

Measure: Viral load over time

Time: 14 days

Secondary Outcomes

Description: PaO2/FiO2 ratio

Measure: P/F ratio over time

Time: 14 days

Description: SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.

Measure: Sequential organ failure assessment score(SOFA score) over time

Time: 14 days

Measure: Pulmonary Severity Index (PSI)

Time: 14 days

Description: Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.

Measure: Image examination of chest over time

Time: 14 days

Measure: Proportion of subjects who progressed to critical illness or death

Time: 14 days

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

Time: 14 days

Measure: T-lymphocyte counts over time

Time: 14 days

Measure: C-reactive protein levels over time

Time: 14 days

Measure: Angiotensin II (Ang II) changes over time

Time: 14 days

Measure: Angiotensin 1-7 (Ang 1-7) changes over time

Time: 14 days

Measure: Angiotensin 1-5 (Ang 1-5) changes over time

Time: 14 days

Measure: Renin changes over time

Time: 14 days

Measure: Aldosterone changes over time

Time: 14 days

Measure: Angiotensin-converting enzyme (ACE) changes over time

Time: 14 days

Measure: Angiotensin-converting enzyme 2 (ACE2) changes over time

Time: 14 days

Measure: Interleukin 6 (IL-6) changes over time

Time: 14 days

Measure: Interleukin 8 (IL-8) changes over time

Time: 14 days

Measure: Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time

Time: 14 days

Measure: Plasminogen activator inhibitor type-1 (PAI-1) changes over time

Time: 14 days

Measure: Von willebrand factor (vWF) changes over time

Time: 14 days

Measure: Tumor necrosis factor-α (TNF-α) changes over time

Time: 14 days

Measure: Soluble receptor for advanced glycation end products (sRAGE) changes over time

Time: 14 days

Measure: Surfactant protein-D (SP-D) changes over time

Time: 14 days

Measure: Angiopoietin-2 changes over time

Time: 14 days

Measure: Frequency of adverse events and severe adverse events

Time: 14 days
189 Health-related Quality of Life (HRQOL) and Physical Performance in Individuals After COVID-19 Induced Hospitalisation and the Impact of a Standard Care Follow-up Program: a Longitudinal Observational Cohort Study

This study aims to observe the long-term health-related quality of life (HRQOL) and physical performance in individuals hospitalized due to a COVID-19 infection. Therefore, data is extracted from a study-site standard aftercare program which has been adjusted for this patient population. This comprehensive aftercare program includes education sessions and physical exercise. A second aim is to observe adherence and feasibility to the program and if indicated compare the clinical data and outcomes from patients following the program with patients denying to participate in guided exercise and education sessions. It is expected that patients hospitalized due to COVID-19 infection show a reduction in physical performance and HRQOL directly after discharge. The severity of illness is hypothesized to be associated with a reduction as well in HRQOL and physical performance after one-year post-discharge.

NCT04375709
Conditions
  1. Covid-19 (New Coronavirus) Infection
Interventions
  1. Other: Physical exercise
  2. Behavioral: Education sessions
MeSH:Infection Coronavirus Infections

Primary Outcomes

Description: Self-managed questionnaire on functional status, anxiety, pain and independence in daily living; The EuroQoL includes a five item scale and a visual analog scale from 0-100 in order to quantify perception of current health. The five item scale includes ordinary scores from 0-5. Lower numbers equal less problems and better quality of life. For the visual analog scale a higher number represents a better health status perceived.

Measure: Health-related quality of life; EuroQoL (EQ-5D-5L)

Time: 01.04.2020 - 30.05.2021

Description: 6-minute walk test measures the distance acquired during six minutes walking, it quantifies the physical performance, dyspnoea and endurance.

Measure: 6-minute walk test

Time: 01.04.2020 - 30.05.2021

Secondary Outcomes

Description: Measures the handgrip strength and is associated with sarcopenia, mortality and independence in life (e.g. for older individuals and patients after or with critical illness)

Measure: Jamar dynamometer

Time: 01.04.2020 - 30.05.2021

Description: Self-administered questionnaire on anxiety and depression after hospitalization; bot, anxiety and depression is quantified by an ordinal scale from 0-3, respectively. The lower the number the less signs of depression or anxiety are present.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: 01.04.2020 - 30.05.2021

Description: Questionnaire on avoidance, intrusion and arousal (or overreaction) in order to identify potential risk for post-traumatic stress. The Scale includes 22 questions ordinally scored from "not at all" to " very frequent" with four scores. The scores are transformed into numbers (0,1,3,5). The values are put in a formula resulting in a single value.A value below zero indicates no risk of post-traumatic stress disorder (PTSD) is present. Values equal or higher than zero indicate the risk of a PTSD

Measure: revised Impact of Event Scale (IES-R)

Time: 01.04.2020 - 30.05.2020

Description: Questionnaire on the nutritional condition of the patient. It includes 16 questions and 2 measures. Points range from 0-30; A score <17 indicates malnutirtion, a score from 17-23.5 indicates a risk of malnutrition and scores between 24-30 indicate normal nutritional behaviour.

Measure: Mini-Nutritional Assessment (MNA)

Time: 01.04.2020 - 30.05.2021

Description: Measures the lung function (bedside screening)

Measure: Spirometry (bed-side)

Time: 01.04.2020 - 30.05.2021

Description: This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.

Measure: Post-Covid Functional Scale (PCFS)

Time: 01.04.2020 - 30.05.2021

Description: Quantifies and stratifies the perception of dyspnoea with a score ranging from 0-4. The higher the value the more frequent and more severe is the perception of dyspnoea during daily life activities.

Measure: modified Medical Research Council Dyspnoea Scale (mMRC Dyspnoea)

Time: 01.04.2020 - 30.05.2021
190 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
191 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
192 18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection

This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

NCT04376593
Conditions
  1. COVID-19
  2. SARS-CoV-2 Infection
Interventions
  1. Drug: 18F-αvβ6-BP
MeSH:Infection

Primary Outcomes

Description: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

Measure: Administration of 18F-αvβ6-BP

Time: baseline

Description: Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients

Measure: Administration of 18F-αvβ6-BP

Time: 3 months

Descript