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Coronavirus Infections (722) Severe Acute Respiratory Syndrome (493) Infection (402) Pneumonia (331) Communicable Diseases (176) Respiratory Distress Syndrome, Adult (161) Acute Lung Injury (126) Respiratory Distress Syndrome, Newborn (126) (114) Syndrome (106) Virus Diseases (85) Pneumonia, Viral (73) Critical Illness (63) Depression (62) Anxiety Disorders (44) Disease (39) Stress Disorders, Post-Traumatic (34) Emergencies (31) Respiratory Tract Infections (31) Inflammation (30) Neoplasms (30) Cardiovascular Diseases (29) Stress Disorders, Traumatic (29) Wounds and Injuries (29) Lung Injury (27) Stress, Psychological (27) Mental Disorders (26) Diabetes Mellitus (25) Hypoxia (25) Depressive Disorder (24) Thrombosis (23) Hypertension (22) Respiratory Tract Diseases (22) Acute Kidney Injury (21) Lung Diseases (21) Disease Progression (18) Olfaction Disorders (18) Embolism (16) Influenza, Human (16) Stroke (16) Arthritis (15) Pulmonary Embolism (15) Respiration Disorders (15) Blood Coagulation Disorders (14) HIV Infections (14) Hemostatic Disorders (14) Thromboembolism (14) Burnout, Psychological (13) Chronic Disease (13) Fibrosis (13) Lung Diseases, Obstructive (13) Multiple Sclerosis (13) Sclerosis (13) Cognitive Dysfunction (12) Diabetes Mellitus, Type 2 (12) Lung Diseases, Interstitial (12) Myocardial Infarction (12) Pulmonary Disease, Chronic Obstructive (12) Pulmonary Fibrosis (12) Respiratory Aspiration (12) Arthritis, Rheumatoid (11) Autism Spectrum Disorder (11) Brain Injuries (11) Chronic Pain (11) Heart Diseases (11) Kidney Diseases (11) Substance-Related Disorders (11) Venous Thrombosis (11) Crohn Disease (10) Diabetes Mellitus, Type 1 (10) Heart Failure (10) Infarction (10) Lung Neoplasms (10) Autistic Disorder (9) Dyspnea (9) Myocarditis (9) Obesity (9) Pneumonia, Ventilator-Associated (9) Pregnancy Complications (9) Brain Injuries, Traumatic (8) Carcinoma (8) Colitis (8) Colitis, Ulcerative (8) Depression, Postpartum (8) Liver Diseases (8) Renal Insufficiency, Chronic (8) Respiratory Syncytial Virus Infections (8) Rheumatic Diseases (8) Ulcer (8) Vitamin D Deficiency (8) Coronary Artery Disease (7) Coronary Disease (7) Dementia (7) Feeding and Eating Disorders (7) Hematologic Neoplasms (7) Infertility (7) Inflammatory Bowel Diseases (7) Kidney Failure, Chronic (7) Parkinson Disease (7) Problem Behavior (7) Pulmonary Valve Insufficiency (7) Venous Thromboembolism (7) Burnout, Professional (6) Collagen Diseases (6) Frailty (6) Immune System Diseases (6) Immunologic Deficiency Syndromes (6) Ischemia (6) Lupus Erythematosus, Systemic (6) Lymphoma (6) Musculoskeletal Pain (6) Overweight (6) Parasomnias (6) Pediatric Obesity (6) Psychotic Disorders (6) RNA Virus Infections (6) Sepsis (6) Shock (6) Spinal Cord Injuries (6) Acute Coronary Syndrome (5) Alcohol Drinking (5) Alcoholism (5) Autoimmune Diseases (5) Breast Neoplasms (5) Carcinoma, Non-Small-Cell Lung (5) Child Development Disorders, Pervasive (5) Convalescence (5) Coronaviridae Infections (5) Cystic Fibrosis (5) Delirium (5) Depressive Disorder, Major (5) Disease Susceptibility (5) Dyssomnias (5) Gastroparesis (5) Hypersensitivity (5) Leukemia (5) Lymphopenia (5) Multiple Organ Failure (5) Myocardial Ischemia (5) Neurologic Manifestations (5) Osteoarthritis (5) Prostatic Neoplasms (5) Renal Insufficiency (5) Alzheimer Disease (4) Asthma (4) Attention Deficit Disorder with Hyperactivity (4) Behavior, Addictive (4) Body Weight (4) Brain Diseases (4) Coinfection (4) Colonic Neoplasms (4) Death (4) Deglutition Disorders (4) Disseminated Intravascular Coagulation (4) Embolism and Thrombosis (4) Fibromyalgia (4) Head and Neck Neoplasms (4) Heart Arrest (4) Hemorrhage (4) Hypertension, Pulmonary (4) Liver Cirrhosis (4) Metabolic Syndrome (4) Migraine Disorders (4) Mycobacterium Infections (4) Neoplasm Metastasis (4) (4) Pancreatic Neoplasms (4) Postoperative Complications (4) Prediabetic State (4) Signs and Symptoms, Respiratory (4) Sjogren's Syndrome (4) Sleep Apnea Syndromes (4) Sleep Initiation and Maintenance Disorders (4) Thrombophilia (4) Vascular Diseases (4) Weight Loss (4) Acquired Immunodeficiency Syndrome (3) Adenoviridae Infections (3) Appendicitis (3) Arrhythmias, Cardiac (3) Arthritis, Psoriatic (3) Asymptomatic Diseases (3) Bronchiectasis (3) Carcinoma, Renal Cell (3) Cardiomyopathies (3) Chilblains (3) Common Cold (3) Cross Infection (3) Dermatitis (3) Developmental Disabilities (3) Digestive System Diseases (3) Dysgeusia (3) Endometriosis (3) Fatigue (3) Fever (3) Gastrointestinal Diseases (3) Giant Cell Arteritis (3) Glucose Intolerance (3) Glucose Metabolism Disorders (3) Hemophilia A (3) Leukemia, Lymphoid (3) Macular Edema (3) Malnutrition (3) Measles (3) Melanoma (3) Metabolic Diseases (3) Mucocutaneous Lymph Node Syndrome (3) (3) Nervous System Diseases (3) Neuroendocrine Tumors (3) Occupational Stress (3) Osteoarthritis, Knee (3) Ovarian Neoplasms (3) Panic Disorder (3) Paramyxoviridae Infections (3) 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Cognition Disorders (2) Colorectal Neoplasms (2) Communicable Diseases, Emerging (2) Compassion Fatigue (2) Compulsive Personality Disorder (2) Congenital Abnormalities (2) Conjunctivitis (2) Dermatitis, Atopic (2) Diarrhea (2) Drug-Related Side Effects and Adverse Reactions (2) Eczema (2) Emphysema (2) Endocrine System Diseases (2) Fatigue Syndrome, Chronic (2) Ganglion Cysts (2) Gastroenteritis (2) Gastroesophageal Reflux (2) Gaucher Disease (2) Glioblastoma (2) Headache (2) Healthcare-Associated Pneumonia (2) Heart Defects, Congenital (2) Heart Failure, Systolic (2) Hematologic Diseases (2) Huntington Disease (2) Hyperglycemia (2) Hyperkinesis (2) Hyperphagia (2) Hypothermia (2) Hypoventilation (2) Idiopathic Pulmonary Fibrosis (2) Intervertebral Disc Degeneration (2) Intestinal Diseases (2) Ischemic Attack, Transient (2) Jaundice (2) Leukemia, Myeloid, Acute (2) Lymphoproliferative Disorders (2) Macular Degeneration (2) Mobility Limitation (2) Mood Disorders (2) Motor Neuron Disease (2) Multiple Myeloma (2) Multiple Sclerosis, Relapsing-Remitting (2) Muscular Dystrophies (2) Mutism (2) Mycoses (2) Myelodysplastic Syndromes (2) Myeloproliferative Disorders (2) Myositis (2) Necrosis (2) Neoplasms, Plasma Cell (2) Nerve Degeneration (2) Neurodevelopmental Disorders (2) Nidovirales Infections (2) Noncommunicable Diseases (2) Nutrition Disorders (2) Obesity, Morbid (2) Obsessive-Compulsive Disorder (2) Oral Manifestations (2) Pain, Postoperative (2) Peripheral Vascular Diseases (2) Phobia, Social (2) Phobic Disorders (2) Pneumonia, Pneumocystis (2) Psoriasis (2) Purpura, Thrombocytopenic, Idiopathic (2) Rare Diseases (2) Recurrence (2) Respiratory Sounds (2) Sarcoidosis (2) Shock, Septic (2) Small Cell Lung Carcinoma (2) Spinal Diseases (2) Sprains and Strains (2) Suicidal Ideation (2) Suicide (2) Tachycardia (2) Thoracic Diseases (2) Thrombocytopenia (2) Toxemia (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) Adenocarcinoma (1) Adjustment Disorders (1) Adrenal Insufficiency (1) Alcohol Drinking in College (1) Alcohol-Related Disorders (1) Alcoholic Intoxication (1) Alveolitis, Extrinsic Allergic (1) Amblyopia (1) Anemia, Aplastic (1) Angina, Stable (1) Anorexia (1) Anorexia Nervosa (1) Aortic Valve Stenosis (1) Apnea (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) Back Pain (1) Bacteremia (1) Barotrauma (1) Birth Weight (1) Blister (1) Body Weight Changes (1) Bone Diseases, Metabolic (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) Bulimia (1) Calculi (1) Carcinoma, Hepatocellular (1) Carcinoma, Ovarian Epithelial (1) Carcinoma, Small Cell (1) Carcinoma, Squamous Cell (1) Cardiovascular Abnormalities (1) Cataract (1) Celiac Disease (1) Cellulitis (1) Cerebral Hemorrhage (1) Cerebral Palsy (1) Cerebrovascular Disorders (1) Chest Pain (1) Chlamydia Infections (1) Cholangiocarcinoma (1) Cholangitis (1) Cholecystitis (1) Cholecystitis, Acute (1) Chronic Traumatic Encephalopathy (1) Clostridium Infections (1) (1) Colonic Diseases (1) Communication Disorders (1) Compulsive Behavior (1) Consciousness Disorders (1) Constipation (1) Constriction, Pathologic (1) Conversion Disorder (1) (1) (1) Coronary Artery (1) Coronary Stenosis (1) (1) Cough (1) Coxsackievirus Infections (1) Cryopyrin-Associated Periodic Syndromes (1) Deafness (1) Death, Sudden, Cardiac (1) Dental Calculus (1) Dental Plaque (1) Depressi (1) Depressive Disorder, Treatment-Resistant (1) DiGeorge Syndrome (1) Diabetic Nephropathies (1) Diabetic Neuropathies (1) Diphtheria (1) (1) Down Syndrome (1) Dyspareunia (1) Emergence Delirium (1) Encephalitis (1) Endocarditis (1) Endophthalmitis (1) Endotoxemia (1) Enuresis (1) Epilepsy (1) Esophageal and Gastric Varices (1) Esophagitis, Peptic (1) Eye Diseases (1) Eye Infections (1) Fabry Disease (1) Facial Pain (1) Familial Mediterranean Fever (1) Fatty Liver (1) (1) Femoral Neck Fractures (1) Fetal Growth Retardation (1) Fetal Membranes, Premature Rupture (1) Fever of Unknown Origin (1) Fistula (1) Food Hypersensitivity (1) Fractures, Closed (1) Fractures, Stress (1) Gait Disorders, Neurologic (1) Genetic Diseases, Inborn (1) Genetic Predisposition to Disease (1) Gestational Weight Gain (1) Gingivitis, Necrotizing Ulcerative (1) Gout (1) (1) Headache Disorders, Secondary (1) Hearing Loss (1) Hearing Loss, Conductive (1) Heart Failure, Diastolic (1) Heart Murmurs (1) Helminthiasis (1) Hematoma (1) Hematoma, Subdural (1) Hematoma, Subdural, Chronic (1) Hemoglobinopathies (1) Hepatitis (1) Hepatitis A (1) Hepatitis C (1) Hepatitis, Alcoholic (1) Hereditary Autoinflammatory Diseases (1) Herpes Labialis (1) Herpes Zoster (1) Hodgkin Disease (1) Hyaline Membrane Disease (1) Hyperaldosteronism (1) Hypercapnia (1) Hyperphosphatemia (1) Hyperplasia (1) Hypersensitivity, Immediate (1) Hypertension, Pregnancy-Induced (1) Hypokalemia (1) Hyponatremia (1) Hypoparathyroidism (1) Hypotension (1) Iatrogenic Disease (1) Infant, Newborn, Diseases (1) Infec (1) Infecti (1) Infertility, Female (1) Infertility, Male (1) Intellectual Disability (1) Intestinal Atresia (1) Intracranial Hypertension (1) Intracranial Thrombosis (1) Jaundice, Obstructive (1) Joint Diseases (1) Keratoconjunctivitis (1) Keratosis (1) Keratosis, Actinic (1) Leishmaniasis (1) Leukemia, Lymphocytic, Chronic, B-Cell (1) Leukemia, Myeloid (1) Leukemia, Myelomonocytic, Acute (1) Leukemia, Myelomonocytic, Chronic (1) Liver Cirrhosis, Biliary (1) Liver Failure (1) Low Back Pain (1) Lung (1) Lyme Disease (1) Lymphedema (1) Lymphocytosis (1) Lymphoma, B-Cell (1) Lymphoma, Mantle-Cell (1) Macrophage Activation Syndrome (1) Malaria (1) Maternal Death (1) Maxillofacial Injuries (1) Memory Disorders (1) Meningitis (1) Meningitis, Meningococcal (1) Menorrhagia (1) Menstruation Disturbances (1) Microvascular Rarefaction (1) Mitochondrial Diseases (1) Molluscum Contagiosum (1) Monoclonal Gammopathy of Undetermined Significance (1) Mouth Diseases (1) Mouth, Edentulous (1) Movement Disorders (1) Mucositis (1) Multiple Chronic Conditions (1) Muscle Spasticity (1) Muscular Atrophy (1) Muscular Dystrophy, Duchenne (1) Myalgia (1) Myocardial Reperfusion Injury (1) Myofascial Pain Syndromes (1) Needlestick Injuries (1) Neonatal Sepsis (1) Neoplastic Cells, Circulating (1) Nephritis (1) Neurobehavioral Manifestations (1) Neurocognitive Disorders (1) Neuromyelitis Optica (1) Non-alcoholic Fatty Liver Disease (1) Obsessive Behavior (1) Olfactory Nerve Injuries (1) Orbital Cellulitis (1) Osteoarthritis, Hip (1) Osteochondritis (1) Osteomyelitis (1) Otitis Media with Effusion (1) Overweig (1) Pain (1) Pain, Procedural (1) Pancreatitis (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) Pleuropneumonia (1) (1) (1) Pneumonia, Bacterial (1) Pneumonia, V (1) Pre-Eclampsia (1) Pregnancy in Diabetics (1) Preleukemia (1) Primary Dysautonomias (1) Prostatic Hyperplasia (1) Protein-Energy Malnutrition (1) Psychophysiologic Disorders (1) Puerperal Infection (1) Pulmonary Alveolar Proteinosis (1) Pulmonary Aspergillosis (1) Pulmonary Atelectasis (1) Pulmonary Eosinophilia (1) Radiculopathy (1) Rectal Neoplasms (1) Reperfusion Injury (1) (1) (1) Respiratory Distress Sy (1) Respiratory Hypersensitivity (1) Retinal Vein Occlusion (1) Rupture (1) Sarcoidosis, Pulmonary (1) Sarcopenia (1) Schizophrenia Spectrum and Other Psychotic Disorders (1) (1) Scleroderma, Localized (1) Scleroderma, Systemic (1) Self-Injurious Behavior (1) Severe Acute Respiratory Syn (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 Stenosis (1) Spondylarthritis (1) Spondylolisthesis (1) Status Epilepticus (1) Stillbirth (1) Stomatitis (1) Str (1) Stress Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Superinfection (1) Syncope (1) Syncope, Vasovagal (1) Tachycardia, Sinus (1) Tachycardia, Ventricular (1) Temporomandibular Joint Disorders (1) Temporomandibular Joint Dy (1) Temporomandibular Joint Dysfunction Syndrome (1) Thalassemia (1) Thrombophlebitis (1) Torsades de Pointes (1) Tourette Syndrome (1) Trauma, Nervous System (1) Trichuriasis (1) Tuberculosis, Pulmonary (1) Ulce (1) Urinary Bladder, Underactive (1) Urinary Incontinence (1) Urinary Retention (1) Urologic Diseases (1) Urticaria (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Ventricular Dysfunction, Right (1) Virus Dis (1) Von Willebrand Diseases (1) Vulvar Neoplasms (1) Weight Gain (1) Xerostomia (1) beta-Thalassemia (1)

D014777: Virus Dis

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 (184)


Name (Synonyms) Correlation
drug4053 pregnant women with laboratory-confirmed 2019-n-CoV Wiki 0.15
drug1296 Favipiravir Wiki 0.12
drug1633 Immunofree tablets and Reginmune capsule Wiki 0.11
Name (Synonyms) Correlation
drug2046 Midazolam injection Wiki 0.11
drug1781 Ketamine Injectable Product Wiki 0.11
drug1523 Hydroxychloroquine + Azithromycin Wiki 0.11
drug1669 Inhaled beclomethasone Wiki 0.11
drug2706 Pulmonary function testing Wiki 0.11
drug1765 JNJ-53718678 125 mg Wiki 0.11
drug2566 Placebo- 1.00 mg/kg Wiki 0.11
drug3471 Thrombin Generation Assay (TGA) Wiki 0.11
drug3805 biological samples collection Wiki 0.11
drug2471 Personal Protective Testing Booth Wiki 0.11
drug1690 Interferon-ß-1a Wiki 0.11
drug1817 Lazertinib Wiki 0.11
drug32 25-OH cholecalciferol Wiki 0.11
drug2389 PF-07304814 Wiki 0.11
drug3789 artus Influenza A/B RT-PCR Test Wiki 0.11
drug3519 Transfusion of SARS-CoV-2 Convalescent Plasma. Wiki 0.11
drug3656 Viral Specific T-cells (VSTs) Wiki 0.11
drug378 BAT2020 Wiki 0.11
drug2699 Public Health England Gold Standard Wiki 0.11
drug1747 Ivermectin + Doxycycline Wiki 0.11
drug407 BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki 0.11
drug1784 Kevzara sc Wiki 0.11
drug1845 Listerine Mouthwash Product Wiki 0.11
drug797 Clarithromycin Wiki 0.11
drug2027 Mesenchymal stem cells Wiki 0.11
drug1303 Favipiravir Combined With Tocilizumab Wiki 0.11
drug1685 Interferon alfa Wiki 0.11
drug1865 Lopinavir/ Ritonavir Wiki 0.11
drug2517 Placebo 0.9% NaCl solution Wiki 0.11
drug2916 RoActemra iv Wiki 0.11
drug1551 Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki 0.11
drug898 Convalescent Plasma 1 Unit Wiki 0.11
drug1103 Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki 0.11
drug2418 Pacritinib Wiki 0.11
drug2128 NHANES smell and taste tests Wiki 0.11
drug3026 Saline containing 1% Human serum albumin(solution without UC-MSCs) Wiki 0.11
drug1314 Fidaxomicin Wiki 0.11
drug2564 Placebo- 0.10 mg/kg Wiki 0.11
drug3430 Tetrandrine Wiki 0.11
drug701 CYNK-001 Wiki 0.11
drug3631 Vancomycin with Taper/Pulse Wiki 0.11
drug420 BNT162a1 Wiki 0.11
drug3473 Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki 0.11
drug1097 Drug: GS-5734 - 2.00 mg/kg Wiki 0.11
drug3756 Zinc gluconate Wiki 0.11
drug2014 MenCare+/Bandebereho fathers'/couples' group education Wiki 0.11
drug2145 NaCl Solution Wiki 0.11
drug1923 MELT-100 Wiki 0.11
drug1766 JNJ-53718678 2.5 mg/kg Wiki 0.11
drug3463 Thoracic CT Scan Wiki 0.11
drug2348 Oral-B Mouth Sore mouthwash Wiki 0.11
drug1388 Gargle/Mouthwash Wiki 0.11
drug1214 Ergoferon Wiki 0.11
drug1625 Imaging by thoracic scanner Wiki 0.11
drug2133 NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells Wiki 0.11
drug1647 Inactivated SARS-CoV-2 vaccine (Vero cell) Wiki 0.11
drug3937 labs Wiki 0.11
drug1867 Lopinavir/ Ritonavir Placebo Wiki 0.11
drug2906 Risk of MERS infection Wiki 0.11
drug1100 Drug: NA-831 - 0.10 mg/kg Wiki 0.11
drug3358 TLRs activation measurement Wiki 0.11
drug961 Cytokines measurement Wiki 0.11
drug1768 JNJ-53718678 3 mg/kg Wiki 0.11
drug222 Ambrisentan Wiki 0.11
drug1201 Enoxaparin Prefilled Syringe [Lovenox] Wiki 0.11
drug440 Bariatric procedures Wiki 0.11
drug899 Convalescent Plasma 2 Units Wiki 0.11
drug1601 IP-10 in CDS protocol Wiki 0.11
drug1372 GPs reports of potential patient safety incidents, non-COVID-19 related Wiki 0.11
drug1539 Hydroxychloroquine Sulfate (HCQ) Wiki 0.11
drug208 AlloStim Wiki 0.11
drug1767 JNJ-53718678 250 mg Wiki 0.11
drug3219 Standard medical care Wiki 0.11
drug2567 Placebo- 2.00 mg/kg Wiki 0.11
drug1096 Drug: GS-5734 - 1.00 mg/kg Wiki 0.11
drug368 Azithromycin 500 milligram (mg) oral Tablet Wiki 0.11
drug424 BNT162c2 Wiki 0.11
drug1101 Drug: NA-831 - 0.20 mg/kg Wiki 0.11
drug2938 SAMBA II (Diagnostic for the Real World) Wiki 0.11
drug2704 Pulmonary and Motor Rehabilitation Wiki 0.11
drug2335 Only Standard Treatment Wiki 0.11
drug810 CloSYS mouthwash Wiki 0.11
drug1504 Hospitalized Patients for COVID-19 Infection Wiki 0.11
drug714 Cambridge Validated Viral Detection Method Wiki 0.11
drug2137 NO intervention planned due to the observational study design only a diagnostic testing Wiki 0.11
drug1158 Educational meetings and visual prompts Wiki 0.11
drug835 Coldamaris lozenges Wiki 0.11
drug3630 Vancomycin Wiki 0.11
drug2694 Psychological and Behaviour Change Support Wiki 0.11
drug2787 RT-PCR Covid-19 Wiki 0.11
drug1769 JNJ-53718678 4.5 mg/kg Wiki 0.11
drug942 Crest Pro-Health Multi-Protection mouthwash Wiki 0.11
drug1291 Family Nurture Intervention (FNI) Wiki 0.11
drug4006 nosocomial infection/hospital acquired infection Wiki 0.11
drug354 Aviptadil 67μg Wiki 0.11
drug2797 Radiological Detection Wiki 0.11
drug2102 Multifrequency Bioimpedance Spectroscopy Wiki 0.11
drug2565 Placebo- 0.20 mg/kg Wiki 0.11
drug986 Daily Vitamin D3 Wiki 0.11
drug534 Bolus vitamin D3 Wiki 0.11
drug1104 Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki 0.11
drug3747 Zavegepant (BHV-3500) Wiki 0.11
drug1088 Dose Finding Phase (MTD) Wiki 0.11
drug533 Bolus placebo Wiki 0.11
drug987 Daily placebo Wiki 0.11
drug2515 Placebo 0.10 mg + 1.00 mg/kg Wiki 0.11
drug1302 Favipiravir + Standard of Care Wiki 0.11
drug1213 Equipment with smartwatch throughout hospital stay on the general ward Wiki 0.11
drug1756 Ivermectin Tablets Wiki 0.11
drug251 Anluohuaxian Wiki 0.11
drug1403 Glucose tablets Wiki 0.11
drug565 Broncho-Vaxom® Wiki 0.11
drug743 Cellular response Wiki 0.11
drug3520 Transfusion of standard Plasma. Wiki 0.11
drug1764 JNJ-53718678 Wiki 0.11
drug2271 Nutrition Wiki 0.11
drug671 COVID-19 treatment Wiki 0.11
drug1452 Health Questionnaire Wiki 0.11
drug2896 Rifaximin Novel Formulation Wiki 0.11
drug2516 Placebo 0.20 mg + 2.00 mg/kg Wiki 0.11
drug2995 SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) Wiki 0.11
drug2782 RSV Mobile Application Wiki 0.11
drug1815 Late-Dexamethasone Wiki 0.11
drug1771 JS016 (anti-SARS-CoV-2 monoclonal antibody) Wiki 0.11
drug1499 Home-use Test and Follow-up Questionnaire Wiki 0.11
drug1498 Home-based exercise Wiki 0.11
drug2926 Routine care (no SARS-CoVSTs) Wiki 0.11
drug1866 Lopinavir/ Ritonavir Oral Tablet Wiki 0.11
drug2366 Oxytocin Wiki 0.11
drug2429 Partially HLA-matched SARS-CoVSTs Wiki 0.11
drug2568 Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Wiki 0.11
drug1077 Distilled water Wiki 0.11
drug2108 MuscleSound Ultrasound Wiki 0.11
drug1350 Fourth Trimester Mobile Tool Wiki 0.11
drug989 Dapagliflozin Wiki 0.11
drug4155 trimethoprim/sulfamethoxazole Wiki 0.11
drug2717 Q-NRG Metobolic Cart Device Wiki 0.11
drug1775 KIR phenotype evaluation Wiki 0.11
drug369 Azithromycin 500Mg Oral Tablet Wiki 0.11
drug2917 RoActemra sc Wiki 0.11
drug3483 To assess for development of IgG antibodies against SARS-CoV2 Wiki 0.11
drug1550 Hydroxychloroquine Sulfate Tablets Wiki 0.08
drug1147 Early-Dexamethasone Wiki 0.08
drug1112 Duvelisib Wiki 0.08
drug1304 Favipiravir Placebo Wiki 0.08
drug1121 EDP1815 Wiki 0.08
drug3989 nasopharyngeal swab Wiki 0.08
drug624 COVID Convalescent Plasma Wiki 0.08
drug1822 Lenzilumab Wiki 0.08
drug2468 Peripheral blood draw Wiki 0.08
drug229 Anakinra Wiki 0.08
drug1433 HB-adMSCs Wiki 0.08
drug422 BNT162b2 Wiki 0.08
drug689 CT-Scan Wiki 0.08
drug1532 Hydroxychloroquine 200 Mg Oral Tablet Wiki 0.08
drug2505 Placebo Wiki 0.08
drug1232 Exercise Wiki 0.06
drug1744 Itraconazole Wiki 0.06
drug3077 Selinexor Wiki 0.06
drug4012 observational Wiki 0.06
drug390 BCG vaccine Wiki 0.06
drug421 BNT162b1 Wiki 0.06
drug1150 Echocardiography Wiki 0.06
drug2895 Rifampin Wiki 0.05
drug3485 Tocilizumab Wiki 0.05
drug790 Cholecalciferol Wiki 0.05
drug2637 Presatovir Wiki 0.05
drug3223 Standard of Care (SOC) Wiki 0.05
drug2251 Normal Saline Wiki 0.05
drug3562 UC-MSCs Wiki 0.05
drug3257 Standard treatment Wiki 0.04
drug1520 Hydroxychloroquine Wiki 0.04
drug1030 Dexamethasone Wiki 0.04
drug3221 Standard of Care Wiki 0.04
drug829 Colchicine Wiki 0.03
drug1538 Hydroxychloroquine Sulfate Wiki 0.03
drug2194 Nitazoxanide Wiki 0.03
drug2572 Placebos Wiki 0.03
drug3231 Standard of care Wiki 0.02
drug2557 Placebo oral tablet Wiki 0.02
drug364 Azithromycin Wiki 0.02

Correlated MeSH Terms (54)


Name (Synonyms) Correlation
D012327 RNA Virus Infections NIH 0.22
D003333 Coronaviridae Infections NIH 0.19
D007239 Infection NIH 0.19
Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.19
D030341 Nidovirales Infections NIH 0.15
D018357 Respiratory Syncytial Virus Infections NIH 0.15
D012141 Respiratory Tract Infections NIH 0.14
D018352 Coronavirus Infections NIH 0.13
D015817 Eye Infections NIH 0.11
D003384 Coxsackievirus Infections NIH 0.11
D010608 Pharyngeal Diseases NIH 0.11
D006562 Herpes Zoster NIH 0.11
D006560 Herpes Labialis NIH 0.11
D055501 Macrophage Activation Syndrome NIH 0.11
D045169 Severe Acute Respiratory Syndrome NIH 0.11
D009767 Obesity, Morbid NIH 0.08
D009410 Nerve Degeneration NIH 0.08
D003231 Conjunctivitis NIH 0.08
D000208 Acute Disease NIH 0.08
D000370 Ageusia NIH 0.08
D012140 Respiratory Tract Diseases NIH 0.07
D001987 Bronchiectasis NIH 0.06
D044342 Malnutrition NIH 0.06
D058070 Asymptomatic Diseases NIH 0.06
D018184 Paramyxoviridae Infections NIH 0.06
D003139 Common Cold NIH 0.06
D000257 Adenoviridae Infections NIH 0.06
D003428 Cross Infection NIH 0.06
D007251 Influenza, Human NIH 0.05
D004211 Disseminated Intravascular Coagulation NIH 0.05
D008231 Lymphopenia NIH 0.05
D007154 Immune System Diseases NIH 0.04
D003327 Coronary Disease NIH 0.04
D014808 Vitamin D Deficiency NIH 0.04
D009765 Obesity NIH 0.04
D020246 Venous Thrombosis NIH 0.03
D006331 Heart Diseases NIH 0.03
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.03
D008173 Lung Diseases, Obstructive NIH 0.03
D011014 Pneumonia NIH 0.03
D020141 Hemostatic Disorders NIH 0.03
D001778 Blood Coagulation Disorders NIH 0.03
D016638 Critical Illness NIH 0.03
D000857 Olfaction Disorders NIH 0.03
D011024 Pneumonia, Viral NIH 0.03
D008171 Lung Diseases, NIH 0.02
D013927 Thrombosis NIH 0.02
D013577 Syndrome NIH 0.02
D055370 Lung Injury NIH 0.02
D007249 Inflammation NIH 0.02
D004630 Emergencies NIH 0.02
D012127 Respiratory Distress Syndrome, Newborn NIH 0.01
D055371 Acute Lung Injury NIH 0.01
D012128 Respiratory Distress Syndrome, Adult NIH 0.01

Correlated HPO Terms (17)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.15
HP:0000224 Hypogeusia HPO 0.11
HP:0000509 Conjunctivitis HPO 0.08
Name (Synonyms) Correlation
HP:0002180 Neurodegeneration HPO 0.08
HP:0004395 Malnutrition HPO 0.06
HP:0002110 Bronchiectasis HPO 0.06
HP:0005521 Disseminated intravascular coagulation HPO 0.05
HP:0001888 Lymphopenia HPO 0.05
HP:0100512 Low levels of vitamin D HPO 0.04
HP:0001513 Obesity HPO 0.04
HP:0006510 Chronic pulmonary obstruction HPO 0.04
HP:0002625 Deep venous thrombosis HPO 0.03
HP:0006536 Pulmonary obstruction HPO 0.03
HP:0002090 Pneumonia HPO 0.03
HP:0000458 Anosmia HPO 0.03
HP:0001928 Abnormality of coagulation HPO 0.03
HP:0002088 Abnormal lung morphology HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 86 clinical trials


1 Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth

This QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.

NCT04532411
Conditions
  1. SARS-CoV Infection
  2. Respiratory Viral Infection
  3. Personal Protective Equipment
  4. Covid19
Interventions
  1. Other: Personal Protective Testing Booth
MeSH:Infection Communicable Diseases Virus Dis Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Testing Throughput After Hexapod Implementation

Time: Up to 22 weeks

Description: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Isolation Gowns Utilized After Hexapod Utilization

Time: Up to 22 weeks

Description: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.

Measure: Change in Cost per Test After Hexapod Implementation

Time: Up to 22 weeks

Description: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.

Measure: Return on Investment

Time: Up to 22 weeks

Secondary Outcomes

Description: The difference in median shift salaries before and after Hexapod implementation will be calculated.

Measure: Change in Testing Personnel Cost Per Test

Time: Up to 22 weeks

Description: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.

Measure: Change in Cost of Isolation Gowns Utilized

Time: Up to 22 weeks

Other Outcomes

Description: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.

Measure: Cost of Additional Consumable Supplies Utilized

Time: Up to 22 weeks
2 An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

NCT01056185
Conditions
  1. Influenza
  2. Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV)
  3. Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)
MeSH:Virus Diseases Influenza, Human Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Measure: Death

Time: 60-day period following enrollment

Secondary Outcomes

Measure: Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome

Time: approximately 60 days
3 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. Respirat
  4. Respiratory Syncytial Virus Infections
  5. Infection Due to Human Parainfluenza Virus 1
  6. Parainfluenza Type 2
  7. Parainfluenza Type 3
  8. Parainfluenza Type 4
  9. Human Metapneumovirus A/B
  10. Rhinovirus
  11. Coxsackie Virus/Echovirus
  12. Adenovirus Types B/C/E
  13. Coronavirus Subtypes 229E
  14. Coronavirus Subtype NL63
  15. Coronavirus Subtype OC43
  16. Coronavirus Subtype HKU1
  17. Human Bocavirus
  18. Artus Influenza A/B RT-PCR Test
  19. 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.
4 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
5 Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents

This study will be conducted in a 208-bed nursing home in Maribor. The investigators will observe a group of a 100 nursing-home residents and 50 health care workers- employees in the nursing home- in a six months period.Influenza vaccination status will be recorded in all participants at the beginning. At the beginning and at the end of the study the blood samples for vitamin D concentration determination and nasopharyngeal swabs for molecular detection of respiratory viruses will taken in all of the participants. The study will observe number of viral respiratory tract infection in participants and identify the viral etiology of infections during 6 months observational period.Nasopharyngeal swab and blood sample will be taken in each of the participant who will suffer an acute respiratory tract infection (upper or lower respiratory tract infection) and viral agents of respiratory tract diseases will be searched for. The investigators will try to detect different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the participants. During the study period the investigators will monitor the daily number of visitors (adults, preschool children and pupils) in each nursing home room. The epidemiological aspect of respiratory viral infection will be assessed. Our study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza. The investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees. The investigators would also like to know if the number of respiratory tract infections in elderly correlates with the number of visitors in nursing home, small children in particular.

NCT01486160
Conditions
  1. Acute Viral Respiratory Tract Diseases
MeSH:Virus Diseases Respiratory Tract Diseases

Primary Outcomes

Description: Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified

Measure: Number of viral respiratory tract infection in participants according to etiology

Time: 6 months

Secondary Outcomes

Description: Serum concentration of vitamine D will be measured retrospectively from the blood samples taken at the beginning of the study and correlation between vitamine D concentration and the frequency of respiratory tract infection in participants will be made

Measure: Serum vitamine D concentration in participants

Time: 6 months

Description: Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.

Measure: Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents

Time: 6 months
6 The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults

Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway flow limitation, which may be accompanied by recurrent exacerbations.It has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. However,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.This study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis.

NCT01801657
Conditions
  1. Bronchiectasis
MeSH:Virus Diseases Bronchiectasis
HPO:Bronchiectasis

Primary Outcomes

Description: Respiratory viruses in the nasal swab and sputum will be identified using the polymerase chain reaction(PCR)technique when clinically stable and during exacerbation.The following viruses will be tested for:influenza A,B(including influenza A H1N1),respiratory syncytial virus(RSV),Enterovirus,Parainfluenza 1-4,Rhinovirus,human Coronaviruses(subtypes OC43、229E、HKU1),human metapneumovirus,adenovirus, human bocavirus,chlamydia,mycoplasma.

Measure: The prevalence of respiratory virus infection in adults with bronchiectasis during a pulmonary exacerbation and when clinically stable.

Time: 1 year

Secondary Outcomes

Description: Systemic and airway inflammatory cytokines including IL-1β、IL-6、IL-8、TNF-a were measured using a commercial multiplex bead-based assay.

Measure: The effect of respiratory virus infection on systemic and pulmonary inflammatory markers.

Time: 1 year

Description: Spirometric indices in the present study is referred to as forced expiratory vilume in 1s(FEV1),forced vital capacity(FVC).Spirometry tests are carried out using a spirometer (COSMED, QUARK PFT, Italy). All operation procedures meet the joint recommendation by ATS and ERS. A total of at least 3 (not more than 8) spirometric maneuvers are performed, with the variation between the best two maneuvers of <5% or 200ml in FVC and FEV1. The maximal values of FVC and FEV1 are reported.

Measure: The effect of respiratory virus on lung function

Time: 1 year

Description: Type of bacterial infection, also referred to as potentially pathogenic organisms, and bacterial load, as expressed in cfu per mililiter

Measure: The effect of respiratory virus infection on the bacterial load in bronchiectasis.

Time: 1 year

Description: The time from exacerbation onset by which a 3-d moving average was equal to or exceeded the baseline value

Measure: Time to recovery of respective symptom

Time: 1 year

Description: Quality of life in patients with bronchiectasis were measured by St.George Respiratory Questionnaire、Leicester Cough Questionnaire and COPD assessment test during exacerbations,and then compared between virus-postive and virus-negative patients

Measure: The effect of respiratory virus on quality of life in patients with bronchiectasis

Time: 1 year

Measure: To investigate if upper respiratory tract symptoms are associated with viral infections.

Time: 1 year
7 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
8 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
9 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
10 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.
11 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
12 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
13 A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.

NCT04068792
Conditions
  1. Respiratory Syncytial Viruses
Interventions
  1. Other: RSV Mobile Application
  2. Drug: Placebo
  3. Drug: JNJ-53718678 2.5 mg/kg
  4. Drug: JNJ-53718678 3 mg/kg
  5. Drug: JNJ-53718678 4.5 mg/kg
MeSH:Virus Diseases

Primary Outcomes

Description: Respiratory Syncytial Virus (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 quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.

Measure: Part 2: RSV Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

Time: On the day of diagnosis (Baseline) through Day 5 of interventional stage

Secondary Outcomes

Description: Total Respiratory Symptom Score over time will be captured by RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV positive participants that do not enter in the interventional stage.

Measure: Part 1: Total Respiratory Symptom Score Over Time

Time: Up to 21 Days of observational stage

Description: Clinician PRESORS scores will be reported for hospitalized RSV positive participants. Clinician 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: Part 1: Change from Baseline in Clinician Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Scores

Time: On the day of RSV diagnosis (Baseline) up to Discharge post-diagnosis (21 Days) of observational stage

Description: RSV Viral load during pre-diagnostic phase will be determined based on measurements of RSV viral load in nasal secretions by a qRT-PCR assay in mid-turbinate nasal swab specimens.

Measure: Part 1: RSV Viral Load

Time: Pre-diagnostic phase: Within 24hrs of Observation Day 1

Description: RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) will be measured by real-time qRT-PCR assay in the mid-turbinate nasal swab specimens.

Measure: Part 1: RSV Viral Load Kinetics from Day 1 to Day 8

Time: On the day of diagnosis (Baseline) through Day 8 of observational stage

Description: Change from baseline in Parent(s)/Caregiver(s) PRESORS scores (worsening or improvement) will be reported.

Measure: Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time

Time: On the day of diagnosis (Baseline) up to 21 Days of the observational stage

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

Measure: Part 2: RSV Viral Load and Change from Baseline Over Time

Time: On the day of diagnosis (Baseline) through Day 21 of interventional stage

Description: RSV viral load AUC will be determined by qRT-PCR assay in mid-turbinate nasal swab specimens.

Measure: Part 2: RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

Time: On the day of diagnosis (Baseline) through Days 3, 8 and 14 of interventional stage

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

Measure: Part 2: Time to Undetectable RSV Viral Load

Time: Up to 21 days of interventional stage

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

Measure: Part 2: Percentage of Participants with Undetectable RSV Viral Load at each timepoint

Time: Up to 21 days of interventional stage

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: Part 2: Duration of Signs and Symptoms of RSV Disease Assessed by the PRESORS

Time: Up to 21 days of interventional stage

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: Part 2: Severity of RSV Disease Assessed by PRESORS

Time: Up to 21 days of interventional stage

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: Part 2: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

Time: On the day of diagnosis (Baseline) up to 21 days of interventional stage

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: Part 2: Change from Baseline in Clinician PRESORS Scores

Time: On the day of diagnosis (Baseline) up to 21 days of interventional stage

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

Measure: Part 2: Time to Resolution of RSV Symptoms

Time: Up to 21 days of interventional stage

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

Measure: Part 2: Time to Improvement on Overall Health

Time: Up to 21 days of interventional stage

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

Measure: Part 2: Percentage of Participants with Improvement or Worsening of RSV Disease

Time: Up to 21 days of interventional stage

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

Measure: Part 2: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

Time: Up to 21 days of interventional stage

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

Measure: Part 2: Percentage of Participants with Vital Sign Abnormalities

Time: Up to 28 days of interventional stage

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

Measure: Part 2: Percentage of Participants who Require (re)Hospitalization During Treatment and Follow-up

Time: Up to 28 days of interventional stage

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: Part 2: Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability

Time: Up to 28 days of interventional stage

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

Measure: Part 2: Percentage of Participants with Abnormal Laboratory Findings

Time: Up to 28 days of interventional stage

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

Measure: Part 2: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

Time: Up to 28 days of interventional stage

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

Measure: Part 2: Plasma Concentrations of JNJ-53718678

Time: Day 1 and Day 3 of interventional stage
14 A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Severe COVID-19 Patients

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

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

Primary Outcomes

Description: Evaluation of Pneumonia Improvement

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

Time: Day 28

Secondary Outcomes

Description: Evaluation of Pneumonia Improvement

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

Time: Day 10, Day 90

Description: Evaluation of Pneumonia Improvement

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

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

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

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

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

Time: Day 90

Description: Evaluation of Pneumonia Improvement

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

Time: Day 10, Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

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

Time: Day 10, Day 28, Day 90

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

Measure: Time to clinical improvement in 28 days.

Time: Day 28

Description: Evaluation of Pneumonia Improvement

Measure: Oxygenation index( PaO2/FiO2)

Time: Day 6, Day 10, Day 28

Description: Evaluation of Pneumonia Improvement

Measure: Duration of oxygen therapy(days)

Time: Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Blood oxygen saturation

Time: Day 6, Day 10, Day 28

Description: Evaluation of Pneumonia Improvement

Measure: 6-minute walk test

Time: Day 28, Day 90

Description: Evaluation of Pneumonia Improvement

Measure: Maximum vital capacity (VCmax)

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

Description: Evaluation of Pneumonia Improvement

Measure: Diffusing Capacity (DLCO)

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

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

Measure: mMRC (Modified Medical Research Council) dyspnea scale

Time: Day 28, Day 90

Description: Marker of Immunological function

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

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

Description: Marker of Immunological function

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

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

Description: Safety endpoints

Measure: Adverse events

Time: Day 0 through Day 90

Description: Safety endpoints

Measure: Serious adverse events

Time: Day 0 through Day 90

Description: Safety endpoints

Measure: All-cause mortality

Time: Day 0 through Day 90
15 Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus

Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported. The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2. Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals. The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals. Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.

NCT04290780
Conditions
  1. Infection Viral
Interventions
  1. Other: nosocomial infection/hospital acquired infection
MeSH:Virus Diseases

Primary Outcomes

Description: The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.

Measure: nosocomial infection

Time: At inclusion
16 Clinical Study of Tetrandrine Tablets Adjuvant Treatment With COVID-19

The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

NCT04308317
Conditions
  1. Corona Virus Disease 2019,COVID-19
Interventions
  1. Drug: Tetrandrine
MeSH:Virus Diseases

Primary Outcomes

Description: Death event

Measure: Survival rate

Time: 12 weeks

Secondary Outcomes

Description: inflammatory indicator

Measure: body temperature

Time: 2 weeks
17 Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study

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

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

Primary Outcomes

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

Measure: Clinical cure rate

Time: 3 months

Secondary Outcomes

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

Time: 14 days after taking medicine

Measure: Duration of fever

Time: 14 days after taking medicine

Measure: Lung imaging improvement time

Time: 14 days after taking medicine

Measure: Mortality rate because of Corona Virus Disease 2019

Time: 3 months

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

Time: 3 months

Measure: Mean in-hospital time

Time: 3 months
18 Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy

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

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

Primary Outcomes

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

Measure: Maternal and perinatal outcomes

Time: during gestation and at the time of delivery of the baby
19 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
20 Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.

NCT04319016
Conditions
  1. Infection Viral
Interventions
  1. Other: pregnant women with laboratory-confirmed 2019-n-CoV
MeSH:Virus Diseases

Primary Outcomes

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

Measure: Maternal and perinatal outcomes

Time: at the time of delivery
21 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 Inf 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
22 Effectiveness of Interleukin-6 Receptor Inhibitors in the Management of Patients With Severe SARS-CoV-2 Pneumonia: An Open-Label, Multicenter Sequential and Cluster Randomized Trial

Coronavirus disease 2019 (COVID-19) is caused by the newly discovered coronavirus, SARS-CoV-2. The median time from onset of symptoms of COVID-19 to development of acute respiratory distress syndrome (ARDS) has been reported as short as 9 days. No effective prophylactic or post-exposure therapy is currently available. According to data from the Danish Health Authority (www.sst.dk/corona), as of March 21st, 2020, there were 1326 patients infected with the disease in Denmark, more than 250 are admitted to a hospital, and >50 of them have required intensive care. Nearly 350.000 cases and 15.000 deaths have been reported globally. These numbers are likely to markedly increase during the coming weeks, challenging the capacity of health systems worldwide. In patients infected with SARS-CoV-2, it has been described that disease severity and outcomes are related to the characteristics of the immune response. Interleukin (IL)-6 and other components of the inflammatory cascade contribute to host defense against infections. However, exaggerated synthesis of IL-6 can lead to an acute severe systemic inflammatory response known as 'cytokine storm'. In the pathogenesis of SARS-CoV-2 pneumonia, a study found that a cytokine storm involving a considerable release of proinflammatory cytokines occurred, including IL-6, IL-12, and tumor necrosis factor α (TNF-α). Studies on the Middle East respiratory syndrome caused by another coronavirus (MERS-CoV), indicate that cytokine genes of IL-6, IL-1β, and IL-8 can be markedly upregulated. Similarly, patients with SARS-CoV-2 pneumonia admitted to an intensive care unit had higher plasma levels of cytokines including IL-6, IL-2, IL-7, IL-10, granulocyte-colony stimulating factor (G-CSF), interferon-γ-inducible protein (IP10), monocyte chemoattractant protein (MCP1), macrophage inflammatory protein 1 alpha (MIP1A), and TNF-α. These findings indicate that the magnitude and characteristics of the cytokine response is related to the severity and prognosis of patients with SARS-CoV-2 pneumonia. It has been suggested that IL-6 blockade may constitute a novel therapeutic strategy for other types of cytokine storm, such as the systemic inflammatory response syndrome including sepsis, macrophage activation syndrome and hemophagocytic lymphohistiocytosis. Remarkable beneficial effects of IL-6 blockade therapy using a IL-6 receptor inhibitor has been described in patients with severe SARS-CoV-2 pneumonia in a retrospective case series from China. Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi). IL-6 receptor inhibitors are currently licensed for several autoimmune disorders and are considered well tolerated and safe in general. The most common side effects reported are upper respiratory tract infections, headache, hypertension, and abnormal liver function tests. The most serious side effects are serious infections, complications of diverticulitis, and hypersensitivity reactions. it is hypothesized that IL-6 might play a key role in the cytokine storm associated with serious adverse outcomes in patients infected with SARS-CoV-2 pneumonia, and that blockade of IL-6 would be suitable therapeutic target for these patients. The study will investigate the effect of different types of IL-6 inhibition versus no adjuvant treatment compared to standard of care in patients with severe SARS-CoV-2 pneumonia. Primary objective: To compare the effect of either one of three IL-6 inhibitor administrations, relative to the standard of care, on time to independence from supplementary oxygen therapy, measured in days from baseline to day 28, in patients with severe SARS-CoV-2 pneumonia.

NCT04322773
Conditions
  1. Corona Virus Disease
Interventions
  1. Drug: RoActemra iv
  2. Drug: RoActemra sc
  3. Drug: Kevzara sc
  4. Other: Standard medical care
MeSH:Virus Diseases

Primary Outcomes

Measure: Time to independence from supplementary oxygen therapy

Time: days from enrolment up 28 days

Secondary Outcomes

Measure: Number of deaths

Time: 28 days from enrolment

Measure: Days out of hospital and alive

Time: 28 days from enrolment

Measure: Ventilator free days alive and out of hospital

Time: 28 days from enrolment

Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: baseline

Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: peak during hospitalisation, up to 28 days

Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: 14 days

Description: Measured from standard blood test

Measure: C-reactive protein (CRP) level

Time: 28 days

Description: Measured as occurrence of any serious adverse events

Measure: Number of participants with serious adverse events

Time: During treatment, up to 28 days
23 Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)

Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

NCT04323787
Conditions
  1. Coronavirus
Interventions
  1. Other: observational
MeSH:Virus Diseases

Primary Outcomes

Description: Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients

Measure: ICU and hospital mortality of COVID-19 patients

Time: 7 days

Secondary Outcomes

Description: Secondary outcome will be to measure 30 days mortality from Hospital discharge

Measure: 30 days mortality

Time: 30 days
24 Evaluation of Novel Diagnostic Tests for 2019-nCOV

COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.

NCT04326387
Conditions
  1. Acute Disease
  2. Coronavirus
  3. Respiratory Viral Infection
Interventions
  1. Diagnostic Test: SAMBA II (Diagnostic for the Real World)
  2. Diagnostic Test: Public Health England Gold Standard
  3. Diagnostic Test: Cambridge Validated Viral Detection Method
  4. Diagnostic Test: Radiological Detection
MeSH:Coronavirus Infections Virus Diseases Acute Disease

Primary Outcomes

Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard

Measure: SAMBA COVID-19 POC PCR Test

Time: 28 days

Secondary Outcomes

Description: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale

Measure: Patient acceptability

Time: 28 days

Description: Time to positive IgM/IgG test positivity

Measure: Immune Response Positivity

Time: 40 days
25 The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention

Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.

NCT04326790
Conditions
  1. Corona Virus Disease 19 (Covid 19)
Interventions
  1. Drug: Colchicine
  2. Drug: Standard treatment
MeSH:Virus Diseases

Primary Outcomes

Description: Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)

Measure: Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee

Time: 3 weeks

Description: Maximal concentration of high-sensitivity cardiac troponin

Measure: Maximal concentration of cardiac troponin

Time: 10 days
26 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
27 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
28 The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.

NCT04333589
Conditions
  1. COVID-19
Interventions
  1. Drug: Favipiravir
MeSH:Virus Diseases Coronavirus Infections

Primary Outcomes

Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).

Measure: Viral nucleic acid test negative conversion rate

Time: 5 months

Secondary Outcomes

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

Measure: Clinical cure rate

Time: 5 months
29 Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study

To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.

NCT04334265
Conditions
  1. COVID-19
Interventions
  1. Drug: Anluohuaxian
MeSH:Virus Diseases Coronavirus Infections

Primary Outcomes

Description: Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography

Measure: Changes in high-resolution computer tomography of the lung

Time: 3 months

Measure: Change in 6-minute walking distance

Time: 3 months

Secondary Outcomes

Measure: Changes in compound physiological index

Time: 3 months

Description: St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.

Measure: Changes in the scores of the St. George's Hospital Respiratory Questionnaire

Time: 3 months

Description: mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.

Measure: Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores

Time: 3 months

Description: Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.

Measure: Changes in vital capacity of the lung

Time: 3 months
30 Low-dose Hydroxychloroquine for Primary Prophylaxis Against SARS-CoV-2 in Health-care Workers - a Randomized, Double-blind, Controlled Trial

Background: Aim: To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design, participants and interventions: Prospective, randomized, parallel group, double-blinded, placebo controlled, study. including 440 participants who will be randomised to 2 treatment arms: hydroxychloroquine or placebo. Outcome variables: symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR, viral load during SARS-CoV-2 infection, seroconversion during the study period, incidence of any acute respiratory infection, days of sick leave. Statistical considerations: No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers. Thus, sample size calculations in the proposed trial are based on the investigators' best estimates for several parameters. In accordance to the effect of oseltamivir against symptomatic influenza, we assumed an approximate effectiveness of approximately 60% (HR of 0.4) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464969/) as realistic. As a prophylactic intervention with HCQ, which may have side effects and for which supply shortage can be expected, was judged justifiable only if its effectiveness is high, we based our sample size consideration on a HR of 0.3. To estimate the probability of an event in both the experimental and the control group, very little data is available. In a Dutch point-prevalence study 0-10% of health-care workers were infected depending on the healthcare institution, depending on the hospital. This point-prevalence study was performed between 6 and 9 March, when the reported number of cases in the Netherlands was 33 and 77, respectively, according to the RIVM (https://www.rivm.nl/nieuws/resultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus). Additionally, in an a report published in the Lancet, 20% of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext). Several media reports indicate that this proportion is similar across various healthcare institutions and countries (https://www.nytimes.com/2020/03/24/world/europe/coronavirus-europe-covid-19.html) and (https://www.aljazeera.com/news/2020/03/spain-tightens-restrictions-week-lockdown-begins-2003 30191539568.html). As the proposed study will be performed in a high-risk setting, we assumed an event (i.e. PCR positivity) probability of 10% in the control group and 3% in the experimental arm after the maximum study period. In summary, a sample size of 210 participants per arm is necessary to detect a HR of 0.3 with a power of 80.3% with an alpha-error of 0.05. To account for drop-outs and asymptomatic, undetected infection at inclusion or past infection with existing immunity, an additional 10 participants will randomized per treatment arm. The overall study population is therefore 440 participants. Statistical analysis will be based on two populations: A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline. And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80% of all doses of study medication.

NCT04336748
Conditions
  1. Sars-CoV2
  2. Infection Viral
  3. Healthcare Worker
  4. Prophylaxis
Interventions
  1. Drug: Hydroxychloroquine
MeSH:Virus Diseases

Primary Outcomes

Measure: Symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR

Time: 4 weeks

Secondary Outcomes

Measure: Viral load during SARS-CoV-2 infection

Time: 4 weeks

Measure: Seroconversion during the study period

Time: 4 weeks

Measure: Incidence of any acute respiratory infection

Time: 4 weeks

Measure: Days of sick leave

Time: 4 weeks
31 Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France

Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.

NCT04336761
Conditions
  1. Coronavirus
  2. COVID
  3. Infection Viral
Interventions
  1. Diagnostic Test: nasopharyngeal swab
MeSH:Virus Diseases Emergencies

Primary Outcomes

Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR

Time: At 28 days

Secondary Outcomes

Description: children admitted to pediatric emergencies for respiratory signs Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs Respiratory asymptomatic children admitted to pediatric emergencies

Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients

Time: at the end an average 28 days

Measure: Respiratory signs of children tested within 28 day

Time: through study completion, an average 28 days

Measure: Percentage of children hospitalized tested within 28 day

Time: through study completion, an average 28 days

Description: the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency

Measure: Contact frequency

Time: At inclusion

Measure: Prevalence of positivity of other respiratory viruses measured by rt-PCR

Time: at 28 days
32 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
33 Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic

There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting. In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources. This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.

NCT04341792
Conditions
  1. Infection Viral
  2. Coronavirus
  3. COVID-19
MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: Secondary aggravation is defined as : a re-hospitalization or aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death

Measure: Rate of secondary aggravation

Time: an average at 30 days (- 2 days +3 days) of admission to the emergency department

Secondary Outcomes

Description: the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.

Measure: Change of standart biological parameters

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

Measure: Change of Von willebrand factor (vWF) changes over time

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

Measure: Change of the Factor VIII (FVIII)

Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department

Measure: Prevalence of positivity of COVID-19 virus measured by PCR or serology

Time: an average at 30 days (- 2 days +3 days) of admission to the emergency department
34 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
35 CoVid-19 - Infection and Antibody Formation in the Viennese Population - Data From the Vienna Health Study LEAD

Summary of the study Study population: A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD) Potential output and analysis: - Extent of age-specific infection and antibody formation - Cumulative incidence of infection - Rate of asymptomatic infection - Relationship with socioeconomics, lifestyle and risk factors (comorbidities) Study design: Prospective, longitudinal, stratified by age and gender Duration of study: Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months) Information to be obtained from participants: - serum samples for information on SARS-CoV2 infection and antibody formation - data on clinical symptoms

NCT04346264
Conditions
  1. Virus Diseases
  2. COVID-19
Interventions
  1. Diagnostic Test: NO intervention planned due to the observational study design only a diagnostic testing
MeSH:Virus Diseases

Primary Outcomes

Description: Antibody Titres IgG and IgM

Measure: Prevalence of SARS-CoV-2 antibody titres

Time: 5 weeks

Secondary Outcomes

Description: Re-Calculation including incidence of the general population

Measure: Prevalence of SARS-CoV-2 antibody titres after 3 Months

Time: 4 Months
36 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
37 COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).

NCT04354155
Conditions
  1. Infection Viral
  2. Thromboses, Venous
  3. COVID-19
Interventions
  1. Drug: Enoxaparin Prefilled Syringe [Lovenox]
MeSH:Virus Diseases Thrombosis Venous Thrombosis
HPO:Deep venous thrombosis Venous thrombosis

Primary Outcomes

Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.

Measure: Safety of in-hospital thromboprophylaxis

Time: Day 30

Secondary Outcomes

Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).

Measure: Median twice-daily enoxaparin dose

Time: 4 hours post initial dose

Other Outcomes

Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.

Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels

Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized

Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.

Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE

Time: Day 30

Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).

Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support

Time: Day 30
38 Study of the Dissemination of SARS-COV-2 in the Environment of Infected Patients Admitted to Intensive Care Unit

The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

NCT04355481
Conditions
  1. Covid-19
  2. Viral Infection
MeSH:Virus Diseases

Primary Outcomes

Description: The primary objective of the study will be evaluated by the proportion of patients contaminating the air 1 meter from their face. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR.

Measure: Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter.

Time: within 48 hours of the confirmation of SARS-Cov-2 infection documented by RT-PCR
39 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
40 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. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

NCT04357366
Conditions
  1. COVID-19
  2. Virus Dis
  3. Virus Diseases
  4. Corona Virus Infection
  5. Lower Respiratory Tract Infection Viral
Interventions
  1. Drug: Anakinra
  2. Drug: trimethoprim/sulfamethoxazole
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 not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.

Measure: The ratio of patients who will not 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 historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of the rate of patients who will not develop serious respiratory failure (SRF) until day 14 with historical comparators from Hellenic Sepsis Study Group Database

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 cytokine stimulation from peripheral blood mononuclear cells of enrolled subjects will be compared between days 1 and 7

Measure: Change of cytokine production 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
41 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. Analgesic
  20. Analgesics
  21. Antimetabolites, Antineoplastic
Interventions
  1. Biological: CYNK-001
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral 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
42 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
43 A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic

Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.

NCT04369365
Conditions
  1. COVID
Interventions
  1. Drug: Azithromycin 500 milligram (mg) oral Tablet
  2. Drug: Placebo
MeSH:Virus Diseases Coronavirus Infections

Primary Outcomes

Description: assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)

Measure: Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections

Time: 12 weeks after initiation of therapy

Secondary Outcomes

Description: defined as combined endpoint of hospitalization rate or death

Measure: Number of severe COVID-19 cases

Time: 12 weeks after initiation of therapy

Description: grading as outlined by the world health organization (WHO)

Measure: Severity of COVID-19 cases

Time: 12 weeks after initiation of therapy

Description: significant clinical and laboratory abnormalities according to CTCAE criteria

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: 12 weeks after initiation of therapy

Description: other than COVID-19

Measure: Number of viral and bacterial infections

Time: 12 weeks after initiation of therapy

Description: Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test

Measure: Number of participants with azithromycin-resistant bacterial strains in nasal swabs test

Time: 12 weeks after initiation of therapy
44 Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients Presenting With Conjunctivitis to the Ophthalmology Clinics During the COVID-19 Pandemic

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.

NCT04374656
Conditions
  1. Conjunctivitis
  2. SARS-CoV-2
  3. COVID-19
  4. Ocular Infection, Viral
  5. Ocular Inflammation
MeSH:Eye Infections Virus Diseases Eye Infections, Viral Conjunctivitis Inflammation
HPO:Conjunctivitis

Primary Outcomes

Description: Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples

Measure: Proportion of conjunctival samples tested positive for SARS-CoV-2

Time: 1 year

Secondary Outcomes

Description: Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR

Measure: Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

Time: 1 year

Description: Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR

Measure: Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples

Time: 1 year

Description: Number of patients developed COVID-19 divided by the number of the study population

Measure: Rate of development of COVID-19 in the study patient population

Time: 1 year

Description: Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19

Measure: Positive conjunctival sample rate in patient developed COVID-19

Time: 1 year
45 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
46 Longitudinal Serological Study on the Spread and Course of COVID-19 Infections

The overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.

NCT04377724
Conditions
  1. Covid-19
  2. Virus Disease
MeSH:Virus Diseases

Primary Outcomes

Measure: seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens

Time: 12 months

Secondary Outcomes

Measure: the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens

Time: 12 months

Measure: the property of IgM and IgA antibody titers against the nucleocapsid protein of SARS-CoV-2 in symptomatic as well as asymptomatic COVID-19 infections over the course of time following an infection

Time: 12 months

Measure: the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections

Time: 12 months
47 Incidence of Covid-19 in School Children During the Pandemic Period in Nice

The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children

NCT04377737
Conditions
  1. Infection; Viral, Coronavirus
Interventions
  1. Diagnostic Test: RT-PCR Covid-19
MeSH:Coronavirus Infections Virus Diseases

Primary Outcomes

Description: measure by two rt-PCR COVID-19 tests regardless the serological status of the child

Measure: evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice

Time: at 42 days

Secondary Outcomes

Description: measure by two serological COVID-19 test (IgG and/or IgM)

Measure: evaluation of the serological prevalence of the Covid-19 infection

Time: at inclusion and at 42 days

Description: measure by two serological COVID-19 test (IgG and/or IgM)

Measure: evaluation of the COVID-19 reinfection among seropositive children at the inclusion time

Time: at inclusion and at 42 days

Description: positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)

Measure: evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus)

Time: at 42 days

Description: measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)

Measure: comparison of inflammatory response level between different coronavirus strains

Time: at 42 days

Description: measure of the medico-social relative risk associated with rt-PCR COVID-19 test positivity among : school level, gender, school type, day care facilities before 11th May, number of siblings, housing type, number of bedrooms, precariousness level, by score EPICES ( (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'examens de santé, means Assessment of precariousness and health inequalities in health examination centers). Questionnaire of EPICES counts 11 items, the answer to each question is assigned a coefficient, the sum of the 11 answers gives the score EPICES. The score is continuous, it varies from 0 (lack of precariousness) to 100 (maximum precariousness).

Measure: Estimation of medico-social risk factors associated with COVID-19 infection

Time: at 42 days
48 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults

The trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.

NCT04380701
Conditions
  1. Infections, Respiratory
  2. Virus Diseases
  3. Infection Viral
  4. Vaccine Adverse Reaction
  5. RNA Virus Infections
Interventions
  1. Biological: BNT162a1
  2. Biological: BNT162b1
  3. Biological: BNT162b2
  4. Biological: BNT162c2
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases RNA Virus Infections
HPO:Respiratory tract infection

Primary Outcomes

Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

Time: up to 7 days following each dose administration

Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

Time: up to 7 days following each dose administration

Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.

Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

Time: 21 days following dose administration

Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.

Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

Time: 28 days following dose administration

Secondary Outcomes

Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

Time: up to 162 days following dose administration

Description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

Time: up to 162 days following dose administration

Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

Time: up to 162 days following dose administration

Description: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

Measure: For BNT162c2 (SD):

Time: up to 183 days following dose administration

Description: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

Measure: For BNT162c2 (SD):

Time: up to 183 days following dose administration

Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

Measure: For BNT162c2 (SD):

Time: up to 183 days following dose administration
49 Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital

COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.

NCT04381338
Conditions
  1. Corona Virus Disease 19 (COVID-19)
  2. COVID
  3. Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
  4. Critical Illness
Interventions
  1. Other: Pulmonary and Motor Rehabilitation
MeSH:Virus Diseases Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Critical Illness

Primary Outcomes

Description: days of ICU stay

Measure: Length of ICU stay

Time: up to 60 days

Secondary Outcomes

Description: days of hospital stay

Measure: Length of hospital stay

Time: up to 90 days
50 Hypertonic Saline Nasal Irrigation and Gargling for Suspected or Confirmed COVID-19: Pragmatic Web-based Bayesian Adaptive Randomised Controlled Trial (ELVIS COVID-19)

ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.

NCT04382131
Conditions
  1. Upper Respiratory Tract Infections
  2. Virus
  3. COVID
  4. Virus Shedding
  5. Virus Diseases
Interventions
  1. Other: NaCl Solution
MeSH:Respiratory Tract Infections Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: Time until participant reports well

Measure: Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'.

Time: Maximum of 14 days

Secondary Outcomes

Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

Measure: Severity of all symptoms

Time: 1-14 days or until the participant reports that they are well

Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

Measure: The length of time for individual symptoms to resolve

Time: 1-14 days or until the participant reports that they are well

Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

Measure: Severity of individual symptoms

Time: 1-14 days or until the participant reports that they are well

Description: Number of participants and frequency of contacts

Measure: Contacting healthcare (NHS 24, OOH, GP)

Time: 1-14 days or until the participant reports that they are well

Description: Number of participants and frequency of contacts

Measure: Participants needing GP appointments

Time: 1-14 days or until the participant reports that they are well

Description: Number of participants

Measure: Participants attending hospital

Time: 1-14 days or until the participant reports that they are well

Description: Number of days

Measure: Length of stay in hospital if admitted

Time: 1-14 days or until the participant reports that they are well

Description: Number of participants

Measure: Number of participants reporting over the counter medication use

Time: 1-14 days or until the participant reports that they are well

Description: Number of people within participant's household who develop symptoms

Measure: Reduction in transmission to household contacts

Time: 1-14 days or until the participant reports that they are well

Description: Number of participants in intervention arm reporting side effects

Measure: Number of participants reporting side effects of nasal irrigation

Time: 1-14 days or until the participant reports that they are well

Description: Participants asked if they have experienced common side effects or other and to rate the severity on a 7 point scale of 'Did not have this side effect' to 'severe'

Measure: Types and severity of side effects reported

Time: 1-14 days or until the participant reports that they are well

Description: Estimated cost requested when participant states over the counter medication used

Measure: Cost of over the counter medication used

Time: 1-14 days or until the participant reports that they are well
51 Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19

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

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

Primary Outcomes

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

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

Time: 14 days

Secondary Outcomes

Description: Mortality 28 days after randomization

Measure: Mortality 28 days after randomization

Time: 28 days
52 Covid-19 and Prevention of Malnutrition After Confinement by Dentists: Prospective Study Among 100 Adults Received in Dental Consultation at Nice University Hospital and Sent to Their Physician for Assessment and Nutritional Care

Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:

NCT04386460
Conditions
  1. Nutrition Poor
  2. Infection Viral
  3. Oral Disease
MeSH:Virus Diseases Malnutrition
HPO:Malnutrition

Primary Outcomes

Description: Body Mass Index evolution from baseline

Measure: Body Mass Index

Time: 1 Month

Description: Body Mass Index evolution from baseline

Measure: Body Mass Index

Time: 3 Months

Secondary Outcomes

Description: Usual weight at baseline vs weight before confinement (gk)

Measure: Weight changes during confinement

Time: 8 weeks

Description: number and type of nutritional supplements from baseline

Measure: prescription of nutritional supplements and observance

Time: 3 months
53 Investigating Anosmia and Ageusia in COVID-19 Adult Patients in Saudi Arabia

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

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

Primary Outcomes

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

Measure: correlation of anosmia and ageusia to covid19 positive patients

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

Secondary Outcomes

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

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

Time: from 1/06/2020 to 31/12/2020
54 Anti-inflammatory Clarithromycin to Improve SARS-CoV-2 (COVID-19) Infection Early: The ACHIEVE Open-label Non-randomized Clinical Trial

Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.

NCT04398004
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Corona Virus Infection
Interventions
  1. Drug: Clarithromycin
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.

Measure: Clinical outcome negative for two parameters(hospital admission/disease progression)

Time: Day 1 to Day 8

Description: This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).

Measure: At least 50% change of the score of respiratory symptoms from the baseline

Time: Day 1 to Day 8

Secondary Outcomes

Description: Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database

Time: Day 1 to Day 8

Description: Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).

Measure: Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database

Time: Day 1 to Day 8

Description: Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.

Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4

Time: Day 4

Description: This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).

Measure: At least 50% change of the score of respiratory symptoms from the baseline on day 4

Time: Day 4

Description: Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following pO2/FiO2 less than 150 Need for mechanical or non-mechanical ventilation (CPAP)

Measure: Range of development of severe respiratory failure

Time: Day 1 to Day 14

Description: Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.

Measure: Range of hospital readmission until day 14

Time: Day 1 to Day 14

Description: Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8

Measure: Change of viral load in respiratory secretions from baseline on day 8

Time: Day 1 to Day 8

Description: Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of function of monocytes at days 1 and 8

Time: Day 1 to Day 8

Description: Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.

Measure: Change of function of Th1 cells at days 1 and 8

Time: Day 1 to Day 8

Description: Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.

Measure: Change of function of Th2 cells at days 1 and 8

Time: Day 1 to Day 8

Description: Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8

Time: Day 1 to day 8

Description: Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8

Time: Day 1 to day 8

Description: Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of serum human beta defensin-2 (hBD-2) between days 1 and 8

Time: Day 1 to day 8

Description: Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8

Time: Day 1 to day 8

Description: Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8

Time: Day 1 to day 8

Description: Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection

Measure: Change of the IL-10/TNFα ratio between days 1 and 8

Time: Day 1 to Day 8
55 Searching for SARS-CoV 2 in Personal Protective Equipment in Physicians in a University Hospital

SARS-CoV-2 transmission is frequently occurring in hospital settings, with numerous reported cases of nosocomial transmission highlighting the vulnerability of healthcare workers. If products proved to be efficacious against COVID-19, why are so many HCW getting COVID-19? Is it related to experience? Is it generated by the exhaustive job? Is there any degree of relationship to stress? These questions are still without fully correct answers. Achieving global benefits for HCW is still waiting.

NCT04398043
Conditions
  1. rt PCR
  2. COVID
  3. Personal Protective Equipment PPE
  4. SARS-CoV 2
  5. Health Personnel Attitude
  6. Virus Diseases
MeSH:Virus Diseases

Primary Outcomes

Description: To assess the prevalence of surface contamination with COVID-19 from personal protective equipment (PPE) worn by medical doctors, immediately after evaluating sick patients

Measure: Asses surface contamination personel protective equipment

Time: 2 months

Secondary Outcomes

Description: Quantify the amount of COVID-19 in the PPE doctor´s in contact with infected patients.

Measure: Virus charge cuantification

Time: 2 months

Description: Determine the most frequent location of viruses inPPE

Measure: Place in PPE contamination

Time: 2 month

Other Outcomes

Description: using the information found, carry out tips to reduce the risk of contagion

Measure: Prevention risk advice

Time: 2 month
56 BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19

This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.

NCT04401410
Conditions
  1. SARS-CoV 2
  2. Viral Infection
  3. COVID 19
Interventions
  1. Biological: Dose Finding Phase (MTD)
  2. Biological: Partially HLA-matched SARS-CoVSTs
  3. Other: Routine care (no SARS-CoVSTs)
MeSH:Virus Diseases

Primary Outcomes

Description: Incidence of ≥ Grade 3 acute GvHD; or Grade 2 acute GvHD persisting beyond 14 days.

Measure: Graft versus Host Disease (GvHD)

Time: 14 days post infusion or until treatment toxicity resolves

Description: Incidence of ≥ Grade 3 persisting beyond 72 hours and worsens despite treatment. If the first 2 patients treated at any dose level or any 2 consecutively treated patients that receive VSTs during the randomized phase experience grade ≥ 2 CRS that persists for 7 days or is non-responsive to 2 doses of tocilizumab/Anakinra irrespective of attribution.

Measure: Cytokine Release Syndrome (CRS)

Time: 14 days post infusion or until treatment toxicity resolves

Description: Incidence of ≥ Grade 3 persisting beyond 72 hours and worsens despite treatment. If the first 2 patients treated at any DL or any 2 consecutively treated patients that receive VSTs during the randomized phase experience grade ≥ 2 ICANS that persists for 7 days or is non-responsive to 2 doses of tocilizumab/Anakinra irrespective of attribution.

Measure: Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Time: 14 days or until treatment toxicity resolves

Description: Incidence of any ≥ Grade 3 adverse event related to the T cell product [Treatment-related adverse events (tAE)] within 14 days of the VST infusion and not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.

Measure: Adverse Events

Time: 14 days post infusion or until treatment toxicity resolves

Description: Randomized Trial: Record the daily measurement of clinical response using the WHO Ordinal scale [Scored on a scale from 0 to 8; where 0 = Uninfected and 8 =Dead] or until patient is discharged. The proportion of patients in the treatment arm will be compared to the control arm who have a clinical response by day 7 post-randomization (measured by a decrease in 2 or more points on the WHO scale)

Measure: Clinical Response Assessment: World Health Organization (WHO) Ordinal Scale

Time: 7 Days or at time of hospital discharge
57 COVID-19 Associated Lymphopenia Pathogenesis Study in Blood (CALYPSO)

Background: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done. ...

NCT04401436
Conditions
  1. Corona Virus Disease 2019
MeSH:Virus Diseases Lymphopenia
HPO:Lymphopenia

Primary Outcomes

Description: To characterize lymphopenia and immunologic phenotypes and inflammatory responses including inflammasome responses and coagulopathy in patients with COVID-19.

Measure: Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery.

Time: Throughout the study

Secondary Outcomes

Description: 1. Correlation of lymphopenia, immunologic phenotypes, and inflammatory responses with clinical outcomes. 2. Characterization of complement activation in patients with COVID-19. 3. Evaluation of activationinduced cell death and activated T cell autonomous death through measurement of intracellular reactive oxygen species in monocyte, natural killer (NK), and T cell subsets in peripheral blood and correlation with double stranded (ds)-DNA damage ( >=-H2AX), FAS/FasL, BCL-2, caspase-1 activation, and activation-induced proliferation. 4. Evaluation of homing receptors to lymphoid, skin, and mucosal surfaces on B and T cells and correlate with ACE2, bradykinin, and homing chemokine levels.

Measure: Evaluation of inflammatory pathways that may contribute to COVID-19 disease pathogenesis.

Time: Throughout the study
58 Th1/Th2/Th17/TREG Response and TLRs Activation/KIR Receptors for Predicting the Evolution of the SARS Cov-2 Infected Patients

To ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies

NCT04403061
Conditions
  1. Disease, Viral
  2. Cytokine Release Syndrome
  3. TLRs
Interventions
  1. Diagnostic Test: Cytokines measurement
  2. Diagnostic Test: Cellular response
  3. Diagnostic Test: TLRs activation measurement
  4. Diagnostic Test: KIR phenotype evaluation
MeSH:Virus Diseases

Primary Outcomes

Measure: Changes in cytokines associated with SARS CoV-2 infection

Time: 1 month

Measure: Evaluation of cellular response

Time: 1 month

Measure: TLRs activation

Time: 1 month

Measure: KIR phenotype determination

Time: 1 month
59 Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.

NCT04403100
Conditions
  1. COVID-19
  2. Coronavirus Infection
  3. Virus Disease
  4. Acute Respiratory Infection
  5. SARS-CoV Infection
Interventions
  1. Drug: Hydroxychloroquine Sulfate Tablets
  2. Drug: Lopinavir/ Ritonavir Oral Tablet
  3. Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets
  4. Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)

Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease

Time: Measuring during 28-day period since randomization (Intention to treat analysis)

Measure: Proportion of participants who died due to COVID-19 progression and/ or complications

Time: Measuring during 28-day period since randomization (Intention to treat analysis)

Secondary Outcomes

Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)

Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization

Time: Measuring during 14-day period since randomization

Description: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.

Measure: Time to clinical improvement

Time: Measuring during 28-day period since randomization

Description: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;

Measure: Time to clinical failure

Time: Measuring during 28-day period since randomization

Description: Proportion of participants with hospitalization for any cause

Measure: Hospitalization for any cause

Time: Measuring during 28-day period since randomization

Measure: Proportion of participants who died due to pulmonary complications

Time: Measuring during 28-day period since randomization

Measure: Proportion of participants who died due to cardiovascular complications

Time: Measuring during 28-day period since randomization

Description: Evaluation of adverse events evaluated as associated to any of study arms

Measure: Proportion of participants who presented with adverse events

Time: Measuring during 28-day period since randomization

Description: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.

Measure: Time to improvement on respiratory scale symptoms

Time: Measuring during 28-day period since randomization

Measure: proportion of non-adherent participants to any of study drugs

Time: Measuring during 10-day period since randomization
60 Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA). COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.

NCT04406064
Conditions
  1. Viral Infection
Interventions
  1. Biological: Viral Specific T-cells (VSTs)
MeSH:Virus Diseases

Primary Outcomes

Description: Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.

Measure: Successful production of viral specific T-cells

Time: Within 30 days post culture initiation

Secondary Outcomes

Description: Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay

Measure: Presence of viral-specific T-cells

Time: At 30 days after infusion
61 Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19)

In this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 30 seconds, for 4 weeks.

NCT04409873
Conditions
  1. COVID-19
  2. SARS-CoV 2
  3. Severe Acute Respiratory Syndrome Coronavirus 2
  4. Virus Disease
  5. Coronavirus Infections
  6. Pharyngeal Diseases
Interventions
  1. Drug: Oral-B Mouth Sore mouthwash
  2. Drug: Crest Pro-Health Multi-Protection mouthwash
  3. Drug: CloSYS mouthwash
  4. Drug: Distilled water
  5. Drug: Listerine Mouthwash Product
MeSH:Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome Pharyngeal Diseases

Primary Outcomes

Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load

Measure: Change in SARS-Cov-2 viral load

Time: Baseline to 4 weeks

Secondary Outcomes

Description: Change in self-reported (questionnaire) clinical symptom onset. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.

Measure: Change in self-reported clinical symptom onset

Time: Baseline to 4 weeks

Description: Change in healthcare utilization and hospitalization

Measure: Change in healthcare utilization and hospitalization

Time: Baseline to 4 weeks

Other Outcomes

Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers

Measure: Change in SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers

Time: Baseline to 4 weeks

Description: Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.

Measure: Change in self-reported clinical symptom onset in tobacco users, marijuana smokers, or vapers

Time: Baseline to 4 weeks

Description: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers

Measure: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers

Time: Baseline to 4 weeks
62 Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.

NCT04412551
Conditions
  1. Corona Virus Infection
  2. Virus Diseases
  3. Coronaviridae Infections
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections

Primary Outcomes

Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU

Measure: Identification of requirement of mechanical ventilation

Time: 3 weeks

Secondary Outcomes

Description: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU

Measure: Prediction of requirement of mechanical ventilation

Time: 3 weeks

Description: Descriptive assessment of clinical parameters and LUS-score over time

Measure: Association of LUS to clinical parameters

Time: 3 weeks

Description: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19

Measure: Description of findings on LUS

Time: 3 weeks
63 A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial

Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

NCT04414267
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Corona Virus Infection
  4. Coronary Heart Disease
  5. Chronic Obstructive Pulmonary Disease
Interventions
  1. Biological: BCG vaccine
  2. Biological: Placebo
MeSH:Infection Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Heart Diseases Coronary Disease
HPO:Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

Time: Visit 3 (90 +/- 5 days)

Secondary Outcomes

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

Time: Visit 4 (135 +/- 5 days)

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

Time: Visit 5 (180 +/- 5 days)

Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

Measure: Prevalence of IgG/IgM against SARS-CoV-2

Time: Screening Visit and Visit 3 (90 +/- 5 days)

Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

Measure: The impact of new cardiovascular events between the two study groups

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)
64 Knowledge About Covid-19 Infection in Pregnant Women

Covid 19 is a pandemic infection developed in late 2019

NCT04423692
Conditions
  1. Viral Infection
Interventions
  1. Other: labs
MeSH:Infection Communicable Diseases Virus Diseases

Primary Outcomes

Description: The proper knowledge about covid-19

Measure: The number of pregnant women who have knowledge about covid-19

Time: one month
65 Evaluation of Immune Response in COVID-19 Patients

The aim of the project is to evaluate the immunological features of COVID-19 patients. Patients are recruited without any pharmacological treatments restriction. The number of samples is estimated on the basis of feasibility, that means on the maximum number of patients with COVID-19, who are expected to be able to be enrolled by the units involved. Based on the investigators' experience, gained in the onco-immunological field, considering the time and economic resources available, the investigators expect to enroll at least 80 patients.

NCT04438629
Conditions
  1. Allergy and Immunology
  2. Infection Viral
Interventions
  1. Drug: COVID-19 treatment
MeSH:Virus Diseases

Primary Outcomes

Description: Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]

Measure: COVID-19 associated immune disorder

Time: 24 hours

Description: Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]

Measure: COVID-19 associated inflammation

Time: 48 hours

Description: Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)

Measure: Oxygenation

Time: 24 hours

Description: SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab

Measure: Diagnostic of COVID disease composite

Time: On admission of hospital

Secondary Outcomes

Description: Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]

Measure: Changes at the cytokine pattern

Time: 14 Days

Description: Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]

Measure: Changes at circulating immune cell composition

Time: 14 Days

Description: Proportion of patients with Intensive Care Unit Admission requirement

Measure: Intensive Care Unit Admission

Time: Day 7-14

Description: Days of Hospitalization

Measure: Length of hospital stay

Time: Day 7-14

Description: Clinical status assessed according to the World Health Organization guideline

Measure: Clinical Status

Time: Day 7-14

Description: Proportion of death patients at days

Measure: Mortality

Time: Day 7-14
66 Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults

This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.

NCT04441047
Conditions
  1. Virus Diseases
Interventions
  1. Drug: AlloStim
MeSH:Virus Diseases

Primary Outcomes

Description: vaccine events such as fever, rash, abnormal vital signs

Measure: frequency of vaccine events

Time: day 0 to day 28

Description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response

Measure: Proportion of subjects with positive T-cell response

Time: day 0 to 1 year

Description: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B

Measure: Proportion of subjects able to suppress viral propagation

Time: day 0 to 1 year
67 Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients

Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage. The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial. The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone. The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.

NCT04449380
Conditions
  1. COVID-19 Virus Infection
Interventions
  1. Drug: Interferon-ß-1a
  2. Combination Product: Standard of Care (SOC)
MeSH:Virus Diseases

Primary Outcomes

Description: Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)

Measure: Time to negative conversion of SARS-CoV-2 nasopharyngeal swab

Time: From baseline to day 29

Secondary Outcomes

Description: Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale

Measure: Improvement in clinical severity score (a)

Time: Baseline, days 7, 15, 21, 29

Description: Defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital, whichever comes first

Measure: Improvement in clinical severity score (b)

Time: Baseline, days 7, 15, 21, 29

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

Time: From baseline to day 29

Measure: Oxygenation free days in the first 28 days

Time: From baseline to day 29

Measure: Ventilator free days in the first 28 days

Time: From baseline to day 29

Measure: Incidence of new mechanical ventilation use during the trial

Time: From baseline to day 29

Measure: Number of patients transferred to Intensive Care Unit (ICU)

Time: From baseline to day 29

Measure: Mortality rate

Time: From baseline to day 29

Description: Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)

Measure: Changes from baseline in pulmonary computed tomography (CT) imaging severity score

Time: Baseline, day 21; extra follow up at 90 days

Measure: Duration of hospital stay expressed in days

Time: From baseline to day 29

Measure: Viral load measured on plasma with RT-PCR

Time: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29

Other Outcomes

Measure: Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG)

Time: Baseline, day 15

Measure: Antibodies to SARS-CoV-2

Time: Baseline, days 7, 15, 29

Measure: Antibodies to IFN-β1a

Time: Baseline, days 7, 15, 29
68 TARGet Kids! COVID-19 Study of Children and Families

The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research in China suggests that children are no more susceptible to COVID-19 infection than adults and that children with confirmed COVID-19 have generally presented with milder symptoms. However, the impact of COVID-19 among Canadian children remains unclear. The prevalence of COVID-19 in children in Canada is currently unknown and no published research exists regarding the risk factors of COVID-19 in children or its potential long-term health effects on physical health or development. Using TARGet Kids!, Canada's largest children's cohort study with over 11,000 children involved, the researchers will conduct a longitudinal observational study aimed to evaluate the cumulative incidence of COVID-19 in children and parents; differences among infected and uninfected children in terms of age, sex, and income; risk factors of COVID-19; and longer term health effects of COVID-19 among children. Given the rapid spread of COVID-19 and the unknown health effects of the virus in children, research must be conducted to determine the extent of infections of COVID-19 in children, disease severity, risk factors for infection, and how the virus affects children as they become older.

NCT04449978
Conditions
  1. Coronavirus
  2. COVID-19
  3. Virus
  4. Family and Household
  5. Infection Viral
MeSH:Virus Diseases

Primary Outcomes

Description: To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada

Measure: Cumulative Incidence of COVID-19

Time: 12 months

Secondary Outcomes

Description: To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions

Measure: Risk Factors for COVID-19

Time: 12 months

Description: To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.

Measure: Parent-reported probable case definition of COVID-19

Time: 12 months

Description: To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.

Measure: Dynamics of COVID-19

Time: 12 months

Description: To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.

Measure: Risk to family members

Time: 12 months

Description: To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents

Measure: Severity of COVID-19

Time: 12 months

Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health

Measure: Longer term effects of COVID-19 on physical health

Time: 12 months

Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health

Measure: Longer term effects of COVID-19 on mental health

Time: 12 months

Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on child development

Measure: Longer term effects of COVID-19 on child development

Time: 12 months

Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning

Measure: Longer term effects of COVID-19 on family functioning

Time: 12 months

Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours

Measure: Longer term effects of COVID-19 on health behaviours

Time: 12 months

Description: To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization

Measure: Longer term effects of COVID-19 on healthcare utilization

Time: 12 months

Description: To determine the effect of preventive measures on COVID-19 infection

Measure: Effects of preventive measures on infection

Time: 12 months

Description: To determine the effect of preventive measures on physical health

Measure: Effects of preventive measures on physical health

Time: 12 months

Description: To determine the effect of preventive measures on mental health

Measure: Effects of preventive measures on mental health

Time: 12 months

Description: To determine the effect of preventive measures on child development

Measure: Effects of preventive measures on child development

Time: 12 months

Description: To determine the effect of preventive measures on family functioning

Measure: Effects of preventive measures on family functioning

Time: 12 months

Description: To determine the effect of preventive measures on health behaviours

Measure: Effects of preventive measures on health behaviours

Time: 12 months

Description: To determine the effect of preventive measures on healthcare utilization

Measure: Effects of preventive measures on healthcare utilization

Time: 12 months
69 Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoC-2 Virus Infection (COVID-19). A Pilot, Randomized, Simple Blind, Placebo-controlled, Parallel-group Study

Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.

NCT04463264
Conditions
  1. COVID-19
Interventions
  1. Drug: Nitazoxanide
  2. Drug: Placebo
MeSH:Infection Virus Diseases

Primary Outcomes

Description: Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo. Extraction of genomic material will be performed using a QIAgen mini kit (QIAmp viral RNA) validated by the CDC (United States Center for Disease Control and Prevention (https://www.fda.gov/media/134922/download) (CDC-006-00019) Viral load will be quantified with the following detection kits: Commercial Kit: PCR-EUA-CDC-nCoV-IFU. Commercial KIT SENTINEL - STAT-NAT Covid 19B (Berlín). Rational: In mild cases of COVID-19, 50% of the patients eradicated the virus within a period of 3 weeks, 25% eradicated the virus before the 13th day, 75% during the first month and the rest were " late eradicators." This latter subgroup of patients has been associated with severe cases of COVID-19 disease.

Measure: Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th.

Time: 7 day

Secondary Outcomes

Description: Consequently, in mild cases, viral eradication will likely occur more frequently during the first to second week of COVID-19 disease; less than 15% could eradicate the virus during the first week of symptom onset. From an epidemiological point of view, increasing the viral eradication rate from less than 15% to more than 35% during the first two weeks of treatment would be clinically relevant.(seven), 14 (fourteen) and 35 (thirty-five) after starting treatment compared to the baseline measurement.

Measure: Comparative decrease of the viral load

Time: 3 - 35 days

Description: Clinical improvement according to the WHO COVID-19 ordinal scale. Minimun 0 (zero), (best), maximum 8 (eight) (worst)

Measure: Clinical improvement

Time: 1 - 35 days

Description: Percentage of pneumonia patients meeting severity criteria.

Measure: Pneumonia patients meeting severity criteria.

Time: 1 - 35 days

Description: Number of days with fever (axillary temperature higher than 37.5°C).

Measure: Number of days with fever

Time: 1 - 35 days

Other Outcomes

Description: Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.

Measure: Patients requiring mechanical ventilation

Time: 1 - 35 days

Description: Mortality rate.

Measure: Mortality rate.

Time: 1- 35 days

Description: Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).

Measure: Lymphocyte recovery

Time: 7 day

Description: Days of ICU hospitalization.

Measure: ICU hospitalization.

Time: 1 - 35 days

Description: Oxygen saturation (SpO2) > 92% (at ambient FiO2).

Measure: Oxygen saturation

Time: 1 - 35 days

Description: Days of hospitalization

Measure: Days of hospitalization

Time: 1 - 35 days

Description: Respiratory rate per minute (in afebrile state conditions).

Measure: Respiratory rate

Time: 1 - 35 days
70 Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients

NCT04476979
Conditions
  1. Coronavirus Infection
  2. SARS (Severe Acute Respiratory Syndrome)
  3. Virus Diseases
  4. Coronaviridae Infections
  5. Nidovirales Infections
  6. RNA Virus Infections
  7. Respiratory Tract Infections
  8. Respiratory Tract Disease
Interventions
  1. Drug: Tocilizumab
  2. Drug: Dexamethasone
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Nidovirales Infections Respiratory Tract Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.

Measure: Survival without needs of ventilator utilization at day 14

Time: day 14

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: WHO progression scale at day 7 and 14

Time: day 7 and day 14

Description: Overall survival

Measure: Overall survival at 14, 28, 60 and 90 days

Time: 14, 28, 60 and 90 days

Description: Cumulative incidence of discharge alive

Measure: Cumulative incidence of discharge alive at 14 and 28 days

Time: 14 and 28 days

Description: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of mechanical ventilation at day 1

Time: day 1

Description: Cumulative incidence of oxygen supply independency

Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days

Time: 14 and 28 days
71 Laparoscopic Bariatric Surgery During Phase 2-3 Covid-19 Pandemic in Italy: a Multicenter, Prospective, Observational Study.

The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.

NCT04480034
Conditions
  1. Bariatric Surgery Candidate
  2. Covid19
  3. Complication of Surg
  4. Complication of Surgical Procedure
  5. Pneumonia, Viral
  6. Viral Infection
  7. Obesity, Morbid
  8. Safety Issues
  9. Readmission
Interventions
  1. Procedure: Bariatric procedures
MeSH:Virus Diseases Pneumonia, Viral Pneumonia Obesity Obesity, Morbid
HPO:Obesity Pneumonia

Primary Outcomes

Description: Postbariatric surgery COVID-19 infection, mortality and complications

Measure: Postoperative COVID-19 infection

Time: 30 postoperative days

Secondary Outcomes

Description: Complications, reoperations for any reason related to bariatric surgery.

Measure: Complications related to bariatric surgery

Time: 30 postoperative days
72 A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers

The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.

NCT04480333
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. Severe Acute Respiratory Syndrome
  4. Severe Acute Respiratory Infection
  5. Severe Acute Respiratory Syndrome (SARS) Pneumonia
  6. Severe Acute Respiratory Syndrome of Upper Respiratory Tract
  7. Neurodegeneration
  8. Neuroinflammatory Response
Interventions
  1. Drug: Drug: NA-831 - 0.10 mg/kg
  2. Drug: Placebo- 0.10 mg/kg
  3. Drug: Drug: NA-831 - 0.20 mg/kg
  4. Drug: Placebo- 0.20 mg/kg
  5. Drug: Drug: GS-5734 - 1.00 mg/kg
  6. Drug: Placebo- 1.00 mg/kg
  7. Drug: Drug: GS-5734 - 2.00 mg/kg
  8. Drug: Placebo- 2.00 mg/kg
  9. Combination Product: Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)
  10. Combination Product: Placebo 0.10 mg + 1.00 mg/kg
  11. Combination Product: Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)
  12. Combination Product: Placebo 0.20 mg + 2.00 mg/kg
MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Nerve Degeneration
HPO:Neurodegeneration Pneumonia Respiratory tract infection

Primary Outcomes

Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events

Time: First dose date up to Day 30 Follow-up Assessment

Description: This will be assessed at various time points by clinical laboratory tests and vital signs.

Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities

Time: First dose date up to Day 30 Follow-up Assessment

Secondary Outcomes

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.

Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum

Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734

Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734

Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞)

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.

Measure: Half-Life (t1/2) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.

Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment

Time: 7 days

Description: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.

Measure: Clearance [CL] - Pharmacokinetic Assessment

Time: 7 days
73 Study of the COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector in 3 French Regions Facing the COVID-19 Epidemic With Varying Degrees of Intensity

Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers. This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate. Since june 2020, all staff in French health establishments could benefit a serological test. Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.

NCT04481529
Conditions
  1. Infection Viral
Interventions
  1. Other: Health Questionnaire
MeSH:Virus Diseases

Primary Outcomes

Description: Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver).

Measure: Number of subjects with a COVID-19 seroconversion

Time: through study completion, an average of 5 month
74 The Role of Vitamin D in Mitigating COVID-19 Infection Severity: Focusing on Reducing Health Disparities in South Carolina

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.

NCT04482673
Conditions
  1. COVID-19
  2. Vitamin D Deficiency
  3. Respiratory Viral Infection
Interventions
  1. Drug: Daily Vitamin D3
  2. Drug: Daily placebo
  3. Drug: Bolus vitamin D3
  4. Drug: Bolus placebo
MeSH:Infection Communicable Diseases Virus Diseases Vitamin D Deficiency
HPO:Low levels of vitamin D

Primary Outcomes

Description: metabolite of vitamin D

Measure: Change in total circulating 25(OH)D concentration

Time: monthly in COVID-19 negative participants through study completion for 1 year

Description: metabolite of vitamin D

Measure: Change in total circulating 25(OH)D concentration in COVID-19 positives

Time: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participants

Description: The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.

Measure: Change in SARS-CoV-2 antibody titers

Time: every 3 months up to 12 months

Secondary Outcomes

Description: At baseline, 3, 6, 9 and 12 months, inflammatory cytokines will be measured in participant plasma samples. Cytokines to be measured are Interferon-gamma (IFN-g), Interleukin-1beta (IL-1B), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13, and Tumor Necrosis Factor-alpha (TNFa). Values of these cytokines at baseline will compared to those at 3, 6, 9, and 12 months

Measure: Change in inflammatory cytokine concentration (10 cytokine panel Elisa: Interferon (INF)-gamma, Interleukin (IL)-1beta, IL-2, IL-3, IL-4, IL-6, IL-8, IL-10, IL-13, Tumor Necrosis Factor (TNF)-alpha

Time: baseline and every 3 months up to 12 months

Description: COVID-19 positive participants or if COVID-19 negatives develop respiratory symptoms will complete this respiratory survey daily for 2 weeks

Measure: Respiratory symptoms

Time: daily for 2 weeks

Description: Inventory of signs and symptoms of rhino/sinusitis. These signs include sneezing, running nose, cough, dizziness, fatigue, and sense of smell. Each sign is rated on a scale of 0 to 5, with 0 indicating not problem, for instance 1 indicating mild problem, 4 indicating severe problem and 5 indicating problem as bad as it can be.

Measure: Signs and symptoms of rhino/sinusitis

Time: Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positives

Description: Dietary intake assessment

Measure: NCI Dietary Intake

Time: baseline then at 6 and 12 months

Description: Survey of participant health problems

Measure: Charlson Comorbidity survey

Time: baseline then at 6 and 12 months

Description: Assessment of physical activity of each participant

Measure: Paffenberger Physical Activity Assessment

Time: Baseline then at 6 and 12 months

Description: Each participant will complete the Perceived Stress Scale Questionnaire (PSS) to assess their perceived stress. Assessments are base on a scale of 0 to 4, with 0 indicating "never" and 4 indicating "very often"

Measure: Perceived stress

Time: monthly for 1 year

Description: Each participant will complete the and Pandemic Stress Index Questionnaire (PSI) to assess their perceived stress cause by the pandemic. Assessments are base on a scale of 0 to 6, with 0 indicating "not at all" and 5 indicating "extremely," and 6 indicating "decline to answer."

Measure: Pandemic stress

Time: monthly for 1 year

Description: Personality characteristics of each participant

Measure: NEO-Personality Inventory

Time: baseline visit

Description: A health assessment will be completed by each participant monthly for 1year. This health. This is for information on health status only and not for comparative assessment.

Measure: GrassrootsHealth Monthly Health assessment

Time: baseline, 6, and 12 months
75 An Open Label, Multicenter, Randomized, Controlled, Clinical Study to Evaluate the Efficacy and Safety of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets Compared With Standard Treatment Protocol in the Treatment of Mild to Moderate COVID-19 Patients.

While novel drug discovery and vaccine studies are time taking process, re-purposing old drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical, pharmacokinetic, pharmacodynamic, and toxicity profiles, which can rapidly enter Phase 3 or 4 or can be used directly in clinical settings. Immunofree has many of the herbs which have been evaluated by other trials published for Covid-19 treatment. The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a combination of polyherbal mixture. The components of this formulation are known for their anti-viral and immunomodulatory effects. Also, Reginmune, owing to its immunomodulatory effect might help in easing the symptoms and decrease the viral load.

NCT04494204
Conditions
  1. Treatment of Covid-19 Virus Infection
Interventions
  1. Combination Product: Immunofree tablets and Reginmune capsule
MeSH:Virus Diseases

Primary Outcomes

Description: This includes overall time it takes for negative covid-19 results, improvement based on a customized questionnaire for fever, cough, body ache, loss of taste or smell, or other similar conditions

Measure: Time (Days) to clinical improvement from study enrollment

Time: Day 0 - Day 10

Secondary Outcomes

Description: Being an important part, each patient has to be monitored for oxygen saturation level, and this would help us analyze when a subject enters from Mild to moderate stage

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

Time: Day 0, Day 5±1 and Day of discharge i.e Day 10±1

Description: D Dimer levels has to be measured to study the D dimer levels of the patient as most researchers claiming covid-19 to be relative to coagulation. This study will help us identity the same.

Measure: Value of coagulation indicators

Time: Day 0, Day 5±1 and Day of discharge i.e Day 10±1

Description: via ICMR recognized RT-PCR to identify when a patient is coronavirusfree

Measure: Time to first negative SARS-CoV-2 PCR in NP swab

Time: Day 0, Day 5±1 and Day of discharge i.e Day 10±1

Description: To identify how long a patient needs oxygen therapy in certain case

Measure: Duration of oxygen therapy

Time: upto day 10+1

Description: This is considered as a part of pharmacovigilance, as how many people enters moderate to severe case, if any

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

Time: upto day 10+1

Description: most mild cases that becomes asymptomatic are sent back from hospital and treated at home quarantine. this is to identify when a patient becomes asymptomatic

Measure: Duration of hospitalization

Time: upto day 10+1
76 Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85

Parallel group, Wait-list design, with treatment delayed for 3 months. Participants will be randomized on a 1:1 ratio with 500 participants per group in Australia. Group 1: Wait-list control. One capsule OM85 (7.0 mg) will be given daily for 3 months, commencing in Month 3, with 3 months follow-up off treatment. Group 2: Initial treatment. One capsule OM85 (7.0 mg) will be given daily for 3 months, commencing on day 0, with 3 months follow-up off treatment.

NCT04496245
Conditions
  1. Respiratory Viral Infection
  2. Covid19
Interventions
  1. Drug: Broncho-Vaxom®
MeSH:Virus Diseases

Primary Outcomes

Description: The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 3 months.

Measure: Acute Respiratory Infection necessitating workforce removal

Time: 3 months

Secondary Outcomes

Description: The time to the first ARI necessitating workforce removal in the initial treatment and wait-list control groups.

Measure: Time to ARI necessitating workforce removal.

Time: 12 months

Description: The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 6 and 12 months

Measure: The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal

Time: 12 months

Description: The proportion of HCW in the initial treatment and wait-list control group with Cov infection documented by molecular techniques of seroconversion

Measure: The proportion of HCW with documented Cov infection.

Time: 12 months

Description: The time to the first LRI necessitating workforce removal in the initial treatment and wait-list control groups.

Measure: Time to Lower respiratory infection (LRI) necessitating workforce removal.

Time: 12 months

Description: The proportion of Health Care Workers contracting LRI necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 3, 6 and 12 months

Measure: The proportion of Health Care Workers contracting a LRI necessitating workforce removal

Time: 12 months

Description: The proportion of HCW in the initial treatment and wait-list control group with LRI due to Cov infection documented by molecular techniques of seroconversion

Measure: The proportion of HCW with documented Cov LRI.

Time: 12 months
77 Evaluation of Newborns Presenting With Suspected COVID 19: A Single Center Experience

This study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission

NCT04519307
Conditions
  1. Viral Infection
MeSH:Infection Virus Diseases

Primary Outcomes

Description: Demographical characteristics will be recorded

Measure: General Characteristics of the infants with respiratory infection at the NICU admission

Time: 5 months
78 Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents: A Randomized, Doubled-Blinded, Comparative Group Observational Study

The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.

NCT04523246
Conditions
  1. Herpes Zoster
  2. Allergy and Immunology
  3. Corona Virus Infection
Interventions
  1. Biological: SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)
  2. Drug: Normal Saline
MeSH:Virus Diseases Herpes Zoster Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.

Measure: Evidenced of active and trained innate immunity

Time: Day 61 and 90 (post vaccination)

Secondary Outcomes

Description: cases ( nasal swab for viral antigen and antibody testing), symptoms (symptom checklist), hospitalizations (MDS 3.0 report/chart reviews) and deaths (MDS 3.0 report/chart reviews) associated with flu, pneumonia, and COVID-19.

Measure: Respiratory Disease Severity (6 month)

Time: Days 90 through 180
79 Is Respiratory Syncytial Virus Infection More Dangerous Than Covid 19 in the Neonatal Period?

Investigators aimed to compare clinical and radiographic markers between SARS-CoV-2 positive and RSV positive infants

NCT04531735
Conditions
  1. RSV Infection
  2. Covid19
MeSH:Infection Communicable Diseases Virus Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

Description: Total neonatal intensive care duration, total duration of oxygen supplement

Measure: Oxygen status and evaluation of neonatal intensive care stay

Time: 3 months
80 Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth

This QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.

NCT04532411
Conditions
  1. SARS-CoV Infection
  2. Respiratory Viral Infection
  3. Personal Protective Equipment
  4. Covid19
Interventions
  1. Other: Personal Protective Testing Booth
MeSH:Infection Communicable Diseases Virus Dis Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Testing Throughput After Hexapod Implementation

Time: Up to 22 weeks

Description: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

Measure: Change in Isolation Gowns Utilized After Hexapod Utilization

Time: Up to 22 weeks

Description: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.

Measure: Change in Cost per Test After Hexapod Implementation

Time: Up to 22 weeks

Description: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.

Measure: Return on Investment

Time: Up to 22 weeks

Secondary Outcomes

Description: The difference in median shift salaries before and after Hexapod implementation will be calculated.

Measure: Change in Testing Personnel Cost Per Test

Time: Up to 22 weeks

Description: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.

Measure: Change in Cost of Isolation Gowns Utilized

Time: Up to 22 weeks

Other Outcomes

Description: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.

Measure: Cost of Additional Consumable Supplies Utilized

Time: Up to 22 weeks
81 Study to Investigate if Sucking a Coldamaris Lozenge Elutes Sufficient Iota-carrageenan to Inactivate Usual Common Cold Viruses

Coldamaris lozenges are a medical device containing 10 mg carrageenan/lozenge. The goal of the study is to determine whether the iota-carrageenan content in the saliva of subjects who sucked Coldamaris® lozenges is sufficient to inhibit the replication of 4 of the most common respiratory viruses causing common cold. At least 29 subjects will be screened, in order to get 24 subjects included.

NCT04533906
Conditions
  1. Common Cold
  2. Viral Infection
Interventions
  1. Device: Coldamaris lozenges
MeSH:Virus Diseases Common Cold

Primary Outcomes

Description: The mean iota-carrageenan concentration in saliva during sucking an iota-carrageenan containing lozenge should reach published IC90 values for 2 human rhinoviruses.

Measure: The primary outcome measure is the iota-carrageenan concentration in saliva.

Time: 3 months

Secondary Outcomes

Description: Iota-carrageenan concentration in saliva of subjects should be high enough to inhibit replication of human rhinoviruses, human Coronavirus OC43, human influenzavirus H1N1n, and Coxsackievirus A10.

Measure: The secondary outcome measure is the iota-carrageenan concetration in salvia.

Time: 3 months
82 COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomised Trial; C-SMART Study.

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

NCT04534725
Conditions
  1. Cancer
  2. Covid19
  3. Respiratory Viral Infection
Interventions
  1. Drug: Interferon alfa
  2. Drug: Selinexor
  3. Drug: Lenzilumab
MeSH:Virus Diseases

Primary Outcomes

Description: Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19 (COVID-19 confirmed by qPCR from respiratory swab)

Measure: Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19 (COVID-19 confirmed by qPCR from respiratory swab)

Time: 3 months from baseline.

Description: incidence of any upper or lower community acquired respiratory viral infection (define as identification of respiratory viruses such as coronavirus other than SARS-CoV-2, influenza, parainfluenza, respiratory syncytial virus, rhinovirus, adenovirus, human metapneumovirus). assessed using local standard of care testing (e.g. respiratory swabs, saliva and/or blood)

Measure: incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing

Time: 3 months from baseline.

Description: incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab .

Measure: incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab .

Time: 28 days from baseline

Description: incidence of any upper or lower community acquired respiratory viral infection (define as identification of respiratory viruses such as coronavirus other than SARS-CoV-2, influenza, parainfluenza, respiratory syncytial virus, rhinovirus, adenovirus, human metapneumovirus). Assessed using local standard of care testing (e.g. respiratory swabs, saliva and/or blood)

Measure: incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing

Time: 28 days from baseline

Description: composite outcome: incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records

Measure: incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records

Time: 60 days from baseline

Description: time to clinical improvement (defined as a two point reduction in clinical progress ordinal scale) or discharge from hospital, whichever occurs first. assessed using medical records

Measure: time to clinical improvement or discharge from hospital assessed using medical records

Time: 28 days from baseline

Secondary Outcomes

Description: ARM 1, secondary endpoint 1 Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. (composite either COVID-19 or other respiratory viral infection). assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.

Measure: ARM 1: Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. Assessed using patient symptom Diary PRO tool

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 2 Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records

Measure: ARM 1: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 3. Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records

Measure: ARM 1: Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 4 Illness severity in case of confirmed COVID-19 diagnosed during the study period, defined as the maximal score on the World Health Organization (WHO)'s clinical progression scale ranging from 0 (uninfected) to 10 (death)

Measure: ARM 1: Illness severity in case of confirmed COVID-19 diagnosed during the study period using WHO clinical progression scale

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 5 Incidence of unplanned all-cause hospital admission during the study period. Composite measure: duration of hospital stay if outcome met. assessed using medical records

Measure: ARM 1: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 6 Incidence of unplanned infection-related hospital admission during the study period. Composite measure: duration of hospital stay if outcome met. assessed using medical records

Measure: ARM 1: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 7 Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR

Measure: ARM 1: Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 8 Incidence of death from any cause during the study period. assessed using patient medical records

Measure: ARM 1: Incidence of death from any cause during the study period. assessed using patient medical records

Time: 120 days from baseline

Description: ARM 1, secondary endpoint 9 Incidence of testing for COVID-19 during the study period. Composite measure: frequency of testing if outcome is met. assessed using medical records

Measure: ARM 1: Incidence of testing for COVID-19 during the study period. assessed using medical records

Time: 120 days from baseline

Description: ARM 2: secondary outcome 1. Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period (days). assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.

Measure: ARM 2 Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period. assessed with PRO and medical records.

Time: 28 days from baseline

Description: ARM 2: secondary outcome 2. Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records

Measure: ARM 2: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records

Time: 28 days from baseline

Description: ARM 2: secondary outcome 3. Illness severity in case of confirmed COVID-19 diagnosed during the study period, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)

Measure: ARM 2: Illness severity in case of confirmed COVID-19 diagnosed during the study period. assessed using WHO clinical progression scale.

Time: 28 days from baseline

Description: ARM 2: secondary outcome 4. Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.

Measure: ARM 2: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.

Time: 28 days from baseline

Description: ARM 2: secondary outcome 5 Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records

Measure: ARM 2: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records

Time: 28 days from baseline

Description: ARM 2: secondary outcome 6 Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.

Measure: ARM 2: Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.

Time: 28 days from baseline

Description: ARM 2: secondary outcome 7. Incidence of testing for COVID-19 during the study period. Composite measure: frequency of testing if outcome is met. assessed using medical records

Measure: ARM 2: Incidence of testing for COVID-19 during the study period assessed using medical records

Time: 28 days from baseline

Description: ARM 3: secondary outcome 1 Time to clinical improvement defined as Resolution of fever - oral temperature < 38oC for 24 hours without antipyretics AND Respiratory rate < 20 breaths/minute OR Oxygen saturation > 94% on room air OR Hospital discharge assessed using medical records

Measure: ARM 3: Time to clinical improvement assessed using medical records.

Time: 60 days from baseline

Description: ARM 3: secondary outcome 2. Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)

Measure: ARM 3: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale

Time: 60 days from baseline

Description: ARM 3: secondary outcome 3 change to clinical condition assessed with Karnofsky Performance score

Measure: ARM 3: change to clinical condition assessed with Karnofsky Performance score

Time: 60 days from baseline

Description: ARM 3: secondary outcome 4. Time to progression to severe COVID-19, defined by WHO ordinal scale

Measure: ARM 3: Time to progression to severe COVID-19, defined by WHO ordinal scale

Time: 60 days from baseline

Description: ARM 3: secondary outcome 5 Time to all-cause mortality

Measure: ARM 3: Time to all-cause mortality

Time: 60 days from baseline

Description: ARM 3: secondary outcome 6. Duration of hospitalisation. assessed using medical records

Measure: ARM 3:Duration of hospitalisation assessed using medical records

Time: at discharge or day 60 whichever is sooner

Description: ARM 3: secondary outcome 7 Duration of COVID-19 symptoms assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.

Measure: ARM 3: Duration of COVID-19 symptoms assessed using patient reported symptom diary.

Time: 60 days from baseline

Description: ARM 3: secondary outcome 8. Duration of oxygen supplementation (days). assessed using medical records.

Measure: ARM 3: Duration of oxygen supplementation (days). assessed using medical records.

Time: 60 days from baseline

Description: ARM 3: secondary outcome 9 change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)

Measure: ARM 3: change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)

Time: 60 days from baseline

Description: ARM 3: secondary outcome 10. Safety and tolerability of selinexor defined as listing and documentation of frequency and severity of adverse effects. Outcome assessed using any/all of medical records, patient reported, vital signs, ECG, imaging, other investigative procedure as per standard local practice.

Measure: ARM 3: Safety and tolerability of selinexor using relevant medical records

Time: 60 days from baseline

Description: ARM 3: secondary outcome 11. composite outcome: incidence of changes in blood results relevant to clinical improvement. Changes in C-reactive protein (CRP) Changes in ferritin level Changes in lactate dehydrogenase (LDH) level

Measure: ARM 3: incidence of changes in blood results relevant to clinical improvement assessed using medical records

Time: 60 days from baseline

Description: ARM 4: secondary outcome 1 Incidence of all cause death by day 28 and 60 assessed using medical records

Measure: ARM 4: Incidence of all cause death by day 28 and 60

Time: day 28 from baseline and day 60 from baseline

Description: ARM 4: secondary outcome 2 Time to all-cause mortality assessed using medical records

Measure: ARM 4: Time to all-cause mortality

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 3 - composite outcome: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death) Proportion who have recovered (defined as 0-4) Proportion who had 1 point improvement Proportion who had 2 point improvement

Measure: ARM 4: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 4 Incidence of ARDS. assessed using medical records

Measure: ARM 4: Incidence of ARDS assessed using medical records

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 5 incidence of HLH. assessed using medical records

Measure: ARM 4: incidence of HLH. assessed using medical records

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 6 Duration of hospitalisation. assessed using hospital medical records.

Measure: ARM 4: Duration of hospitalisation. assessed using hospital medical records.

Time: at discharge or by day 60 whichever is sooner

Description: ARM 4: secondary outcome 7 Proportion discharged from hospital. assessed using medical records

Measure: ARM 4: Proportion discharged from hospital. assessed using medical records

Time: at discharge

Description: ARM 4: secondary outcome 8. Incidence of mechanical ventilation up to day 28. assessed using medical records

Measure: ARM 4: Incidence of mechanical ventilation up to day 28. assessed using medical records

Time: any time up day 28 from baseline

Description: ARM 4: secondary outcome 9 composite outcome: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records

Measure: ARM 4: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 10. composite outcome: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.

Measure: ARM 4: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 11 composite outcome: Incidence and duration of ICU admission. assessed using medical records

Measure: ARM 4: Incidence and duration of ICU admission. assessed using medical records

Time: at discharge or by day 60 from baseline.

Description: ARM 4: secondary outcome 12 composite outcome: incidence and duration of supplemental oxygen use. assessed using medical records

Measure: ARM 4: incidence and duration of supplemental oxygen use. assessed using medical records

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 13. Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours. assessed using medical records

Measure: ARM 4: Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours.

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 14 incidence of non-invasive ventilation. assessed using medical records

Measure: ARM 4: incidence of non-invasive ventilation. assessed using medical records

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 15. composite outcome: number of participants alive and off oxygen at day 60. assessed using medical records.

Measure: ARM 4: number of participants alive and off oxygen at day 60. assessed using medical records.

Time: any time up to 60 days from baseline

Description: ARM 4: secondary outcome 16 proportion of participants who had improved oxygenation for >48 hours. assessed using medical records

Measure: ARM 4: proportion of participants who had improved oxygenation for >48 hours. assessed using medical records

Time: any time up to 28 days from baseline

Description: ARM 4: secondary outcome 17 Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records

Measure: ARM 4: Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records

Time: any time up to day 28 from baseline.

Description: ARM 4: secondary outcome 18 incidence of SAEs based on NCI CTCAE v5 assessed using medical records

Measure: ARM 4: incidence of SAEs based on NCI CTCAE v5 assessed using medical records

Time: any time up to 28 days from baseline.

Description: ARM 4: secondary outcome 19 change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.

Measure: ARM 4: change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.

Time: any time up to day 60 from baseline
83 A Phase 1b, 2-Part, Double-blind, Placebo-controlled, Sponsor-open Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending (24-hour, Part 1) and Extended (120-hour, Part 2) Intravenous Infusions of PF-07304814 in Hospitalized Participants With Mild to Moderate COVID-19

It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients with SARS-CoV-2 virus infection and with mild-to-moderate symptoms.

NCT04535167
Conditions
  1. Viral Disease
Interventions
  1. Drug: PF-07304814
  2. Drug: Placebo
MeSH:Virus Diseases

Primary Outcomes

Description: Adverse Events (AEs)

Measure: Frequency of treatment-emergent adverse events (TEAEs)

Time: 0 hours up to 41 days

Description: Adverse Events

Measure: Number of participants who withdraw due to treatment-emergent adverse events (TEAEs)

Time: 0 hours up to 41 days

Description: Adverse Events

Measure: Frequency of treatment-emergent adverse events (TEAEs), causally related to study intervention

Time: 0 hours up to 41 days

Description: Serious Adverse Events

Measure: Frequency of treatment-emergent serious adverse events

Time: 0 hours up to 41 days

Description: Adverse Events

Measure: Frequency of treatment-emergent infusion site reactions

Time: 0 hours up to 41 days

Description: Percent change in laboratory parameters

Measure: Magnitude of abnormal hematologic laboratory findings

Time: 0 hours up to 41 days

Description: Adverse Events

Measure: Frequency of abnormal chemistry values

Time: 0 hours up to 41 days

Description: Adverse Events

Measure: Frequency of abnormal hematologic laboratory findings

Time: 0 hours up to 41 days

Description: Percent change in urinalysis parameters

Measure: Magnitude of abnormal urinalysis findings

Time: 0 hours up to 41 days

Description: ECG parameters

Measure: Change from baseline in PR values

Time: 0 hours up to 41 days

Description: ECG parameters

Measure: Change from baseline in RR values

Time: 0 hours up to 41 days

Description: ECG parameters

Measure: Change from baseline in QTc values

Time: 0 hours up to 41 days

Description: ECG parameters

Measure: Change from baseline in QTcF values

Time: 0 hours up to 41 days

Description: ECG parameters

Measure: Change from baseline in QRS values

Time: 0 hours up to 41 days

Description: Vital sign measurements

Measure: Change from baseline in pulse rate measurements

Time: 0 hours up to 41 days

Description: Vital sign measurements

Measure: Change from baseline in temperature values

Time: 0 hours up to 41 days

Description: Vital sign measurements

Measure: Change from baseline in respiratory rate values

Time: 0 hours up to 41 days

Description: Vital sign measurements

Measure: Change from baseline in systolic blood pressure

Time: 0 hours up to 41 days

Description: Vital sign measurements

Measure: Change from baseline in diastolic blood pressure

Time: 0 hours up to 41 days

Description: Vital sign measurements

Measure: Change from baseline in pulse oximetry/SpO2 measurement

Time: 0 hours up to 41 days

Secondary Outcomes

Description: plasma PK parameters

Measure: Change in concentration at 24 hours (C24[end of infusion]) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in concentration, dose normalised, at 24 hours (C24 (dn) [end of infusion]) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in concentration at 120 hours (C120[end of infusion]) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in maximum observed concentration (Cmax) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in maximum observed concentration, dose normalised (Cmax [dn]) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in concentration at steady state (Css) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in concentration at steady state, dose normalised (Css [dn]) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in terminal half life (t1/2) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in clearance (CL) of PF-07304814

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in area-under-the-curve plasma concentration from 0 to time extrapolated to infinity (AUCinf) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in area-under-the-curve plasma concentration from 0 to last quantifiable concentration (AUClast) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in area-under-the-curve plasma concentration from 0 to time extrapolated to infinity, dose normalised (AUCinf [dn]) of PF-07304814 and PF-00835231

Time: 0 to 32 hours

Description: plasma PK parameters

Measure: Change in steady state volume of distribution (Vss) of PF-00835231

Time: 0 to 32 hours

Description: urinary PK parameters (Cohort 2 only)

Measure: Cumulative amount of unchanged drug excreted into urine (Ae)

Time: 0 to 36 hours

Description: urinary PK parameters (Cohort 2 only)

Measure: Percent of dose excreted as unchanged drug (Ae%) over dosing period

Time: 0 to 36 hours
84 Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS: a Randomized, Placebo Controlled, Multicenter Trial

The world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.

NCT04536350
Conditions
  1. Covid19
  2. Corona Virus Infection
  3. ARDS
  4. Aviptadil
Interventions
  1. Drug: Aviptadil 67μg
  2. Drug: Placebo 0.9% NaCl solution
MeSH:Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time to clinical improvement of a decrease of at least two points on a seven-point ordinal scale of clinical status or discharged alive from hospital. The seven-point scale consists of the following categories: not hospitalized; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; hospitalized, intubation and mechanical ventilation; ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); death

Measure: time to clinical improvement

Time: Randomization until discharge from hospital but up to maximum 28 days

Secondary Outcomes

Description: Frequency of Patient who need mechanical ventilation during hospital stay

Measure: Frequency of mechanical ventilation

Time: Randomization until discharge from hospital up to maximum 28 days

Measure: Time requiring oxygen supplementation

Time: Randomization until discharge from hospital up to maximum 28 days

Measure: Slope in SaO2

Time: Randomization until discharge from hospital up to maximum 28 days

Measure: Slope in FiO2

Time: Randomization until discharge from hospital but up to maximum 28 days

Measure: Slope in C-reactive Protein

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: Neutrophile ratio

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: lymphocyte ratio

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: Interleukine 6 level

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Measure: Procalcitonin level

Time: measured at baseline, at least every 7 days and at discharge up to maximum 28 days

Description: Frequency of Patient who showed a multi organ dysfunction Syndrome during Hospital stay

Measure: Frequency of Multi organ dysfunction Syndrome (MODS)

Time: Randomization until discharge from hospital up to maximum 28 days

Other Outcomes

Measure: duration of hospitalization in survivors

Time: randomization till discharge of hospital up to 28 days

Measure: Time from treatment initiation to death

Time: Treatment initiation to death up to maximum 28 days

Description: Blood pressure will be assessed daily in mmHg

Measure: Blood pressure

Time: Daily until discharge up to maximum 28 days

Description: Heart rate will be assessed daily in bpm

Measure: Heart rate

Time: Daily until discharge up to maximum 28 days

Description: Respiratory rate will be assessed daily in Counts per minute

Measure: Respiratory rate

Time: Daily until discharge up to maximum 28 days

Description: Body temperature (auricular) will be assessed daily in °C

Measure: Body temperature (auricular) in °C

Time: Daily until discharge up to maximum 28 days

Description: Pulse oximetry will be assessed daily in %

Measure: Pulse oximetry

Time: Daily until discharge up to maximum 28 days

Description: Glasgow Coma Scale will be assessed daily The lowes possible score is 3 = deep coma or death The highest possible score is 15 = Fully awake

Measure: Glasgow Coma Scale

Time: Daily until discharge up to maximum 28 days

Description: Visual analogue scale for dyspnea and cough as patient-related outcome parameter

Measure: Dispnea and caugh

Time: Randomization until discharge from hospital up to maximum 28 days
85 Randomized, Double Blind, Placebo Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Argentine Healthy Population Aged Between 18 and 85 Years

This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.

NCT04560881
Conditions
  1. COVID-19 Virus Infection
Interventions
  1. Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)
  2. Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine
MeSH:Infection Virus Diseases

Primary Outcomes

Description: All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.

Measure: Incidence of COVID-19 cases after two-doses of vaccination

Time: 14 days after the full course of vaccination

Secondary Outcomes

Measure: The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

Time: 14 days after 2-dose of immunization and 28 days after full course of immunization

Measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

Time: 14 days after 2-dose of immunization and 28 days after full course of immunization

Measure: The Geometric Mean Increase (GMI) of anti-SARS-CoV-2 neutralizing antibody

Time: 14 days after 2-dose of immunization and 28 days after full course of immunization

Measure: Incidence of any adverse reactions/events

Time: Within 30 minutes after each dose of vaccine

Measure: Incidence of adverse reactions/events

Time: 0 ~ 21/28 days after each dose of vaccine

Measure: Incidence of serious adverse events (SAE)

Time: From the beginning of the first dose to 12 months after the whole course of immunization

Other Outcomes

Description: The protective level of Anti-SARS-CoV-2 NtAbs

Measure: Anti-SARS-CoV-2 neutralizing antobody (NtAb) (immunological surrogate endpoint)

Time: 14 days after 2-dose of immunization.
86 Corona Virus Infection Among Liver Transplant Recipients: A Multicenter Study

A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020. The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on. Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic. Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm. Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2. The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia. They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases. Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization. Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.

NCT04565782
Conditions
  1. SARS-CoV Infection
  2. Corona Virus Infection
  3. Liver Transplant Recipient
  4. COVID-19
MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: The occurrence of corona virus infection (confirmed or suspected) among liver transplant recipients

Time: 1 month

Secondary Outcomes

Measure: The presence of Neutralizing Ab against SARS-Corona virus 2 among liver transplant recipients whether who give symptoms for corona virus or asymptomatic and who accept to give blood sample

Time: 2 month

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook